Compositions and uses for increasing biometabolism

Abstract

Disclosed herein are compositions and uses for healthy weight management by providing a consumable composition comprising N-trans-caffeoyltyramine and N-transferuloyltyramine. Some embodiments provide for glucose management in a subject. Some embodiments provided include, for example, the consumable composition capable of supporting abdominal fat loss, visceral fat loss, maintaining lean body mass, and supporting normal blood glucose regulation.

Description

BSEED.053WO2 PATENT COMPOSITIONS AND USES FOR INCREASING BIOMETABOLISM BACKGROUND

[0001] An individual’s metabolism plays a crucial role in healthy weight management, serving as an optimal tool for achieving and maintaining a healthy weight. By understanding and optimizing one's metabolic processes, individuals can more effectively regulate their energy balance, which is the key to weight control. This involves the body's ability to convert food into energy, manage nutrient absorption, and eliminate waste. Strategies to enhance metabolism include maintaining a balanced diet rich in nutrients, engaging in regular physical activity to boost metabolic rate, and ensuring adequate rest and recovery. By focusing on these areas, individuals can support their body's natural metabolic functions, leading to more efficient energy use, improved body composition, and overall better health outcomes. SUMMARY OF THE DISCLOSURE

[0002] Aspects of the disclosure relate to methods for healthy weight management in a subject. In some embodiments, the method includes providing to the subject a composition comprising from about 50 mg to about 150 mg N-trans-caffeoyltyramine and N-trans- feruloyltyramine. In some embodiments, the composition comprises about 60 mg N-trans- caffeoyltyramine and N-trans-feruloyltyramine. In some embodiments, the composition comprises about 120 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine. In some embodiments, the composition is in a form of a capsule, gummy, table, functional beverage, and functional food. In some embodiments, the capsule is a sustained release capsule. In some embodiments, providing to the subject the composition provides sustained weight management. In some embodiments, providing to the subject the composition provides visceral and abdominal fat loss. In some embodiments, providing to the subject the composition provides visceral fat loss. In some embodiments, providing to the subject the composition provides abdominal fat loss. In some embodiments, providing to the subject the composition preserves lean body mass. In some embodiments, providing to the subject the composition supports normal blood glucose regulation. In some embodiments, providing to the subject the composition provides glucose level normalization followed by fat loss benefits. In someembodiments, providing to the subject the composition provides normal blood glucose regulation followed by fat loss benefits. In some embodiments, the subject has a BMI ≥ 28.0 kg / m2. In some embodiments, the subject has a Total-C level of ≥ 200 mg / dL. In some embodiments, the subject has a HDL-C level of ≤ 40 mg / dL. In some embodiments, the subject has a triglyceride level of ≥ 150 mg / dL. In some embodiments, the subject has pre-diabetes. In some embodiments, the subject is administered the composition once per day. In some embodiments, the subject is administered the composition for at least 6 six months. In some embodiments, the composition is provided in combination with a dietary regimen designed to enhance the weight management in the subject. In some embodiments, the subject is advised to engage in a physical activity program in conjunction with the administration of the composition. In some embodiments, the composition provides improvement in metabolic rate. In some embodiments, the subject has a waist circumference reduction of at least 5% from baseline after administration of the composition for 3 months. In some embodiments, providing to the subject the composition improves insulin sensitivity. In some embodiments, the composition improves one or more biomarkers associated with inflammation and obesity. In some embodiments, the subject is administered the composition and is further instructed to answer a dietary questionnaire. In some embodiments, the subject is administered the composition before, concurrently, or after taking one or more of the following medical tests: Body Weight, Study Instructions / Query, Chemistry Profile, Urine Pregnancy Test, Lipid Panel, HbA1c, Glucose, Insulin, FGF-21, Archive Plasma / Serum Samples, Randomization, 3D Body Scan, and DEXA Scan. In some embodiments, a treatment outcome comprises a reduction in body fat mass by at least 5% to 15% from baseline measurements, as measured in kilograms (kg) or pounds (lbs). In some embodiments, the method further includes achieving a decrease in body weight of no less than 5% to 20% compared to initial measurements. In some embodiments, a treatment outcome comprises a reduction in visceral fat by a range of 10% to 30% from baseline measurements, quantified in cubic centimeters (cm³) or inches (in³). In some embodiments, a treatment outcome comprises a decrease in abdominal fat by a range of 5% to 25% from baseline measurements. In some embodiments, the method further includes maintaining fat loss within a range of ±3% to ±10% of the achieved reduction in body fat mass. In some embodiments, a treatment outcome comprises achieving controlled blood sugar levelswithin a target range of 70 to 120 milligrams per deciliter (mg / dL) or 3.9 to 6.7 millimoles per liter (mmol / L).

[0003] Aspects of the disclosure relate to a method for fat loss in a subject. In some embodiments, the method includes providing to the subject a composition comprising from about 50 mg to about 150 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine, wherein the N-trans-caffeoyltyramine and the N-trans-feruloyltyramine is in a ratio of 10:1 to 1:10. In some embodiments, the fat loss is visceral fat loss. In some embodiments, the fat loss is abdominal fat loss. In some embodiments, the ratio of N-trans-caffeoyltyramine and N-trans- feruloyltyramine is 5:1 to 1:5. In some embodiments, the composition comprises about 60 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine. In some embodiments, the composition comprises about 120 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine. In some embodiments, providing to the subject the composition provides glucose level normalization followed by fat loss benefits. In some embodiments, providing to the subject the composition provides normal blood glucose regulation followed by fat loss benefits. In some embodiments, the subject has a BMI ≥ 28.0 kg / m2. In some embodiments, the subject maintains lean body mass during fat loss.

[0004] Aspects of the disclosure relate to a method to maintain, support, improve, or regulate healthy blood glucose levels in a subject. In some embodiments, the method includes providing to the subject a composition comprising from about 50 mg to about 150 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine. In some embodiments, the maintaining, supporting, improving, or regulating healthy blood glucose levels in the subject improves glycemic control in the subject. In some embodiments, the maintaining, supporting, improving, or regulating healthy blood glucose levels in the subject reduces fasting blood glucose levels in a human subject with hyperglycemia or prediabetes. In some embodiments, the wherein maintaining, supporting, improving, or regulating healthy blood glucose levels in the subject provides for healthy weight management in the subject. In some embodiments, the providing the composition reduces 24-hour glucose exposure in the subject, wherein the reduction is measured by a decrease in 24-hour AUC or 24-hour mean glucose. In some embodiments, the maintaining, supporting, improving, or regulating healthy blood glucose levels in the subject reduces glucose variability in the subject, wherein glucose variability is reduced as measured by a decrease in Mean Amplitude of Glucose Excursion (MAGE) orMean of Daily Differences (MoDD). In some embodiments, the maintaining, supporting, improving, or regulating healthy blood glucose levels in the subject reduces postprandial glucose levels in a human subject. In some embodiments, the maintaining, supporting, improving, or regulating healthy blood glucose levels in the subject reduces blood glucose levels in the subject without significantly lowering minimum nighttime blood glucose. In some embodiments, the maintaining, supporting, improving, or regulating healthy blood glucose levels in the subject manages hyperglycemia in the subject. In some embodiments, the composition comprises about 60 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine. In some embodiments, the composition comprises about 120 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine. In some embodiments, the composition is formulated as a sustained release formulation. In some embodiments, the composition is formulated for once-daily administration. In some embodiments, the sustained released formulation provides a reduction in glucose variability. In some embodiments, the composition is in a form of a capsule, gummy, table, functional beverage, and functional food. In some embodiments, the capsule is a sustained release capsule. In some embodiments, the providing to the subject the composition provides sustained weight management. In some embodiments, the providing to the subject the composition provides visceral and abdominal fat loss. In some embodiments, the providing to the subject the composition provides visceral fat loss. In some embodiments, the providing to the subject the composition provides abdominal fat loss. In some embodiments, the providing to the subject the composition preserves lean body mass. In some embodiments, the providing to the subject the composition supports normal blood glucose regulation. In some embodiments, the providing to the subject the composition provides glucose level normalization followed by fat loss benefits. In some embodiments, the providing to the subject the composition provides normal blood glucose regulation followed by fat loss benefits. In some embodiments, the subject has a BMI ≥ 28.0 kg / m2. In some embodiments, the subject has a Total-C level of ≥ 200 mg / dL. In some embodiments, the subject has a HDL-C level of ≤ 40 mg / dL. In some embodiments, the subject has a triglyceride level of ≥ 150 mg / dL. In some embodiments, the subject has pre-diabetes. In some embodiments, the providing to the subject the composition comprises administering the composition once per day. In some embodiments, the subject is administered the composition for at least 6 six months. In some embodiments, the composition is provided in combination with a dietary regimen designed to enhance aweight management in the subject. In some embodiments, the subject is advised to engage in a physical activity program in conjunction with the providing of the composition. In some embodiments, the composition provides improvement in metabolic rate. In some embodiments, the subject has a waist circumference reduction of at least 5% from baseline after administration of the composition for 3 months. In some embodiments, the providing to the subject the composition improves insulin sensitivity. In some embodiments, the composition improves one or more biomarkers associated with inflammation and obesity. In some embodiments, the subject is administered the composition and is further instructed to answer a dietary questionnaire. In some embodiments, the subject is administered the composition before, concurrently, or after taking one or more of the following medical tests: Body Weight, Study Instructions / Query, Chemistry Profile, Urine Pregnancy Test, Lipid Panel, HbA1c, Glucose, Insulin, FGF-21, Archive Plasma / Serum Samples, Randomization, 3D Body Scan, and DEXA Scan. In some embodiments, a treatment outcome comprises a reduction in body fat mass by at least 5% to 15% from baseline measurements, as measured in kilograms (kg) or pounds (lbs). In some embodiments, the method further comprises achieving a decrease in body weight of no less than 5% to 20% compared to initial measurements. In some embodiments, a treatment outcome comprises a reduction in visceral fat by a range of 10% to 30% from baseline measurements, quantified in cubic centimeters (cm³) or inches (in³). In some embodiments, a treatment outcome comprises a decrease in abdominal fat by a range of 5% to 25% from baseline measurements. In some embodiments, the method further comprises maintaining fat loss within a range of ±3% to ±10% of the achieved reduction in body fat mass. In some embodiments, a treatment outcome comprises achieving controlled blood sugar levels within a target range of 70 to 120 milligrams per deciliter (mg / dL) or 3.9 to 6.7 millimoles per liter (mmol / L). In some embodiments, the N-trans-caffeoyltyramine and the N-trans-feruloyltyramine is in a ratio of 10:1 to 1:10. In some embodiments, the N-trans- caffeoyltyramine and the N-trans-feruloyltyramine is in a ratio of 5:1 to 1:5. In some embodiments, the subject experiences a reduction in visceral fat mass, waist circumference, hip circumference, HbA1c level, or a combination thereof. In some embodiments, the providing the composition significantly decreases overall total glucose, as measured by 24- hour AUC, 24-hour mean glucose, or both. In some embodiments, the providing the composition results in one or more effects selected from the group consisting of: a decrease intime spent outside of an ideal glucose range, a decrease in basal hyperglycemia, a decrease in peak glucose levels, and a decrease in postprandial glucose levels. BRIEF DESCRIPTION OF THE DRAWINGS

[0005] The features and advantages of the compositions and methods described herein will become apparent from the following description, taken in conjunction with the accompanying drawings. These drawings depict certain aspects of the compositions and methods described in the present application, and thus, are not to be considered limiting. In the drawings, similar reference numbers or symbols typically identify similar components, unless context dictates otherwise. The drawings may not be drawn to scale.

[0006] FIG. 1 illustrates a study design of a randomized, placebo-controlled, parallel study.

[0007] FIG.2 illustrates a study design of a randomized, controlled parallel design with one screening and two test periods with four test visits.

[0008] FIG.3 illustrates a consort diagram.

[0009] FIG.4 are box-plots illustrating the distribution of the change from week 0 body composition measurements.

[0010] FIG.5 is a scatter-plot illustrating the fat mass (kg) interaction plot within sex.

[0011] FIG.6 is a scatter-plot illustrating the fat mass (kg) interaction plot within BMI group.

[0012] FIG.7 is a scatter-plot illustrating the fat mass (kg) interaction plot within glucose group.

[0013] FIG.8 is a scatter-plot illustrating the fat mass (%) interaction plot within sex.

[0014] FIG.9 is a scatter-plot illustrating the fat mass (%) interaction plot within BMI group.

[0015] FIG.10 is a scatter-plot illustrating the fat mass (%) interaction plot within glucose group.

[0016] FIG. 11 is a scatter-plot illustrating android fat mass (kg) interaction plot within sex.

[0017] FIG. 12 is a scatter-plot illustrating android fat mass (kg) interaction plot within BMI group.

[0018] FIG. 13 is a scatter-plot illustrating android fat mass (kg) interaction plot within glucose group.

[0019] FIG. 14 is a scatter-plot illustrating gynoid fat mass (kg) interaction plot within sex.

[0020] FIG. 15 is a scatter-plot illustrating gynoid fat mass (kg) interaction plot within BMI group.

[0021] FIG. 16 is a scatter-plot illustrating gynoid fat mass (kg) interaction plot within glucose group.

[0022] FIG. 17 is a scatter-plot illustrating visceral fat mass (g) interaction plot within sex.

[0023] FIG. 18 is a scatter-plot illustrating visceral fat mass (g) interaction plot within BMI group.

[0024] FIG. 19 is a scatter-plot illustrating visceral fat mass (g) interaction plot within glucose group.

[0025] FIG. 20 are box-plots illustrating distribution of the change from week 0 body circumference measurements.

[0026] FIG.21 is a scatter-plot illustrating waist (cm) interaction plot within sex.

[0027] FIG.22 is a scatter-plot illustrating waist (cm) interaction plot within BMI group.

[0028] FIG. 23 is a scatter-plot illustrating waist (cm) interaction pot within glucose group.

[0029] FIG.24 is a scatter-plot illustrating hip (cm) interaction plot within sex.

[0030] FIG. 25 is a scatter-plot illustrating hip (cm) interaction plot within BMI group.

[0031] FIG. 26 is a scatter-plot illustrating hip (cm) interaction within glucose group.

[0032] FIG.27 is a scatter-plot illustrating chest (cm) interaction plot within sex.

[0033] FIG.28 is a scatter-plot illustrating chest (cm) interaction plot within BMI group.

[0034] FIG. 29 is a scatter-plot illustrating chest (cm) interaction plot within glucose group.

[0035] FIG.30 is a scatter-plot illustrating upper thigh (cm) interaction plot within sex.

[0036] FIG.31 is a scatter-plot illustrating upper thigh (cm) interaction plot within BMI group.

[0037] FIG.32 is a scatter-plot illustrating upper thigh (cm) interaction plot within glucose group.

[0038] FIG.33 is a scatter-plot illustrating bicep (cm) interaction plot within sex.

[0039] FIG.34 is a scatter-plot illustrating bicep (cm) interaction plot within BMI group.

[0040] FIG. 35 is a scatter-plot illustrating bicep (cm) interaction plot within glucose group.

[0041] FIG.36 is a scatter-plot illustrating WHR interaction plot within sex.

[0042] FIG. 37 is a scatter-plot illustrating WHR interaction plot within BMI group.

[0043] FIG. 38 is a scatter-plot illustrating WHR interaction plot within glucose group.

[0044] FIG.39 are box-plots illustrating the distribution of change from baseline in glucose, insulin, and HbA1c.

[0045] FIG.40 are box-plots illustrating the distribution of change from baseline blood pressure measures.

[0046] FIG.41 are box-plots illustrating the distribution of change from week 0 for blood lipids.

[0047] FIG. 42 are box-plots illustrating the distribution of body weight change from baseline.

[0048] FIG.43 are box-plots illustrating the distribution of change from week 0 for SF-36 domain scores.

[0049] FIG.44 are box-plots illustrating the distribution of change from week 0 in FFQ outcomes.

[0050] FIG. 45 are box-plots illustrating the distribution in change from week 0 liver enzymes (ALT and AST).

[0051] FIG.46 is a consort diagram.

[0052] FIG. 47 is a graph illustrating average continuous glucose measured over time for baseline (dashed lines) and after 4 weeks of intervention (solid lines). DETAILED DESCRIPTION

[0053] The present disclosure provides evidence indicating that the compositions disclosed herein along with novel formulations, are particularly beneficial in metabolic health. As disclosed herein, the compounds and formulations may be provided to a subject to help maintain, support, improve, regulate healthy blood glucose levels, abdominal fat loss, and visceral fat loss in a subject. Abdominal and visceral fat are closely associated with various health complications. Furthermore, the compositions unexpectedly contribute to the preservation of lean body mass during weight loss, which positively impacts metabolic health and physical function. The support for glucose regulation is significant, leading to improved glycemic control, decreased mean glucose and Area Under the Curve (AUC), and reduced glucose variability, all of which are important in preventing metabolic disorders.

[0054] This disclosure provides, among other things, the discovery of compositions and uses thereof for providing optimal biometabolism in a subject. As described herein, “biometabolism” refers to one or more bioactives capable of activating a metabolic regulator to promote a healthy body composition. While not wishing to be bound by theory, it is believed that biometabolism is an optimal tool for healthy weight management. Aspects of biometabolism may contain a series of benefits including burning dangerous abdominal and visceral fat, maintaining lean body mass, and supporting normal blood glucose regulation. Compositions

[0055] In some aspects, the composition includes one or more tyramine containing hydroxycinnamic acid amides. In some embodiments, the one or more tyramine containing hydroxycinnamic acid amides is N-trans-caffeoyltyramine (“NCT”). The structure of NCT is represented below:

[0056] In some embodiments, the one or more tyramine containing hydroxycinnamic acid amides is N-trans-feruloyltyramine (“NFT”). The structure of NFT is represented below:

[0057] In some embodiments, the NCT is plant derived. In some embodiments, the NFT is plant derived. Plant derived as used herein refers to sourcing a compound from a plant, and may or may not refer to a pure extract from the plant. In some embodiments, the NCT is produced by a host strain engineered to produce NCT. In some embodiments, the NFT is produced by a host strain engineered to produce NFT.

[0058] In some embodiments, the one or more tyramine containing hydroxycinnamic acid amides is from a recombinant host cell. In some embodiments, the recombinant host cell is a fungal cell, an algal or protist cell, a plant cell, or a bacterial cell. In some embodiments, the fungal cell is a yeast cell selected from the group consisting of Yarrowia, Saccharomyces, Candida, Ashbya, Cyberlindnea, Kluveromyces, Arxula, Xanthophyllomyces, Schizosaccharomyces, Hansenula, Xanthophyllomyces, Lypomyces, Rhodotorula, Rhodosporidiumm, Candida, Cryptococcus or Pichia. In some embodiments, the yeast cell is Yarrowia. In some embodiments, the fungal cell is a Mucor, Mortierella, Fusarium, Sarocladium, Trichosporon or Aspergillus. In some embodiments the algal or protist cell is a Thraustochytrium, Schizochytrium, Aurantiochytrium, Chlorella,Auxenochlorella, Nannochloropsis, Scenedesmus, Tetraselmis, Botryococcus, or Chlamydomonas. In some embodiments, the plant cell is Arabidopsis, Artemisia, Bambusoideae, Catharanthus, Glycine, Medicago, Nicotiana, Oryza, Oryzoideae, Phyllostachys, Physcomitrella, Pooideae, Silybum, Solanum, Taxus, or Vitis vinifera. In some embodiments the bacterial cell is a Rhodococcus or Gordonia. In some embodiments, the recombinant host cell is a bacterial strain, for example E. Coli, or a yeast strain, for example Yarrowia lipolytica. In some embodiments, the compounds may be produced in separate recombinant host cells.

[0059] In some embodiments, the one or more tyramine containing hydroxycinnamic acid amides is provided as a pharmaceutically acceptable salt. The term “pharmaceutically acceptable salt” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to a salt of a compound that does not cause significant irritation to an organism to which it is administered and does not abrogate the biological activity and properties of the compound. In some embodiments, the salt is an acid addition salt of the compound. Pharmaceutical salts can be obtained by reacting a compound with inorganic acids such as hydrohalic acid (e.g., hydrochloric acid or hydrobromic acid), sulfuric acid, nitric acid, and phosphoric acid. Pharmaceutical salts can also be obtained by reacting a compound with an organic acid such as aliphatic or aromatic carboxylic or sulfonic acids, for example formic acid, acetic acid (AcOH), propionic acid, glycolic acid, pyruvic acid, malonic acid, maleic acid, fumaric acid, trifluoroacetic acid (TFA), benzoic acid, cinnamic acid, mandelic acid, succinic acid, lactic acid, malic acid, tartaric acid, citric acid, ascorbic acid, nicotinic acid, methanesulfonic acid, ethanesulfonic acid, p-toluensulfonic acid, salicylic acid, stearic acid, muconic acid, butyric acid, phenylacetic acid, phenylbutyric acid, valproic acid, 1,2-ethanedisulfonic acid, 2-hydroxyethanesulfonic acid, benzenesulfonic acid, 2-naphthalenesulfonic acid, or naphthalenesulfonic acid. Pharmaceutical salts can also be obtained by reacting a compound with a base to form a salt such as an ammonium salt, an alkali metal salt, such as a lithium, sodium or a potassium salt, an alkaline earth metal salt, such as a calcium, magnesium or aluminum salt, a salt of organic bases such as dicyclohexylamine, N- methyl-D-glucamine, tris(hydroxymethyl)methylamine, C1-C7alkylamine, cyclohexylamine, dicyclohexylamine, triethanolamine, ethylenediamine, ethanolamine, diethanolamine,triethanolamine, tromethamine, and salts with amino acids such as arginine and lysine; or a salt of an inorganic base, such as aluminum hydroxide, calcium hydroxide, potassium hydroxide, sodium carbonate, sodium hydroxide, or the like.

[0060] In some embodiments, the composition includes one or more isomers of the one or more tyramine containing hydroxycinnamic acid amides. “Isomer" refers to especially optical isomers (for example essentially pure enantiomers, essentially pure diastereomers, and mixtures thereof) as well as conformation isomers (i.e., isomers that differ only in their angles of at least one chemical bond), position isomers (particularly tautomers), and geometric isomers (e.g., cis-trans isomers).

[0061] In some embodiments, the composition includes one or more salt forms of the one or more tyramine containing hydroxycinnamic acid amides. A salt of a compound of this disclosure refers to a compound that possesses the desired pharmacological activity of the parent compound and includes: (1) an acid addition salt, formed with an inorganic acid such as hydrochloric acid, hydrobromic acid, sulfuric acid, nitric acid, phosphoric acid, and the like; or formed with an organic acid such as acetic acid, propionic acid, hexanoic acid, cyclopentanepropionic acid, glycolic acid, pyruvic acid, lactic acid, malonic acid, succinic acid, malic acid, maleic acid, fumaric acid, tartaric acid, citric acid, benzoic acid, 3-(4- hydroxybenzoyl)benzoic acid, cinnamic acid, mandelic acid, methanesulfonic acid, ethanesulfonic acid, 1,2-ethane-disulfonic acid, 2-hydroxyethanesulfonic acid, benzenesulfonic acid, 4-chlorobenzenesulfonic acid, 2-naphthalenesulfonic camphorsulfonic acid, acid, 4-toluenesulfonic acid, 4-methylbicyclo[2.2.2]-oct-2-ene-1- carboxylic acid, glucoheptonic acid, 3-phenylpropionic acid, trimethylacetic acid, tertiary butylacetic acid, lauryl sulfuric acid, gluconic acid, glutamic acid, hydroxynaphthoic acid, salicylic acid, stearic acid, muconic acid, and the like; or (2) a salt formed when an acidic proton present in the parent compound is replaced.

[0062] It is understood that the compositions and uses described herein include the use of crystalline forms, amorphous phases, and / or pharmaceutically acceptable salts, solvates, hydrates, and conformers of compounds of some embodiments, as well as metabolites and active metabolites of these compounds having the same type of activity. A conformer is a structure that is a conformational isomer. Conformational isomerism is the phenomenon of molecules with the same structural formula but different conformations (conformers) of atomsabout a rotating bond. In specific embodiments, the compounds described herein exist in solvated forms with pharmaceutically acceptable solvents such as water, ethanol, or the like. In other embodiments, the compounds described herein exist in unsolvated form. Solvates contain either stoichiometric or non-stoichiometric amounts of a solvent and may be formed during the process of crystallization with pharmaceutically acceptable solvents such as water, ethanol, or the like. Hydrates are formed when the solvent is water, or alcoholates are formed when the solvent is alcohol. In addition, the compounds provided herein can exist in unsolvated as well as solvated forms. In general, the solvated forms are considered equivalent to the unsolvated forms for the purposes of the compounds and methods provided herein. Other forms in which the compounds of some embodiments can be provided include amorphous forms, milled forms and nano-particulate forms.

[0063] A substantially pure compound as described herein can be combined with a carrier and provided in any suitable form for consumption by or administration to a subject. As used herein, “substantially pure” refers to a state where one or more of the desired active compound or compounds have been isolated and / or concentrated to a high degree, with minimal undesired impurities present. In some embodiments, the compound or extract is added as an exogenous ingredient or additive to the consumable. Suitable consumable forms include, but are not limited to, a dietary supplement, food ingredient or additive, a medical food, nutraceutical or pharmaceutical composition. In some embodiments, the compound or extract is provided in either a liquid or powder form. In some embodiments, the compound is plant derived and may be concentrated in the plant source without necessarily extracting the compound entirely or in part from the plant. By way of a non-limiting example a plant containing NCT may be processed to isolate a particular part of the plant that is rich in NCT from different parts of the plant that is comparatively low in NCT concentration. By way of another non-limiting example, a plant containing NCT may be heated or crushed whereupon any NCT in the interior of the plant may be more accessible to chemical extraction or digestion.

[0064] In some embodiments, the one or more tyramine containing hydroxycinnamic acid amides may be in a ratio from about 10:1 to about 1:10, or ranges including and / or spanning the aforementioned values. In some embodiments, the one or more compounds described herein may be in a ratio from about 10:1, 9.5:1, 8.5:1, 8.0:1, 7.5:1, 7:1, 6.5:1, 6:1, 5.5:1, 5:1, 4.5:1, 4:1, 3.5:1, 3.0:1, 2.5:1, 2.0:1, 1.5:1, 1:1, 1:1.5, 1:2, 1:2.5, 1:3, 1:3.5,1:4, 1:4.5, 1:5, 1:5.5, 1:6, 1:6.5, 1:7, 1:7.5, 1:8, 1:8.5, 1:9, 1:9.5, 1:10. In some embodiments, the one or more compounds is N-trans-caffeoyltyramine and N-trans-feruloyltyramine, a salt, or isomer thereof. In some embodiments, the ratio of N-trans-caffeoyltyramine to N-trans- feruloyltyramine is from about 10:1 to about 1:10. In some embodiments, the ratio of N-trans- caffeoyltyramine to N-trans-feruloyltyramine is from about 5:1 to about 1:5. In some embodiments, the N-trans-caffeoyltyramine and the N-trans-feruloyltyramine is in a ratio from about 2.5:1 to about 2:1. In some embodiments, the ratio of N-trans-caffeoyltyramine to N- trans-feruloyltyramine is from about 2.5:1 to about 1:2.5. In some embodiments, the ratio of N-trans-caffeoyltyramine to N-trans-feruloyltyramine is from about 5:1. In some embodiments, the ratio of N-trans-caffeoyltyramine to N-trans-feruloyltyramine is from about 4:1. In some embodiments, the ratio of N-trans-caffeoyltyramine to N-trans-feruloyltyramine is from about 3:1. In some embodiments, the ratio of N-trans-caffeoyltyramine to N-trans- feruloyltyramine is from about 2.2:1. In some embodiments, the ratio of N-trans- caffeoyltyramine to N-trans-feruloyltyramine is from about 2:1. In some embodiments, the ratio of N-trans-caffeoyltyramine to N-trans-feruloyltyramine is from about 1:2. In some embodiments, the ratio of N-trans-caffeoyltyramine to N-trans-feruloyltyramine is from about 1:2.2. In some embodiments, the ratio of N-trans-caffeoyltyramine to N-trans-feruloyltyramine is from about 1:3. In some embodiments, the ratio of N-trans-caffeoyltyramine to N-trans- feruloyltyramine is from about 1:4. In some embodiments, the ratio of N-trans- caffeoyltyramine to N-trans-feruloyltyramine is from about 1:5.

[0065] In some embodiments, the one or more tyramine containing hydroxycinnamic acid amides is an extract of a plant or a plant source. In some embodiments, the plant source is selected from the group comprising Allium, Amoracia, Chenopodium, Cannabis, Spinacia, Fagopyrum, Annona, Jatropha, Piper, Eragrostis, Zea, Nelumbo, Ipomoea, Capsicum, Lycium, Solanum, and Tribulus. In some embodiments, the plant source is hemp hulls, peppercorn, or black seed. In some embodiments, the plant source is from hemp hulls. In some embodiments, the one or more tyramine containing hydroxycinnamic acid amides is produced by a host strain engineered to produce NCT and NFT. In some embodiments, the host strain is Yarrowia lipolytica. Formulations

[0066] Aspects of the disclosure relate to formulation including one or more compounds as described herein. In some embodiments, a substantially pure compound or extract comprising one or more compounds of this disclosure can be combined with a carrier and provided in any suitable form for consumption by, provided to, or administration to a subject. In some embodiments, the one or more compounds or extract comprising one or more compounds is added as an exogenous ingredient or additive to a consumable. Suitable consumable forms include, but are not limited to, a dietary supplement, food ingredient or additive, a food product, a medical food, nutraceutical or pharmaceutical composition. In some embodiments, the one or more compounds or extract comprising one or more compounds is provided in either a liquid, granular, or powder form. In some embodiments, the formulation may be a food product.

[0067] A “food ingredient” or “food additive” as referred to herein includes an edible substance intended to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristic of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food). A food product, in particular a functional food, includes a food fortified or enriched during processing to include additional complementary nutrients and / or beneficial ingredients. A food product according to this disclosure can, e.g., be in the form of butter, margarine, sweet or savory spreads, condiment, biscuits, food bar, crisp, cracker, granola, health bar, bread, cake, cereal, candy, confectionery, soup, milk, yogurt or a fermented milk product, cheese, juice-based and vegetable-based beverages, functional beverage, powdered beverage mix, fermented beverages, shakes, flavored waters, tea, oil, or any other suitable food. In some embodiments, the food product includes a whole-food product in which the concentration of the one or more compounds have been enriched through particular post- harvest and food production processing methods to levels that provide an efficacious amount of the compound. In some embodiments, the food product includes one or more compounds as described herein and a fiber source. In some embodiments, the food product includes a compound selected from the group consisting of: N-trans-caffeoyltyramine, N-trans- feruloyltyramine, or a pharmaceutically acceptable salt, solvates, and combinations of the foregoing. In some embodiments, the food product includes N-trans-feruloyltyramine. In some embodiments, the food product includes N-trans-caffeoyltyramine. In some embodiments, thefood product includes N-trans-caffeoyltyramine and N-trans-feruloyltyramine. In some embodiments, the N-trans-caffeoyltyramine and the N-trans-feruloyltyramine are in a ratio from about 10:1 to about 1:10. In some embodiments, the N-trans-caffeoyltyramine and the N- trans-feruloyltyramine are in a ratio from about 5:1 to about 1:5. In some embodiments, the N- trans-caffeoyltyramine and the N-trans-feruloyltyramine are in a ratio from about 5:1 to about 1:1. In some embodiments, the N-trans-caffeoyltyramine and the N-trans-feruloyltyramine is in a ratio from about 2.5:1 to about 2:1. In some embodiments, the N-trans-caffeoyltyramine and the N-trans-feruloyltyramine are in a ratio at about 2.2:1. In some embodiments, the food product is a food bar. In some embodiments, the food bar comprises from about 0.01% to about 20% (w / w) N-trans-caffeoyltyramine. In some embodiments, the food bar comprises from about 0.01% to about 20% (w / w) N-trans-feruloyltyramine. In some embodiments, the food product is a crisp. In some embodiments, the food bar comprises from about 0.01% to about 20% (w / w) N-trans-caffeoyltyramine. In some embodiments, the food bar comprises from about 0.01% to about 20% (w / w) N-trans-feruloyltyramine.

[0068] In some embodiments, food product includes a carbohydrate. A variety of carbohydrates are used in food products, such as various sugars and starches. Carbohydrates are an important source of energy for the body, including complex carbohydrates (like whole grains and vegetables) and simple carbohydrates (like sugar and refined grains). There are several common carbohydrates that are used in food products, including: starch, sugar, fructose, maltodextrin, dextrose, corn syrup, oligosaccharides, cellulose, complex carbohydrates, such as inulin that may be added as a prebiotic fiber in processed foods. According to the disclosure, the concentration of carbohydrates may vary depending on the intended use of a product. In some embodiments, carbohydrates may comprise from about 1% by weight to about 95% by weight of a food product. In some embodiments, carbohydrates may comprise from about 1% by weight to about 95% by weight of a food product. In some embodiments, a food product may comprise carbohydrates in a range with high and low values independently selected from about 1%, 3%, 5%, 8%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95% or ranges including, between, and / or spanning the aforementioned values.

[0069] In some embodiments, the food product may include a sugar. Sugars, such as high fructose corn syrup, sucrose, glucose syrup, dextrose, and other sweeteners are oftenadded to processed foods to make them more palatable. Additionally, sugar alcohols or maltodextrins, may be added to food products to reduce caloric content and / or to enhance nutritional profile of the product. In some embodiments, a food product may comprise one or a plurality of saccharides that are slowly or incompletely digested by humans, if not totally indigestible. These sugars can include isomaltose, panose and branched oligomers having a degree of polymerization of four or greater. Additional non-limiting examples of sugars include sucrose, HFCS, fructose, brown sugar (which can be either partially or fully refined), powdered sugar (also known as confectioner's sugar), high fructose corn syrup, honey, molasses, maple syrup, agave nectar, coconut sugar, date sugar, fruit juice concentrates, maltodextrin, dextrose, glucose syrup, maple syrup, molasses, and lactose. According to the disclosure, the concentration of sugars may vary depending on the intended use of a product. In some embodiments, sugar may comprise from about 1% by weight to about 95% by weight of a food product. In some embodiments, the sugar(s) component comprises from about 2% to about 10% by weight of the composition. In some embodiments, sugars may comprise from about 1% by weight to about 95% by weight of a food product. In some embodiments, a food product may comprise sugars in a range with high and low values independently selected from about 1%, 3%, 5%, 8%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95% or ranges including, between, and / or spanning the aforementioned values.

[0070] In some embodiments, the food product includes a fiber source. In some embodiments, the food product includes from about 5% to about 30% (w / w) fiber. In some embodiments, the food product includes at least 10% fiber. In some embodiments, the food product includes at least 15% fiber. In some embodiments, the food product includes at least 20% fiber. In some embodiments, the food product includes at least 30% fiber.

[0071] In some embodiments, the food product may include a protein. Proteins may be included in a range of concentrations depending on the product. Protein sources can include soy protein, soy flour, soy protein isolate, whey protein isolate, casein, gelatin, legume protein isolates, soy protein concentrate, egg albumin or egg white, wheat protein concentrate, legume protein concentrates and mixtures thereof. In some embodiments, meat products like beef jerky, sausages, or meatballs, may include proteins as a primary ingredient. Proteins may be included at concentrations ranging from about 10% to about 25% of the total ingredients. Indairy products like cheese, yogurt, or milk, proteins like casein or whey may be the primary ingredient. Proteins may be included at concentrations ranging from about 3% to about 15% of the total ingredients. In plant-based products like tofu, tempeh, or seitan, proteins from soy, peas, legumes, or wheat may be primary ingredients. Proteins may be included at concentrations ranging from about 10% to about 25% of the total ingredients. In energy bars and protein bars, proteins like whey or soy, or any protein according to the disclosure may be added to provide a source of protein. Proteins may be included at concentrations ranging from about 10% to about 25% of the total ingredients. According to the disclosure, the concentration of proteins may vary depending on the intended use of a product. In some embodiments, proteins may comprise from about 1% by weight to about 95% by weight of a food product. In some embodiments, proteins may comprise from about 1% by weight to about 95% by weight of a food product. In some embodiments, a food product may comprise proteins in a range with high and low values independently selected from about 1%, 3%, 5%, 8%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95% or ranges including, between, and / or spanning the aforementioned values.

[0072] In some embodiments, the food product may include a starch. In some embodiments, food products may additionally comprise a starch ingredient(s) in amounts sufficient to provide about 5% to 45%, or about 10%-30%, or about 15%-25 starch in the food products. Starchy components may include not only pure added cereal flours or other granulations but also any starchy fraction provided by other ingredients such as oat bran or soy protein. In some embodiments, a starch may comprise any conventionally employed starch or cereal flour ingredient, for use in a ready-to-eat cereal. Exemplary suitable starchy cereals include cereal flours from major cereal grains including wheat, rice, corn (maize), oats, barley, rye, or starch fractions isolated from the cereal flowers including, for example cornstarch, wheat starch, rice starch, and various treated starches including pre-gelatinized starches and / or modified starches.

[0073] In some embodiments, the food product may include a flour. Several types of flour may be used according to the disclosure. For example, common types of flour used in food products, include all-purpose flour (which like most other flour may include protein content), Whole wheat flour, Bread flour, Cake flour, pastry flour, self-rising flour, and gluten- free flour. According to the disclosure, the concentration of flour may vary depending on theintended use of a product. For example, in baked goods like bread, cakes, and cookies, flour is typically a main ingredient and may be included at concentrations ranging from 50% to 100% of the total dry ingredients. In soups and sauces, flour is often used as a thickener and may be included at concentrations ranging from 1% to 5% of the total ingredients. Batter and breading: In fried foods like chicken or fish, flour is often used as part of the batter or breading and may be included at concentrations ranging from 20% to 50% of the total dry ingredients. In snack foods, like crackers and chips, flour may be included at concentrations ranging from 30% to 70% of the total ingredients. In some embodiments, flour may comprise from about 1% by weight to about 95% by weight of a food product. In some embodiments, flours may comprise from about 1% by weight to about 95% by weight of a food product. In some embodiments, a food product may comprise flour in a range with high and low values independently selected from about 1%, 3%, 5%, 8%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%,95% or ranges including, between, and / or spanning the aforementioned values.

[0074] In some embodiments, the food product may include a fat. In some embodiments, the food product may include an oil. In some embodiments, the food product may include one or more fats or oils. Several types of fats may be used according to the disclosure. For example, common types of fats include butter, margarine, vegetable oils, shortening, and lard. According to the disclosure, the concentration of fats may vary depending on the intended use of a product. In baked goods like cakes, cookies, and pastries, fats like butter, shortening, or oil are often used to provide moisture, flavor, and texture. In some embodiments, Fats may be included at concentrations ranging from 10% to 30% of the total ingredients. In some embodiments, like in sauces and dressings, fats like olive oil or mayonnaise are often used to provide flavor and texture. In some embodiments, Fats may be included at concentrations ranging from 10% to 30% of the total ingredients. In fried foods like chicken or French fries, fats like vegetable oil or lard are used for frying and may be included at concentrations ranging from 30% to 60% of the total ingredients. In snack foods like chips and crackers, fats like vegetable oil or palm oil are often used to provide flavor and texture. In some embodiments, Fats may be included at concentrations ranging from 10% to 30% of the total ingredients. In some embodiments, fats may comprise from about 1% by weight to about 95% by weight of a food product. In some embodiments, fats may comprisefrom about 1% by weight to about 95% by weight of a food product. In some embodiments, a food product may comprise fat in a range with high and low values independently selected from about 1%, 3%, 5%, 8%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95% or ranges including, between, and / or spanning the aforementioned values.

[0075] In some embodiments, the food product may include one or more additional ingredients. If desired, the disclosed food products may additionally include a variety of materials designed to improve their aesthetic or nutritional qualities. These adjuvant materials can include vitamin and / or mineral fortification, colors, flavors, sweetener(s), and mixtures thereof. The precise ingredient concentration may vary. Generally, however, such materials can each include about 0.01% to about 5%, or about 0.1% to 2% dry weight of a food product. One especially useful material is common salt. In some embodiments, salt comprises about 0.1 to 5%, or about 0.5 to 4.0% of the food products.

[0076] In some embodiments, the food product is derived from a plant. In some embodiments, the food product is derived from hemp hulls. In some embodiments, the food product is a solid food. In some embodiments, the food product is a semi-solid food. In some embodiments, the food product is a puffed product, a bakery product, a pressed cake, a cooked product, a food bar, a cereal, a crisp, or a spread.

[0077] A dietary supplement is a product taken by mouth that contains a compound or extract of the disclosure and is intended to supplement the diet. A nutraceutical is a product derived from a food source that provides extra health benefits, in addition to the basic nutritional value found in the food. A pharmaceutical composition is defined as any component of a drug product intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans or other animals. Dietary supplements, nutraceuticals and pharmaceutical compositions can be found in many capsules, forms such as tablets, coated tablets, pills, capsules, pellets, granules, softgels, gelcaps, liquids, powders, emulsions, suspensions, elixirs, syrup, and any other form suitable for use.

[0078] The pharmaceutical compositions disclosed herein may be manufactured in a manner that is itself known, e.g., by means of conventional mixing, dissolving, granulating, dragee-making, levigating, emulsifying, encapsulating, entrapping or tableting processes.Additionally, the active ingredients are contained in an amount effective to achieve its intended purpose. Many of the compounds used in the pharmaceutical combinations disclosed herein may be provided as salts with pharmaceutically compatible counterions.

[0079] Multiple techniques of administering a compound, salt and / or composition exist in the art including, but not limited to, oral, rectal, pulmonary, topical, aerosol, injection, infusion and parenteral delivery, including intramuscular, subcutaneous, intravenous, intramedullary injections, intrathecal, direct intraventricular, intraperitoneal, intranasal and intraocular injections. In some embodiments, a compound described herein, including NCT and NFT, or a pharmaceutically acceptable salt thereof, can be administered orally. In some embodiments, a compound described herein, including NCT and NFT, or a pharmaceutically acceptable salt thereof, can be provided in a form for oral consumption.

[0080] One may also provide or administer the one or more compounds, salt and / or composition in a local rather than systemic manner, for example, via injection or implantation of the compound directly into the affected area, often in a depot or sustained release formulation. Furthermore, one may provide or administer the compound in a targeted drug delivery system, for example, in a liposome coated with a tissue-specific antibody. The liposomes will be targeted to and taken up selectively by the organ. For example, intranasal or pulmonary delivery to target a respiratory disease or condition may be desirable.

[0081] The compositions may, if desired, be presented in a pack or dispenser device which may contain one or more unit dosage forms containing the active ingredient. The pack may for example comprise metal or plastic foil, such as a blister pack. The pack or dispenser device may be accompanied by instructions for administration. The pack or dispenser may also be accompanied with a notice associated with the container in form prescribed by a governmental agency regulating the manufacture, use, or sale of pharmaceuticals, which notice is reflective of approval by the agency of the form of the drug for human or veterinary administration. Such notice, for example, may be the labeling approved by the U.S. Food and Drug Administration for prescription drugs, or the approved product insert. Compositions that can include a compound and / or salt described herein formulated in a compatible pharmaceutical excipient may also be prepared, placed in an appropriate container, and labeled for treatment of an indicated condition.

[0082] The compounds, salt and / or pharmaceutical composition can be provided to an administering physician or other health care professional in the form of a kit. The kit is a package which houses a container which contains the compound(s) in a suitable pharmaceutical composition, and instructions for administering the pharmaceutical composition to a subject. The kit can optionally also contain one or more additional therapeutic agents. The kit can also contain separate doses of a compound(s) or pharmaceutical composition for serial or sequential administration. The kit can optionally contain one or more diagnostic tools and instructions for use. The kit can contain suitable delivery devices, for example., syringes, and the like, along with instructions for administering the compound(s) and any other therapeutic agent. The kit can optionally contain instructions for storage, reconstitution (if applicable), and administration of any or all therapeutic agents included. The kits can include a plurality of containers reflecting the number of administrations to be given to a subject.

[0083] In some embodiments, the composition may be administered at a dose in a range from about .1 - 200 mg / kg body weight. In some embodiments, the composition is provided or administered at a dose in the range of about 0.1-1, 0.5-1, 0.1-10, 0.5-10, 1-10, 1- 20, 1-30, 1-40, 1-50, 1-60, 1-70, 1-80, 1-90, 1-100, 1-200, 1-300, 1-400, 1-500, 1-600, 1-700, 1-800, 1-900, 1-1000, 1-11, 1-12, 1-13, 1-13, 1-14, 1-15, 1-16, 1-17, 1-18, 1-19, 10-20, 10-30, 10-40, 10-50, 10-60, 10-70, 10-80, 10-90, 10-100, 10-200, 10-300, 10-400, 10-500, 10-600, 10-700, 10-800, 10-900, 10-1000, 20-30, 20-40, 20-50, 20-60, 20-70, 20-80, 20-90, 20-100, 20-200, 20-300, 20-400, 20-500, 20-600, 20-700, 20-800, 20-900, 20-1000, 30-40, 30-50, 30- 60, 30-70, 30-80, 30-90, 30-100, 30-200, 30-300, 30-400, 30-500, 30-600, 30-700, 30-800, 30- 900, 30-1000, 40-50, 40-60, 40-70, 40-80, 40-90, 40-100, 40-200, 40-300, 40-400, 40-500, 40- 600, 40-700, 40-800, 40-900, 40-1000, 50-60, 50-70, 50-80, 50-90, 50-100, 50-200, 50-300, 50-400, 50-500, 50-600, 50-700, 50-800, 50-900, 60-70, 60-80, 60-90, 60-100, 60-200, 60- 300, 60-400, 60-500, 60-600, 60-700, 60-800, 60-900, 60-1000, 70-80, 70-90, 70-100, 70-200, 70-300, 70-400, 70-500, 70-600, 70-700, 70-800, 70-900, 70-1000, 80-90, 80-100, 80-200, 80- 300, 80-400, 80-500, 80-600, 80-700, 80-800, 80-900, 80-100, 90-100, 90-200, 90-300, 90- 400, 90-500, 90-600, 90-700, 90-800, 90-900, 90-1000, 100-150, 100-200, 100-300, 100-400, 100-500, 100-600, 100-700, 100-800, 100-900, or 100-1000 mg / kg of body weight. In some embodiments, the composition is provided or administered at a dose of about 0.01, 0.02, 0.03,0.05, 0.07, 0.1, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 13.5, 14, 14.5, 15, 15.5, 16, 16.5, 17, 17.5, 18, 18.5, 19, 19.5, 20, 20.5, 21, 21.5, 22, 22.5, 23, 23.5, 24, 24.5, 25, 25.5, 26, 26.5, 27, 27.5, 28, 28.5, 29, 29.5, 30, 30.5, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 55, 60, 65, 70, 80, 90, or 95 mg / kg of the body weight. In some embodiments, the composition is administered at a dose less than about 0.01, 0.02, 0.03, 0.05, 0.07, 0.1, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 13.5, 14, 14.5, 15, 15.5, 16, 16.5, 17, 17.5, 18, 18.5, 19, 19.5, 20, 20.5, 21, 21.5, 22, 22.5, 23, 23.5, 24, 24.5, 25, 25.5, 26, 26.5, 27, 27.5, 28, 28.5, 29, 29.5, 30, 30.5, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40 mg / m2of the body surface area. In some embodiments, the composition is provided or administered at a dose greater than about 0.01, 0.02, 0.03, 0.05, 0.07, 0.1, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 13.5, 14, 14.5, 15, 15.5, 16, 16.5, 17, 17.5, 18, 18.5, 19, 19.5, 20, 20.5, 21, 21.5, 22, 22.5, 23, 23.5, 24, 24.5, 25, 25.5, 26, 26.5, 27, 27.5, 28, 28.5, 29, 29.5, 30, 30.5, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100 mg / kg of a subjects body weight.

[0084] In some embodiments, the composition dose may be from about 0.1 mg - 10 mg, 0.1 mg - 25 mg, 0.1 mg - 30mg, 0.1 mg - 50 mg, 0.1 mg - 75 mg, 0.1 mg-100 mg, 0.5 mg-10 mg, 0.5 mg-25 mg, 0.5 mg-30 mg, 0.5 mg-50 mg, 0.5 mg-75 mg, 0.5 mg-100 mg, 1 mg-10 mg, 1 mg-25 mg, 1 mg-30 mg, 1 mg-50 mg, 1 mg-75mg, 1 mg-100 mg, 2 mg-10 mg, 2 mg-25 mg, 2 mg-30 mg, 2 mg-50 mg, 2 mg-75 mg, 2 mg-100 mg, 3 mg-10 mg, 3 mg-25 mg, 3 mg-30 mg, 3 mg-50 mg, 3 mg-75 mg, 3 mg-100 mg, 4 mg-100 mg, 5mg-10 mg, 5 mg-25 mg, 5 mg-30 mg, 5 mg-50 mg, 5 mg-75mg, 5 mg - 300 mg, 5 mg -200 mg, 7.5 mg-15 mg, 7.5 mg-25 mg, 7.5 mg-30 mg, 7.5 mg-50 mg, 7.5 mg-75 mg, 7.5 mg-100 mg, 7.5 mg - 200 mg, 10 mg-20 mg, 10 mg-25 mg, 10 mg -50 mg, 10 mg-75 mg, 10 mg - 100 mg, 15 mg - 30 mg, 15 mg - 50 mg, 15 mg - 100 mg, 20 mg-20 mg, 20 mg - 100 mg, 30 mg - 100 mg, 40 mg - 100 mg, 10 mg - 80 mg, 15 mg - 80 mg, 20 mg - 80 mg, 30 mg - 80 mg, 40 mg - 80 mg, 10 mg - 60 mg, 15 mg - 60 mg, 20 mg - 60 mg, 30 mg - 60 mg, or about 40 mg - 60 mg. In some embodiments, the composition dose may be provided or administered is about 20 mg - 60 mg, 27 mg - 60 mg, 20 mg - 45 mg, or 27 mg - 45 mg. In some embodiments, the composition dose may be provided or administered is about 1 mg - 5 mg, 1 mg - 7.5 mg, 2.5 mg - 5 mg, 2.5 mg- 7.5 mg, 5 mg - 7.5 mg, 5 mg - 9 mg, 5 mg - 10 mg, 5 mg-12 mg, 5 mg – 14 mg, 5 mg - 15 mg, 5 mg - 16 mg, 5 mg - 18 mg, 5 mg - 20 mg, 5 mg - 22 mg, 5 mg - 24 mg, 5 mg - 26 mg, 5 mg – 28 mg, 5 mg – 30 mg, 5 mg – 32 mg, 5 mg - 34mg, 5 mg – 36 mg, 5 mg - 38mg, 5 mg – 40 mg, 5 mg – 42 mg, 5 mg – 44 mg, 5 mg – 46 mg, 5 mg – 48 mg, 5 mg – 50 mg, 5 mg – 52 mg, 5 mg – 54 mg, 5 mg – 56 mg, 5 mg – 58 mg, 5 mg – 60 mg, 7 mg - 7.7 mg, 7 mg - 9 mg, 7 mg - 10 mg, 7 mg – 12 mg, 7 mg – 14 mg, 7 mg - 15 mg, 7 mg-16 mg, 7 mg-18 mg, 7 mg - 20 mg, 7 mg - 22 mg, 7 mg - 24 mg, 7 mg-26 mg, 7 mg - 28mg, 7mg-30mg, 7mg-32mg, 7mg- 34mg, 7mg-36mg, 7mg-38mg, 7mg-40mg, 7mg-42mg, 7mg-44mg, 7mg-46mg, 7mg-48mg, 7mg-50mg, 7mg-52mg, 7mg-54mg, 7mg-56mg, 7mg-58mg, 7mg-60mg, 9 mg-10 mg, 9 mg- 12mg, 9mg-14mg, 9mg-15 mg, 9 mg-16 mg, 9 mg-18 mg, 9 mg-20 mg, 9 mg-22 mg, 9 mg-24 mg, 9 mg-26 mg, 9 mg-28mg, 9mg-30mg, 9mg-32mg, 9mg-34mg, 9mg-36mg, 9mg-38mg, 9mg-40mg, 9mg-42mg, 9mg-44mg, 9mg-46mg, 9mg-48mg, 9mg-50mg, 9mg-52mg, 9mg- 54mg, 9mg-56mg, 9mg-58mg, 9mg-60mg, 10 mg-12mg, 10mg-14mg, 10mg-15 mg, 10 mg- 16 mg, 10 mg-18 mg, 10 mg-20 mg, 10 mg-22 mg, 10 mg-24 mg, 10 mg-26 mg, 10 mg-28mg, 10mg-30mg, 10mg-32mg, 10mg-34mg, 10mg-36mg, 10mg-38mg, 10mg-40mg, 10mg-42mg, 10mg-44mg, 10mg-46mg, 10mg-48mg, 10mg-50mg, 10mg-52mg, 10mg-54mg, 10mg-56mg, 10mg-58mg, 10mg-60mg, 12mg-14mg, 12mg-15 mg, 12 mg-16 mg, 12 mg-18 mg, 12 mg-20 mg, 12 mg-22 mg, 12 mg-24 mg, 12 mg-26 mg, 12 mg-28mg, 12mg-30mg, 12mg-32mg, 12mg-34mg, 12mg-36mg, 12mg-38mg, 12mg-40mg, 12mg-42mg, 12mg-44mg, 12mg-46mg, 12mg-48mg, 12mg-50mg, 12mg-52mg, 12mg-54mg, 12mg-56mg, 12mg-58mg, 12mg-60mg, 15 mg-16 mg, 15 mg-18 mg, 15 mg-20 mg, 15 mg-22 mg, 15 mg-24 mg, 15 mg-26 mg, 15 mg-28mg, 15mg-30mg, 15mg-32mg, 15mg-34mg, 15mg-36mg, 15mg-38mg, 15mg-40mg, 15mg-42mg, 15mg-44mg, 15mg-46mg, 15mg-48mg, 15mg-50mg, 15mg-52mg, 15mg-54mg, 15mg-56mg, 15mg-58mg, 15mg-60mg, 17 mg-18 mg, 17 mg-20 mg, 17 mg-22 mg, 17 mg-24 mg, 17 mg-26 mg, 17 mg-28mg, 17mg-30mg, 17mg-32mg, 17mg-34mg, 17mg-36mg, 17mg- 38mg, 17mg-40mg, 17mg-42mg, 17mg-44mg, 17mg-46mg, 17mg-48mg, 17mg-50mg, 17mg- 52mg, 17mg-54mg, 17mg-56mg, 17mg-58mg, 17mg-60mg, 20 mg-22 mg, 20 mg-24 mg, 20 mg-26 mg, 20 mg-28mg, 20mg-30mg, 20mg-32mg, 20mg-34mg, 20mg-36mg, 20mg-38mg, 20mg-40mg, 20mg-42mg, 20mg-44mg, 20mg-46mg, 20mg-48mg, 20mg-50mg, 20mg-52mg, 20mg-54mg, 20mg-56mg, 20mg-58mg, 20mg-60mg, 22 mg-24 mg, 22 mg-26 mg, 22 mg- 28mg, 22mg-30mg, 22mg-32mg, 22mg-34mg, 22mg-36mg, 22mg-38mg, 22mg-40mg, 22mg-42mg, 22mg-44mg, 22mg-46mg, 22mg-48mg, 22mg-50mg, 22mg-52mg, 22mg-54mg, 22mg- 56mg, 22mg-58mg, 22mg-60mg, 25 mg-26 mg, 25 mg-28mg, 25mg-30mg, 25mg-32mg, 25mg-34mg, 25mg-36mg, 25mg-38mg, 25mg-40mg, 25mg-42mg, 25mg-44mg, 25mg-46mg, 25mg-48mg, 25mg-50mg, 25mg-52mg, 25mg-54mg, 25mg-56mg, 25mg-58mg, 25mg-60mg, 27 mg-28mg, 27mg-30mg, 27mg-32mg, 27mg-34mg, 27mg-36mg, 27mg-38mg, 27mg-40mg, 27mg-42mg, 27mg-44mg, 27mg-46mg, 27mg-48mg, 27mg-50mg, 27mg-52mg, 27mg-54mg, 27mg-56mg, 27mg-58mg, 27mg-60mg, 30mg-32mg, 30mg-34mg, 30mg-36mg, 30mg-38mg, 30mg-40mg, 30mg-42mg, 30mg-44mg, 30mg-46mg, 30mg-48mg, 30mg-50mg, 30mg-52mg, 30mg-54mg, 30mg-56mg, 30mg-58mg, 30mg-60mg, 33mg-34mg, 33mg-36mg, 33mg-38mg, 33mg-40mg, 33mg-42mg, 33mg-44mg, 33mg-46mg, 33mg-48mg, 33mg-50mg, 33mg-52mg, 33mg-54mg, 33mg-56mg, 33mg-58mg, 33mg-60mg, 36mg-38mg, 36mg-40mg, 36mg-42mg, 36mg-44mg, 36mg-46mg, 36mg-48mg, 36mg-50mg, 36mg-52mg, 36mg-54mg, 36mg-56mg, 36mg-58mg, 36mg-60mg, 40mg-42mg, 40mg-44mg, 40mg-46mg, 40mg-48mg, 40mg-50mg, 40mg-52mg, 40mg-54mg, 40mg-56mg, 40mg-58mg, 40mg-60mg, 43mg-46mg, 43mg-48mg, 43mg-50mg, 43mg-52mg, 43mg-54mg, 43mg-56mg, 43mg-58mg, 42mg-60mg, 45mg-48mg, 45mg-50mg, 45mg-52mg, 45mg-54mg, 45mg-56mg, 45mg-58mg, 45mg-60mg, 48mg- 50 mg, 48 mg - 52 mg, 48 mg - 54 mg, 48 mg - 56 mg, 48 mg - 58 mg, 48 mg - 60 mg, 50 mg - 52 mg, 50 mg - 54 mg, 50 mg - 56 mg, 50 mg - 58 mg, 50 mg - 60 mg, 52 mg - 54 mg, 52 mg - 56mg , 52 mg - 58 mg, or 52 mg - 60 mg. In some embodiments, the composition dose may be greater than, equal to, or about 0.1 mg, 0.3mg, 0.5mg, 0.75mg, 1mg, 1.25mg, 1.5mg, 1.75mg, 2mg, 2.5mg, 3mg, 3.5mg, 4mg, 5 mg, about 10 mg, about 12.5 mg, about 13.5 mg, about 15 mg, about 17.5 mg, about 20 mg, about 22.5 mg, about 25 mg, about 27 mg, about 30 mg, about 40 mg, about 50 mg, about 60 mg, about 70 mg, about 80 mg, about 90 mg, about 100 mg, about 125 mg, about 150mg, about 200 mg, about 300 mg. about 400 mg, about 500 mg, about 600 mg, about 700 mg, about 800 mg, about 900 mg, or about 1000 mg. In some embodiments, the composition dose may be less than about 0.5mg, 0.75mg, 1mg, 1.25mg, 1.5mg, 1.75mg, 2mg, 2.5mg, 3mg, 3.5mg, 4mg, 5 mg, about 10 mg, about 12.5 mg, about 13.5 mg, about 15 mg, about 17.5 mg, about 20 mg, about 22.5 mg, about 25 mg, about 27 mg, about 30 mg, about 40 mg, about 50 mg, about 60 mg, about 70 mg, about 80 mg, about 90 mg, about 100 mg, about 125 mg, about 150mg, or about 200 mg.

[0085] In some embodiments, the formulation includes an excipient. In some embodiments, the excipient is a nutraceutically acceptable excipient. In some embodiments, the nutraceutically acceptable excipient is selected from medium chain triglycerides, diglycerides, and monoglycerides, caprylic acid, linoleic acid, linoleic acid, oleic acid, keto- oleic acid. In some embodiments, the nutraceutically acceptable excipient further includes a second fatty acid component having one or more non-activated fatty acids selected from linoleic acid, α-linoleic acid, γ-linoleic acid, oleic acid, eicosapentaenoic acid (EPA), docosahexaenoic acid (DEIA), or derivatives thereof.

[0086] In some embodiments, the formulation includes a carrier. In some embodiments, the carrier is a nutraceutically acceptable carrier. Each carrier should be compatible with the other ingredients of the formulation and not injurious to the subject. Some examples of materials that can serve as carriers include: (1) sugars, such as lactose, glucose and sucrose; (2) starches, such as corn starch and potato starch; (3) cellulose, and its derivatives, such as sodium carboxymethyl cellulose, ethyl cellulose, cellulose acetate, and hydroxyl propyl methyl cellulose; (4) powdered tragacanth; (5) malt; (6) gelatin; (7) talc; (8) excipients, such as cocoa butter and suppository waxes; (9) oils, such as peanut oil, cottonseed oil, safflower oil, sesame oil, olive oil, corn oil and soybean oil; (10) glycols, such as propylene glycol; (11) polyols, such as glycerin, sorbitol, mannitol and polyethylene glycol; (12) esters, such as ethyl oleate and ethyl laurate; (13) agar; (14) buffering agents, such as magnesium hydroxide and aluminum hydroxide; (15) alginic acid; (16) pyrogen-free water; (17) isotonic saline; (18) Ringer's solution; (19) ethyl alcohol; (20) pH buffered solutions; (21) polyesters, polycarbonates and / or polyanhydrides; and (22) other nontoxic compatible substances employed in conventional formulations. In some embodiments, the carrier is microcrystalline cellulose. In some embodiments, the carrier is about 0.5% to about 80% (w / w) of the formulation. In some embodiments, the carrier is about 0.5%, about 1.0%, about 1.5%, about 2.0%, about 2.5%, about 3.0%, about 3.5%, about 4.0%, about 4.5%, about 5.0%, about 7.5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 70%, about 75%, about 80% (w / w) of the formulation, or ranges including, between, and / or spanning the aforementioned values.

[0087] For preparing solid compositions such as tablets or capsules, the compound or extract is mixed with a carrier (e.g., conventional tableting ingredients such as corn starch,lactose, sucrose, sorbitol, talc, stearic acid, magnesium stearate, dicalcium phosphate or gums) and other diluents (e.g., water) to form a solid composition. This solid composition is then subdivided into unit dosage forms containing an effective amount of the compound of the present disclosure. The tablets or pills containing the compound or extract can be coated or otherwise compounded to provide a dosage form affording the advantage of prolonged action.

[0088] In particular embodiments of this disclosure, a consumable composition includes the one or more compounds or an extract comprising one or more compounds described herein, a carrier and a preservative to reduce or retard microbial growth. In some embodiments, the preservative is about 0.01% to about 5% (w / w) of the formulation. In some embodiments, the preservative is about 0.5%, about 1.0%, about 1.5%, about 2.0%, about 2.5%, about 3.0%, about 3.5%, about 4.0%, about 4.5%, about 5.0% w / w of the formulation, or ranges including, between, and / or spanning the aforementioned values. In some embodiments, the preservative is added in amounts up to about 5%, for example, from about 0.01% to 1% (w / w). In some embodiments, the preservative may include sodium benzoate, methyl parabens, propyl parabens, sodium nitrite, sulphur dioxide, sodium sorbate and potassium sorbate. Other suitable preservatives include, but are not limited to, salts of edetate, (also known as salts of ethylenediaminetetraacetic acid, or EDTA, such a disodium EDTA), or a combination thereof.

[0089] In some embodiments, the formulation is a liquid. In some embodiments, the formulation is a liquid product. In some embodiments, the liquid product is produced from hemp hulls. In some embodiments, the liquid product is produced from a recombinant cell. In some embodiments, the liquid product is a beverage. In some embodiments, the formulation may be incorporated into a milk-based beverage. In some embodiments, the formulation may be incorporated into a sports drink beverage. In some embodiments, the formulation may be incorporated into a fruit juice beverage. In some embodiments, the formulation may be incorporated into an alcoholic beverage. In some embodiments, the formulation may be incorporated into a water-based beverage. In some embodiments, the formulation may be a smoothie. In some embodiments, the liquid may include one or more compounds or an extract of the disclosure. In some embodiments, the liquid may be incorporated for oral administration or consumption. In some embodiments, the liquid may include aqueous solution, suitably flavored syrups, aqueous or oil suspensions, and flavored emulsions with edible oils as well aselixirs and similar vehicles. Suitable dispersing or suspending agents for aqueous suspensions include synthetic natural gums, such as tragacanth, acacia, alginate, dextran, sodium carboxymethyl cellulose, methylcellulose, polyvinylpyrrolidone or gelatin. Liquid preparations for oral administration or consumption may take the form of, for example, solutions, syrups or suspensions, or they may be presented as a dry product for reconstitution with water or other suitable vehicles before use. Such liquid preparations may be prepared by conventional means with acceptable additives such as suspending agents (e.g., sorbitol syrup, methyl cellulose or hydrogenated edible fats); emulsifying agents (e.g., lecithin or acacia); non-aqueous vehicles (e.g., almond oil, oily esters or ethyl alcohol); preservatives (e.g., methyl or propyl p-hydroxybenzoates or sorbic acid); and artificial or natural colors and / or sweeteners.

[0090] Methods of preparing formulations or compositions of this disclosure include the step of bringing into association a compound or extract of the present disclosure with the carrier and, optionally, one or more accessory and / or active ingredients. In general, the formulations are prepared by uniformly and intimately bringing into association a compound or extract of the present disclosure with liquid carriers, or finely divided solid carriers, or both, and then, if necessary, shaping the product. As such, the disclosed formulation may consist of, or consist essentially of a compound or extract described herein in combination with a suitable carrier.

[0091] In some embodiments, the formulation includes one or more compounds of the present disclosure at about 0.1, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99% w / w, or ranges including and / or spanning the aforementioned values. In some embodiments, the formulation includes from about 0.1% to about 10% of one or more compounds as described herein. In some embodiments, the formulation includes from about 0.1% to about 5% of one or more compounds as described herein. In some embodiments, the formulation includes from about 1% to about 10% of one or more compounds or an extract as described herein. In some embodiments, when one or more compounds of the present disclosure is provided or administered as pharmaceuticals, nutraceuticals, or dietary supplements to humans and animals, they can be given per se or as a composition containing, for example, 0.1 to 99% active ingredient in combination with an acceptable carrier. In some embodiments, the compound or extract of the present disclosure may be provided or administered at about 0.1,0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99 % w / w, or ranges including and / or spanning the aforementioned values.

[0092] In some embodiments, the formulation may include one or more compounds as described herein and a suitable carrier or excipient. In some embodiments, the one or more compounds described herein may be in a ratio from about 10:1 to about 1:10, or ranges including and / or spanning the aforementioned values. In some embodiments, the one or more compounds described herein may be in a ratio from about 10:1, 9.5:1, 8.5:1, 8.0:1, 7.5:1, 7:1, 6.5:1, 6:1, 5.5:1, 5:1, 4.5:1, 4:1, 3.5:1, 3.0:1, 2.5:1, 2.0:1, 1.5:1, 1:1, 1:1.5, 1:2, 1:2.5, 1:3, 1:3.5, 1:4, 1:4.5, 1:5, 1:5.5, 1:6, 1:6.5, 1:7, 1:7.5, 1:8, 1:8.5, 1:9, 1:9.5, 1:10. In some embodiments, the one or more compounds may be selected from NCT, NFT, a salt, or isomer thereof. In some embodiments, the one or more compounds is NCT. In some embodiments, the one or more compounds is NFT. In some embodiments, the one or more compounds includes NCT and NFT. In some embodiments, the ratio of NCT to NFT is from about 10:1 to about 1:10. In some embodiments, the ratio of NCT to NFT is from about 5:1 to about 1:5. In some embodiments, the NCT to NFT is in a ratio from about 2.5:1 to about 2:1. In some embodiments, the ratio of NCT to NFT is from about 2.5:1 to about 1:2.5. In some embodiments, the ratio of NCT to NFT is about 5:1. In some embodiments, the ratio of NCT to NFT is from about 4:1. In some embodiments, the ratio of NCT to NFT is about 3:1. In some embodiments, the ratio of NCT to NFT is about 2.2:1. In some embodiments, the ratio of NCT to NFT is about 2:1. In some embodiments, the ratio of NCT to NFT is about 1:2. In some embodiments, the ratio of NCT to NFT is about 1:2.2. In some embodiments, the ratio of NCT to NFT is about 1:3. In some embodiments, the ratio of NCT to NFT is about 1:4. In some embodiments, the ratio of NCT to NFT is about 1:5.

[0093] In some embodiments, the formulation may comprise additional dietary supplements or related products that may be likely to affect weight loss or appetite. Non- limiting examples include Chromium picolinate, Cinnamon (as a supplement), Ginseng, Starch blockers generally (See, for example, similar products such as Carb Away, Carb Cutter, Carb Eliminator, CarboLock, Ultimate Carb Phaser 1000, Ultra Carb Blocker, Detrine, Trimspa), Green Coffee Extract, Green Tea Extract, Caffeine (usually as added caffeine or from guarana, kola nut, yerba maté, or other herbs) >200 mg per serving, Ephedra or derivatives thereof,Bitter orange (Citrus aurantium L.), Capsaicin and other capsaicinoids, Conjugated linoleic acid, Hoodia (Hoodia gordonii), and Ketone products.

[0094] In some embodiments, a formulation according to the disclosure may meet or exceed one or more of the following specifications. In some embodiments, a formulation according to the disclosure may include a product profile that may provide a sustained release of NCT / NFT at 120 mg. In some embodiments, a formulation according to the disclosure may meet or exceed a purity of the active ingredient of 85% for GRAS application and a minimum of 90% for commercial applications. In some embodiments, a formulation according to the disclosure may be one or more of heat stable, pH stable (3 – 7), Flowable, and / or have a small particle size (sufficient for 90% to pass 80 mesh). In some embodiments, a formulation according to the disclosure may be provided in the form of Tablets, capsules, gummies, functional ready-to-drink (RTD) or ready-to-mix (RTM) beverages. In some embodiments, a formulation according to the disclosure may meet and / or be certified to meet the requirements of being Kosher, Halal, and / or free of top 9 allergens.

[0095] In some embodiments, a formulation according to the disclosure may be shelf stable for at least 1 year, at least 2 years, at least 3 years, and / or at least 5 years. Methods

[0096] In aspects, the disclosure also provides methods for improving, restoring, or maintaining a subject’s biometabolism in a subject. In some embodiments, the subject is provided or administered a composition comprising one or more tyramine containing hydroxycinnamic acid amides. In some embodiments, the one or more tyramine containing hydroxycinnamic acid amides is NCT and NFT. In some embodiments, the one or more tyramine NCT and NFT are provided as a capsule, gummy, table, functional beverage, and functional food. In some embodiments, the NCT and NFT are provided or administered from about 50 mg to about 150 mg. In some embodiments, the NCT and NFT are provided or administered from about 60 mg. In some embodiments, the NCT and NFT are provided or administered from about 120 mg. In some embodiments, the ratio of NCT to NFT is from about 5:1 to about 1:5. In some embodiments, the NCT and the NFT is in a ratio from about 2.5:1 to about 2:1. In some embodiments, the ratio of NCT to NFT is from about 2.5:1 to about 1:2.5. In some embodiments, the ratio of NCT to NFT is about 5:1. In some embodiments, the ratioof NCT to NFT is from about 4:1. In some embodiments, the ratio of NCT to NFT is about 3:1. In some embodiments, the ratio of NCT to NFT is about 2.2:1. In some embodiments, the ratio of NCT to NFT is about 2:1. In some embodiments, the ratio of NCT to NFT is about 1:2. In some embodiments, the ratio of NCT to NFT is about 1:2.2. In some embodiments, the subject is obese. In some embodiments, the subject has a BMI ≥28.0 kg / m2. In some embodiments, the subject has a Total-C level of ≥ 200 mg / dL. In some embodiments, the subject has a HDL-C level of ≤ 40 mg / dL. In some embodiments, the subject has a triglyceride level of ≥ 150 mg / dL. In some embodiments, the composition is provided with a second active agent. In some embodiments, the second active agent is effective for improving glycemic control or promoting weight management. In some embodiments, the second active agent may include, but is not limited to, a biguanide, a GLP-1 receptor agonist, a DPP-4 inhibitor, and an SGLT2 inhibitor. In some embodiments, the composition is formulated as a sustained release formulation. In some embodiments, the composition is formulated for once-daily administration. In some embodiments, the sustained released formulation provides a reduction in glucose variability. In some embodiments, the subject has pre-diabetes. In some embodiments, the subject with pre-diabetes has a fasting blood glucose level between 100 mg / dL and 125 mg / dL or an HbA1c level between 5.7% and 6.4%. In some embodiments, the subject has a fasting blood glucose level between 100 mg / dL and 125 mg / dL or an HbA1c level between 5.7% and 6.4%.

[0097] In some embodiment, methods are provided for improving, restoring, or maintaining healthy weight management in a subject. In some embodiments, the subject is provided or administered a composition comprising one or more tyramine containing hydroxycinnamic acid amides. In some embodiments, the one or more tyramine containing hydroxycinnamic acid amides is NCT and NFT. In some embodiments, the one or more tyramine NCT and NFT are provided as a capsule, gummy, table, functional beverage, and functional food. In some embodiments, the NCT and NFT are provided or administered from about 50 mg to about 150 mg. In some embodiments, the NCT and NFT are provided or administered from about 60 mg. In some embodiments, the NCT and NFT are provided or administered from about 120 mg. In some embodiments, the ratio of NCT to NFT is from about 5:1 to about 1:5. In some embodiments, the NCT and the NFT is in a ratio from about 2.5:1 to about 2:1. In some embodiments, the ratio of NCT to NFT is from about 2.5:1 to about 1:2.5.In some embodiments, the ratio of NCT to NFT is about 5:1. In some embodiments, the ratio of NCT to NFT is from about 4:1. In some embodiments, the ratio of NCT to NFT is about 3:1. In some embodiments, the ratio of NCT to NFT is about 2.2:1. In some embodiments, the ratio of NCT to NFT is about 2:1. In some embodiments, the ratio of NCT to NFT is about 1:2. In some embodiments, the ratio of NCT to NFT is about 1:2.2. In some embodiments, the subject is obese. In some embodiments, the subject has a BMI ≥28.0 kg / m2. In some embodiments, the subject has a Total-C level of ≥ 200 mg / dL. In some embodiments, the subject has a HDL-C level of ≤ 40 mg / dL. In some embodiments, the subject has a triglyceride level of ≥ 150 mg / dL. In some embodiments, the composition is provided with a second active agent. In some embodiments, the second active agent is effective for improving glycemic control or promoting weight management. In some embodiments, the second active agent may include, but is not limited to, a biguanide, a GLP-1 receptor agonist, a DPP-4 inhibitor, and an SGLT2 inhibitor. In some embodiments, the composition is formulated as a sustained release formulation. In some embodiments, the composition is formulated for once-daily administration. In some embodiments, the sustained released formulation provides a reduction in glucose variability. In some embodiments, the subject has pre-diabetes. In some embodiments, the subject with pre-diabetes has a fasting blood glucose level between 100 mg / dL and 125 mg / dL or an HbA1c level between 5.7% and 6.4%. In some embodiments, the subject has a fasting blood glucose level between 100 mg / dL and 125 mg / dL or an HbA1c level between 5.7% and 6.4%.

[0098] In some embodiments, methods are provided for treating, reducing, or supporting abdominal fat loss. In some embodiments, the subject is provided or administered a composition comprising one or more tyramine containing hydroxycinnamic acid amides. In some embodiments, the one or more tyramine containing hydroxycinnamic acid amides is NCT and NFT. In some embodiments, the one or more tyramine NCT and NFT are provided as a capsule, gummy, table, functional beverage, and functional food. In some embodiments, the NCT and NFT are provided or administered from about 50 mg to about 150 mg. In some embodiments, the NCT and NFT are provided or administered from about 60 mg. In some embodiments, the NCT and NFT are provided or administered from about 120 mg. In some embodiments, the ratio of NCT to NFT is from about 5:1 to about 1:5. In some embodiments, the NCT and the NFT is in a ratio from about 2.5:1 to about 2:1. In some embodiments, theratio of NCT to NFT is from about 2.5:1 to about 1:2.5. In some embodiments, the ratio of NCT to NFT is about 5:1. In some embodiments, the ratio of NCT to NFT is from about 4:1. In some embodiments, the ratio of NCT to NFT is about 3:1. In some embodiments, the ratio of NCT to NFT is about 2.2:1. In some embodiments, the ratio of NCT to NFT is about 2:1. In some embodiments, the ratio of NCT to NFT is about 1:2. In some embodiments, the ratio of NCT to NFT is about 1:2.2. In some embodiments, the subject is obese. In some embodiments, the subject has a BMI ≥28.0 kg / m2. In some embodiments, the subject has a Total-C level of ≥ 200 mg / dL. In some embodiments, the subject has a HDL-C level of ≤ 40 mg / dL. In some embodiments, the subject has a triglyceride level of ≥ 150 mg / dL. In some embodiments, the composition is provided with a second active agent. In some embodiments, the second active agent is effective for improving glycemic control or promoting weight management. In some embodiments, the second active agent may include, but is not limited to, a biguanide, a GLP- 1 receptor agonist, a DPP-4 inhibitor, and an SGLT2 inhibitor. In some embodiments, the composition is formulated as a sustained release formulation. In some embodiments, the composition is formulated for once-daily administration. In some embodiments, the sustained released formulation provides a reduction in glucose variability. In some embodiments, the subject has pre-diabetes. In some embodiments, the subject with pre-diabetes has a fasting blood glucose level between 100 mg / dL and 125 mg / dL or an HbA1c level between 5.7% and 6.4%. In some embodiments, the subject has a fasting blood glucose level between 100 mg / dL and 125 mg / dL or an HbA1c level between 5.7% and 6.4%.

[0099] In some embodiments, methods are provided for treating, reducing, or supporting abdominal visceral fat loss. In some embodiments, the subject is provided or administered a composition comprising one or more tyramine containing hydroxycinnamic acid amides. In some embodiments, the one or more tyramine containing hydroxycinnamic acid amides is NCT and NFT. In some embodiments, the one or more tyramine NCT and NFT are provided as a capsule, gummy, table, functional beverage, and functional food. In some embodiments, the NCT and NFT are provided or administered from about 50 mg to about 150 mg. In some embodiments, the NCT and NFT are provided or administered from about 60 mg. In some embodiments, the NCT and NFT are provided or administered from about 120 mg. In some embodiments, the ratio of NCT to NFT is from about 5:1 to about 1:5. In some embodiments, the NCT and the NFT is in a ratio from about 2.5:1 to about 2:1. In someembodiments, the ratio of NCT to NFT is from about 2.5:1 to about 1:2.5. In some embodiments, the ratio of NCT to NFT is about 5:1. In some embodiments, the ratio of NCT to NFT is from about 4:1. In some embodiments, the ratio of NCT to NFT is about 3:1. In some embodiments, the ratio of NCT to NFT is about 2.2:1. In some embodiments, the ratio of NCT to NFT is about 2:1. In some embodiments, the ratio of NCT to NFT is about 1:2. In some embodiments, the ratio of NCT to NFT is about 1:2.2. In some embodiments, the subject is obese. In some embodiments, the subject has a BMI ≥28.0 kg / m2. In some embodiments, the subject has a Total-C level of ≥ 200 mg / dL. In some embodiments, the subject has a HDL-C level of ≤ 40 mg / dL. In some embodiments, the subject has a triglyceride level of ≥ 150 mg / dL. In some embodiments, the composition is provided with a second active agent. In some embodiments, the second active agent is effective for improving glycemic control or promoting weight management. In some embodiments, the second active agent may include, but is not limited to, a biguanide, a GLP-1 receptor agonist, a DPP-4 inhibitor, and an SGLT2 inhibitor. In some embodiments, the composition is formulated as a sustained release formulation. In some embodiments, the composition is formulated for once-daily administration. In some embodiments, the sustained released formulation provides a reduction in glucose variability. In some embodiments, the subject has pre-diabetes. In some embodiments, the subject with pre-diabetes has a fasting blood glucose level between 100 mg / dL and 125 mg / dL or an HbA1c level between 5.7% and 6.4%. In some embodiments, the subject has a fasting blood glucose level between 100 mg / dL and 125 mg / dL or an HbA1c level between 5.7% and 6.4%.

[0100] In some embodiments, methods are provided for treating, improving, or maintaining lean body mass. In some embodiments, the subject is provided or administered a composition comprising one or more tyramine containing hydroxycinnamic acid amides. In some embodiments, the one or more tyramine containing hydroxycinnamic acid amides is NCT and NFT. In some embodiments, the one or more tyramine NCT and NFT are provided as a capsule, gummy, table, functional beverage, and functional food. In some embodiments, the NCT and NFT are provided or administered from about 50 mg to about 150 mg. In some embodiments, the NCT and NFT are provided or administered from about 60 mg. In some embodiments, the NCT and NFT are provided or administered from about 120 mg. In some embodiments, the ratio of NCT to NFT is from about 5:1 to about 1:5. In some embodiments, the NCT and the NFT is in a ratio from about 2.5:1 to about 2:1. In some embodiments, theratio of NCT to NFT is from about 2.5:1 to about 1:2.5. In some embodiments, the ratio of NCT to NFT is about 5:1. In some embodiments, the ratio of NCT to NFT is from about 4:1. In some embodiments, the ratio of NCT to NFT is about 3:1. In some embodiments, the ratio of NCT to NFT is about 2.2:1. In some embodiments, the ratio of NCT to NFT is about 2:1. In some embodiments, the ratio of NCT to NFT is about 1:2. In some embodiments, the ratio of NCT to NFT is about 1:2.2. In some embodiments, the subject is obese. In some embodiments, the subject has a BMI ≥28.0 kg / m2. In some embodiments, the subject has a Total-C level of ≥ 200 mg / dL. In some embodiments, the subject has a HDL-C level of ≤ 40 mg / dL. In some embodiments, the subject has a triglyceride level of ≥ 150 mg / dL. In some embodiments, the composition is provided with a second active agent. In some embodiments, the second active agent is effective for improving glycemic control or promoting weight management. In some embodiments, the second active agent may include, but is not limited to, a biguanide, a GLP- 1 receptor agonist, a DPP-4 inhibitor, and an SGLT2 inhibitor. In some embodiments, the composition is formulated as a sustained release formulation. In some embodiments, the composition is formulated for once-daily administration. In some embodiments, the sustained released formulation provides a reduction in glucose variability. In some embodiments, the subject has pre-diabetes. In some embodiments, the subject with pre-diabetes has a fasting blood glucose level between 100 mg / dL and 125 mg / dL or an HbA1c level between 5.7% and 6.4%. In some embodiments, the subject has a fasting blood glucose level between 100 mg / dL and 125 mg / dL or an HbA1c level between 5.7% and 6.4%.

[0101] In some embodiments, methods are provided for treating, reducing, or supporting normal blood glucose regulation. In some embodiments, the subject is provided or administered a composition comprising one or more tyramine containing hydroxycinnamic acid amides. In some embodiments, the one or more tyramine containing hydroxycinnamic acid amides is NCT and NFT. In some embodiments, the one or more tyramine NCT and NFT are provided as a capsule, gummy, table, functional beverage, and functional food. In some embodiments, the NCT and NFT are provided or administered from about 50 mg to about 150 mg. In some embodiments, the NCT and NFT are provided or administered from about 60 mg. In some embodiments, the NCT and NFT are provided or administered from about 120 mg. In some embodiments, the ratio of NCT to NFT is from about 5:1 to about 1:5. In some embodiments, the NCT and the NFT is in a ratio from about 2.5:1 to about 2:1. In someembodiments, the ratio of NCT to NFT is from about 2.5:1 to about 1:2.5. In some embodiments, the ratio of NCT to NFT is about 5:1. In some embodiments, the ratio of NCT to NFT is from about 4:1. In some embodiments, the ratio of NCT to NFT is about 3:1. In some embodiments, the ratio of NCT to NFT is about 2.2:1. In some embodiments, the ratio of NCT to NFT is about 2:1. In some embodiments, the ratio of NCT to NFT is about 1:2. In some embodiments, the ratio of NCT to NFT is about 1:2.2. In some embodiments, the subject is obese. In some embodiments, the subject has a BMI ≥28.0 kg / m2. In some embodiments, the subject has a Total-C level of ≥ 200 mg / dL. In some embodiments, the subject has a HDL-C level of ≤ 40 mg / dL. In some embodiments, the subject has a triglyceride level of ≥ 150 mg / dL. In some embodiments, the composition is provided with a second active agent. In some embodiments, the second active agent is effective for improving glycemic control or promoting weight management. In some embodiments, the second active agent may include, but is not limited to, a biguanide, a GLP-1 receptor agonist, a DPP-4 inhibitor, and an SGLT2 inhibitor. In some embodiments, the composition is formulated as a sustained release formulation. In some embodiments, the composition is formulated for once-daily administration. In some embodiments, the sustained released formulation provides a reduction in glucose variability. In some embodiments, the subject has pre-diabetes. In some embodiments, the subject with pre-diabetes has a fasting blood glucose level between 100 mg / dL and 125 mg / dL or an HbA1c level between 5.7% and 6.4%. In some embodiments, the subject has a fasting blood glucose level between 100 mg / dL and 125 mg / dL or an HbA1c level between 5.7% and 6.4%.

[0102] In some embodiments, methods are provided for fat loss in a subject. In some embodiments, the fat loss is visceral fat loss. In some embodiments, the fat loss is abdominal fat loss. In some embodiments, the subject may maintain lead body mass during fat loss. In some embodiments, the subject is provided or administered a composition comprising one or more tyramine containing hydroxycinnamic acid amides. In some embodiments, providing the subject the composition provides glucose level normalization followed by fat loss benefits. In some embodiments, providing to the subject the composition provides normal blood glucose regulation followed by fat loss benefits. In some embodiments, the one or more tyramine containing hydroxycinnamic acid amides is NCT and NFT. In some embodiments, the one or more tyramine NCT and NFT are provided as a capsule, gummy, table, functional beverage, and functional food. In some embodiments, the NCT and NFT are provided oradministered from about 50 mg to about 150 mg. In some embodiments, the NCT and NFT are provided or administered from about 60 mg. In some embodiments, the NCT and NFT are provided or administered from about 120 mg. In some embodiments, the ratio of NCT to NFT is from about 5:1 to about 1:5. In some embodiments, the NCT and the NFT is in a ratio from about 2.5:1 to about 2:1. In some embodiments, the ratio of NCT to NFT is from about 2.5:1 to about 1:2.5. In some embodiments, the ratio of NCT to NFT is about 5:1. In some embodiments, the ratio of NCT to NFT is from about 4:1. In some embodiments, the ratio of NCT to NFT is about 3:1. In some embodiments, the ratio of NCT to NFT is about 2.2:1. In some embodiments, the ratio of NCT to NFT is about 2:1. In some embodiments, the ratio of NCT to NFT is about 1:2. In some embodiments, the ratio of NCT to NFT is about 1:2.2. In some embodiments, the subject is obese. In some embodiments, the subject has a BMI ≥28.0 kg / m2. In some embodiments, the subject has a Total-C level of ≥ 200 mg / dL. In some embodiments, the subject has a HDL-C level of ≤ 40 mg / dL. In some embodiments, the subject has a triglyceride level of ≥ 150 mg / dL. In some embodiments, the composition is provided with a second active agent. In some embodiments, the second active agent is effective for improving glycemic control or promoting weight management. In some embodiments, the second active agent may include, but is not limited to, a biguanide, a GLP-1 receptor agonist, a DPP-4 inhibitor, and an SGLT2 inhibitor. In some embodiments, the composition is formulated as a sustained release formulation. In some embodiments, the composition is formulated for once-daily administration. In some embodiments, the sustained released formulation provides a reduction in glucose variability. In some embodiments, the subject has pre-diabetes. In some embodiments, the subject with pre-diabetes has a fasting blood glucose level between 100 mg / dL and 125 mg / dL or an HbA1c level between 5.7% and 6.4%. In some embodiments, the subject has a fasting blood glucose level between 100 mg / dL and 125 mg / dL or an HbA1c level between 5.7% and 6.4%.

[0103] In some embodiments, methods are provided for glucose management in a subject. In some embodiments, glucose management may induce fat loss in the subject. In some embodiments, glucose management may induce to visceral fat loss. In some embodiments, glucose management may induce abdominal fat loss. In some embodiments, glucose management may induce lean body mass during fat loss in the subject. In some embodiments, the subject is provided or administered a composition comprising one or moretyramine containing hydroxycinnamic acid amides. In some embodiments, providing the subject the composition provides glucose level normalization followed by fat loss benefits. In some embodiments, providing to the subject the composition provides normal blood glucose regulation followed by fat loss benefits. In some embodiments, the one or more tyramine containing hydroxycinnamic acid amides is NCT and NFT. In some embodiments, the one or more tyramine NCT and NFT are provided as a capsule, gummy, table, functional beverage, and functional food. In some embodiments, the NCT and NFT are provided or administered from about 50 mg to about 150 mg. In some embodiments, the NCT and NFT are provided or administered from about 60 mg. In some embodiments, the NCT and NFT are provided or administered from about 120 mg. In some embodiments, the ratio of NCT to NFT is from about 5:1 to about 1:5. In some embodiments, the NCT and the NFT is in a ratio from about 2.5:1 to about 2:1. In some embodiments, the ratio of NCT to NFT is from about 2.5:1 to about 1:2.5. In some embodiments, the ratio of NCT to NFT is about 5:1. In some embodiments, the ratio of NCT to NFT is from about 4:1. In some embodiments, the ratio of NCT to NFT is about 3:1. In some embodiments, the ratio of NCT to NFT is about 2.2:1. In some embodiments, the ratio of NCT to NFT is about 2:1. In some embodiments, the ratio of NCT to NFT is about 1:2. In some embodiments, the ratio of NCT to NFT is about 1:2.2. In some embodiments, the subject is obese. In some embodiments, the subject has a BMI ≥28.0 kg / m2. In some embodiments, the subject has a Total-C level of ≥ 200 mg / dL. In some embodiments, the subject has a HDL-C level of ≤ 40 mg / dL. In some embodiments, the subject has a triglyceride level of ≥ 150 mg / dL. In some embodiments, the composition is provided with a second active agent. In some embodiments, the second active agent is effective for improving glycemic control or promoting weight management. In some embodiments, the second active agent may include, but is not limited to, a biguanide, a GLP-1 receptor agonist, a DPP-4 inhibitor, and an SGLT2 inhibitor. In some embodiments, the composition is formulated as a sustained release formulation. In some embodiments, the composition is formulated for once-daily administration. In some embodiments, the sustained released formulation provides a reduction in glucose variability. In some embodiments, the subject has pre-diabetes. In some embodiments, the subject with pre-diabetes has a fasting blood glucose level between 100 mg / dL and 125 mg / dL or an HbA1c level between 5.7% and 6.4%. In some embodiments, thesubject has a fasting blood glucose level between 100 mg / dL and 125 mg / dL or an HbA1c level between 5.7% and 6.4%.

[0104] In some embodiments, methods are provided for improving biometabolism in a subject. In some embodiments, improving biometabolism in a subject activates a metabolic regulator to promote a healthy body composition. In some embodiments, improving biometabolism may include promoting healthy weight management in a subject. In some embodiments, improving biometabolism may include treating, reducing, or removing abdominal fat in a subject. In some embodiments, improving biometabolism may include treating, reducing, or removing visceral fat in a subject. In some embodiments, improving biometabolism mayinclude maintaining lean body mass in a subject. In some embodiments, improving biometabolsim may include supporting normal blood glucose regulation. In some embodiments, the subject is provided or administered a composition comprising one or more tyramine containing hydroxycinnamic acid amides. In some embodiments, providing the subject the composition provides glucose level normalization followed by fat loss benefits. In some embodiments, providing to the subject the composition provides normal blood glucose regulation followed by fat loss benefits. In some embodiments, the one or more tyramine containing hydroxycinnamic acid amides is NCT and NFT. In some embodiments, the one or more tyramine NCT and NFT are provided as a capsule, gummy, table, functional beverage, and functional food. In some embodiments, the NCT and NFT are provided or administered from about 50 mg to about 150 mg. In some embodiments, the NCT and NFT are provided or administered from about 60 mg. In some embodiments, the NCT and NFT are provided or administered from about 120 mg. In some embodiments, the ratio of NCT to NFT is from about 5:1 to about 1:5. In some embodiments, the NCT and the NFT is in a ratio from about 2.5:1 to about 2:1. In some embodiments, the ratio of NCT to NFT is from about 2.5:1 to about 1:2.5. In some embodiments, the ratio of NCT to NFT is about 5:1. In some embodiments, the ratio of NCT to NFT is from about 4:1. In some embodiments, the ratio of NCT to NFT is about 3:1. In some embodiments, the ratio of NCT to NFT is about 2.2:1. In some embodiments, the ratio of NCT to NFT is about 2:1. In some embodiments, the ratio of NCT to NFT is about 1:2. In some embodiments, the ratio of NCT to NFT is about 1:2.2. In some embodiments, the subject is obese. In some embodiments, the subject has a BMI ≥28.0 kg / m2. In some embodiments, the subject has a Total-C level of ≥ 200 mg / dL. In some embodiments, thesubject has a HDL-C level of ≤ 40 mg / dL. In some embodiments, the subject has a triglyceride level of ≥ 150 mg / dL. In some embodiments, the composition is provided with a second active agent. In some embodiments, the second active agent is effective for improving glycemic control or promoting weight management. In some embodiments, the second active agent may include, but is not limited to, a biguanide, a GLP-1 receptor agonist, a DPP-4 inhibitor, and an SGLT2 inhibitor. In some embodiments, the composition is formulated as a sustained release formulation. In some embodiments, the composition is formulated for once-daily administration. In some embodiments, the sustained released formulation provides a reduction in glucose variability. In some embodiments, the subject has pre-diabetes. In some embodiments, the subject with pre-diabetes has a fasting blood glucose level between 100 mg / dL and 125 mg / dL or an HbA1c level between 5.7% and 6.4%. In some embodiments, the subject has a fasting blood glucose level between 100 mg / dL and 125 mg / dL or an HbA1c level between 5.7% and 6.4%.

[0105] Some embodiments relate to a method to provide or support abdominal fat loss in a subject. In some embodiments, the method includes providing to the subject a composition comprising from about 50 mg to about 150 mg N-trans-caffeoyltyramine and N- trans-feruloyltyramine, wherein the N-trans-caffeoyltyramine and the N-trans- feruloyltyramine is in a ratio of 10:1 to 1:10. In some embodiments, the composition comprises about 60 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine. In some embodiments, the composition comprises about 120 mg N-trans-caffeoyltyramine and N-trans- feruloyltyramine. In some embodiments, the ratio of N-trans-caffeoyltyramine and N-trans- feruloyltyramine is 5:1 to 1:5. In some embodiments, the NCT and the NFT is in a ratio from about 2.5:1 to about 2:1. In some embodiments, the ratio of NCT to NFT is from about 2.5:1 to about 1:2.5. In some embodiments, the ratio of NCT to NFT is about 5:1. In some embodiments, the ratio of NCT to NFT is from about 4:1. In some embodiments, the ratio of NCT to NFT is about 3:1. In some embodiments, the ratio of NCT to NFT is about 2.2:1. In some embodiments, the ratio of NCT to NFT is about 2:1. In some embodiments, the ratio of NCT to NFT is about 1:2. In some embodiments, the ratio of NCT to NFT is about 1:2.2. In some embodiments, the composition is in a form of a capsule, gummy, table, functional beverage, and functional food. In some embodiments, the capsule is a sustained release capsule. In some embodiments, providing to the subject the composition provides or supportssustained abdominal fat loss. In some embodiments, the subject has a body mass index (BMI) of about ≥29.0 to about <40.0 kg / m2. In some embodiments, the subject has a BMI ≥ 28.0 kg / m2. In some embodiments, the subject has a Total-C level of ≥ 200 mg / dL. In some embodiments, the subject has a HDL-C level of ≤ 40 mg / dL. In some embodiments, the subject has a triglyceride level of ≥ 150 mg / dL. In some embodiments, the subject has pre-diabetes. In some embodiments, the subject is administered the composition once per day. In some embodiments, the subject is administered the composition for at least 6 six months. In some embodiments, the composition is provided in combination with a dietary regimen designed to enhance the weight management in the subject. In some embodiments, the subject is advised to engage in a physical activity program in conjunction with the administration of the composition. In some embodiments, the composition provides improvement in metabolic rate. In some embodiments, the subject has a waist circumference reduction of at least 5% from baseline after administration of the composition for 3 months. In some embodiments, providing to the subject the composition improves insulin sensitivity. In some embodiments, a treatment outcome comprises a reduction in abdominal fat mass by at least 5% to 15% from baseline measurements, as measured in kilograms (kg) or pounds (lbs). In some embodiments, achieving a decrease in body weight of no less than 5% to 20% compared to initial measurements. In some embodiments, a treatment outcome comprises a reduction in abdominal fat by a range of 10% to 30% from baseline measurements, quantified in cubic centimeters (cm³) or inches (in³). In some embodiments, a treatment outcome comprises a decrease in abdominal fat by a range of 5% to 25% from baseline measurements. In some embodiments, the method further includes maintaining abdominal fat loss within a range of ±3% to ±10% of the achieved reduction in body fat mass. In some embodiments, a treatment outcome comprises achieving controlled blood sugar levels within a target range of 70 to 120 milligrams per deciliter (mg / dL) or 3.9 to 6.7 millimoles per liter (mmol / L). In some embodiments, the subject is a human female. In some embodiments, the subject is a human male. In some embodiments, the composition is provided with a second active agent. In some embodiments, the second active agent is effective for improving glycemic control or promoting weight management. In some embodiments, the second active agent may include, but is not limited to, a biguanide, a GLP-1 receptor agonist, a DPP-4 inhibitor, and an SGLT2 inhibitor. In some embodiments, the composition is formulated as a sustained release formulation. Insome embodiments, the composition is formulated for once-daily administration. In some embodiments, the sustained released formulation provides a reduction in glucose variability. In some embodiments, the subject has pre-diabetes. In some embodiments, the subject with pre-diabetes has a fasting blood glucose level between 100 mg / dL and 125 mg / dL or an HbA1c level between 5.7% and 6.4%. In some embodiments, the subject has a fasting blood glucose level between 100 mg / dL and 125 mg / dL or an HbA1c level between 5.7% and 6.4%.

[0106] Some embodiments relate to a method to provide or support visceral fat loss in a subject. In some embodiments, the method includes providing to the subject a composition comprising from about 50 mg to about 150 mg N-trans-caffeoyltyramine and N-trans- feruloyltyramine, wherein the N-trans-caffeoyltyramine and the N-trans-feruloyltyramine is in a ratio of 10:1 to 1:10. In some embodiments, the NCT and the NFT is in a ratio from about 2.5:1 to about 2:1. In some embodiments, the ratio of NCT to NFT is from about 2.5:1 to about 1:2.5. In some embodiments, the ratio of NCT to NFT is about 5:1. In some embodiments, the ratio of NCT to NFT is from about 4:1. In some embodiments, the ratio of NCT to NFT is about 3:1. In some embodiments, the ratio of NCT to NFT is about 2.2:1. In some embodiments, the ratio of NCT to NFT is about 2:1. In some embodiments, the ratio of NCT to NFT is about 1:2. In some embodiments, the ratio of NCT to NFT is about 1:2.2. In some embodiments, the composition comprises about 60 mg N-trans-caffeoyltyramine and N-trans- feruloyltyramine. In some embodiments, the composition comprises about 120 mg N-trans- caffeoyltyramine and N-trans-feruloyltyramine. In some embodiments, the ratio of N-trans- caffeoyltyramine and N-trans-feruloyltyramine is 5:1 to 1:5. In some embodiments, the composition is in a form of a capsule, gummy, table, functional beverage, and functional food. In some embodiments, the capsule is a sustained release capsule. In some embodiments, providing to the subject the composition provides or supports sustained visceral fat loss. In some embodiments, the subject has a body mass index (BMI) of about ≥29.0 to about <40.0 kg / m2. In some embodiments, the subject has a BMI ≥ 28.0 kg / m2. In some embodiments, the subject has a Total-C level of ≥ 200 mg / dL. In some embodiments, the subject has a HDL-C level of ≤ 40 mg / dL. In some embodiments, the subject has a triglyceride level of ≥ 150 mg / dL. In some embodiments, the subject has pre-diabetes. In some embodiments, the subject is administered the composition once per day. In some embodiments, the subject is administered the composition for at least 6 six months. In some embodiments, the composition is providedin combination with a dietary regimen designed to enhance the weight management in the subject. In some embodiments, the subject is advised to engage in a physical activity program in conjunction with the administration of the composition. In some embodiments, the composition provides improvement in metabolic rate. In some embodiments, the subject has a waist circumference reduction of at least 5% from baseline after administration of the composition for 3 months. In some embodiments, providing to the subject the composition improves insulin sensitivity. In some embodiments, a treatment outcome comprises a reduction in visceral fat mass by at least 5% to 15% from baseline measurements, as measured in kilograms (kg) or pounds (lbs). In some embodiments, the method further includes achieving a decrease in body weight of no less than 5% to 20% compared to initial measurements. In some embodiments, a treatment outcome comprises a reduction in visceral fat by a range of 10% to 30% from baseline measurements, quantified in cubic centimeters (cm³) or inches (in³). In some embodiments, a treatment outcome comprises a decrease in visceral fat by a range of 5% to 25% from baseline measurements. In some embodiments, the method further includes maintaining visceral fat loss within a range of ±3% to ±10% of the achieved reduction in body fat mass. In some embodiments, a treatment outcome comprises achieving controlled blood sugar levels within a target range of 70 to 120 milligrams per deciliter (mg / dL) or 3.9 to 6.7 millimoles per liter (mmol / L). In some embodiments, the subject is a human female. In some embodiments, the subject is a human male. In some embodiments, the composition is provided with a second active agent. In some embodiments, the second active agent is effective for improving glycemic control or promoting weight management. In some embodiments, the second active agent may include, but is not limited to, a biguanide, a GLP-1 receptor agonist, a DPP-4 inhibitor, and an SGLT2 inhibitor. In some embodiments, the composition is formulated as a sustained release formulation. In some embodiments, the composition is formulated for once-daily administration. In some embodiments, the sustained released formulation provides a reduction in glucose variability. In some embodiments, the subject has pre-diabetes. In some embodiments, the subject with pre-diabetes has a fasting blood glucose level between 100 mg / dL and 125 mg / dL or an HbA1c level between 5.7% and 6.4%. In some embodiments, the subject has a fasting blood glucose level between 100 mg / dL and 125 mg / dL or an HbA1c level between 5.7% and 6.4%.

[0107] Some embodiments relate to a method to maintain lean body mass in a subject. In some embodiments, the method includes providing to the subject a composition comprising from about 50 mg to about 150 mg N-trans-caffeoyltyramine and N-trans- feruloyltyramine, wherein the N-trans-caffeoyltyramine and the N-trans-feruloyltyramine is in a ratio of 10:1 to 1:10. In some embodiments, the composition comprises about 60 mg N-trans- caffeoyltyramine and N-trans-feruloyltyramine. In some embodiments, the composition comprises about 120 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine. In some embodiments, the ratio of N-trans-caffeoyltyramine and N-trans-feruloyltyramine is 5:1 to 1:5. In some embodiments, the NCT and the NFT is in a ratio from about 2.5:1 to about 2:1. In some embodiments, the ratio of NCT to NFT is from about 2.5:1 to about 1:2.5. In some embodiments, the ratio of NCT to NFT is about 5:1. In some embodiments, the ratio of NCT to NFT is from about 4:1. In some embodiments, the ratio of NCT to NFT is about 3:1. In some embodiments, the ratio of NCT to NFT is about 2.2:1. In some embodiments, the ratio of NCT to NFT is about 2:1. In some embodiments, the ratio of NCT to NFT is about 1:2. In some embodiments, the ratio of NCT to NFT is about 1:2.2. In some embodiments, the composition is in a form of a capsule, gummy, table, functional beverage, and functional food. In some embodiments, the capsule is a sustained release capsule. In some embodiments, providing to the subject the composition maintains lean body mass. In some embodiments, the subject has a body mass index (BMI) of about ≥29.0 to about <40.0 kg / m2. In some embodiments, the subject has a BMI ≥ 28.0 kg / m2. In some embodiments, the subject has a Total-C level of ≥ 200 mg / dL. In some embodiments, the subject has a HDL-C level of ≤ 40 mg / dL. In some embodiments, subject has a triglyceride level of ≥ 150 mg / dL. In some embodiments, the subject has pre-diabetes. In some embodiments, the subject is administered the composition once per day. In some embodiments, the subject is administered the composition for at least 6 six months. In some embodiments, the composition is provided in combination with a dietary regimen designed to enhance the weight management in the subject. In some embodiments, the subject is advised to engage in a physical activity program in conjunction with the administration of the composition. In some embodiments, the composition provides improvement in metabolic rate. In some embodiments, the subject has a waist circumference reduction of at least 5% from baseline after administration of the composition for 3 months. In some embodiments, providing to the subject the composition improves insulin sensitivity. Insome embodiments, a treatment outcome comprises a reduction in abdominal or visceral fat mass by at least 5% to 15% from baseline measurements, as measured in kilograms (kg) or pounds (lbs). In some embodiments, the method further includes achieving a decrease in body weight of no less than 5% to 20% compared to initial measurements. In some embodiments, a treatment outcome comprises a reduction in abdominal or visceral fat by a range of 10% to 30% from baseline measurements, quantified in cubic centimeters (cm³) or inches (in³). In some embodiments, a treatment outcome comprises a decrease in abdominal or visceral fat by a range of 5% to 25% from baseline measurements. In some embodiments, the method further includes maintaining visceral fat loss within a range of ±3% to ±10% of the achieved reduction in body fat mass. In some embodiments, a treatment outcome comprises achieving controlled blood sugar levels within a target range of 70 to 120 milligrams per deciliter (mg / dL) or 3.9 to 6.7 millimoles per liter (mmol / L). In some embodiments, the subject is a human female. In some embodiments, the subject is a human male. In some embodiments, the composition is provided with a second active agent. In some embodiments, the second active agent is effective for improving glycemic control or promoting weight management. In some embodiments, the second active agent may include, but is not limited to, a biguanide, a GLP-1 receptor agonist, a DPP-4 inhibitor, and an SGLT2 inhibitor. In some embodiments, the composition is formulated as a sustained release formulation. In some embodiments, the composition is formulated for once-daily administration. In some embodiments, the sustained released formulation provides a reduction in glucose variability. In some embodiments, the subject has pre-diabetes. In some embodiments, the subject with pre-diabetes has a fasting blood glucose level between 100 mg / dL and 125 mg / dL or an HbA1c level between 5.7% and 6.4%. In some embodiments, the subject has a fasting blood glucose level between 100 mg / dL and 125 mg / dL or an HbA1c level between 5.7% and 6.4%.

[0108] Some embodiments relate to a method to support normal blood glucose regulation in a subject. In some embodiments, the method includes providing to the subject a composition comprising from about 50 mg to about 150 mg N-trans-caffeoyltyramine and N- trans-feruloyltyramine, wherein the N-trans-caffeoyltyramine and the N-trans- feruloyltyramine is in a ratio of 10:1 to 1:10. In some embodiments, the composition comprises about 60 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine. In some embodiments, the composition comprises about 120 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine. In some embodiments, the ratio of N-trans-caffeoyltyramine and N-trans- feruloyltyramine is 5:1 to 1:5. In some embodiments, the NCT and the NFT is in a ratio from about 2.5:1 to about 2:1. In some embodiments, the ratio of NCT to NFT is from about 2.5:1 to about 1:2.5. In some embodiments, the ratio of NCT to NFT is about 5:1. In some embodiments, the ratio of NCT to NFT is from about 4:1. In some embodiments, the ratio of NCT to NFT is about 3:1. In some embodiments, the ratio of NCT to NFT is about 2.2:1. In some embodiments, the ratio of NCT to NFT is about 2:1. In some embodiments, the ratio of NCT to NFT is about 1:2. In some embodiments, the ratio of NCT to NFT is about 1:2.2. In some embodiments, the composition is in a form of a capsule, gummy, table, functional beverage, and functional food. In some embodiments, the capsule is a sustained release capsule. In some embodiments, providing to the subject the composition maintains lean body mass. In some embodiments, the subject has a body mass index (BMI) of about ≥29.0 to about <40.0 kg / m2. In some embodiments, the subject has a BMI ≥ 28.0 kg / m2. In some embodiments, the subject has a Total-C level of ≥ 200 mg / dL. In some embodiments, the subject has a HDL-C level of ≤ 40 mg / dL. In some embodiments, subject has a triglyceride level of ≥ 150 mg / dL. In some embodiments, the subject has pre-diabetes. In some embodiments, the subject is administered the composition once per day. In some embodiments, the subject is administered the composition for at least 6 six months. In some embodiments, the composition is provided in combination with a dietary regimen designed to enhance the weight management in the subject. In some embodiments, the subject is advised to engage in a physical activity program in conjunction with the administration of the composition. In some embodiments, the composition provides improvement in metabolic rate. In some embodiments, the subject has a waist circumference reduction of at least 5% from baseline after administration of the composition for 3 months. In some embodiments, providing to the subject the composition improves insulin sensitivity. In some embodiments, a treatment outcome comprises a reduction in abdominal or visceral fat mass by at least 5% to 15% from baseline measurements, as measured in kilograms (kg) or pounds (lbs). In some embodiments, the method further includes achieving a decrease in body weight of no less than 5% to 20% compared to initial measurements. In some embodiments, a treatment outcome comprises a reduction in abdominal or visceral fat by a range of 10% to 30% from baseline measurements, quantified in cubic centimeters (cm³) or inches (in³). In some embodiments, a treatmentoutcome comprises a decrease in abdominal or visceral fat by a range of 5% to 25% from baseline measurements. In some embodiments, the method further includes maintaining visceral fat loss within a range of ±3% to ±10% of the achieved reduction in body fat mass. In some embodiments, a treatment outcome comprises achieving controlled blood sugar levels within a target range of 70 to 120 milligrams per deciliter (mg / dL) or 3.9 to 6.7 millimoles per liter (mmol / L). In some embodiments, the subject is a human female. In some embodiments, the subject is a human male. In some embodiments, the composition is provided with a second active agent. In some embodiments, the second active agent is effective for improving glycemic control or promoting weight management. In some embodiments, the second active agent may include, but is not limited to, a biguanide, a GLP-1 receptor agonist, a DPP-4 inhibitor, and an SGLT2 inhibitor. In some embodiments, the composition is formulated as a sustained release formulation. In some embodiments, the composition is formulated for once- daily administration. In some embodiments, the sustained released formulation provides a reduction in glucose variability. In some embodiments, the subject has pre-diabetes. In some embodiments, the subject with pre-diabetes has a fasting blood glucose level between 100 mg / dL and 125 mg / dL or an HbA1c level between 5.7% and 6.4%. In some embodiments, the subject has a fasting blood glucose level between 100 mg / dL and 125 mg / dL or an HbA1c level between 5.7% and 6.4%.

[0109] Some embodiments relate to a method to provide glycemic control in a subject. In some embodiments, the method includes providing to the subject a composition comprising from about 50 mg to about 150 mg N-trans-caffeoyltyramine and N-trans- feruloyltyramine, wherein the N-trans-caffeoyltyramine and the N-trans-feruloyltyramine is in a ratio of 10:1 to 1:10. In some embodiments, the composition comprises about 60 mg N-trans- caffeoyltyramine and N-trans-feruloyltyramine. In some embodiments, the composition comprises about 120 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine. In some embodiments, the ratio of N-trans-caffeoyltyramine and N-trans-feruloyltyramine is 5:1 to 1:5. In some embodiments, the NCT and the NFT is in a ratio from about 2.5:1 to about 2:1. In some embodiments, the ratio of NCT to NFT is from about 2.5:1 to about 1:2.5. In some embodiments, the ratio of NCT to NFT is about 5:1. In some embodiments, the ratio of NCT to NFT is from about 4:1. In some embodiments, the ratio of NCT to NFT is about 3:1. In some embodiments, the ratio of NCT to NFT is about 2.2:1. In some embodiments, the ratio of NCTto NFT is about 2:1. In some embodiments, the ratio of NCT to NFT is about 1:2. In some embodiments, the ratio of NCT to NFT is about 1:2.2. In some embodiments, the composition is in a form of a capsule, gummy, table, functional beverage, and functional food. In some embodiments, the capsule is a sustained release capsule. In some embodiments, providing to the subject the composition maintains lean body mass. In some embodiments, the subject has a body mass index (BMI) of about ≥29.0 to about <40.0 kg / m2. In some embodiments, the subject has a BMI ≥ 28.0 kg / m2. In some embodiments, the subject has a Total-C level of ≥ 200 mg / dL. In some embodiments, the subject has a HDL-C level of ≤ 40 mg / dL. In some embodiments, subject has a triglyceride level of ≥ 150 mg / dL. In some embodiments, the subject has pre-diabetes. In some embodiments, the subject is administered the composition once per day. In some embodiments, the subject is administered the composition for at least 6 six months. In some embodiments, the composition is provided in combination with a dietary regimen designed to enhance the weight management in the subject. In some embodiments, the subject is advised to engage in a physical activity program in conjunction with the administration of the composition. In some embodiments, the composition provides improvement in metabolic rate. In some embodiments, the subject has a waist circumference reduction of at least 5% from baseline after administration of the composition for 3 months. In some embodiments, providing to the subject the composition improves insulin sensitivity. In some embodiments, a treatment outcome comprises a reduction in abdominal or visceral fat mass by at least 5% to 15% from baseline measurements, as measured in kilograms (kg) or pounds (lbs). In some embodiments, the method further includes achieving a decrease in body weight of no less than 5% to 20% compared to initial measurements. In some embodiments, a treatment outcome comprises a reduction in abdominal or visceral fat by a range of 10% to 30% from baseline measurements, quantified in cubic centimeters (cm³) or inches (in³). In some embodiments, a treatment outcome comprises a decrease in abdominal or visceral fat by a range of 5% to 25% from baseline measurements. In some embodiments, the method further includes maintaining visceral fat loss within a range of ±3% to ±10% of the achieved reduction in body fat mass. In some embodiments, a treatment outcome comprises achieving controlled blood sugar levels within a target range of 70 to 120 milligrams per deciliter (mg / dL) or 3.9 to 6.7 millimoles per liter (mmol / L). In some embodiments, the subject is a human female. In some embodiments, the subject is a human male. In some embodiments, the composition isprovided with a second active agent. In some embodiments, the second active agent is effective for improving glycemic control or promoting weight management. In some embodiments, the second active agent may include, but is not limited to, a biguanide, a GLP-1 receptor agonist, a DPP-4 inhibitor, and an SGLT2 inhibitor. In some embodiments, the composition is formulated as a sustained release formulation. In some embodiments, the composition is formulated for once-daily administration. In some embodiments, the sustained released formulation provides a reduction in glucose variability. In some embodiments, the subject has pre-diabetes. In some embodiments, the subject with pre-diabetes has a fasting blood glucose level between 100 mg / dL and 125 mg / dL or an HbA1c level between 5.7% and 6.4%. In some embodiments, the subject has a fasting blood glucose level between 100 mg / dL and 125 mg / dL or an HbA1c level between 5.7% and 6.4%.

[0110] Some embodiments relate to a method to provide type-2 diabetes management in a subject. In some embodiments, the method includes providing to the subject a composition comprising from about 50 mg to about 150 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine, wherein the N-trans-caffeoyltyramine and the N-trans- feruloyltyramine is in a ratio of 10:1 to 1:10. In some embodiments, the composition comprises about 60 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine. In some embodiments, the composition comprises about 120 mg N-trans-caffeoyltyramine and N-trans- feruloyltyramine. In some embodiments, the ratio of N-trans-caffeoyltyramine and N-trans- feruloyltyramine is 5:1 to 1:5. In some embodiments, the NCT and the NFT is in a ratio from about 2.5:1 to about 2:1. In some embodiments, the ratio of NCT to NFT is from about 2.5:1 to about 1:2.5. In some embodiments, the ratio of NCT to NFT is about 5:1. In some embodiments, the ratio of NCT to NFT is from about 4:1. In some embodiments, the ratio of NCT to NFT is about 3:1. In some embodiments, the ratio of NCT to NFT is about 2.2:1. In some embodiments, the ratio of NCT to NFT is about 2:1. In some embodiments, the ratio of NCT to NFT is about 1:2. In some embodiments, the ratio of NCT to NFT is about 1:2.2. In some embodiments, the composition is in a form of a capsule, gummy, table, functional beverage, and functional food. In some embodiments, the capsule is a sustained release capsule. In some embodiments, providing to the subject the composition maintains lean body mass. In some embodiments, the subject has a body mass index (BMI) of about ≥29.0 to about <40.0 kg / m2. In some embodiments, the subject has a BMI ≥ 28.0 kg / m2. In someembodiments, the subject has a Total-C level of ≥ 200 mg / dL. In some embodiments, the subject has a HDL-C level of ≤ 40 mg / dL. In some embodiments, subject has a triglyceride level of ≥ 150 mg / dL. In some embodiments, the subject has pre-diabetes. In some embodiments, the subject is administered the composition once per day. In some embodiments, the subject is administered the composition for at least 6 six months. In some embodiments, the composition is provided in combination with a dietary regimen designed to enhance the weight management in the subject. In some embodiments, the subject is advised to engage in a physical activity program in conjunction with the administration of the composition. In some embodiments, the composition provides improvement in metabolic rate. In some embodiments, the subject has a waist circumference reduction of at least 5% from baseline after administration of the composition for 3 months. In some embodiments, providing to the subject the composition improves insulin sensitivity. In some embodiments, a treatment outcome comprises a reduction in abdominal or visceral fat mass by at least 5% to 15% from baseline measurements, as measured in kilograms (kg) or pounds (lbs). In some embodiments, the method further includes achieving a decrease in body weight of no less than 5% to 20% compared to initial measurements. In some embodiments, a treatment outcome comprises a reduction in abdominal or visceral fat by a range of 10% to 30% from baseline measurements, quantified in cubic centimeters (cm³) or inches (in³). In some embodiments, a treatment outcome comprises a decrease in abdominal or visceral fat by a range of 5% to 25% from baseline measurements. In some embodiments, the method further includes maintaining visceral fat loss within a range of ±3% to ±10% of the achieved reduction in body fat mass. In some embodiments, a treatment outcome comprises achieving controlled blood sugar levels within a target range of 70 to 120 milligrams per deciliter (mg / dL) or 3.9 to 6.7 millimoles per liter (mmol / L). In some embodiments, the subject is a human female. In some embodiments, the subject is a human male. In some embodiments, the composition is provided with a second active agent. In some embodiments, the second active agent is effective for improving glycemic control or promoting weight management. In some embodiments, the second active agent may include, but is not limited to, a biguanide, a GLP-1 receptor agonist, a DPP-4 inhibitor, and an SGLT2 inhibitor. In some embodiments, the composition is formulated as a sustained release formulation. In some embodiments, the composition is formulated for once- daily administration. In some embodiments, the sustained released formulation provides areduction in glucose variability. In some embodiments, the subject has pre-diabetes. In some embodiments, the subject with pre-diabetes has a fasting blood glucose level between 100 mg / dL and 125 mg / dL or an HbA1c level between 5.7% and 6.4%. In some embodiments, the subject has a fasting blood glucose level between 100 mg / dL and 125 mg / dL or an HbA1c level between 5.7% and 6.4%.

[0111] Some embodiments relate to a method to improve blood sugar regulation in a subject. In some embodiments, the method includes providing to the subject a composition comprising from about 50 mg to about 150 mg N-trans-caffeoyltyramine and N-trans- feruloyltyramine, wherein the N-trans-caffeoyltyramine and the N-trans-feruloyltyramine is in a ratio of 10:1 to 1:10. In some embodiments, the composition comprises about 60 mg N-trans- caffeoyltyramine and N-trans-feruloyltyramine. In some embodiments, the composition comprises about 120 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine. In some embodiments, the ratio of N-trans-caffeoyltyramine and N-trans-feruloyltyramine is 5:1 to 1:5. In some embodiments, the NCT and the NFT is in a ratio from about 2.5:1 to about 2:1. In some embodiments, the ratio of NCT to NFT is from about 2.5:1 to about 1:2.5. In some embodiments, the ratio of NCT to NFT is about 5:1. In some embodiments, the ratio of NCT to NFT is from about 4:1. In some embodiments, the ratio of NCT to NFT is about 3:1. In some embodiments, the ratio of NCT to NFT is about 2.2:1. In some embodiments, the ratio of NCT to NFT is about 2:1. In some embodiments, the ratio of NCT to NFT is about 1:2. In some embodiments, the ratio of NCT to NFT is about 1:2.2. In some embodiments, the composition is in a form of a capsule, gummy, table, functional beverage, and functional food. In some embodiments, the capsule is a sustained release capsule. In some embodiments, providing to the subject the composition maintains lean body mass. In some embodiments, the subject has a body mass index (BMI) of about ≥29.0 to about <40.0 kg / m2. In some embodiments, the subject has a BMI ≥ 28.0 kg / m2. In some embodiments, the subject has a Total-C level of ≥ 200 mg / dL. In some embodiments, the subject has a HDL-C level of ≤ 40 mg / dL. In some embodiments, subject has a triglyceride level of ≥ 150 mg / dL. In some embodiments, the subject has pre-diabetes. In some embodiments, the subject is administered the composition once per day. In some embodiments, the subject is administered the composition for at least 6 six months. In some embodiments, the composition is provided in combination with a dietary regimen designed to enhance the weight management in the subject. In some embodiments,the subject is advised to engage in a physical activity program in conjunction with the administration of the composition. In some embodiments, the composition provides improvement in metabolic rate. In some embodiments, the subject has a waist circumference reduction of at least 5% from baseline after administration of the composition for 3 months. In some embodiments, providing to the subject the composition improves insulin sensitivity. In some embodiments, a treatment outcome comprises a reduction in abdominal or visceral fat mass by at least 5% to 15% from baseline measurements, as measured in kilograms (kg) or pounds (lbs). In some embodiments, the method further includes achieving a decrease in body weight of no less than 5% to 20% compared to initial measurements. In some embodiments, a treatment outcome comprises a reduction in abdominal or visceral fat by a range of 10% to 30% from baseline measurements, quantified in cubic centimeters (cm³) or inches (in³). In some embodiments, a treatment outcome comprises a decrease in abdominal or visceral fat by a range of 5% to 25% from baseline measurements. In some embodiments, the method further includes maintaining visceral fat loss within a range of ±3% to ±10% of the achieved reduction in body fat mass. In some embodiments, a treatment outcome comprises achieving controlled blood sugar levels within a target range of 70 to 120 milligrams per deciliter (mg / dL) or 3.9 to 6.7 millimoles per liter (mmol / L). In some embodiments, the subject is a human female. In some embodiments, the subject is a human male. In some embodiments, the composition is provided with a second active agent. In some embodiments, the second active agent is effective for improving glycemic control or promoting weight management. In some embodiments, the second active agent may include, but is not limited to, a biguanide, a GLP-1 receptor agonist, a DPP-4 inhibitor, and an SGLT2 inhibitor. In some embodiments, the composition is formulated as a sustained release formulation. In some embodiments, the composition is formulated for once-daily administration. In some embodiments, the sustained released formulation provides a reduction in glucose variability. In some embodiments, the subject has pre-diabetes. In some embodiments, the subject with pre-diabetes has a fasting blood glucose level between 100 mg / dL and 125 mg / dL or an HbA1c level between 5.7% and 6.4%. In some embodiments, the subject has a fasting blood glucose level between 100 mg / dL and 125 mg / dL or an HbA1c level between 5.7% and 6.4%.

[0112] Some embodiments relate to a method to maintain, support, improve, or regulate healthy blood glucose levels in a subject. In some embodiments, the method includesproviding to the subject a composition comprising from about 50 mg to about 150 mg N-trans- caffeoyltyramine and N-trans-feruloyltyramine. In some embodiments, the maintaining, supporting, improving, or regulating healthy blood glucose levels in the subject improves glycemic control in the subject. In some embodiments, the maintaining, supporting, improving, or regulating healthy blood glucose levels in the subject reduces fasting blood glucose levels in a human subject with hyperglycemia or prediabetes. In some embodiments, the maintaining, supporting, improving, or regulating healthy blood glucose levels in the subject provides for healthy weight management in the subject. In some embodiments, the method includes providing the composition reduces 24-hour glucose exposure in the subject, wherein the reduction is measured by a decrease in 24-hour AUC or 24-hour mean glucose. In some embodiments, the maintaining, supporting, improving, or regulating healthy blood glucose levels in the subject reduces glucose variability in the human subject, wherein glucose variability is reduced as measured by a decrease in Mean Amplitude of Glucose Excursion (MAGE) or Mean of Daily Differences (MoDD). In some embodiments, the maintaining, supporting, improving, or regulating healthy blood glucose levels in the subject reduces postprandial glucose levels in a human subject. In some embodiments, the maintaining, supporting, improving, or regulating healthy blood glucose levels in the subject reduces blood glucose levels in the subject without significantly lowering minimum nighttime blood glucose. In some embodiments, the maintaining, supporting, improving, or regulating healthy blood glucose levels in the subject manages hyperglycemia in the subject. In some embodiments, the composition comprises about 60 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine. In some embodiments, the composition comprises about 120 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine. In some embodiments, the composition is in a form of a capsule, gummy, table, functional beverage, and functional food. In some embodiments, the capsule is a sustained release capsule. In some embodiments, the method includes providing to the subject the composition provides sustained weight management. In some embodiments, the method includes providing to the subject the composition provides visceral and abdominal fat loss. In some embodiments, the method includes providing to the subject the composition provides visceral fat loss. In some embodiments, the method includes providing to the subject the composition provides abdominal fat loss. In some embodiments, the method includes providing to the subject the composition preserves lean body mass. In some embodiments, themethod includes providing to the subject the composition supports normal blood glucose regulation. In some embodiments, the method includes providing to the subject the composition provides glucose level normalization followed by fat loss benefits. In some embodiments, the method includes providing to the subject the composition provides normal blood glucose regulation followed by fat loss benefits. In some embodiments, the subject has a BMI ≥ 28.0 kg / m2. In some embodiments, the subject has a Total-C level of ≥ 200 mg / dL. In some embodiments, the subject has a HDL-C level of ≤ 40 mg / dL. In some embodiments, the subject has a triglyceride level of ≥ 150 mg / dL. In some embodiments, the subject has pre- diabetes. In some embodiments, the subject is administered the composition once per day. In some embodiments, the subject is administered the composition for at least 6 six months. In some embodiments, the composition is provided in combination with a dietary regimen designed to enhance the weight management in the subject. In some embodiments, the subject is advised to engage in a physical activity program in conjunction with the administration of the composition. In some embodiments, the composition provides improvement in metabolic rate. In some embodiments, the subject has a waist circumference reduction of at least 5% from baseline after administration of the composition for 3 months. In some embodiments, the method includes providing to the subject the composition improves insulin sensitivity. In some embodiments, the composition improves one or more biomarkers associated with inflammation and obesity. In some embodiments, the subject is administered the composition and is further instructed to answer a dietary questionnaire. In some embodiments, the subject is administered the composition before, concurrently, or after taking one or more of the following medical tests: Body Weight, Study Instructions / Query, Chemistry Profile, Urine Pregnancy Test, Lipid Panel, HbA1c, Glucose, Insulin, FGF-21, Archive Plasma / Serum Samples, Randomization, 3D Body Scan, and DEXA Scan. In some embodiments, a treatment outcome comprises a reduction in body fat mass by at least 5% to 15% from baseline measurements, as measured in kilograms (kg) or pounds (lbs). In some embodiments, the method includes further comprising achieving a decrease in body weight of no less than 5% to 20% compared to initial measurements. In some embodiments, a treatment outcome comprises a reduction in visceral fat by a range of 10% to 30% from baseline measurements, quantified in cubic centimeters (cm³) or inches (in³). In some embodiments, a treatment outcome comprises a decrease in abdominal fat by a range of 5% to 25% from baseline measurements.In some embodiments, the method further includes maintaining fat loss within a range of ±3% to ±10% of the achieved reduction in body fat mass. In some embodiments, a treatment outcome comprises achieving controlled blood sugar levels within a target range of 70 to 120 milligrams per deciliter (mg / dL) or 3.9 to 6.7 millimoles per liter (mmol / L). In some embodiments, the N-trans-caffeoyltyramine and the N-trans-feruloyltyramine is in a ratio of 10:1 to 1:10. In some embodiments, the N-trans-caffeoyltyramine and the N-trans- feruloyltyramine is in a ratio of 5:1 to 1:5. In some embodiments, the subject experiences a reduction in visceral fat mass. In some embodiments, the subject experiences a reduction in waist circumference. In some embodiments, the subject experiences a reduction in hip circumference. In some embodiments, the subject experiences a reduction in HbA1c level. In some embodiments, providing the composition significantly decreases overall total glucose, as measured by 24-hour AUC, 24-hour mean glucose, or both. In some embodiments, providing the composition results in one or more effects selected from the group consisting of: a decrease in time spent outside of an ideal glucose range, a decrease in basal hyperglycemia, a decrease in peak glucose levels, and a decrease in postprandial glucose levels. In some embodiments, the composition is provided with a second active agent. In some embodiments, the second active agent is effective for improving glycemic control or promoting weight management. In some embodiments, the second active agent may include, but is not limited to, a biguanide, a GLP-1 receptor agonist, a DPP-4 inhibitor, and an SGLT2 inhibitor. In some embodiments, the composition is formulated as a sustained release formulation. In some embodiments, the composition is formulated for once-daily administration. In some embodiments, the sustained released formulation provides a reduction in glucose variability. In some embodiments, the subject has pre-diabetes. In some embodiments, the subject with pre-diabetes has a fasting blood glucose level between 100 mg / dL and 125 mg / dL or an HbA1c level between 5.7% and 6.4%. In some embodiments, the subject has a fasting blood glucose level between 100 mg / dL and 125 mg / dL or an HbA1c level between 5.7% and 6.4%.

[0113] Some embodiments relate to a method for reducing fasting plasma glucose in a subject. In some embodiments, the method includes providing to the subject a composition comprising from about 50 mg to about 150 mg N-trans-caffeoyltyramine and N-trans- feruloyltyramine. In some embodiments, reducing fasting plasma glucose in the subject improves glycemic control in the subject. In some embodiments, reducing fasting plasmaglucose in the subject reduces fasting blood glucose levels in a human subject with hyperglycemia or prediabetes. In some embodiments, reducing fasting plasma glucose in the subject provides for healthy weight management in the subject. In some embodiments, the method includes providing the composition reduces 24-hour glucose exposure in the subject, wherein the reduction is measured by a decrease in 24-hour AUC or 24-hour mean glucose. In some embodiments, reducing fasting plasma glucose in the subject reduces glucose variability in the human subject, wherein glucose variability is reduced as measured by a decrease in Mean Amplitude of Glucose Excursion (MAGE) or Mean of Daily Differences (MoDD). In some embodiments, reducing fasting plasma glucose in the subject reduces postprandial glucose levels in a human subject. In some embodiments, reducing fasting plasma glucose in the subject without significantly lowering minimum nighttime blood glucose. In some embodiments, reducing fasting plasma glucose in the subject manages hyperglycemia in the subject. In some embodiments, the composition comprises about 60 mg N-trans- caffeoyltyramine and N-trans-feruloyltyramine. In some embodiments, the composition comprises about 120 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine. In some embodiments, the composition is in a form of a capsule, gummy, table, functional beverage, and functional food. In some embodiments, the capsule is a sustained release capsule. In some embodiments, the method includes providing to the subject the composition provides sustained weight management. In some embodiments, the method includes providing to the subject the composition provides visceral and abdominal fat loss. In some embodiments, the method includes providing to the subject the composition provides visceral fat loss. In some embodiments, the method includes providing to the subject the composition provides abdominal fat loss. In some embodiments, the method includes providing to the subject the composition preserves lean body mass. In some embodiments, the method includes providing to the subject the composition supports normal blood glucose regulation. In some embodiments, the method includes providing to the subject the composition provides glucose level normalization followed by fat loss benefits. In some embodiments, the method includes providing to the subject the composition provides normal blood glucose regulation followed by fat loss benefits. In some embodiments, the subject has a BMI ≥ 28.0 kg / m2. In some embodiments, the subject has a Total-C level of ≥ 200 mg / dL. In some embodiments, the subject has a HDL-C level of ≤ 40 mg / dL. In some embodiments, the subject has a triglyceridelevel of ≥ 150 mg / dL. In some embodiments, the subject has pre-diabetes. In some embodiments, the subject is administered the composition once per day. In some embodiments, the subject is administered the composition for at least 6 six months. In some embodiments, the composition is provided in combination with a dietary regimen designed to enhance the weight management in the subject. In some embodiments, the subject is advised to engage in a physical activity program in conjunction with the administration of the composition. In some embodiments, the composition provides improvement in metabolic rate. In some embodiments, the subject has a waist circumference reduction of at least 5% from baseline after administration of the composition for 3 months. In some embodiments, the method includes providing to the subject the composition improves insulin sensitivity. In some embodiments, the composition improves one or more biomarkers associated with inflammation and obesity. In some embodiments, the subject is administered the composition and is further instructed to answer a dietary questionnaire. In some embodiments, the subject is administered the composition before, concurrently, or after taking one or more of the following medical tests: Body Weight, Study Instructions / Query, Chemistry Profile, Urine Pregnancy Test, Lipid Panel, HbA1c, Glucose, Insulin, FGF-21, Archive Plasma / Serum Samples, Randomization, 3D Body Scan, and DEXA Scan. In some embodiments, a treatment outcome comprises a reduction in body fat mass by at least 5% to 15% from baseline measurements, as measured in kilograms (kg) or pounds (lbs). In some embodiments, the method includes further comprising achieving a decrease in body weight of no less than 5% to 20% compared to initial measurements. In some embodiments, a treatment outcome comprises a reduction in visceral fat by a range of 10% to 30% from baseline measurements, quantified in cubic centimeters (cm³) or inches (in³). In some embodiments, a treatment outcome comprises a decrease in abdominal fat by a range of 5% to 25% from baseline measurements. In some embodiments, the method further includes maintaining fat loss within a range of ±3% to ±10% of the achieved reduction in body fat mass. In some embodiments, a treatment outcome comprises achieving controlled blood sugar levels within a target range of 70 to 120 milligrams per deciliter (mg / dL) or 3.9 to 6.7 millimoles per liter (mmol / L). In some embodiments, the N-trans-caffeoyltyramine and the N-trans-feruloyltyramine is in a ratio of 10:1 to 1:10. In some embodiments, the N-trans-caffeoyltyramine and the N-trans- feruloyltyramine is in a ratio of 5:1 to 1:5. In some embodiments, the subject experiences areduction in visceral fat mass. In some embodiments, the subject experiences a reduction in waist circumference. In some embodiments, the subject experiences a reduction in hip circumference. In some embodiments, the subject experiences a reduction in HbA1c level. In some embodiments, providing the composition significantly decreases overall total glucose, as measured by 24-hour AUC, 24-hour mean glucose, or both. In some embodiments, providing the composition results in one or more effects selected from the group consisting of: a decrease in time spent outside of an ideal glucose range, a decrease in basal hyperglycemia, a decrease in peak glucose levels, and a decrease in postprandial glucose levels. In some embodiments, the composition is provided with a second active agent. In some embodiments, the second active agent is effective for improving glycemic control or promoting weight management. In some embodiments, the second active agent may include, but is not limited to, a biguanide, a GLP-1 receptor agonist, a DPP-4 inhibitor, and an SGLT2 inhibitor. In some embodiments, the composition is formulated as a sustained release formulation. In some embodiments, the composition is formulated for once-daily administration. In some embodiments, the sustained released formulation provides a reduction in glucose variability. In some embodiments, the subject has pre-diabetes. In some embodiments, the subject with pre-diabetes has a fasting blood glucose level between 100 mg / dL and 125 mg / dL or an HbA1c level between 5.7% and 6.4%. In some embodiments, the subject has a fasting blood glucose level between 100 mg / dL and 125 mg / dL or an HbA1c level between 5.7% and 6.4%.

[0114] Some embodiments relate to a method for reducing postprandial glucose levels in a subject. In some embodiments, the method includes providing to the subject a composition comprising from about 50 mg to about 150 mg N-trans-caffeoyltyramine and N- trans-feruloyltyramine. In some embodiments, reducing postprandial glucose levels in a subject improves glycemic control in the subject. In some embodiments, reducing postprandial glucose levels in a subject reduces fasting blood glucose levels in a human subject with hyperglycemia or prediabetes. In some embodiments, reducing postprandial glucose levels in a subject provides for healthy weight management in the subject. In some embodiments, the method includes providing the composition reduces 24-hour glucose exposure in the subject, wherein the reduction is measured by a decrease in 24-hour AUC or 24-hour mean glucose. In some embodiments, reducing postprandial glucose levels in a subject in a subject reduces glucose variability in the human subject, wherein glucose variability is reduced as measuredby a decrease in Mean Amplitude of Glucose Excursion (MAGE) or Mean of Daily Differences (MoDD). In some embodiments, reducing postprandial glucose levels in a subject reduces postprandial glucose levels in a human subject. In some embodiments, for reducing postprandial glucose levels in a subject without significantly lowering minimum nighttime blood glucose. In some embodiments, reducing fasting plasma glucose in the subject manages hyperglycemia in the subject. In some embodiments, the composition comprises about 60 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine. In some embodiments, the composition comprises about 120 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine. In some embodiments, the composition is in a form of a capsule, gummy, table, functional beverage, and functional food. In some embodiments, the capsule is a sustained release capsule. In some embodiments, the method includes providing to the subject the composition provides sustained weight management. In some embodiments, the method includes providing to the subject the composition provides visceral and abdominal fat loss. In some embodiments, the method includes providing to the subject the composition provides visceral fat loss. In some embodiments, the method includes providing to the subject the composition provides abdominal fat loss. In some embodiments, the method includes providing to the subject the composition preserves lean body mass. In some embodiments, the method includes providing to the subject the composition supports normal blood glucose regulation. In some embodiments, the method includes providing to the subject the composition provides glucose level normalization followed by fat loss benefits. In some embodiments, the method includes providing to the subject the composition provides normal blood glucose regulation followed by fat loss benefits. In some embodiments, the subject has a BMI ≥ 28.0 kg / m2. In some embodiments, the subject has a Total-C level of ≥ 200 mg / dL. In some embodiments, the subject has a HDL-C level of ≤ 40 mg / dL. In some embodiments, the subject has a triglyceride level of ≥ 150 mg / dL. In some embodiments, the subject has pre-diabetes. In some embodiments, the subject is administered the composition once per day. In some embodiments, the subject is administered the composition for at least 6 six months. In some embodiments, the composition is provided in combination with a dietary regimen designed to enhance the weight management in the subject. In some embodiments, the subject is advised to engage in a physical activity program in conjunction with the administration of the composition. In some embodiments, the composition provides improvement in metabolic rate. In someembodiments, the subject has a waist circumference reduction of at least 5% from baseline after administration of the composition for 3 months. In some embodiments, the method includes providing to the subject the composition improves insulin sensitivity. In some embodiments, the composition improves one or more biomarkers associated with inflammation and obesity. In some embodiments, the subject is administered the composition and is further instructed to answer a dietary questionnaire. In some embodiments, the subject is administered the composition before, concurrently, or after taking one or more of the following medical tests: Body Weight, Study Instructions / Query, Chemistry Profile, Urine Pregnancy Test, Lipid Panel, HbA1c, Glucose, Insulin, FGF-21, Archive Plasma / Serum Samples, Randomization, 3D Body Scan, and DEXA Scan. In some embodiments, a treatment outcome comprises a reduction in body fat mass by at least 5% to 15% from baseline measurements, as measured in kilograms (kg) or pounds (lbs). In some embodiments, the method includes further comprising achieving a decrease in body weight of no less than 5% to 20% compared to initial measurements. In some embodiments, a treatment outcome comprises a reduction in visceral fat by a range of 10% to 30% from baseline measurements, quantified in cubic centimeters (cm³) or inches (in³). In some embodiments, a treatment outcome comprises a decrease in abdominal fat by a range of 5% to 25% from baseline measurements. In some embodiments, the method further includes maintaining fat loss within a range of ±3% to ±10% of the achieved reduction in body fat mass. In some embodiments, a treatment outcome comprises achieving controlled blood sugar levels within a target range of 70 to 120 milligrams per deciliter (mg / dL) or 3.9 to 6.7 millimoles per liter (mmol / L). In some embodiments, the N-trans-caffeoyltyramine and the N-trans-feruloyltyramine is in a ratio of 10:1 to 1:10. In some embodiments, the N-trans-caffeoyltyramine and the N-trans- feruloyltyramine is in a ratio of 5:1 to 1:5. In some embodiments, the subject experiences a reduction in visceral fat mass. In some embodiments, the subject experiences a reduction in waist circumference. In some embodiments, the subject experiences a reduction in hip circumference. In some embodiments, the subject experiences a reduction in HbA1c level. In some embodiments, providing the composition significantly decreases overall total glucose, as measured by 24-hour AUC, 24-hour mean glucose, or both. In some embodiments, providing the composition results in one or more effects selected from the group consisting of: a decrease in time spent outside of an ideal glucose range, a decrease in basal hyperglycemia, a decreasein peak glucose levels, and a decrease in postprandial glucose levels. In some embodiments, the composition is provided with a second active agent. In some embodiments, the second active agent is effective for improving glycemic control or promoting weight management. In some embodiments, the second active agent may include, but is not limited to, a biguanide, a GLP-1 receptor agonist, a DPP-4 inhibitor, and an SGLT2 inhibitor. In some embodiments, the composition is formulated as a sustained release formulation. In some embodiments, the composition is formulated for once-daily administration. In some embodiments, the sustained released formulation provides a reduction in glucose variability. In some embodiments, the subject has pre-diabetes. In some embodiments, the subject with pre-diabetes has a fasting blood glucose level between 100 mg / dL and 125 mg / dL or an HbA1c level between 5.7% and 6.4%. In some embodiments, the subject has a fasting blood glucose level between 100 mg / dL and 125 mg / dL or an HbA1c level between 5.7% and 6.4%.

[0115] Some embodiments relate to a method for reducing glucose variability levels in a subject. In some embodiments, the method includes providing to the subject a composition comprising from about 50 mg to about 150 mg N-trans-caffeoyltyramine and N- trans-feruloyltyramine. In some embodiments, reducing glucose variability levels in a subject improves glycemic control in the subject. In some embodiments, reducing glucose variability levels in a subject reduces fasting blood glucose levels in a human subject with hyperglycemia or prediabetes. In some embodiments, reducing glucose variability levels in a subject provides for healthy weight management in the subject. In some embodiments, the method includes providing the composition reduces 24-hour glucose exposure in the subject, wherein the reduction is measured by a decrease in 24-hour AUC or 24-hour mean glucose. In some embodiments, reducing glucose variability levels in a subject reduces glucose variability in the human subject, wherein glucose variability is reduced as measured by a decrease in Mean Amplitude of Glucose Excursion (MAGE) or Mean of Daily Differences (MoDD). In some embodiments, reducing glucose variability levels in a subject reduces postprandial glucose levels in a human subject. In some embodiments, for reducing postprandial glucose levels in a subject without significantly lowering minimum nighttime blood glucose. In some embodiments, reducing fasting plasma glucose in the subject manages hyperglycemia in the subject. In some embodiments, the composition comprises about 60 mg N-trans- caffeoyltyramine and N-trans-feruloyltyramine. In some embodiments, the compositioncomprises about 120 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine. In some embodiments, the composition is in a form of a capsule, gummy, table, functional beverage, and functional food. In some embodiments, the capsule is a sustained release capsule. In some embodiments, the method includes providing to the subject the composition provides sustained weight management. In some embodiments, the method includes providing to the subject the composition provides visceral and abdominal fat loss. In some embodiments, the method includes providing to the subject the composition provides visceral fat loss. In some embodiments, the method includes providing to the subject the composition provides abdominal fat loss. In some embodiments, the method includes providing to the subject the composition preserves lean body mass. In some embodiments, the method includes providing to the subject the composition supports normal blood glucose regulation. In some embodiments, the method includes providing to the subject the composition provides glucose level normalization followed by fat loss benefits. In some embodiments, the method includes providing to the subject the composition provides normal blood glucose regulation followed by fat loss benefits. In some embodiments, the subject has a BMI ≥ 28.0 kg / m2. In some embodiments, the subject has a Total-C level of ≥ 200 mg / dL. In some embodiments, the subject has a HDL-C level of ≤ 40 mg / dL. In some embodiments, the subject has a triglyceride level of ≥ 150 mg / dL. In some embodiments, the subject has pre-diabetes. In some embodiments, the subject is administered the composition once per day. In some embodiments, the subject is administered the composition for at least 6 six months. In some embodiments, the composition is provided in combination with a dietary regimen designed to enhance the weight management in the subject. In some embodiments, the subject is advised to engage in a physical activity program in conjunction with the administration of the composition. In some embodiments, the composition provides improvement in metabolic rate. In some embodiments, the subject has a waist circumference reduction of at least 5% from baseline after administration of the composition for 3 months. In some embodiments, the method includes providing to the subject the composition improves insulin sensitivity. In some embodiments, the composition improves one or more biomarkers associated with inflammation and obesity. In some embodiments, the subject is administered the composition and is further instructed to answer a dietary questionnaire. In some embodiments, the subject is administered the composition before, concurrently, or after taking one or more of thefollowing medical tests: Body Weight, Study Instructions / Query, Chemistry Profile, Urine Pregnancy Test, Lipid Panel, HbA1c, Glucose, Insulin, FGF-21, Archive Plasma / Serum Samples, Randomization, 3D Body Scan, and DEXA Scan. In some embodiments, a treatment outcome comprises a reduction in body fat mass by at least 5% to 15% from baseline measurements, as measured in kilograms (kg) or pounds (lbs). In some embodiments, the method includes further comprising achieving a decrease in body weight of no less than 5% to 20% compared to initial measurements. In some embodiments, a treatment outcome comprises a reduction in visceral fat by a range of 10% to 30% from baseline measurements, quantified in cubic centimeters (cm³) or inches (in³). In some embodiments, a treatment outcome comprises a decrease in abdominal fat by a range of 5% to 25% from baseline measurements. In some embodiments, the method further includes maintaining fat loss within a range of ±3% to ±10% of the achieved reduction in body fat mass. In some embodiments, a treatment outcome comprises achieving controlled blood sugar levels within a target range of 70 to 120 milligrams per deciliter (mg / dL) or 3.9 to 6.7 millimoles per liter (mmol / L). In some embodiments, the N-trans-caffeoyltyramine and the N-trans-feruloyltyramine is in a ratio of 10:1 to 1:10. In some embodiments, the N-trans-caffeoyltyramine and the N-trans- feruloyltyramine is in a ratio of 5:1 to 1:5. In some embodiments, the subject experiences a reduction in visceral fat mass. In some embodiments, the subject experiences a reduction in waist circumference. In some embodiments, the subject experiences a reduction in hip circumference. In some embodiments, the subject experiences a reduction in HbA1c level. In some embodiments, providing the composition significantly decreases overall total glucose, as measured by 24-hour AUC, 24-hour mean glucose, or both. In some embodiments, providing the composition results in one or more effects selected from the group consisting of: a decrease in time spent outside of an ideal glucose range, a decrease in basal hyperglycemia, a decrease in peak glucose levels, and a decrease in postprandial glucose levels. In some embodiments, the composition is provided with a second active agent. In some embodiments, the second active agent is effective for improving glycemic control or promoting weight management. In some embodiments, the second active agent may include, but is not limited to, a biguanide, a GLP-1 receptor agonist, a DPP-4 inhibitor, and an SGLT2 inhibitor. In some embodiments, the composition is formulated as a sustained release formulation. In some embodiments, the composition is formulated for once-daily administration. In some embodiments, the sustainedreleased formulation provides a reduction in glucose variability. In some embodiments, the subject has pre-diabetes. In some embodiments, the subject with pre-diabetes has a fasting blood glucose level between 100 mg / dL and 125 mg / dL or an HbA1c level between 5.7% and 6.4%. In some embodiments, the subject has a fasting blood glucose level between 100 mg / dL and 125 mg / dL or an HbA1c level between 5.7% and 6.4%.

[0116] Some embodiments relate to a method for decreasing glycated hemoglobin (HbA1c) levels in a subject. In some embodiments, the method includes providing to the subject a composition comprising from about 50 mg to about 150 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine. In some embodiments, decreasing HbA1c levels in a subject improves glycemic control in the subject. In some embodiments, decreasing HbA1c levels in a subject reduces fasting blood glucose levels in a human subject with hyperglycemia or prediabetes. In some embodiments, decreasing HbA1c levels in a subject provides for healthy weight management in the subject. In some embodiments, the method includes providing the composition reduces 24-hour glucose exposure in the subject, wherein the reduction is measured by a decrease in 24-hour AUC or 24-hour mean glucose. In some embodiments, decreasing HbA1c levels in a subject reduces glucose variability in the human subject, wherein glucose variability is reduced as measured by a decrease in Mean Amplitude of Glucose Excursion (MAGE) or Mean of Daily Differences (MoDD). In some embodiments, decreasing HbA1c levels in a subject reduces postprandial glucose levels in a human subject. In some embodiments, for reducing postprandial glucose levels in a subject without significantly lowering minimum nighttime blood glucose. In some embodiments, decreasing HbA1c levels in a subject manages hyperglycemia in the subject. In some embodiments, the composition comprises about 60 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine. In some embodiments, the composition comprises about 120 mg N-trans-caffeoyltyramine and N-trans- feruloyltyramine. In some embodiments, the composition is in a form of a capsule, gummy, table, functional beverage, and functional food. In some embodiments, the capsule is a sustained release capsule. In some embodiments, the method includes providing to the subject the composition provides sustained weight management. In some embodiments, the method includes providing to the subject the composition provides visceral and abdominal fat loss. In some embodiments, the method includes providing to the subject the composition provides visceral fat loss. In some embodiments, the method includes providing to the subject thecomposition provides abdominal fat loss. In some embodiments, the method includes providing to the subject the composition preserves lean body mass. In some embodiments, the method includes providing to the subject the composition supports normal blood glucose regulation. In some embodiments, the method includes providing to the subject the composition provides glucose level normalization followed by fat loss benefits. In some embodiments, the method includes providing to the subject the composition provides normal blood glucose regulation followed by fat loss benefits. In some embodiments, the subject has a BMI ≥ 28.0 kg / m2. In some embodiments, the subject has a Total-C level of ≥ 200 mg / dL. In some embodiments, the subject has a HDL-C level of ≤ 40 mg / dL. In some embodiments, the subject has a triglyceride level of ≥ 150 mg / dL. In some embodiments, the subject has pre- diabetes. In some embodiments, the subject is administered the composition once per day. In some embodiments, the subject is administered the composition for at least 6 six months. In some embodiments, the composition is provided in combination with a dietary regimen designed to enhance the weight management in the subject. In some embodiments, the subject is advised to engage in a physical activity program in conjunction with the administration of the composition. In some embodiments, the composition provides improvement in metabolic rate. In some embodiments, the subject has a waist circumference reduction of at least 5% from baseline after administration of the composition for 3 months. In some embodiments, the method includes providing to the subject the composition improves insulin sensitivity. In some embodiments, the composition improves one or more biomarkers associated with inflammation and obesity. In some embodiments, the subject is administered the composition and is further instructed to answer a dietary questionnaire. In some embodiments, the subject is administered the composition before, concurrently, or after taking one or more of the following medical tests: Body Weight, Study Instructions / Query, Chemistry Profile, Urine Pregnancy Test, Lipid Panel, HbA1c, Glucose, Insulin, FGF-21, Archive Plasma / Serum Samples, Randomization, 3D Body Scan, and DEXA Scan. In some embodiments, a treatment outcome comprises a reduction in body fat mass by at least 5% to 15% from baseline measurements, as measured in kilograms (kg) or pounds (lbs). In some embodiments, the method includes further comprising achieving a decrease in body weight of no less than 5% to 20% compared to initial measurements. In some embodiments, a treatment outcome comprises a reduction in visceral fat by a range of 10% to 30% from baseline measurements, quantifiedin cubic centimeters (cm³) or inches (in³). In some embodiments, a treatment outcome comprises a decrease in abdominal fat by a range of 5% to 25% from baseline measurements. In some embodiments, the method further includes maintaining fat loss within a range of ±3% to ±10% of the achieved reduction in body fat mass. In some embodiments, a treatment outcome comprises achieving controlled blood sugar levels within a target range of 70 to 120 milligrams per deciliter (mg / dL) or 3.9 to 6.7 millimoles per liter (mmol / L). In some embodiments, the N-trans-caffeoyltyramine and the N-trans-feruloyltyramine is in a ratio of 10:1 to 1:10. In some embodiments, the N-trans-caffeoyltyramine and the N-trans- feruloyltyramine is in a ratio of 5:1 to 1:5. In some embodiments, the subject experiences a reduction in visceral fat mass. In some embodiments, the subject experiences a reduction in waist circumference. In some embodiments, the subject experiences a reduction in hip circumference. In some embodiments, the subject experiences a reduction in HbA1c level. In some embodiments, providing the composition significantly decreases overall total glucose, as measured by 24-hour AUC, 24-hour mean glucose, or both. In some embodiments, providing the composition results in one or more effects selected from the group consisting of: a decrease in time spent outside of an ideal glucose range, a decrease in basal hyperglycemia, a decrease in peak glucose levels, and a decrease in postprandial glucose levels. In some embodiments, the composition is provided with a second active agent. In some embodiments, the second active agent is effective for improving glycemic control or promoting weight management. In some embodiments, the second active agent may include, but is not limited to, a biguanide, a GLP-1 receptor agonist, a DPP-4 inhibitor, and an SGLT2 inhibitor. In some embodiments, the composition is formulated as a sustained release formulation. In some embodiments, the composition is formulated for once-daily administration. In some embodiments, the sustained released formulation provides a reduction in glucose variability. In some embodiments, the subject has pre-diabetes. In some embodiments, the subject with pre-diabetes has a fasting blood glucose level between 100 mg / dL and 125 mg / dL or an HbA1c level between 5.7% and 6.4%. In some embodiments, the subject has a fasting blood glucose level between 100 mg / dL and 125 mg / dL or an HbA1c level between 5.7% and 6.4%.

[0117] Some embodiments relate to a method for decreasing mean glucose or glucose area under the curve (AUC) levels in a subject. In some embodiments, the method includes providing to the subject a composition comprising from about 50 mg to about 150 mgN-trans-caffeoyltyramine and N-trans-feruloyltyramine. In some embodiments, decreasing mean glucose or glucose AUC levels in a subject reduces fasting blood glucose levels in a human subject with hyperglycemia or prediabetes. In some embodiments, decreasing mean glucose or glucose AUC levels in the subject provides for healthy weight management in the subject. In some embodiments, the method includes providing the composition reduces 24- hour glucose exposure in the subject, wherein the reduction is measured by a decrease in 24- hour AUC or 24-hour mean glucose. In some embodiments, decreasing mean glucose or glucose AUC levels in a subject reduces glucose variability in the human subject, wherein glucose variability is reduced as measured by a decrease in Mean Amplitude of Glucose Excursion (MAGE) or Mean of Daily Differences (MoDD). In some embodiments, decreasing mean glucose or glucose AUC levels in the subject reduces postprandial glucose levels in a human subject. In some embodiments, for reducing postprandial glucose levels in a subject without significantly lowering minimum nighttime blood glucose. In some embodiments, decreasing mean glucose or glucose AUC levels in the subject manages hyperglycemia in the subject. In some embodiments, the composition comprises about 60 mg N-trans- caffeoyltyramine and N-trans-feruloyltyramine. In some embodiments, the composition comprises about 120 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine. In some embodiments, the composition is in a form of a capsule, gummy, table, functional beverage, and functional food. In some embodiments, the capsule is a sustained release capsule. In some embodiments, the method includes providing to the subject the composition provides sustained weight management. In some embodiments, the method includes providing to the subject the composition provides visceral and abdominal fat loss. In some embodiments, the method includes providing to the subject the composition provides visceral fat loss. In some embodiments, the method includes providing to the subject the composition provides abdominal fat loss. In some embodiments, the method includes providing to the subject the composition preserves lean body mass. In some embodiments, the method includes providing to the subject the composition supports normal blood glucose regulation. In some embodiments, the method includes providing to the subject the composition provides glucose level normalization followed by fat loss benefits. In some embodiments, the method includes providing to the subject the composition provides normal blood glucose regulation followed by fat loss benefits. In some embodiments, the subject has a BMI ≥ 28.0 kg / m2. In someembodiments, the subject has a Total-C level of ≥ 200 mg / dL. In some embodiments, the subject has a HDL-C level of ≤ 40 mg / dL. In some embodiments, the subject has a triglyceride level of ≥ 150 mg / dL. In some embodiments, the subject has pre-diabetes. In some embodiments, the subject is administered the composition once per day. In some embodiments, the subject is administered the composition for at least 6 six months. In some embodiments, the composition is provided in combination with a dietary regimen designed to enhance the weight management in the subject. In some embodiments, the subject is advised to engage in a physical activity program in conjunction with the administration of the composition. In some embodiments, the composition provides improvement in metabolic rate. In some embodiments, the subject has a waist circumference reduction of at least 5% from baseline after administration of the composition for 3 months. In some embodiments, the method includes providing to the subject the composition improves insulin sensitivity. In some embodiments, the composition improves one or more biomarkers associated with inflammation and obesity. In some embodiments, the subject is administered the composition and is further instructed to answer a dietary questionnaire. In some embodiments, the subject is administered the composition before, concurrently, or after taking one or more of the following medical tests: Body Weight, Study Instructions / Query, Chemistry Profile, Urine Pregnancy Test, Lipid Panel, HbA1c, Glucose, Insulin, FGF-21, Archive Plasma / Serum Samples, Randomization, 3D Body Scan, and DEXA Scan. In some embodiments, a treatment outcome comprises a reduction in body fat mass by at least 5% to 15% from baseline measurements, as measured in kilograms (kg) or pounds (lbs). In some embodiments, the method includes further comprising achieving a decrease in body weight of no less than 5% to 20% compared to initial measurements. In some embodiments, a treatment outcome comprises a reduction in visceral fat by a range of 10% to 30% from baseline measurements, quantified in cubic centimeters (cm³) or inches (in³). In some embodiments, a treatment outcome comprises a decrease in abdominal fat by a range of 5% to 25% from baseline measurements. In some embodiments, the method further includes maintaining fat loss within a range of ±3% to ±10% of the achieved reduction in body fat mass. In some embodiments, a treatment outcome comprises achieving controlled blood sugar levels within a target range of 70 to 120 milligrams per deciliter (mg / dL) or 3.9 to 6.7 millimoles per liter (mmol / L). In some embodiments, the N-trans-caffeoyltyramine and the N-trans-feruloyltyramine is in a ratio of10:1 to 1:10. In some embodiments, the N-trans-caffeoyltyramine and the N-trans- feruloyltyramine is in a ratio of 5:1 to 1:5. In some embodiments, the subject experiences a reduction in visceral fat mass. In some embodiments, the subject experiences a reduction in waist circumference. In some embodiments, the subject experiences a reduction in hip circumference. In some embodiments, the subject experiences a reduction in HbA1c level. In some embodiments, providing the composition significantly decreases overall total glucose, as measured by 24-hour AUC, 24-hour mean glucose, or both. In some embodiments, providing the composition results in one or more effects selected from the group consisting of: a decrease in time spent outside of an ideal glucose range, a decrease in basal hyperglycemia, a decrease in peak glucose levels, and a decrease in postprandial glucose levels. In some embodiments, the composition is provided with a second active agent. In some embodiments, the second active agent is effective for improving glycemic control or promoting weight management. In some embodiments, the second active agent may include, but is not limited to, a biguanide, a GLP-1 receptor agonist, a DPP-4 inhibitor, and an SGLT2 inhibitor. In some embodiments, the composition is formulated as a sustained release formulation. In some embodiments, the composition is formulated for once-daily administration. In some embodiments, the sustained released formulation provides a reduction in glucose variability. In some embodiments, the subject has pre-diabetes. In some embodiments, the subject with pre-diabetes has a fasting blood glucose level between 100 mg / dL and 125 mg / dL or an HbA1c level between 5.7% and 6.4%. In some embodiments, the subject has a fasting blood glucose level between 100 mg / dL and 125 mg / dL or an HbA1c level between 5.7% and 6.4%.

[0118] The dosage may vary broadly, depending upon the desired effects and the therapeutic indication, such as marker values. Alternatively, dosages may be based and calculated upon the surface area or weight of the patient, as understood by those of skill in the art. The exact dosage will be determined on a case-by-case basis, or, in some cases, will be left to the informed discretion of the subject. The daily dosage regimen for an adult human patient may be, for example, an oral dose of a compound or composition as described herein, from about 10 mg to about 1000 mg, from about 10 mg to about 500 mg, from about 5 mg to about 200 mg, from about 10 mg to about 100 mg, from about 50 mg to about 150 mg, or from about 50 mg to about 500 mg. A single dose may include a compound or composition as described herein, in about 1 mg, about 5 mg, about 10 mg, about 20 mg, about 50 mg, about 100 mg,about 200 mg, about 300 mg, about 400 mg, about 500 mg, about 600 mg, about 800 mg, about 900 mg, about 1000 mg, or more.

[0119] The dosage may be a single one or a series of two or more given in the course of one or more days, as is appropriate for the individual subject. In some embodiments, a compound or composition as described herein will be administered for a period of continuous therapy, for example for about a week or more (e.g., one week, two weeks, three weeks, four weeks, five weeks, six weeks, seven weeks, eight weeks, or more), for several weeks, for about a month or more (e.g., one month, two months, three months, four months, five months, six months, seven months, eight months, nine months, ten months, eleven months, twelve months, or more), for about a year or more, or for a plurality of years. In some embodiments, a compound or composition as described herein can be administered or ingested one time per day, two times per day, three times per day, or more.

[0120] As will be understood by those of skill in the art, in certain situations it may be necessary to administer the compounds disclosed herein in amounts that exceed the above- stated, preferred dosage range in order to effectively treat a subject.

[0121] Unit dosage forms can also be provided, e.g., individual packages with a premeasured amount of the composition, configured for administration on a predetermined schedule. Unit dosage forms configured for administration one to three times a day are preferred; however, in certain embodiments it may be desirable to configure the unit dosage form for administration more than three times a day, or less than one time per day.

[0122] Dosage amount and interval may be adjusted to the individual subject to provide plasma levels of the active moiety which are sufficient to maintain predetermined parameters, indicators, or marker values, or minimal effective concentration (MEC). Dosages necessary to achieve the desired result will depend on individual characteristics and route of administration. However, assays, for example, HPLC assays or bioassays, may be used to determine serum concentrations.

[0123] As will be understood by those of skill in the art, in certain situations a subject may be screened for taking certain medications before taking compounds or formulations according to this disclosure. By way of non-limiting example, a subject taking compounds or formulations according to the disclosure may be advised not to take the compounds or formulations while simultaneously taking another weight loss medication. Forexample, a subject may be advised not to take the compounds according to the disclosure, or alternatively not take a medication, if the subject is taking or plans to take a medication according to the following non-limiting examples Benzphetamine HCl (Didrex), Naltrexone and bupropion (Contrave), Diethylpropion HCl (Tenuate,Tenuate Dospan), Mazindol (Sanorex), Orlistat (Xenical, Alli), Phendimetrazine tartrate (Adipost, Anorex-SR, Appecon, Bontril, Bontril SR, Melfiat, Obesine, Phendiet, Plegine, Prelu-2, Statobex), Phentermine (Adipex-P, Ionamin, Obenix, Oby-Cap, Pro Fast-SA, Teramine, Zantryl), Sibutramine (Meridia), Phentermine and topiramate (Qsymia), Semaglutide (Wegovy, Ozempic), Liraglutide (Saxenda), Setmalanotide (Imcivree).

[0124] However, in some embodiments, a subject may be advised to take compounds or formulations according to the disclosure and another weight loss medication. Accordingly, in some embodiments, a subject taking compounds or formulations according to the disclosure may be advised to take one or more of the abovementioned drugs.

[0125] Accordingly, some aspects described herein relate to the following numbered alternatives:

[0126] 1. A method of treating, preventing, reducing, or ameliorating a condition characterized by impaired glucose metabolism in a subject in need thereof, the method comprises providing to the subject a composition comprising from about 50 mg to about 150 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine.

[0127] 2. A method of maintaining a healthy blood glucose, the method comprising:

[0128] providing to the subject a composition comprising from about 50 mg to about 150 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine.

[0129] 3. A method of improving glycemic control in a human subject in need thereof, the method comprising administering to the subject an effective amount of a composition comprising from about 50 mg to about 150 mg N-trans-caffeoyltyramine and N- trans-feruloyltyramine, wherein the administration results in a statistically significant reduction in fasting blood glucose.

[0130] 4. A method of reducing fasting blood glucose in a human subject with hyperglycemia or prediabetes, the method comprising administering to the subject atherapeutically effective amount of a composition comprising from about 50 mg to about 150 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine.

[0131] 5. A method for healthy weight management in a subject, the method comprising:

[0132] providing to the subject a composition comprising from about 50 mg to about 150 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine.

[0133] 6. A method of reducing 24-hour glucose exposure in a human subject, the method comprising administering to the subject an effective amount of a composition comprising from about 50 mg to about 150 mg N-trans-caffeoyltyramine and N-trans- feruloyltyramine, wherein the reduction is measured by a decrease in 24-hour AUC or 24-hour mean glucose.

[0134] 7. A method of reducing glucose variability in a human subject, the method comprising administering to the subject an effective amount of a composition comprising from about 50 mg to about 150 mg N-trans-caffeoyltyramine and N-trans- feruloyltyramine, wherein glucose variability is reduced as measured by a decrease in Mean Amplitude of Glucose Excursion (MAGE) or Mean of Daily Differences (MoDD).

[0135] 8. A method of reducing postprandial glucose levels in a human subject, the method comprising administering to the subject an effective amount of a composition comprising from about 50 mg to about 150 mg N-trans-caffeoyltyramine and N-trans- feruloyltyramine.

[0136] 9. A method of reducing blood glucose levels in a human subject without significantly lowering minimum nighttime blood glucose, the method comprising administering to the subject an effective amount of a composition comprising from about 50 mg to about 150 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine.

[0137] 10. A method for managing hyperglycemia in a human subject, the method comprising administering daily a composition comprising from about 50 mg to about 150 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine, wherein said administration reduces fasting blood glucose while maintaining insulin levels and without inducing hypoglycemia.

[0138] 11. The method of any one of alternatives 1 to 10, wherein the composition comprises about 60 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine.

[0139] 12. The method of any one of alternatives 1 to 10, wherein the composition comprises about 120 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine.

[0140] 13. The method of any one of alternatives 1 to 12, wherein the composition is in a form of a capsule, gummy, table, functional beverage, and functional food.

[0141] 14. The method of alternative 13, wherein the capsule is a sustained release capsule.

[0142] 15. The method of any one of alternatives 1 to 13, wherein providing to the subject the composition provides sustained weight management.

[0143] 16. The method of any one of alternatives 1 to 13, wherein providing to the subject the composition provides visceral and abdominal fat loss.

[0144] 17. The method of any one of alternatives 1 to 13, wherein providing to the subject the composition provides visceral fat loss.

[0145] 18. The method of any one of alternatives 1 to 13, wherein providing to the subject the composition provides abdominal fat loss.

[0146] 19. The method of any one of alternatives 1 to 13, wherein providing to the subject the composition preserves lean body mass.

[0147] 20. The method of any one of alternatives 1 to 13, wherein providing to the subject the composition supports normal blood glucose regulation.

[0148] 21. The method of any one of alternatives 1 to 13, wherein providing to the subject the composition provides glucose level normalization followed by fat loss benefits.

[0149] 22. The method of any one of alternatives 1 to 13, wherein providing to the subject the composition provides normal blood glucose regulation followed by fat loss benefits.

[0150] 23. The method of any one of alternatives 1 to 22, wherein the subject has a BMI ≥ 28.0 kg / m2.

[0151] 24. The method of any one of alternatives 1 to 23, wherein the subject has a Total-C level of ≥ 200 mg / dL.

[0152] 25. The method of any one of alternatives 1 to 24, wherein the subject has a HDL-C level of ≤ 40 mg / dL.

[0153] 26. The method of any one of alternatives 1 to 25, wherein the subject has a triglyceride level of ≥ 150 mg / dL.

[0154] 27. The method of any one of alternatives 1 to 26, wherein the subject has pre-diabetes.

[0155] 28. The method of any one of alternatives 1 to 27, wherein the subject is administered the composition once per day.

[0156] 29. The method of alternative 28, wherein the subject is administered the composition for at least 6 six months.

[0157] 30. The method of any one of alternatives 1 to 29, wherein the composition is provided in combination with a dietary regimen designed to enhance the weight management in the subject.

[0158] 31. The method of any one of alternatives 1 to 30, wherein the subject is advised to engage in a physical activity program in conjunction with the administration of the composition.

[0159] 32. The method of any one of alternatives 1 to 31, wherein the composition provides improvement in metabolic rate.

[0160] 33. The method of any one of alternatives 1 to 32, wherein the subject has a waist circumference reduction of at least 5% from baseline after administration of the composition for 3 months.

[0161] 34. The method of any one of alternatives 1 to 33, wherein providing to the subject the composition improves insulin sensitivity.

[0162] 35. The method of any one of alternatives 1 to 34, wherein the composition improves one or more biomarkers associated with inflammation and obesity.

[0163] 36. The method of any one of alternatives 1 to 35, wherein the subject is administered the composition and is further instructed to answer a dietary questionnaire.

[0164] 37. The method of any one of alternatives 1 to 36, wherein the subject is administered the composition before, concurrently, or after taking one or more of the following medical tests: Body Weight, Study Instructions / Query, Chemistry Profile, Urine Pregnancy Test, Lipid Panel, HbA1c, Glucose, Insulin, FGF-21, Archive Plasma / Serum Samples, Randomization, 3D Body Scan, and DEXA Scan.

[0165] 38. The method of any one of alternatives 1 to 37, wherein a treatment outcome comprises a reduction in body fat mass by at least 5% to 15% from baseline measurements, as measured in kilograms (kg) or pounds (lbs).

[0166] 39. The method of any one of alternatives 1 to 38, further comprising achieving a decrease in body weight of no less than 5% to 20% compared to initial measurements.

[0167] 40. The method of any one of alternatives 1 to 39, wherein a treatment outcome comprises a reduction in visceral fat by a range of 10% to 30% from baseline measurements, quantified in cubic centimeters (cm³) or inches (in³).

[0168] 41. The method of any one of alternatives 1 to 40, wherein a treatment outcome comprises a decrease in abdominal fat by a range of 5% to 25% from baseline measurements.

[0169] 42. The method of any one of alternatives 1 to 41, further comprising maintaining fat loss within a range of ±3% to ±10% of the achieved reduction in body fat mass.

[0170] 43. The method of any one of alternatives 1 to 42, wherein a treatment outcome comprises achieving controlled blood sugar levels within a target range of 70 to 120 milligrams per deciliter (mg / dL) or 3.9 to 6.7 millimoles per liter (mmol / L).

[0171] 44. A method for fat loss in a subject, the method comprising providing to the subject a composition comprising from about 50 mg to about 150 mg N-trans- caffeoyltyramine and N-trans-feruloyltyramine, wherein the N-trans-caffeoyltyramine and the N-trans-feruloyltyramine is in a ratio of 10:1 to 1:10.

[0172] 45. The method of alternative 44, wherein the fat loss is visceral fat loss.

[0173] 46. The method of alternative 45, wherein the fat loss is abdominal fat loss.

[0174] 47. The method of any one of alternatives 44 to 46, wherein the ratio of N- trans-caffeoyltyramine and N-trans-feruloyltyramine is 5:1 to 1:5.

[0175] 48. The method of any one of alternatives 44 to 47, wherein the composition comprises about 60 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine.

[0176] 49. The method of any one of alternatives 44 to 47, wherein the composition comprises about 120 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine.

[0177] 50. The method of any one of alternatives 44 to 49, wherein providing to the subject the composition provides glucose level normalization followed by fat loss benefits.

[0178] 51. The method of any one of alternatives 44 to 50, wherein providing to the subject the composition provides normal blood glucose regulation followed by fat loss benefits.

[0179] 52. The method of any one of alternatives 44 to 51, wherein the subject has a BMI ≥ 28.0 kg / m2.

[0180] 53. The method of any one of alternatives 44 to 53, wherein the subject maintains lean body mass during fat loss.

[0181] 54. A method for providing glucose management in a subject, the method comprising providing to the subject a composition comprising from about 50 mg to about 150 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine, wherein the N-trans- caffeoyltyramine and the N-trans-feruloyltyramine is in a ratio of 10:1 to 1:10.

[0182] 55. The method of alternative 54, wherein the ratio of N-trans- caffeoyltyramine and N-trans-feruloyltyramine is 5:1 to 1:5.

[0183] 56. The method of alternative 54 or 55, wherein the composition comprises about 60 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine.

[0184] 57. The method of alternative 54 or 55, wherein the composition comprises about 120 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine.

[0185] 58. The method of any one of alternatives 54 to 57, wherein providing to the subject the composition provides glucose level normalization followed by fat loss benefits.

[0186] 59. The method of any one of alternatives 54 to 58, wherein providing to the subject the composition provides normal blood glucose regulation followed by fat loss benefits.

[0187] 60. The method of any one of alternatives 54 to 59, wherein the subject has a BMI ≥ 28.0 kg / m2.

[0188] 61. The method of any one of alternatives 54 to 60, wherein the subject maintains lean body mass during fat loss.

[0189] 62. A method to provide or support abdominal fat loss in a subject, the method comprising providing to the subject a composition comprising from about 50 mg to about 150 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine, wherein the N-trans- caffeoyltyramine and the N-trans-feruloyltyramine is in a ratio of 10:1 to 1:10.

[0190] 63. The method of alternative 62, wherein the composition comprises about 60 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine.

[0191] 64. The method of alternative 62, wherein the composition comprises about 120 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine.

[0192] 65. The method of any one of alternatives 62 to 64, wherein the ratio of N- trans-caffeoyltyramine and N-trans-feruloyltyramine is 5:1 to 1:5.

[0193] 66. The method of any one of alternatives 62 to 64, wherein the composition is in a form of a capsule, gummy, table, functional beverage, and functional food.

[0194] 67. The method of alternative 66, wherein the capsule is a sustained release capsule.

[0195] 68. The method of any one of alternatives 62 to 67, wherein providing to the subject the composition provides or supports sustained abdominal fat loss.

[0196] 69. The method of any one of alternatives 62 to 68, wherein the subject has a body mass index (BMI) of about ≥29.0 to about <40.0 kg / m2.

[0197] 70. The method of any one of alternatives 62 to 68, wherein the subject has a BMI ≥ 28.0 kg / m2.

[0198] 71. The method of any one of alternatives 62 to 70, wherein the subject has a Total-C level of ≥ 200 mg / dL.

[0199] 72. The method of any one of alternatives 62 to 71, wherein the subject has a HDL-C level of ≤ 40 mg / dL.

[0200] 73. The method of any one of alternatives 62 to 72, wherein the subject has a triglyceride level of ≥ 150 mg / dL.

[0201] 74. The method of any one of alternatives 62 to 73, wherein the subject has pre-diabetes.

[0202] 75. The method of any one of alternatives 62 to 74, wherein the subject is administered the composition once per day.

[0203] 76. The method of alternative 75, wherein the subject is administered the composition for at least 6 six months.

[0204] 77. The method of any one of alternatives 62 to 76, wherein the composition is provided in combination with a dietary regimen designed to enhance the weight management in the subject.

[0205] 78. The method of any one of alternatives 62 to 77, wherein the subject is advised to engage in a physical activity program in conjunction with the administration of the composition.

[0206] 79. The method of any one of alternatives 62 to 78, wherein the composition provides improvement in metabolic rate.

[0207] 80. The method of any one of alternatives 62 to 79, wherein the subject has a waist circumference reduction of at least 5% from baseline after administration of the composition for 3 months.

[0208] 81. The method of any one of alternatives 62 to 80, wherein providing to the subject the composition improves insulin sensitivity.

[0209] 82. The method of any one of alternatives 62 to 81, wherein a treatment outcome comprises a reduction in abdominal fat mass by at least 5% to 15% from baseline measurements, as measured in kilograms (kg) or pounds (lbs).

[0210] 83. The method of any one of alternatives 62 to 82, further comprising achieving a decrease in body weight of no less than 5% to 20% compared to initial measurements.

[0211] 84. The method of any one of alternatives 62 to 83, wherein a treatment outcome comprises a reduction in abdominal fat by a range of 10% to 30% from baseline measurements, quantified in cubic centimeters (cm³) or inches (in³).

[0212] 85. The method of any one of alternatives 62 to 84, wherein a treatment outcome comprises a decrease in abdominal fat by a range of 5% to 25% from baseline measurements.

[0213] 86. The method of any one of alternatives 62 to 85, further comprising maintaining abdominal fat loss within a range of ±3% to ±10% of the achieved reduction in body fat mass.

[0214] 87. The method of any one of alternatives 62 to 86, wherein a treatment outcome comprises achieving controlled blood sugar levels within a target range of 70 to 120 milligrams per deciliter (mg / dL) or 3.9 to 6.7 millimoles per liter (mmol / L).

[0215] 88. The method of any one of alternatives 62 to 87, wherein the subject is a human female.

[0216] 89. The method of any one of alternatives 62 to 87, wherein the subject is a human male.

[0217] 90. A method to provide or support visceral fat loss in a subject, the method comprising providing to the subject a composition comprising from about 50 mg to about 150mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine, wherein the N-trans- caffeoyltyramine and the N-trans-feruloyltyramine is in a ratio of 10:1 to 1:10.

[0218] 91. The method of alternative 90, wherein the composition comprises about 60 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine.

[0219] 92. The method of alternative 90, wherein the composition comprises about 120 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine.

[0220] 93. The method of any one of alternatives 90 to 92, wherein the ratio of N- trans-caffeoyltyramine and N-trans-feruloyltyramine is 5:1 to 1:5.

[0221] 94. The method of any one of alternatives 90 to 93, wherein the composition is in a form of a capsule, gummy, table, functional beverage, and functional food.

[0222] 95. The method of alternative 94, wherein the capsule is a sustained release capsule.

[0223] 96. The method of any one of alternatives 90 to 95, wherein providing to the subject the composition provides or supports sustained visceral fat loss.

[0224] 97. The method of any one of alternatives 90 to 96, wherein the subject has a body mass index (BMI) of about ≥29.0 to about <40.0 kg / m2.

[0225] 98. The method of any one of alternatives 90 to 96, wherein the subject has a BMI ≥ 28.0 kg / m2.

[0226] 99. The method of any one of alternatives 90 to 98, wherein the subject has a Total-C level of ≥ 200 mg / dL.

[0227] 100. The method of any one of alternatives 90 to 99, wherein the subject has a HDL-C level of ≤ 40 mg / dL.

[0228] 101. The method of any one of alternatives 90 to 100, wherein the subject has a triglyceride level of ≥ 150 mg / dL.

[0229] 102. The method of any one of alternatives 90 to 101, wherein the subject has pre-diabetes.

[0230] 103. The method of any one of alternatives 90 to 102, wherein the subject is administered the composition once per day.

[0231] 104. The method of alternative 103, wherein the subject is administered the composition for at least 6 six months.

[0232] 105. The method of any one of alternatives 90 to 104, wherein the composition is provided in combination with a dietary regimen designed to enhance the weight management in the subject.

[0233] 106. The method of any one of alternatives 90 to 105, wherein the subject is advised to engage in a physical activity program in conjunction with the administration of the composition.

[0234] 107. The method of any one of alternatives 90 to 106, wherein the composition provides improvement in metabolic rate.

[0235] 108. The method of any one of alternatives 90 to 107, wherein the subject has a waist circumference reduction of at least 5% from baseline after administration of the composition for 3 months.

[0236] 109. The method of any one of alternatives 90 to 108, wherein providing to the subject the composition improves insulin sensitivity.

[0237] 110. The method of any one of alternatives 90 to 109, wherein a treatment outcome comprises a reduction in visceral fat mass by at least 5% to 15% from baseline measurements, as measured in kilograms (kg) or pounds (lbs).

[0238] 111. The method of any one of alternatives 90 to 110, further comprising achieving a decrease in body weight of no less than 5% to 20% compared to initial measurements.

[0239] 112. The method of any one of alternatives 90 to 111, wherein a treatment outcome comprises a reduction in visceral fat by a range of 10% to 30% from baseline measurements, quantified in cubic centimeters (cm³) or inches (in³).

[0240] 113. The method of any one of alternatives 90 to 112, wherein a treatment outcome comprises a decrease in visceral fat by a range of 5% to 25% from baseline measurements.

[0241] 114. The method of any one of alternatives 90 to 113, further comprising maintaining visceral fat loss within a range of ±3% to ±10% of the achieved reduction in body fat mass.

[0242] 115. The method of any one of alternatives 90 to 114, wherein a treatment outcome comprises achieving controlled blood sugar levels within a target range of 70 to 120 milligrams per deciliter (mg / dL) or 3.9 to 6.7 millimoles per liter (mmol / L).

[0243] 116. The method of any one of alternatives 90 to 115, wherein the subject is a human female.

[0244] 117. The method of any one of alternatives 90 to 116, wherein the subject is a human male.

[0245] 118. A method to maintain lean body mass in a subject, the method comprising providing to the subject a composition comprising from about 50 mg to about 150 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine, wherein the N-trans- caffeoyltyramine and the N-trans-feruloyltyramine is in a ratio of 10:1 to 1:10.

[0246] 119. The method of alternative 118, wherein the composition comprises about 60 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine.

[0247] 120. The method of alternative 118, wherein the composition comprises about 120 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine.

[0248] 121. The method of any one of alternatives 118 to 120, wherein the ratio of N-trans-caffeoyltyramine and N-trans-feruloyltyramine is 5:1 to 1:5.

[0249] 122. The method of any one of alternatives 118 to 121, wherein the composition is in a form of a capsule, gummy, table, functional beverage, and functional food.

[0250] 123. The method of alternative 122, wherein the capsule is a sustained release capsule.

[0251] 124. The method of any one of alternatives 118 to 123, wherein providing to the subject the composition maintains lean body mass.

[0252] 125. The method of any one of alternatives 118 to 124, wherein the subject has a body mass index (BMI) of about ≥29.0 to about <40.0 kg / m2.

[0253] 126. The method of any one of alternatives 118 to 124, wherein the subject has a BMI ≥ 28.0 kg / m2.

[0254] 127. The method of any one of alternatives 118 to 126, wherein the subject has a Total-C level of ≥ 200 mg / dL.

[0255] 128. The method of any one of alternatives 118 to 127, wherein the subject has a HDL-C level of ≤ 40 mg / dL.

[0256] 129. The method of any one of alternatives 118 to 128, wherein the subject has a triglyceride level of ≥ 150 mg / dL.

[0257] 130. The method of any one of alternatives 118 to 129, wherein the subject has pre-diabetes.

[0258] 131. The method of any one of alternatives 118 to 130, wherein the subject is administered the composition once per day.

[0259] 132. The method of alternative 131, wherein the subject is administered the composition for at least 6 six months.

[0260] 133. The method of any one of alternatives 118 to 132, wherein the composition is provided in combination with a dietary regimen designed to enhance the weight management in the subject.

[0261] 134. The method of any one of alternatives 118 to 133, wherein the subject is advised to engage in a physical activity program in conjunction with the administration of the composition.

[0262] 135. The method of any one of alternatives 118 to 134, wherein the composition provides improvement in metabolic rate.

[0263] 136. The method of any one of alternatives 118 to 135, wherein the subject has a waist circumference reduction of at least 5% from baseline after administration of the composition for 3 months.

[0264] 137. The method of any one of alternatives 118 to 136, wherein providing to the subject the composition improves insulin sensitivity.

[0265] 138. The method of any one of alternatives 118 to 137, wherein a treatment outcome comprises a reduction in abdominal or visceral fat mass by at least 5% to 15% from baseline measurements, as measured in kilograms (kg) or pounds (lbs).

[0266] 139. The method of any one of alternatives 118 to 138, further comprising achieving a decrease in body weight of no less than 5% to 20% compared to initial measurements.

[0267] 140. The method of any one of alternatives 118 to 139, wherein a treatment outcome comprises a reduction in abdominal or visceral fat by a range of 10% to 30% from baseline measurements, quantified in cubic centimeters (cm³) or inches (in³).

[0268] 141. The method of any one of alternatives 118 to 140, wherein a treatment outcome comprises a decrease in abdominal or visceral fat by a range of 5% to 25% from baseline measurements.

[0269] 142. The method of any one of alternatives 118 to 141, further comprising maintaining visceral fat loss within a range of ±3% to ±10% of the achieved reduction in body fat mass.

[0270] 143. The method of any one of alternatives 118 to 142, wherein a treatment outcome comprises achieving controlled blood sugar levels within a target range of 70 to 120 milligrams per deciliter (mg / dL) or 3.9 to 6.7 millimoles per liter (mmol / L).

[0271] 144. The method of any one of alternatives 118 to 143, wherein the subject is a human female.

[0272] 145. The method of any one of alternatives 118 to 143, wherein the subject is a human male.

[0273] 146. A method to support normal blood glucose regulation in a subject, the method comprising providing to the subject a composition comprising from about 50 mg to about 150 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine, wherein the N-trans-caffeoyltyramine and the N-trans-feruloyltyramine is in a ratio of 10:1 to 1:10.

[0274] 147. The method of alternative 146, wherein the composition comprises about 60 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine.

[0275] 148. The method of alternative 146, wherein the composition comprises about 120 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine.

[0276] 149. The method of any one of alternatives 146 to 148, wherein the ratio of N-trans-caffeoyltyramine and N-trans-feruloyltyramine is 5:1 to 1:5.

[0277] 150. The method of any one of alternatives 146 to 149, wherein the composition is in a form of a capsule, gummy, table, functional beverage, and functional food.

[0278] 151. The method of alternative 150, wherein the capsule is a sustained release capsule.

[0279] 152. The method of any one of alternatives 146 to 151, wherein providing to the subject the composition maintains lean body mass.

[0280] 153. The method of any one of alternatives 146 to 152, wherein the subject has a body mass index (BMI) of about ≥29.0 to about <40.0 kg / m2.

[0281] 154. The method of any one of alternatives 146 to 153, wherein the subject has a BMI ≥ 28.0 kg / m2.

[0282] 155. The method of any one of alternatives 146 to 154, wherein the subject has a Total-C level of ≥ 200 mg / dL.

[0283] 156. The method of any one of alternatives 146 to 155, wherein the subject has a HDL-C level of ≤ 40 mg / dL.

[0284] 157. The method of any one of alternatives 146 to 156, wherein the subject has a triglyceride level of ≥ 150 mg / dL.

[0285] 158. The method of any one of alternatives 146 to 157, wherein the subject has pre-diabetes.

[0286] 159. The method of any one of alternatives 146 to 158, wherein the subject is administered the composition once per day.

[0287] 160. The method of alternative 159, wherein the subject is administered the composition for at least 6 six months.

[0288] 161. The method of any one of alternatives 146 to 160, wherein the composition is provided in combination with a dietary regimen designed to enhance the weight management in the subject.

[0289] 162. The method of any one of alternatives 146 to 161, wherein the subject is advised to engage in a physical activity program in conjunction with the administration of the composition.

[0290] 163. The method of any one of alternatives 146 to 162, wherein the composition provides improvement in metabolic rate.

[0291] 164. The method of any one of alternatives 146 to 163, wherein the subject has a waist circumference reduction of at least 5% from baseline after administration of the composition for 3 months.

[0292] 165. The method of any one of alternatives 146 to 164, wherein providing to the subject the composition improves insulin sensitivity.

[0293] 166. The method of any one of alternatives 146 to 165, wherein a treatment outcome comprises a reduction in abdominal or visceral fat mass by at least 5% to 15% from baseline measurements, as measured in kilograms (kg) or pounds (lbs).

[0294] 167. The method of any one of alternatives 146 to 166, further comprising achieving a decrease in body weight of no less than 5% to 20% compared to initial measurements.

[0295] 168. The method of any one of alternatives 146 to 167, wherein a treatment outcome comprises a reduction in abdominal or visceral fat by a range of 10% to 30% from baseline measurements, quantified in cubic centimeters (cm³) or inches (in³).

[0296] 169. The method of any one of alternatives 146 to 168, wherein a treatment outcome comprises a decrease in abdominal or visceral fat by a range of 5% to 25% from baseline measurements.

[0297] 170. The method of any one of alternatives 146 to 169, further comprising maintaining visceral fat loss within a range of ±3% to ±10% of the achieved reduction in body fat mass.

[0298] 171. The method of any one of alternatives 146 to 170, wherein a treatment outcome comprises achieving controlled blood sugar levels within a target range of 70 to 120 milligrams per deciliter (mg / dL) or 3.9 to 6.7 millimoles per liter (mmol / L).

[0299] 172. The method of any one of alternatives 146 to 171, wherein the subject is a human female.

[0300] 173. The method of any one of alternatives 146 to 171, wherein the subject is a human male.

[0301] 174. A method to provide glycemic control in a subject, the method comprising providing to the subject a composition comprising from about 50 mg to about 150 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine, wherein the N-trans- caffeoyltyramine and the N-trans-feruloyltyramine is in a ratio of 10:1 to 1:10.

[0302] 175. The method of alternative 174, wherein the composition comprises about 60 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine.

[0303] 176. The method of alternative 174, wherein the composition comprises about 120 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine.

[0304] 177. The method of any one of alternatives 174 to 176, wherein the ratio of N-trans-caffeoyltyramine and N-trans-feruloyltyramine is 5:1 to 1:5.

[0305] 178. The method of any one of alternatives 174 to 177, wherein the composition is in a form of a capsule, gummy, table, functional beverage, and functional food.

[0306] 179. The method of alternative 178, wherein the capsule is a sustained release capsule.

[0307] 180. The method of any one of alternatives 174 to 179, wherein providing to the subject the composition maintains lean body mass.

[0308] 181. The method of any one of alternatives 174 to 180, wherein the subject has a body mass index (BMI) of about ≥29.0 to about <40.0 kg / m2.

[0309] 182. The method of any one of alternatives 174 to 181, wherein the subject has a BMI ≥ 28.0 kg / m2.

[0310] 183. The method of any one of alternatives 174 to 182, wherein the subject has a Total-C level of ≥ 200 mg / dL.

[0311] 184. The method of any one of alternatives 174 to 183, wherein the subject has a HDL-C level of ≤ 40 mg / dL.

[0312] 185. The method of any one of alternatives 174 to 184, wherein the subject has a triglyceride level of ≥ 150 mg / dL.

[0313] 186. The method of any one of alternatives 174 to 185, wherein the subject has pre-diabetes.

[0314] 187. The method of any one of alternatives 174 to 186, wherein the subject is administered the composition once per day.

[0315] 188. The method of alternative 187, wherein the subject is administered the composition for at least 6 six months.

[0316] 189. The method of any one of alternatives 174 to 188, wherein the composition is provided in combination with a dietary regimen designed to enhance the weight management in the subject.

[0317] 190. The method of any one of alternatives 174 to 189, wherein the subject is advised to engage in a physical activity program in conjunction with the administration of the composition.

[0318] 191. The method of any one of alternatives 174 to 190, wherein the composition provides improvement in metabolic rate.

[0319] 192. The method of any one of alternatives 174 to 191, wherein the subject has a waist circumference reduction of at least 5% from baseline after administration of the composition for 3 months.

[0320] 193. The method of any one of alternatives 174 to 192, wherein providing to the subject the composition improves insulin sensitivity.

[0321] 194. The method of any one of alternatives 174 to 193, wherein a treatment outcome comprises a reduction in abdominal or visceral fat mass by at least 5% to 15% from baseline measurements, as measured in kilograms (kg) or pounds (lbs).

[0322] 195. The method of any one of alternatives 174 to 194, further comprising achieving a decrease in body weight of no less than 5% to 20% compared to initial measurements.

[0323] 196. The method of any one of alternatives 174 to 195, wherein a treatment outcome comprises a reduction in abdominal or visceral fat by a range of 10% to 30% from baseline measurements, quantified in cubic centimeters (cm³) or inches (in³).

[0324] 197. The method of any one of alternatives 174 to 196, wherein a treatment outcome comprises a decrease in abdominal or visceral fat by a range of 5% to 25% from baseline measurements.

[0325] 198. The method of any one of alternatives 174 to 197, further comprising maintaining visceral fat loss within a range of ±3% to ±10% of the achieved reduction in body fat mass.

[0326] 199. The method of any one of alternatives 174 to 198, wherein a treatment outcome comprises achieving controlled blood sugar levels within a target range of 70 to 120 milligrams per deciliter (mg / dL) or 3.9 to 6.7 millimoles per liter (mmol / L).

[0327] 200. The method of any one of alternatives 174 to 199, wherein the subject is a human female.

[0328] 201. The method of any one of alternatives 174 to 199, wherein the subject is a human male.

[0329] 202. A method to provide type-2 diabetes management in a subject, the method comprising providing to the subject a composition comprising from about 50 mg to about 150 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine, wherein the N-trans- caffeoyltyramine and the N-trans-feruloyltyramine is in a ratio of 10:1 to 1:10.

[0330] 203. The method of alternative 202, wherein the composition comprises about 60 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine.

[0331] 204. The method of alternative 202, wherein the composition comprises about 120 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine.

[0332] 205. The method of any one of alternatives 202 to 204, wherein the ratio of N-trans-caffeoyltyramine and N-trans-feruloyltyramine is 5:1 to 1:5.

[0333] 206. The method of any one of alternatives 202 to 205, wherein the composition is in a form of a capsule, gummy, table, functional beverage, and functional food.

[0334] 207. The method of alternative 206, wherein the capsule is a sustained release capsule.

[0335] 208. The method of any one of alternatives 202 to 206, wherein providing to the subject the composition maintains lean body mass.

[0336] 209. The method of any one of alternatives 202 to 208, wherein the subject has a body mass index (BMI) of about ≥29.0 to about <40.0 kg / m2.

[0337] 210. The method of any one of alternatives 202 to 209, wherein the subject has a BMI ≥ 28.0 kg / m2.

[0338] 211. The method of any one of alternatives 202 to 210, wherein the subject has a Total-C level of ≥ 200 mg / dL.

[0339] 212. The method of any one of alternatives 202 to 211, wherein the subject has a HDL-C level of ≤ 40 mg / dL.

[0340] 213. The method of any one of alternatives 202 to 212, wherein the subject has a triglyceride level of ≥ 150 mg / dL.

[0341] 214. The method of any one of alternatives 202 to 213, wherein the subject has pre-diabetes.

[0342] 215. The method of any one of alternatives 202 to 214, wherein the subject is administered the composition once per day.

[0343] 216. The method of alternative 215, wherein the subject is administered the composition for at least 6 six months.

[0344] 217. The method of any one of alternatives 202 to 216, wherein the composition is provided in combination with a dietary regimen designed to enhance the weight management in the subject.

[0345] 218. The method of any one of alternatives 202 to 217, wherein the subject is advised to engage in a physical activity program in conjunction with the administration of the composition.

[0346] 219. The method of any one of alternatives 202 to 218, wherein the composition provides improvement in metabolic rate.

[0347] 220. The method of any one of alternatives 202 to 219, wherein the subject has a waist circumference reduction of at least 5% from baseline after administration of the composition for 3 months.

[0348] 221. The method of any one of alternatives 193 to 220, wherein providing to the subject the composition improves insulin sensitivity.

[0349] 222. The method of any one of alternatives 202 to 221, wherein a treatment outcome comprises a reduction in abdominal or visceral fat mass by at least 5% to 15% from baseline measurements, as measured in kilograms (kg) or pounds (lbs).

[0350] 223. The method of any one of alternatives 202 to 222, further comprising achieving a decrease in body weight of no less than 5% to 20% compared to initial measurements.

[0351] 224. The method of any one of alternatives 202 to 223, wherein a treatment outcome comprises a reduction in abdominal or visceral fat by a range of 10% to 30% from baseline measurements, quantified in cubic centimeters (cm³) or inches (in³).

[0352] 225. The method of any one of alternatives 202 to 224, wherein a treatment outcome comprises a decrease in abdominal or visceral fat by a range of 5% to 25% from baseline measurements.

[0353] 226. The method of any one of alternatives 202 to 225, further comprising maintaining visceral fat loss within a range of ±3% to ±10% of the achieved reduction in body fat mass.

[0354] 227. The method of any one of alternatives 202 to 226, wherein a treatment outcome comprises achieving controlled blood sugar levels within a target range of 70 to 120 milligrams per deciliter (mg / dL) or 3.9 to 6.7 millimoles per liter (mmol / L).

[0355] 228. The method of any one of alternatives 202 to 227, wherein the subject is a human female.

[0356] 229. The method of any one of alternatives 202 to 227, wherein the subject is a human male. EXAMPLES

[0357] The following non-limiting examples are provided to further illustrate the present disclosure. Example 1

[0358] This example describes a randomized, double-blind, placebo-controlled, three-arm parallel study to investigate the effects of a dietary supplement containing N-trans- caffeoyltyramine (“NCT”) and N-trans-feruloyltyramine (“NFT”) on body composition and related outcomes.

[0359] Background

[0360] Health promoting properties of foods and beverages extend beyond their content of conventional nutrients (vitamins, minerals, dietary fiber, etc.). Indeed, many other naturally occurring bioactive compounds are well recognized for their health promoting properties. Bioactives are small molecules produced by plants, fungi, and microbes that grow in and adapt to environments that present a wide range of challenges to their survival. Bioactives can be widely found in edible plants, herbs, fruits and vegetables (Wallace et al., 2020) and are known to benefit human health.

[0361] N-trans caffeoyltyramine (NCT) and N-trans feruloyltyramine (NFT) are bioactive compounds that have been identified in a range of edible sources including black pepper and hemp hulls. These compounds have gained recent attention for their involvement in cellular signaling modulation in several different organs. In silico work has revealed NCT and NFT as potential agonists of hepatocyte nuclear factor 4 alpha (“HNF4α”) in humans (Lee et al., 2021). HNF4α is a signaling compound, known as a nuclear transcription factor, which plays a role in regulating metabolism in the liver. HNF4α has also been identified in the muscle, adipose tissue, intestine, pancreas, and kidney where it serves other functions. One study showed that mice lacking intestinal HNF4A are more resistant to weight gain as early as 4 days after commencement of a high-fat diet (Lu et al, 2022). In another study, adult male HNF4α intestinal knockout mice tended to lose weight when fed the high-fat-high-sugar diet for 15 days (Girard et al., 2022). Even though the role of HNF4α is not fully understood and in vivo studies have inconsistent results, these studies indicate a relationship between HNF4α and weight.

[0362] Preclinical support for these compounds (NCT and NFT) have been executed. The principal finding of these studies is that activating HNF4α through NCT led to 35% to 40% difference in body weight gain and increased mitochondrial mass and fatty acid oxidation compared to mice fed only with a high-fat diet (Veeriah et al., 2022). Earlier studies in which NCT was administered to mice for a shorter time showed stimulation of lipophagy with fatty acids appeared to redistribute to the adipose tissue (Lee et al., 2021).

[0363] Formulation of NCT and NFT Under Analysis

[0364] The substance investigated in this study was a preparation including N- trans-caffeoyltyramine (NCT; CAS: 103188-48-3) and N-trans-feruloyltyramine (NFT; CAS: 66648-43-9) that has been identified in a range of edible sources including black peppercorns, garlic, hemp, and onion (confirmed by internal testing). The NCT and NFT to be evaluated in this study were derived via synthetic biology (i.e., fermentation using a recombinant microorganism) to provide a high purity (>85%) form of these compounds that are structurally identical to their naturally occurring counterparts. All ingredients in the encapsulated final test article, including the NCT and NFT, were manufactured under food GMPs and were suitable quality for use in food, dietary supplements, and specialty nutrition products.

[0365] Safety of Recombinant Microorganism and NCT and NFT

[0366] The host strain engineered to produce NCT and NFT was Yarrowia lipolytica, a well-characterized strain of yeast that is nonpathogenic and non-toxigenic with no antibiotic resistance. It has been used extensively in food manufacturing with no documented toxic, allergenic, nor other harmful effects on the health of humans (Groenewald et al., 2014). The strain is recognized as safe for use in human food by the European Food Safety Authority (EFSA, 2023) and the International Dairy Federation (IDF, 2022). In the US, there have been multiple Generally Recognized as Safe (GRAS) submissions for novel food ingredients using Y. lipolytica as the production strain which have received Letters of No Questions from the Food & Drug Administration (indicating the Agencyʼs agreement with the GRAS conclusion; GRN No.940, GRN No.759, GRN No.632, and GRN No.355).

[0367] The Y. lipolytica host strain has been modified to produce either NCT or NFT depending on whether the precursor caffeic acid or ferulic acid was fed during the fermentation process. The genes added to the Y. lipolytica genome were identified in plant or yeast sources and have been codon optimized and integrated stably into the host genomewithout introduction of antibiotic resistance or mobile genetic elements. The manufacturing process for NCT and NFT removes the genetically modified DNA, which is verified by a negative result for a PCR test specifically designed to detect the recombinant DNA.

[0368] The safety of NCT and NFT has been evaluated as part of an assessment for a novel hemp hull fiber ingredient, which was unanimously concluded to be GRAS for human consumption by a qualified panel of scientific experts. The safety of the phenolic content, including NCT and NFT, were based on history of hemp consumption, publicly available literature, and data generated showing no adverse events in 5 studies in male rodents receiving NCT or NFT doses of 400 to 600 mg / kg bw / day for 10 days to 4 months and in a human study with adults receiving 10 NFT mg / day for 7 days. Considering the maximum permissible phenolic spec of 100 mg gallic acid equivalents (GAE) / g and that NCT and NFT compose approximately 4.5% of the phenolic fraction in hemp hulls (Leonard et al., 2021), a cumulative 90th percentile estimated daily intake for adult males of NCT and NFT from hemp hull fiber of 176 mg / d is permitted under the GRAS conclusion.

[0369] Additionally, a human clinical study was recently completed in which no adverse effects were observed in healthy overweight and obese adults (n = 47) receiving 20 mg NFT per day in the form of a black pepper extract for 3 months.

[0370] Safety Conclusion

[0371] Based on the information outlined above and considering the cumulative doses of NCT and NFT of 60 mg per day and 120 mg per day proposed for evaluation in the current study, the test articles containing NCT and NFT produced using a modified strain of Y. lipolytica can be reasonably concluded to be safe at the intended doses and highly unlikely to pose any safety concern to study participants.

[0372] Objective

[0373] The primary objective of this study was to quantify changes in body fat in response to daily consumption of a novel dietary supplement containing NCT and NFT at two different dose levels in free-living adults with overweight and obesity over a 24-week period. The primary hypothesis was that supplementation with NCT and NFT will result in larger reductions in body fat over 24 weeks compared to placebo.

[0374] Study Design

[0375] This study utilized a randomized, placebo-controlled, parallel study design with one screening visit (week -1) and seven test visits (weeks 0, 4, 8, 12, 16, 20, and 24).

[0376] In brief, following initial screening, participants were tested at weeks 0 (baseline), 12, and 24 for body composition, anthropometrics, vital signs, blood chemistry / cardiometabolic biomarkers, and self-reported tolerability outcomes. Participants returned to the clinic each month to assess body weight, ensure compliance with study product consumption, and encourage continued participation throughout the study. The study design is illustrated in FIG.1 and the schedule of activities is outlined in Table 1. Table 1 Screen Intervention1Assess Adverse Events X X X X X X X1Visits 1 and 2 may be separated by 1 to 7 days. A window of ±3 d will be allowed for visits

[0377] Study Procedures

[0378] Medical History

[0379] Each participant’s relevant medical history covering the past 5 years will be reviewed by a Clinical Investigator.

[0380] Physical Exam

[0381] A physical examination will be performed at visit 1 (week -1), which will include an evaluation of the head, ears, eyes, nose, throat (HEENT), skin, neck, lungs, heart, and abdomen.

[0382] Clinic Visit

[0383] Visit 1: Measurement of height with BMI calculation, as well as vital signs (resting blood pressure and heart rate) and last menses query, where applicable. Evaluation of inclusion / exclusion criteria and concomitant medication / supplement use for study eligibility.

[0384] Visits 2-8: Measurement of vital signs (resting blood pressure and heart rate) and last menses query, where applicable. Review inclusion / exclusion criteria and concomitant medication / supplement to confirm study eligibility prior randomization at visit 2 and for possible protocol deviations at visits 3-8.

[0385] Vital signs: Resting blood pressure and heart rate will be measured using an automated blood pressure measurement device. Systolic and diastolic pressures will be measured using an appropriately sized cuff (bladder within the cuff must encircle ≥80% of the arm). After the participant has been sitting quietly for at least 5 min, three repeated measurements will be taken, each separated by at least 2 min. The average of the last two measurements will be used.

[0386] Body Weight

[0387] Body weight will be measured following an overnight fast (≥ 8-15 h; water only) the morning of all clinic visits (visits 1 through 8; weeks -1 through 24). Participants will be asked to empty their bladder / bowels, change into a gown and remove their shoes before their weight is obtained. Weight will be recorded to the nearest 0.1 kg. The same digital scale (Health-O-Meter Professional 349KLX) will be used to measure body weight at each clinicvisit. Attempts will be made to assess body weight at all post-enrollment study visits at approximately the same time of day as in visit 2 (week 0). The scale will be calibrated prior to the start of the study.

[0388] Sample Population

[0389] A total of 150 participants that met all of the following inclusion criteria and none of the exclusion criteria were enrolled. A I / E waiver was requested for any planned deviation. A total of 22 waivers were granted primarily pertaining to the BMI criterion.

[0390] Inclusion Criteria

[0391] The study population included subjects who were male or female, ≥18 years of age at visit 1 (week -1). Subjects presented with a body mass index (BMI) of ≥28.0 kg / m2 to <35.0 kg / m2 at visit 1 (week -1). Subjects also presented with at least one of the following comorbidities based on blood draws at visit 1: Dyslipidemia (any of the following: Total-C ≥200 mg / dL, LDL-C ≥130 mg / dL, HDL-C ≤40 mg / dL, or Triglycerides ≥150 mg / dL) or Pre- diabetes (HbA1c ≥5.7 to ≤6.4%). Stable use of medications was allowed, where stable use was defined as the same dose for at least 90 days prior to visit 1. Subjects were non-users or former users (cessation ≥12 months) of tobacco or nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) with no plans to begin use during the study period. Subjects were willing to maintain a stable intake of current dietary supplements and medications not specifically listed as exclusionary or deemed to interfere with study outcomes throughout the study duration. Subjects were also willing to adhere to all study procedures and sign forms providing informed consent to participate in the study and authorization to release relevant protected health information to the Clinical Investigator.

[0392] Exclusion Criteria

[0393] Subjects were excluded if they presented with any of the following criteria: a weight loss or gain of ≥4.5 kg within 90 days of visit 1; use of weight loss medications within 90 days of visit 1; a history of gastrointestinal surgery such as bariatric surgery or cosmetic procedures such as liposuction for weight or fat reducing purposes; or the use of dietary supplements or related products that, in the judgment of the Investigator, were likely to markedly affect weight loss or appetite within 30 days of visit 1. Also exclusionary were a history of extreme dietary habits as judged by the Investigator; a history of an eating disorder diagnosed by a health professional; or a current medical diagnosis of type 1 or type 2 diabetesmellitus. Subjects were further excluded if they presented with an HbA1c of ≥48 mmol / mol (6.5%) as measured at visit 1; a history of a chronic gastrointestinal disorder such as peptic ulcer disease or malabsorption syndrome, although mild lactose intolerance or gastroesophageal reflux diseases were acceptable; or a history of liver disease, with the exception of non-alcoholic fatty liver disease (NAFLD). Additional exclusion criteria included the unstable use of medications for mental or emotional disorders, where stable use was defined as the same dose for ≥90 days prior to visit 1; uncontrolled stage 2 hypertension, defined as a systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg measured at visit 1, though participants with hypertension on a stable dose of medication for over 90 days were permitted at the Investigator’s discretion; or the habitual daily use of marijuana, hemp, or CBD products within 30 days of visit 1. Also excluded were subjects with a history or presence of cancer within 2 years of visit 1, except for non-melanoma skin cancer; unstable use of thyroid hormone replacement medication, defined as not being on the same dose for ≥90 days prior to visit 1; known intolerance or sensitivity to any ingredients in the study products; or exposure to any non-registered drug product within 4 weeks prior to visit 1. Finally, subjects were excluded if they showed signs or symptoms of a clinically relevant active infection within 5 days of visit 1; if the subject was a female who was pregnant, planning to become pregnant, lactating, or was of childbearing potential and unwilling to use a medically approved form of contraception; had a recent history within 12 months of visit 1 of alcohol or substance abuse, where alcohol abuse was defined as consuming more than 14 drinks per week; or had any condition the Investigator believed would interfere with the ability to provide informed consent, comply with the protocol, confound study results, or place the subject at undue risk.

[0394] Excluded Products

[0395] Habitual use (i.e., daily) of tobacco / nicotine products within 12 months of visit 1 and throughout the study period. Weight loss medications within 90 days of visit 1. Unstable use (initiation or change in dose) of medications for mental or emotional disorders within 90 days of visit 1. Unstable use (initiation or change in dose) of antihypertensive medications within 30 days of visit 1. Unstable use (initiation or change in dose) of thyroid hormone replacement medications within 90 days of visit 1. Dietary supplements or related products that, in the judgment of the Investigator, are likely to markedly affect weight loss or appetite within 30 days of visit 1. Habitual use (i.e., daily) of marijuana and hemp products,including CBD products, within 30 days of visit 1. Participants that require medication taken with food that is not exclusionary should inform study staff so that appropriate accommodation may be planned.

[0396] Study Products

[0397] Placebo: 1 capsule / day

[0398] Active low dose: 60 mg (NCT / NFT) via 1 capsule / day

[0399] Active high dose: 120 mg (NCT / NFT) via 1 capsule / day

[0400] Every day for 24 weeks, participants were instructed to consume their assigned study product with water only after waking and at least 30 minutes before the first eating occasion. If a participant failed to consume the study product at that time (i.e., normally consumes before breakfast but forgot), he / she was instructed to consume their assigned product with water at least 30 minutes prior to the next eating occasion (e.g., if missed prior to breakfast, consume study product at least 30 minutes before lunch). Participants were advised not to consume more than 1 capsule / day. An instruction to not consume the study product with coffee, tea or juice was given.

[0401] Storage and Dispensing

[0402] Study products will be stored in a cool, dry, secure location at ambient temperature. Study product supplies are to be used only in accordance with this protocol and under the supervision of the Clinical Investigator. A product dispensing log will be maintained. All records must be available for inspection and are participant to regulatory agency inspection at any time. Copies of the records will be provided at the conclusion of the study. A written explanation from the study staff will be required for any missing study product. Non- dispensed study products and unconsumed study products returned by the participants will be destroyed after the completion of the study product reconciliation.

[0403] Participants will be dispensed 1 bottle containing 101 capsules at visit 2 (week 0) and 1 bottle containing 101 capsules at visit 5 (week 12).

[0404] Blinding

[0405] Participants were randomized 1:1:1 in permuted blocks to either a placebo, low dose, or high dose arm. Participants were stratified by baseline BMI category (≥28.0 to <30.0 kg / m2; ≥30.0 to <35.0 kg / m2) and sex.

[0406] Study product was packaged as non-descript capsules. Participants and study staff remained blinded to the study product throughout the study. A set of sealed unblinding envelopes were provided to the Clinical Investigator for use in an emergency situation where knowledge of the assignment was essential for the participant’s immediate medical care. No unblinding was required during the study.

[0407] Data Analysis and Statistical Methods

[0408] This study investigated the effects of a dietary supplement containing the bioactives NCT and NFT on body composition and related outcomes in adults with overweight and obesity over 24 weeks. For the primary endpoint, which was the change in body fat mass (kg) from week 0 to week 24 as measured by DEXA, no significant difference was detected for either the low dose or high dose group compared to placebo. Furthermore, the DEXA body composition data suggested no significant decrease in body fat mass was observed within any of the study product groups (placebo, low dose, or high dose) from week 0 to week 12 or week 24. Similar findings were generally observed for most secondary and exploratory outcomes, including other body composition measures (e.g., percent fat mass, android fat, gynoid fat, and abdominal visceral fat), body circumferences (hip, chest, bicep, waist to hip ratio), cardiometabolic parameters (fasting glucose, insulin, HbA1c, blood pressure, blood lipids), body weight, SF-36 health concepts, and dietary intake parameters.

[0409] Post hoc subgroup analyses (sex, BMI group, glucose group) identified some potential differences in how certain subgroups responded, particularly regarding visceral fat mass, waist circumference, and hip circumference interactions. Notably, placebo group changes in visceral fat and some circumference measures appeared to differ by sex and / or glucose status, while the low dose active group showed some potential for decreases in waist and hip circumference in the lower BMI subgroup. These findings should be interpreted with caution.

[0410] The safety assessments indicated the study products were generally well tolerated, with no significant changes were observed in liver enzymes (ALT and AST) and a majority of possibly related adverse events occurred in the placebo group, with only a few mild events reported as possibly related in the active treatment groups.

[0411] Sample Size

[0412] There was no existing data to support a power calculation to determine the appropriate samples size to test the effects of the bioactives NCT and NFT at two different dose levels on body fat changes in free-living humans. However, in commercial weight loss programs utilizing a “usual care” control group, typical mean fat mass change in a similar timeframe was approximately ~1.0 ± 2.0 kg in adult men and women with a BMI ≥28.0 to <40.0 kg / m2. These findings were also generally consistent with other placebo control test conditions in published weight loss studies. Therefore, it was assumed that, on average, the placebo control group will have a 1.0 ± 2.0 kg fat mass change and a conservative estimate of 3.0 ± 4.0 kg change in body fat mass in each active group (reflecting a change in body composition associated with a clinically meaningful change of at least 5% body weight loss at week 24). There was approximately 80% power to detect an effect size of approximately 0.63 (i.e., an actual difference of 2.0 kg with a SD of 2.0 kg and 4.0 kg in the control and active groups, respectively) at a 2-sided 0.05 significance level with 123 subjects (n = 41 per group) using a two sample t-test. Note that comparisons of each active product to placebo were to be made at α = 0.05, which controlled the family wise error rate at 0.10. To allow for possible attrition (~30%), 150 subjects were randomized.

[0413] Primary Endpoint

[0414] The body fat mass (kg) change from week 0 to week 24 as measured by the DEXA scan.

[0415] Secondary Endpoint

[0416] Secondary endpoints included the change in body composition from week 0 to weeks 12 and 24, as measured by a DEXA scan. Specific body composition parameters assessed were body fat mass (kg) at week 12, percent fat mass, android fat mass (kg), gynoid fat mass (kg), and abdominal visceral fat mass (g). Additionally, the change in body circumference was measured from week 0 to weeks 12 and 24 using a 3D body scan, assessing waist (abdominal) circumference (cm), hip circumference (cm), chest circumference (cm), upper thigh circumference (cm), upper arm bicep circumference (cm), and the waist-to-hip ratio.

[0417] Cardiometabolic parameters were assessed by measuring the change from week 0 to specified follow-up visits. These included fasting glucose, fasting insulin, and HbA1c at weeks 12 and 24; FGF21 at week 24; systolic and diastolic blood pressure at weeks4, 8, 12, and 24; and a full blood lipid panel (Total-C, HDL-C, LDL-C, VLDL-C, Non-HDL- C, and Triglycerides) at weeks 12 and 24. The change in body weight from week 0 was also recorded at weeks 4, 8, 12, 16, 20, and 24. Further secondary endpoints included the change in health-related quality of life, as measured by the SF-36 health concepts survey from week 0 to weeks 12 and 24, and the change in dietary intake, assessed via a Food Frequency Questionnaire (FFQ) at weeks 12 and 24, which evaluated total kilocalories, fat, protein, carbohydrates, fiber, and the Healthy Eating Index (HEI) score. Safety parameters were monitored throughout the study and included the documentation of product-emergent adverse events and changes in the chemistry profile, including liver enzymes ALT and AST, from baseline to weeks 12 and 24.

[0418] Outcome Analysis

[0419] A post hoc analysis was conducted evaluating the impact of sex (Male, Female), BMI group (≥28 to <30 kg / m2, ≥30 to <35 kg / m2), and glucose group (<100 mg / dL, ≥100 mg / dL) on the body composition and body circumference outcomes over time. For each set of outcomes, the model contained the 3-way interaction between study group, time, and the respective subgroup (i.e. sex, BMI group, and glucose group) as well as the relevant 2-way interactions and main effects. Model derived estimates were provided for the time point as well as the change from baseline along with the corresponding confidence interval. Boxplots were provided for the raw data and interaction plots were provided for the model derived estimates.

[0420] Study Monitoring

[0421] Concomitant Medication / Supplements

[0422] The participant disposition is presented in FIG. 3. All randomized participants were included in the intent-to-treat (ITT) population (n=150). A total of 132 participants were included in the per protocol (PP) population where removal was due to, early termination of study participation (n=5), not meeting eligibility criteria (n=3), protocol and / or product non-compliance (n=4), and concomitant medication use (n=6).

[0423] Results

[0424] Participant demographic, vitals, and relevant anthropometric measurements obtained during screening are presented in Table 2. Table 2Study Product Demographics Statistic / Group Placebo Low Dose High Dose Overall 5) 0, 0 ) ) ) ) ) 5, 1 .0, ) 0, 0 1) 5, 0 )Study Product Demographics Statistic / Group Placebo Low Dose High Dose Overall Q3,in, inch; mg, milligram

[0425] Compliance

[0426] Of the 145 participants that completed the study, the mean compliance was 99.8% (SD 3.7%). The mean compliance was 100.0 % (SD 4.4%), 99.7% (SD 2.9%), and 99.9% (SD 3.7%) for the placebo, low dose, and high dose, respectively.

[0427] Of the 132 participants in the PP population, the mean compliance was 100.0% (SD 3.2%). By group the mean compliance was 100.0% (SD 3.1%), 99.8% (SD 3.0%), and 100.2 (SD 3.4%) for the placebo, low dose, and high dose, respectively

[0428] Body Composition Analysis Results

[0429] Boxplots, representing the distribution of the change from baseline to each follow-up time point, for the body composition measures are presented in FIG.4.

[0430] Fat Mass (kg)

[0431] No significant interaction term between study product and time was detected (p=0.96) indicating parallel response profiles. Accordingly, compared to the placebo group, no significant difference was detected in the change from baseline to week 12 (secondary outcome) or week 24 (primary outcome) for the low dose (p=0.66 and 0.76, respectively) or high dose (p=0.87 and 0.60, respectively) groups (Table 3). Additionally, the 95% confidence interval for the change from week 0 to week 12 and week 24 within each group contains 0 suggesting no significant decrease in fat mass was observed in any of the study product groups.

[0432] Results were consistent in the PP population where no significant interaction term was detected (p=0.79). Accordingly, compared to the placebo group, no significant difference was detected in the change from baseline to week 12 or week 24 for the low dose (p=0.50 and 0.26, respectively) or high dose (p=0.63 and 0.29, respectively) groups. Table 3Time Point Change from Week 0 Week Statistic^Low Hih Placebo Low Hih Placebo 9)Time Point Change from Week 0 Week Statistic^Low Hi h Placebo Low Hi h Placebo 5) Q3,^Descriptive statistics include n, mean (SD), median (min, max), and Q1, Q3. Model derived estimates include mean Estimate, 95% CI, Estimate (vs. Placebo), and p-value

[0433] No significant 3-way interaction term between study product, time, and sex was detected (p=0.43) indicating the fat mass (kg) response profiles were consistent within subgroups. Within each product, the 95% CI for the change from week 0 to week 12 contained 0 for both the male and the female subgroups indicating no significant within product change in fat mass. Similarly, for the change from week 0 to week 24 the 95% CI contained 0 for both the male and female subgroups with the exception of the male placebo group (95% CI 0.53 to 2.60 kg), which had a slight increase. The interaction plot detailing the time point estimates is presented in FIG.5.

[0434] No significant 3-way interaction term between study product, time, and BMI group was detected (p=0.89), indicating the response profiles were consistent within subgroups. Within each product for each subgroup, the 95% CI contained 0 for the change from week 0 to week 12 and the change from week 0 to week 24 indicating no significantwithin product change in fat mass. The interaction plot detailing the time point estimates is presented in FIG.6.

[0435] No significant 3-way interaction term between study product, time, and glucose group was detected (p=0.39) indicating the response profiles were consistent within subgroups. Within each product for each subgroup, the 95% CI contained 0 for the change from week 0 to week 12 and the change from week 0 to week 24 indicating no significant within product change in fat mass. The interaction plot detailing the time point estimates is presented in FIG.7.

[0436] Fat Mass (%)

[0437] No significant interaction term between study product and time was detected (p=1.00) indicating parallel response profiles. Per the statistical analysis plan (SAP), no further between study product group testing was planned (p>0.10). Additionally, the 95% confidence interval for the change from week 0 to week 12 and week 24 within each group contains 0 suggesting no significant decrease in fat mass percent was observed in any of the study product groups (Table 4). Results were consistent in the PP population where no significant interaction term was detected (p=0.96). Table 4 Fat mass (%) descriptive statistics and model derived estimates Time Point Change from Week 0 ^Time Point Change from Week 0 Week Statistic^Low High Placebo Low Dose High Dose Placebo .8) 2 .2) 6 3rd, , ,^Descriptive statistics include n, mean (SD), median (min, max), and Q1, Q3. Model derived estimates include mean Estimate, 95% CI, Estimate (vs. Placebo), and p-value

[0438] No significant 3-way interaction term between study product, time, and sex was detected (p=0.72) indicating the fat mass (%) response profiles were consistent within subgroups. Within each product, the 95% CI for the change from week 0 to week 12 contained 0 for both the male and the female subgroups indicating no significant within product change in percent fat mass. Similarly, for the change from week 0 to week 24 the 95% CI contained 0for both the male and female subgroups with the exception of the male placebo group (95% CI 0.09 to 1.63%) which had a slight increase. The interaction plot detailing the time point estimates is presented in FIG.8.

[0439] No significant 3-way interaction term between study product, time, and BMI group was detected (p=0.77) indicating the response profiles were consistent within subgroups. Within each product for each subgroup, the 95% CI contained 0 for the change from week 0 to week 12 and the change from week 0 to week 24 indicating no significant within product change in percent fat mass. The interaction plot detailing the time point estimates is presented in FIG.9.

[0440] No significant 3-way interaction term between study product, time, and glucose group was detected (p=0.29) indicating the response profiles were consistent within subgroups. Within each product for each subgroup, the 95% CI contained 0 for the change from week 0 to week 12 and the change from week 0 to week 24 indicating no significant within product change in percent fat mass. The interaction plot detailing the time point estimates is presented in FIG.10.

[0441] Android Fat Mass (kg)

[0442] No significant interaction term between study product and time was detected (p=0.52) indicating parallel response profiles. Per the SAP, no further between study product group testing was planned (p>0.10). Additionally, the 95% confidence interval for the change from week 0 to week 12 and week 24 within each group contains 0 suggesting no significant decrease in android fat mass was observed in any of the study product groups (Table 5). Results were consistent in the PP population where no significant interaction term was detected (p=0.39). Table 5. Android fat mass (kg) descriptive statistics and model derived estimates Time Point Change from Week 0Time Point Change from Week 0 Week Statistic^Low High Placebo Low Dose High Dose Placebo .8) 0 .3) Q3,q , , g, g^Descriptive statistics include n, mean (SD), median (min, max), and Q1, Q3. Model derived estimates include mean Estimate, 95% CI, Estimate (vs. Placebo), and p-value

[0443] No significant 3-way interaction term between study product, time, and sex was detected (p=0.20) indicating the android fat mass (kg) response profiles were consistent within subgroups. Within each product, the 95% CI for the change from week 0 to week 12 contained 0 for both the male and the female subgroups indicating no significant within product change in android fat mass. Similarly, for the change from week 0 to week 24 the 95% CIcontained 0 for both the male and female subgroups with the exception of the male placebo group (95% CI 0.15 to 0.45 kg) which had a slight increase The interaction plot detailing the time point estimates is presented in FIG.11.

[0444] No significant 3-way interaction term between study product, time, and BMI group was detected (p=0.70) indicating the android fat mass (kg) response profiles were consistent within subgroups. Within each product, the 95% CI for the change from week 0 to week 12 contained 0 for both of the BMI subgroups indicating no significant within product change in android fat mass. Similarly, for the change from week 0 to week 24, the 95% CI contained 0 for both of the BMI subgroups with the exception of the ≥30 to <36 kg / m2placebo group (95% CI 0.02 to 0.25 kg) which had a slight increase. The interaction plot detailing the time point estimates is presented in FIG.12.

[0445] No significant 3-way interaction term between study product, time, and glucose group was detected (p=0.39) indicating the android fat mass (kg) response profiles were consistent within subgroups. Within each product, the 95% CI for the change from week 0 to week 12 contained 0 for both of the glucose subgroups indicating no significant within product change in android fat mass. Similarly, for the change from week 0 to week 24 the 95% CI contained 0 for both of the glucose subgroups with the exception of the ≥100 mg / dL placebo group (95% CI 0.03 to 0.31 kg) which had a slight increase. The interaction plot detailing the time point estimates is presented in FIG.13.

[0446] Gynoid Fatt Mass (kg)

[0447] No significant interaction term between study product and time was detected (p=0.67) indicating parallel response profiles. Per the SAP, no further between study product group testing was planned (p>0.10). Additionally, the 95% confidence interval for the change from week 0 to week 12 and week 24 within each group contains 0 suggesting no significant decrease in gynoid fat mass was observed in any of the study product groups (Table 6). Results were consistent in the PP population where no significant interaction term was detected (p=0.71). Table 6. Gynoid fat mass (kg) descriptive statistics and model derived estimatesTime Point Change from Week 0 Week Statistic Low High Placebo Low Dose High Dose Placebo .4) 3 .3) 7 3rdqua e; , co e ce e a; s, esus; g, oga^Descriptive statistics include n, mean (SD), median (min, max), and Q1, Q3. Model derived estimates include mean Estimate, 95% CI, Estimate (vs. Placebo), and p-value

[0448] No significant 3-way interaction term between study product, time, and sex was detected (p=0.53) indicating the gynoid fat mass (kg) response profiles were consistentwithin subgroups. Within each product, the 95% CI for the change from week 0 to week 12 contained 0 for both the male and the female subgroups indicating no significant within product change in gynoid fat mass. Similarly, for the change from week 0 to week 24 the 95% CI contained 0 for both the male and female subgroups with the exception of the male placebo group (95% CI 0.01 to 0.43 kg) which had a slight increase The interaction plot detailing the time point estimates is presented in FIG.14.

[0449] No significant 3-way interaction term between study product, time, and BMI group was detected (p=0.50) indicating the response profiles were consistent within subgroups. Within each product for each subgroup, the 95% CI contained 0 for the change from week 0 to week 12 and the change from week 0 to week 24 indicating no significant within product change in gynoid fat mass. The interaction plot detailing the time point estimates is presented in FIG.15.

[0450] No significant 3-way interaction term between study product, time, and glucose group was detected (p=0.62) indicating the response profiles were consistent within subgroups. Within each product for each subgroup, the 95% CI contained 0 for the change from week 0 to week 12 and the change from week 0 to week 24 indicating no significant within product change in gynoid fat mass. The interaction plot detailing the time point estimates is presented in FIG.16.

[0451] Abdominal Visceral Fat Mass (g)

[0452] No significant interaction term between study product and time was detected (p=1.00) indicating parallel response profiles. Per the SAP, no further between study product group testing was planned (p>0.10). Additionally, the 95% confidence interval for the change from week 0 to week 12 and week 24 within each group contains 0 suggesting no significant decrease in abdominal visceral fat mass was observed in any of the study product groups (Table 7). Results were consistent in the PP population where no significant interaction term was detected (p=0.94). The interaction plot detailing the time point estimates is presented in FIG.17. Table 7. Abdominal visceral fat mass (g) descriptive statistics and model derived estimatesTime Point Change from Week 0 Week Statistic^Low High Placebo Low Dose High Dose Placebo ) 8, .5 5 ) 7, .3 9Time Point Change from Week 0 Week Statistic^Low High Placebo Low Dose High Dose Placebo Q3,Descriptive statistics include n, mean (SD), median (min, max), and Q1, Q3. Model derived estimates include mean Estimate, 95% CI, Estimate (vs. Placebo), and p-value

[0453] A significant 3-way interaction was detected between week, product, and sex (p=0.020). Decomposing the 3-way interaction using contrast statements to explore the week by product interaction within each sex, no significant interaction was detected within male (p=0.12) or female (p=0.30) groups indicating parallel response profiles for each product within the respective subgroup. The week by sex interaction within each product was also explored where a significant interaction was detected in the placebo group (p<0.001) indicating the response profile differed by sex. However, the same trend was not observed for the active products (p=0.88 and 0.34 for low dose and high dose, respectively).

[0454] Within each active product (low dose and high dose), the 95% CI for the change from week 0 to week 12 and from week 0 to week 24 contained 0 indicating no significant within group change. However, in the placebo group, women tended to decrease from week 0 to week 24 (95% CI -158.2 to -3.4 g) whereas men tended to increase from week 0 to week 24 (95% CI 129.9 to 317.2).

[0455] No significant 3-way interaction term between study product, time, and BMI group was detected (p=0.73) indicating the response profiles were consistent within subgroups. Within each product for each subgroup, the 95% CI contained 0 for the change from week 0 to week 12 and the change from week 0 to week 24 indicating no significant within product change in abdominal visceral fat mass. The interaction plot detailing the time point estimates is presented in FIG.18.

[0456] A marginally significant 3-way interaction was detected between week, product, and glucose group (p=0.051). Decomposing the 3-way interaction using contraststatements to explore the week by product interaction within each glucose group, no significant interaction was detected within the <100 mg / dL (p=0.31) or the ≥100 mg / dL (p=0.29) groups indicating parallel response profiles for each product within the respective subgroup. The week by glucose interaction within each product was also explored where a marginally significant interaction was detected in the placebo group (p=0.051) indicating the response profile differed by glucose group. However, the same trend was not observed for the active products (p=0.18 and 0.28 for low dose and high dose, respectively) (FIG.19).

[0457] Within each active product (low dose and high dose), the 95% CI for the change from week 0 to week 12 and from week 0 to week 24 contains 0 indicating no significant within group change overall. However, in the placebo group for the change from week 0 to week 24, the CI for the glucose <100 mg / dL contained 0 but was excluded for the glucose ≥100 mg / dL subgroup (95% CI 21.3 to 203.2 g).

[0458] Body Circumference

[0459] Boxplots, representing the distribution of the change from baseline to each follow-up time point, for the body circumference measures are presented in FIG.20.

[0460] Waist (cm) Circumference

[0461] No significant interaction term between study product and time was detected (p=0.35) indicating parallel response profiles. Per the SAP, no further between study product group testing was planned (p>0.10). Additionally, the 95% confidence interval for the change from week 0 to week 12 and week 24 within each group contains 0 suggesting no significant decrease in waist circumference was observed in any of the study product groups (Table 8).

[0462] In the PP population (Table 9), the interaction term between study product and time reached significance at the 0.10 level (p=0.082). Exploring the difference to placebo in the within group change to week 12, no significant differences were detected compared to the low dose (p=0.14) or the high dose (p=0.56). Compared to placebo, a significant difference was detected in the change from week 0 to week 24 in the low dose (p=0.041) but not the high dose (p=0.24). At week 24, the placebo group trended higher where no within group change was suggested for the low dose or the high dose group (i.e. the confidence interval for the change from week 0 contained 0).Table 8. Waist (cm) circumference descriptive statistics and model derived estimates in the ITT population Time Point Change from Week 0 Week Statistic^Low Dose High Placebo Low Dose High Dose Placebo , 9 4)Time Point Change from Week 0 Week Statistic^Low Dose High Placebo Low Dose High Dose Placebo 5 Q3,Descriptive statistics include n, mean (SD), median (min, max), and Q1, Q3. Model derived estimates include mean Estimate, 95% CI, Estimate (vs. Placebo), and p-value Table 9. Waist (cm) circumference descriptive statistics and model derived estimates in the PP population Time Point Change from Week 0 ^ ,Time Point Change from Week 0 Week Statistic^Low Dose High Placebo Low Dose High Dose Placebo 1 4) Q3,, , ,^Descriptive statistics include n, mean (SD), median (min, max), and Q1, Q3. Model derived estimates include mean Estimate, 95% CI, Estimate (vs. Placebo), and p-value

[0463] No significant 3-way interaction term between study product, time, and sex was detected (p=0.71) indicating the waist circumference (cm) response profiles were consistent within subgroups. For the female subgroup, within each product, the 95% CI for the change from week 0 to week 12 and from week 0 to week 24 contained 0 indicating no significant change in waist circumference. For the male subgroup, within the low and high dose, the 95% CI for the change from week 0 to week 12 and from week 0 to week 24 contained 0 indicating no significant change in waist circumference. However, within the placebo groupthe 95% CI included 0 for the change to week 12 but not the change to week 24 (95% CI 0.1 to 2.4). The interaction plot detailing the time point estimates is presented in FIG.21.

[0464] A significant 3-way interaction was detected between week, product, and BMI group (p=0.037). Decomposing the 3-way interaction using contrast statements to explore the week by product interaction within each BMI group, no significant interaction was detected within the ≥30 to 35 kg / m2(p=0.99) but a significant interaction was detected within the ≥28 to <30 kg / m2(p=0.006) group. The week by BMI group interaction was also explored within each product. No significant interaction was detected for the placebo (p=0.63) or the high dose (p=0.49) but a significant interaction was detected for the low dose (p=0.005) in FIG.22.

[0465] Within each product and the ≥30 to 35 kg / m2BMI group, the 95% CI for the change from week 0 to each of week 12 and week 24 contained 0. For the ≥28 to <30 kg / m2BMI group, the 95% CI for the change from week 0 to each of week 12 and week 24 contained 0 for the high dose and placebo groups. For the low dose, the change from week 0 to week 12 excluded 0 (95% CI -0.29 to -0.7 cm) and to week 24 trended lower (95% CI -2.8 to 0 cm).

[0466] No significant 3-way interaction term between study product, time, and glucose group was detected (p=0.68) indicating the waist circumference (cm) response profiles were consistent within subgroups. The 95% CI for the change from week 0 to each of week 12 and week 24 contained 0 for each product within each glucose subgroup. The interaction plot detailing the time point estimates is presented in FIG.23.

[0467] Hip (cm) Circumference

[0468] No significant interaction term between study product and time was detected (p=0.64) indicating parallel response profiles. Per the SAP, no further between study product group testing was planned (p>0.10). Additionally, the 95% confidence interval for the change from week 0 to week 12 and week 24 within each group contains 0 suggesting no significant decrease in hip circumference was observed in any of the study product groups (Table 10). Results were consistent in the PP population where no significant interaction term was detected (p=0.94). Table 10. Hip (cm) circumference descriptive statistics and model derived estimatesTime Point Change from Week 0 Week Statistic^Low High Placebo Low Dose High Dose Placebo 3) 7 , 5Time Point Change from Week 0 Week Statistic^Low High Placebo Low Dose High Dose Placebo 3rdescr p ve s a s cs nc u e n, mean (S ), me an (m n, max), an Q , Q3. o e er ve es mates include mean Estimate, 95% CI, Estimate (vs. Placebo), and p-value

[0469] No significant 3-way interaction term between study product, time, and sex was detected (p=0.23) indicating the hip circumference (cm) response profiles were consistent within subgroups. For the female subgroup, within each product, the 95% CI for the change from week 0 to each of week 12 and week 24 contained 0 indicating no significant change in hip circumference. For the male subgroup, within the low and high dose, the 95% CI for the change from week 0 to each of week 12 and week 24 contained 0 indicating no significant change in hip circumference. However, within the placebo group the 95% CI included 0 for the change to week 12 but not the change to week 24 (95% CI 0 to 2.1). The interaction plot detailing the time point estimates is presented in FIG.24.

[0470] A marginally significant 3-way interaction was detected between week, product, and BMI group (p=0.060). Decomposing the 3-way interaction using contrast statements to explore the week by product interaction within each BMI group, no significant interaction was detected within the ≥30 to 35 kg / m2(p=0.72) but a marginally significant interaction was detected within the ≥28 to <30 kg / m2(p=0.052) group. The week by BMI group interaction was also explored within each product were no significant interactions were detected (p=0.13, 0.20, and 0.31 for low, high, and placebo, respectively) in FIG.25.

[0471] Within each product and the ≥30 to 35 kg / m2BMI group, the 95% CI for the change from week 0 to each of week 12 and week 24 contained 0. For the ≥28 to <30 kg / m2BMI group, the 95% CI for the change from week 0 to each of week 12 and week 24 contained 0 for the high dose and placebo groups. For the low dose, the change from week 0 to week 12 excluded 0 (95% CI -1.8 to -0.1 cm) but not to week 24 (95% CI -1.7 to 0.8 cm).

[0472] No significant 3-way interaction term between study product, time, and glucose group was detected (p=0.75) indicating the hip circumference (cm) response profiles were consistent within subgroups. The 95% CI for the change from week 0 to each of week 12 and week 24 contained 0 for each product within each glucose subgroup. The interaction plot detailing the time point estimates is presented in FIG.26.

[0473] Chest (cm) Circumference

[0474] No significant interaction term between study product and time was detected (p=0.37) indicating parallel response profiles. Per the SAP, no further between study product group testing was planned (p>0.10). Additionally, the 95% confidence interval for the change from week 0 to week 12 and week 24 within each group contains 0 suggesting no significant decrease in chest circumference was observed in any of the study product groups (Table 11). Results were consistent in the PP population where no significant interaction term was detected (p=0.22). Table 11. Chest (cm) circumference descriptive statistics and model derived estimates Time Point Change from Week 0 ^ ,Time Point Change from Week 0 Week Statistic^Low High Placebo Low Dose High Dose Placebo 4 .6) 2 Q3,q , , g, g^Descriptive statistics include n, mean (SD), median (min, max), and Q1, Q3. Model derived estimates include mean Estimate, 95% CI, Estimate (vs. Placebo), and p-value

[0475] No significant 3-way interaction term between study product, time, and sex was detected (p=0.48) indicating the chest circumference (cm) response profiles were consistent within subgroups. The interaction plot detailing the time point estimates is presented in FIG.27. For the female subgroup, the within product 95% CI for the change from week 0 to week 12 included 0 for the high dose and the placebo but excluded 0 for the low dose (95%CI -2.4 to -0.7 cm). Similarly, the low dose excluded 0 at week 24 (95% CI -1.9 to -0.1 cm) whereas all other CI’s contained 0. For the male subgroup, the 95% CI for the change from week 0 to each of week 12 and week 24 contained 0 with the exception of the placebo group at week 24 (95% CI 0.1, 2.3 cm).

[0476] No significant 3-way interaction term between study product, time, and BMI group was detected (p=0.48) indicating the chest circumference (cm) response profiles were consistent within subgroups. The interaction plot detailing the time point estimates is presented in FIG.28. For the ≥28 to <30 kg / m2subgroup, the within product 95% CI for the change from week 0 to each of week 12 and week 24 contained 0 with the exception of the low dose at week 12 (95% CI -2.6 to -0.2). For the ≥30 to <35 kg / m2, the within product 95% CI for the change from week 0 to each of week 12 and week 24 contained 0 indicating no significant within product change overall.

[0477] No significant 3-way interaction term between study product, time, and glucose group was detected (p=0.88) indicating the chest circumference (cm) response profiles were consistent within subgroups. The interaction plot detailing the time point estimates is presented in FIG. 29. For each glucose subgroup, the within product 95% CI for the change from week 0 to each of week 12 and week 24 contained 0.

[0478] Upper Thigh (cm) Circumference

[0479] The interaction term between study product and time reached significance at the 0.10 level (p=0.055). However, when exploring the difference to placebo in the within group change to week 12, no significant differences were detected compared to the low dose (p=0.24) or the high dose (p=0.35). Compared to placebo, a significant difference was detected in the change from week 0 to week 24 in the low dose (p=0.041) but not the high dose (p=0.24). For the change from week to week 24, no significant differences were detected compared to the low dose (p=0.25) or the high dose (p=0.24) (Table 13).

[0480] Results were relatively consistent in the PP population where the interaction term reached significance (p<0.001). Compared to placebo, the change from week 0 to week 12 was significant for the low dose group (p=0.038) where the low dose group trended higher. No other significant differences were noted in the remaining comparisons of interest. Table 12. Upper thigh (cm) circumference descriptive statistics and model derived estimatesTime Point Change from Week 0 Week Statistic^Low High Placebo Low Dose High Dose Placebo ) 9, 3 65 ) , 9 31Time Point Change from Week 0 Week Statistic^Low High Placebo Low Dose High Dose Placebo Q3,Descriptive statistics include n, mean (SD), median (min, max), and Q1, Q3. Model derived estimates include mean Estimate, 95% CI, Estimate (vs. Placebo), and p-value

[0481] No significant 3-way interaction term between study product, time, and sex was detected (p=0.22) indicating the upper thigh circumference (cm) response profiles were consistent within subgroups. The interaction plot detailing the time point estimates is presented in FIG.30. For the female subgroup, the 95% CI for the within product change from week 0 to each of week 12 and week 24 contained 0. For the male subgroup, the low dose and high dose change from week 0 to week 12 and week 24 contained 0. For the placebo, the change from week 0 to week 12 contained 0 but the change from week 0 to week 24 excluded 0 (95% CI 0.2 to 2.9) indicating a slight increase in upper thigh circumference.

[0482] No significant 3-way interaction term between study product, time, and BMI group was detected (p=0.88) indicating the upper thigh circumference (cm) response profiles were consistent within subgroups. The interaction plot detailing the time point estimates is presented in FIG.31. For each subgroup, the within product 95% CI for the change from week 0 to each of week 12 and week 24 contained 0.

[0483] No significant 3-way interaction term between product, time or glucose group was detected (p=0.42) for the upper thigh circumference. The interaction plot detailing the time point estimates is presented in FIG.32.

[0484] Bicep (cm) Circumference

[0485] No significant interaction term between study product and time was detected (p=0.61) indicating parallel response profiles. Per the SAP, no further between study product group testing was planned (p>0.10). Additionally, the 95% confidence interval for the change from week 0 to week 12 and week 24 within each group contains 0 suggesting no significant decrease in bicep circumference was observed in any of the study product groups (Table 13). Results were consistent in the PP population where no significant interaction term was detected (p=0.94). Table 13. Bicep (cm) circumference descriptive statistics and model derived estimatesTime Point Change from Week 0 Week Statistic^Low High Placebo Low Dose High Dose Placebo .3) 5 .5) 4Q3, 3 quartile; CI, confidence interval; vs, versus; kg, kilogram^Descriptive statistics include n, mean (SD), median (min, max), and Q1, Q3. Model derived estimates include mean Estimate, 95% CI, Estimate (vs. Placebo), and p-value

[0486] No significant 3-way interaction term between study product, time, and glucose group was detected (p=0.68) indicating the bicep circumference (cm) response profiles were consistent within subgroups. The interaction plot detailing the time point estimates is presented in FIG.33. For the female subgroup, the high dose and placebo group 95% CI for the change from week 0 to each of week 12 and week 24 included 0. However, the low dose trended higher at each of week 12 (95% CI 0 to 0.9) and week 24 (0 to 1.0). For the male subgroup, the within product 95% CI for the change from week 0 to each of week 12 and 24 included 0.

[0487] No significant 3-way interaction term between study product, time, and glucose group was detected (p=0.84) indicating the bicep circumference (cm) response profiles were consistent within subgroups. The interaction plot detailing the time point estimates is presented in FIG.34. For each subgroup, the within product 95% CI for the change from week 0 to each of week 12 and week 24 contained 0.

[0488] No significant 3-way interaction term between product, time or glucose group was detected (p=0.76) for the bicep circumference. The interaction plot detailing the time point estimates is presented in FIG.35. For each subgroup, the within product 95% CI for the change from week 0 to each of week 12 and week 24 contained 0.

[0489] Waist to Hip Ratio

[0490] No significant interaction term between study product and time was detected (p=0.41) indicating parallel response profiles. Per the SAP, no further between study product group testing was planned (p>0.10). Additionally, the 95% confidence interval for the change from week 0 to week 12 and week 24 within each group contains 0 suggesting no significant decrease in WHR was observed in any of the study product groups (Table 14). Results were consistent in the PP population where no significant interaction term was detected (p=0.20). Table 14. Waist to hip ratio descriptive statistics and model derived estimates Time Point Change from Week 0Time Point Change from Week 0 Week Statistic^Low High Placebo Low Dose High Dose Placebo ) 7, 1 1 ) 7, 1 1Q3, r quartile; CI, confidence interval; vs, versus; kg, kilogram^Descriptive statistics include n, mean (SD), median (min, max), and Q1, Q3. Model derived estimates include mean Estimate, 95% CI, Estimate (vs. Placebo), and p-value

[0491] No significant 3-way interaction term between study product, time, and glucose group was detected (p=0.97) indicating the waist to hip ratio (WHR) response profiles were consistent within subgroups. In general, the within group change from week 0 to each of week 12 and week 24 showed little to no change. The interaction plot detailing the time point estimates is presented in FIG.36.

[0492] No significant 3-way interaction term between study product, time, and glucose group was detected (p=0.82) indicating the waist to hip ratio (WHR) response profiles were consistent within subgroups. The interaction plot detailing the time point estimates is presented in FIG.37. In general, the within group change from week 0 to each of week 12 and week 24 showed little to no change.

[0493] No significant 3-way interaction term between product, time or glucose group was detected (p=0.69) for the waist to hip ratio (WHR). The interaction plot detailing the time point estimates is presented in FIG.38. In general, the within group change from week 0 to each of week 12 and week 24 showed little to no change.

[0494] Cardio Metabolic Parameters

[0495] Boxplots, representing the distribution of the change from baseline to each follow-up time point, for the glucose, insulin, and HbA1c measures are presented in FIG.39.

[0496] Fasting Glucose

[0497] The interaction term between study product and time reached significance at the 0.10 level (p=0.068). However, when exploring the difference to placebo in the within group change to week 12, no significant differences were detected compared to the low dose (p=0.59) or the high dose (p=0.53). Compared to placebo, a no significant difference was detected in the change from week 0 to week 24 in the low dose (p=0.76) or the high dose (p=0.091). Additionally, the back transformed confidence intervals also tended to contain 1 indicating, on average, no change from baseline within group (Table 15). Results were relatively consistent in the PP population. However, the interaction term did not meet the 0.10 threshold (p=0.11). Table 15. Fasting glucose (mg / dL) descriptive statistics and model derived estimatesTime Point Change from Week 0 Week Statistic^Low Dose High Dose Placebo Low Dose High Dose Placebo ) 0, 0 2 4) 0, 0 5Q3, r quartile; CI, confidence interval; vs, versus^Descriptive statistics include n, mean (SD), median (min, max), and Q1, Q3. Model derived estimates include mean Estimate, 95% CI, Estimate (vs. Placebo), and p-value. Log transformation used for modelling.

[0498] Fasting Insulin

[0499] No significant interaction term between study product and time was detected (p=0.58) indicating parallel response profiles. Per the SAP, no further between study product group testing was planned (p>0.10). Additionally, the back transformed 95% confidence interval for the change from week 0 to week 12 and week 24 within each group contains 1 suggesting no significant change in fasting insulin was observed in any of the study product groups (Table 16). Results were consistent in the PP population where no significant interaction term was detected (p=0.64). Table 16. Fasting insulin (mU / L) descriptive statistics and model derived estimates Time Point Change from Week 0 ^ ) 2, 3Time Point Change from Week 0 Week Statistic^Low High Placebo Low Dose High Dose Placebo ) , 3 Q3,^Descriptive statistics include n, mean (SD), median (min, max), and Q1, Q3. Model derived estimates include mean Estimate, 95% CI, Estimate (vs. Placebo), and p-value. Log transformation used for modelling.

[0500] Fasting HbA1c

[0501] No significant interaction term between study product and time was detected (p=0.81) indicating parallel response profiles. Per the SAP, no further between study product group testing was planned (p>0.10). Additionally, the back transformed 95% confidence interval for the change from week 0 to week 12 and week 24 within each group contains 1 suggesting no significant change in HbA1c was observed in any of the study product groups (Table 17). Results were consistent in the PP population where no significant interaction term was detected (p=0.84). Table 17. Fasting HbA1c (%) descriptive statistics and model derived estimates Time Point Change from Week 0Time Point Change from Week 0 Week Source Statistic^Low High Placebo Low Dose High Dose Placebo .7) .6)Time Point Change from Week 0 Week Source Statistic^Low High Placebo Low Dose High Dose Placebo Q3,Descriptive statistics include n, mean (SD), median (min, max), and Q1, Q3. Model derived estimates include mean Estimate, 95% CI, Estimate (vs. Placebo), and p-value. Log transformation used for modelling.

[0502] Blood Pressure

[0503] Boxplots, representing the distribution of the change in body weight from baseline to each follow-up time point are presented in FIG.40.

[0504] Systolic Blood Pressure (mmHg)

[0505] No significant interaction term between study product and time was detected (p=0.43) indicating parallel response profiles. Per the SAP, no further between study product group testing was planned (p>0.10). Additionally, the within group 95% confidence interval for the change from week 0 each follow-up time point contains 0 suggesting no significant decrease in body weight was observed in any of the study product groups (Table 18). Results were consistent in the PP population where no significant interaction term was detected (p=0.33). Table 18. Systolic blood pressure (mmHg) descriptive statistics and model derived estimates Time Point Change from Week 0Time Point Change from Week 0 Week Statistic^Low Dose High Placebo Low Dose High Dose Placebo ) 5, 5 6 ) 5, 7Time Point Change from Week 0 Week Statistic^Low Dose High Placebo Low Dose High Dose Placebo ) 5, 8 5, 0 3rdq , , g, g^Descriptive statistics include n, mean (SD), median (min, max), and Q1, Q3. Model derived estimates include mean Estimate, 95% CI, Estimate (vs. Placebo), and p-value

[0506] Diastolic Blood Pressure (mmHg)

[0507] No significant interaction term between study product and time was detected (p=0.54) indicating parallel response profiles. Per the SAP, no further between studyproduct group testing was planned (p>0.10). Additionally, the within group 95% confidence interval for the change from week 0 each follow-up time point contains 0 suggesting no significant decrease in body weight was observed in any of the study product groups (Table 19). Results were consistent in the PP population where no significant interaction term was detected (p=0.40). Table 19. Diastolic blood pressure (mmHg) descriptive statistics and model derived estimates Time Point Change from Week 0 Week Statistic^Low Dose Hi h Placebo Low Dose Hi h Dose Placebo ) 5, 4 ) 0,Time Point Change from Week 0 Week Statistic^Low Dose High Placebo Low Dose High Dose Placebo 0 ) 5, 6 ) 0, 4 Q3,3 quart e; C , con dence nterva ; vs, versus; g, ogram^Descriptive statistics include n, mean (SD), median (min, max), and Q1, Q3. Model derived estimates include mean Estimate, 95% CI, Estimate (vs. Placebo), and p-value

[0508] Blood Lipids

[0509] Boxplots, representing the distribution of the change from baseline to each follow-up time point, for the body composition measures are presented in FIG.41.

[0510] Total Cholesterol

[0511] No significant interaction term between study product and time was detected (p=0.74) indicating parallel response profiles. Per the SAP, no further between study product group testing was planned (p>0.10). Additionally, the within group back transformed 95% confidence interval for the change from week 1 each follow-up time point contains 1 suggesting no significant decrease in Total-C was observed in any of the study product groups (Table 20). Results were consistent in the PP population where no significant interaction term was detected (p=0.80). Table 20. Total-C (mg / dL) descriptive statistics and model derived estimates Time Point Change from Week 0 k i i^i h l i h l o 9) .0, .0 04Time Point Change from Week 0 Week Statistic^Low Dose High Dose Placebo Low Dose High Placebo 5) .0, .0 05 Q3,^Descriptive statistics include n, mean (SD), median (min, max), and Q1, Q3. Model derived estimates include mean Estimate, 95% CI, Estimate (vs. Placebo), and p-value. Log transformation used for modelling.

[0512] HDL Cholesterol

[0513] No significant interaction term between study product and time was detected (p=0.94) indicating parallel response profiles. Per the SAP, no further between study product group testing was planned (p>0.10). Additionally, the within group back transformed 95% confidence interval for the change from week 1 each follow-up time point contains 1 suggesting no significant decrease in HDL-C was observed in any of the study product groups (Table 21). Results were consistent in the PP population where no significant interaction term was detected (p=0.75). Table 21. HDL-C (mg / dL) descriptive statistics and model derived estimates Time Point Change from Week 0Time Point Change from Week 0 Week Statistic^Low Dose High Placebo Low Dose High Dose Placebo ) , 3 ) 0, 2 Q3,3 quartile; CI, confidence interval; vs, versus; kg, kilogram^Descriptive statistics include n, mean (SD), median (min, max), and Q1, Q3. Model derived estimates include mean Estimate, 95% CI, Estimate (vs. Placebo), and p-value. Log transformation used for modelling.

[0514] LDL Cholesterol

[0515] No significant interaction term between study product and time was detected (p=0.93) indicating parallel response profiles. Per the SAP, no further between study product group testing was planned (p>0.10). Additionally, the within group back transformed 95% confidence interval for the change from week 1 each follow-up time point contains 1 suggesting no significant decrease in LDL-C was observed in any of the study product groups (Table 22). Results were consistent in the PP population where no significant interaction term was detected (p=0.95). Table 22. LDL-C (mg / dL) descriptive statistics and model derived estimates Time Point Change from Week 0 W k St ti ti^L D Hi h Pl b L D Hi h D Pl bo ) , 0 6Time Point Change from Week 0 Week Statistic^Low Dose High Placebo Low Dose High Dose Placebo ) 0, 0 6 Q3,^Descriptive statistics include n, mean (SD), median (min, max), and Q1, Q3. Model derived estimates include mean Estimate, 95% CI, Estimate (vs. Placebo), and p-value. Log transformation used for modelling.

[0516] VLDL Cholesterol

[0517] No significant interaction term between study product and time was detected (p=0.28) indicating parallel response profiles. Per the SAP, no further between study product group testing was planned (p>0.10). Additionally, the within group back transformed 95% confidence interval for the change from week 1 each follow-up time point contains 1 suggesting no significant decrease in VLDL-C was observed in the active product groups. An increase from week 0 to week 24 was suggested in the placebo group (Table 23). Results were consistent in the PP population where no significant interaction term was detected (p=0.38). Table 23. VLDL-C (mg / dL) descriptive statistics and model derived estimatesTime Point Change from Week 0 Week Statistic^Low High Placebo Low Dose High Dose Placebo ) 0, 1 ) 0, 4Q3, quartile; CI, confidence interval; vs, versus; kg, kilogram^Descriptive statistics include n, mean (SD), median (min, max), and Q1, Q3. Model derived estimates include mean Estimate, 95% CI, Estimate (vs. Placebo), and p-value. Log transformation used for modelling.

[0518] Non-HDL Cholesterol

[0519] No significant interaction term between study product and time was detected (p=0.68) indicating parallel response profiles. Per the SAP, no further between study product group testing was planned (p>0.10). Additionally, the within group back transformed 95% confidence interval for the change from week 1 each follow-up time point contains 1 suggesting no significant decrease in Non-HDL-C was observed in any of the study product groups (Table 24). Results were consistent in the PP population where no significant interaction term was detected (p=0.77). Table 24. Non-HDL-C (mg / dL) descriptive statistics and model derived estimates Time Point Change from Week 0 ^ ) 0, .0Time Point Change from Week 0 Week Statistic^Low Dose High Placebo Low Dose High Dose Placebo 6 ) 0, 0 7 Q3,, , ,^Descriptive statistics include n, mean (SD), median (min, max), and Q1, Q3. Model derived estimates include mean Estimate, 95% CI, Estimate (vs. Placebo), and p-value. Log transformation used for modelling.

[0520] Triglycerides

[0521] No significant interaction term between study product and time was detected (p=0.26) indicating parallel response profiles. Per the SAP, no further between study product group testing was planned (p>0.10). Additionally, the within group back transformed 95% confidence interval for the change from week 1 each follow-up time point contains 1 suggesting no significant decrease in triglycerides was observed in any of the active study product groups (Table 25). The placebo trended higher by week 24 compared to week 0.Results were consistent in the PP population where no significant interaction term was detected (p=0.33). Table 25. Triglycerides (mg / dL) descriptive statistics and model derived estimates Time Point Change from Week 0 Week Statistic^Low High Placebo Low Dose High Dose Placebo ) 0, 0 0 ) 0,Time Point Change from Week 0 Week Statistic^Low High Placebo Low Dose High Dose Placebo 0 4 Q3,^Descriptive statistics include n, mean (SD), median (min, max), and Q1, Q3. Model derived estimates include mean Estimate, 95% CI, Estimate (vs. Placebo), and p-value. Log transformation used for modelling.

[0522] Body Weight

[0523] Boxplots, representing the distribution of the change in body weight from baseline to each follow-up time point are presented in FIG.42. A graphical representation of the individual time points are available in Appendix SR4. No significant interaction term between study product and time was detected (p=0.55) indicating parallel response profiles. Per the SAP, no further between study product group testing was planned (p>0.10). Additionally, the within group 95% confidence interval for the change from week 0 each follow-up time point contains 0 suggesting no significant decrease in body weight was observed in any of the study product groups (Table 26). Results were consistent in the PP population where no significant interaction term was detected (p=0.42). Table 26. Body weight (kg) descriptive statistics and model derived estimates Time Point Change from Week 0Time Point Change from Week 0 Week Statistic^Low High Placebo Low Dose High Dose Placebo .7) 5 .0) 6Time Point Change from Week 0 Week Statistic^Low High Placebo Low Dose High Dose Placebo .9) 5 .2) 1 .5)Time Point Change from Week 0 Week Statistic^Low High Placebo Low Dose High Dose Placebo 6 .3) 3 Q3,, , ,^Descriptive statistics include n, mean (SD), median (min, max), and Q1, Q3. Model derived estimates include mean Estimate, 95% CI, Estimate (vs. Placebo), and p-value

[0524] SF-36

[0525] Boxplots, representing the distribution of the change from baseline to each follow-up time point, for the SF-36 outcomes are presented in FIG.43. As observed in FIG. 43, many of the SF-36 exhibited a ceiling effect where participants tended to indicate the highest QOL for the role limitation due to physical health, role limitations due to emotional problems, and social functioning. Therefore, only model described estimates and study productcomparisons were estimated for physical functioning, energy / fatigue, emotional well-being, pain, and general health.

[0526] Physical Functioning

[0527] No significant interaction term between study product and time was detected (p=0.88) indicating parallel response profiles. Per the SAP, no further between study product group testing was planned (p>0.10). Additionally, the within group 95% confidence interval for the change from week 0 each follow-up time point contains 0 suggesting no change in physical functioning was observed in any of the study product groups (Table 27). Results were consistent in the PP population where no significant interaction term was detected (p=0.95). Table 27. Physical functioning descriptive statistics and model derived estimates Time Point Change from Week 0 k i i^i i l i i l o ) 0, 28Time Point Change from Week 0 Week Statistic^Active 1 Active 2 Placebo Active 1 Active 2 Placebo ) .0, 02 Q3,^Descriptive statistics include n, mean (SD), median (min, max), and Q1, Q3. Model derived estimates include mean Estimate, 95% CI, Estimate (vs. Placebo), and p-value

[0528] Role Limitations Due to Physical Health

[0529] Descriptive statistics at each time point, as well as the within participant change from week 0 to each follow-up time point, for role limitations due to physical health is presented in Table 28. Table 28. Role limitations due to physical health descriptive statistics Time Point Change from Week 0 o 0) .0,Time Point Change from Week 0 Week Statistic^Active 1 Active 2 Placebo Active 1 Active 2 Placebo 7) 0, Q3,^Only descriptive statistics are included due to the apparent ceiling effect

[0530] Role Limitations Due to Emotional Problems

[0531] Descriptive statistics at each time point, as well as the within participant change from week 0 to each follow-up time point, for role limitations due to emotional problems is presented in Table 29. Table 29. Role limitations due to emotional problems descriptive statistics Time Point Change from Week 0 ) 0,Time Point Change from Week 0 Week Statistic Active 1 Active 2 Placebo Active 1 Active 2 Placebo ) 0, Q3,^Only descriptive statistics are included due to the apparent ceiling effect

[0532] Energy / Fatigue

[0533] No significant interaction term between study product and time was detected (p=0.30) indicating parallel response profiles. Per the SAP, no further between study product group testing was planned (p>0.10). Additionally, the within group 95% confidence interval for the change from week 0 each follow-up time point contains 0 suggesting no change in energy / fatigue was observed in any of the study product groups (Table 30). Table 30. Energy / fatigue descriptive statistics and model derived estimates Time Point Change from Week 0 )Time Point Change from Week 0 Week Statistic^Active 1 Active 2 Placebo Active 1 Active 2 Placebo 0, 8 ) 0, 0 8 Q3,, ,^Descriptive statistics include n, mean (SD), median (min, max), and Q1, Q3. Model derived estimates include mean Estimate, 95% CI, Estimate (vs. Placebo), and p-value

[0534] Emotional Well-Being

[0535] No significant interaction term between study product and time was detected (p=0.18) indicating parallel response profiles. Per the SAP, no further between study product group testing was planned (p>0.10). Additionally, the within group 95% confidence interval for the change from week 0 each follow-up time point contains 0 suggesting no change in emotional well-being was observed in any of the study product groups (Table 31).Table 31. Emotional well-being descriptive statistics and model derived estimates Time Point Change from Week 0 Week Statistic^Active 1 Active 2 Placebo Active 1 Active 2 Placebo ) 0, 0 41 ) 0, 0 39 Q3,3 quartile; CI, confidence interval; vs, versus^Descriptive statistics include n, mean (SD), median (min, max), and Q1, Q3. Model derived estimates include mean Estimate, 95% CI, Estimate (vs. Placebo), and p-value

[0536] Social Functioning

[0537] Descriptive statistics at each time point, as well as the within participant change from week 0 to each follow-up time point, for social functioning is presented in Table 32. Table 32. Social functioning descriptive statistics Time Point Change from Week 0 Week Source Statistic Active 1 Active 2 Placebo Active 1 Active 2 Placebo ) 0, 7) 0, Q3,3 quart e; C , con dence nterva ; ...

Claims

WHAT IS CLAIMED IS:

1. A method to maintain, support, improve, or regulate healthy blood glucose levels in a subject, the method comprising: providing to the subject a composition comprising from about 50 mg to about 150 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine.

2. The method of claim 1, wherein maintaining, supporting, improving, or regulating healthy blood glucose levels in the subject improves glycemic control in the subject.

3. The method of claim 1 or 2, wherein maintaining, supporting, improving, or regulating healthy blood glucose levels in the subject reduces fasting blood glucose levels in a human subject with hyperglycemia or prediabetes.

4. The method of any one of claims 1 to 3, wherein maintaining, supporting, improving, or regulating healthy blood glucose levels in the subject provides for healthy weight management in the subject.

5. The method of any one of claims 1 to 4, wherein providing the composition reduces 24-hour glucose exposure in the subject, wherein the reduction is measured by a decrease in 24-hour AUC or 24-hour mean glucose.

6. The method of any one of claims 1 to 5, wherein maintaining, supporting, improving, or regulating healthy blood glucose levels in the subject reduces glucose variability in the subject, wherein glucose variability is reduced as measured by a decrease in Mean Amplitude of Glucose Excursion (MAGE) or Mean of Daily Differences (MoDD).

7. The method of any one of claims 1 to 6, wherein maintaining, supporting, improving, or regulating healthy blood glucose levels in the subject reduces postprandial glucose levels in a human subject.

8. The method of any one of claims 1 to 7, wherein maintaining, supporting, improving, or regulating healthy blood glucose levels in the subject reduces blood glucose levels in the subject without significantly lowering minimum nighttime blood glucose.

9. The method of any one of claims 1 to 8, wherein maintaining, supporting, improving, or regulating healthy blood glucose levels in the subject manages hyperglycemia in the subject.

10. The method of any one of claims 1 to 9, wherein the composition comprises about 60 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine.

11. The method of any one of claims 1 to 9, wherein the composition comprises about 120 mg N-trans-caffeoyltyramine and N-trans-feruloyltyramine.

12. The method of any one of claims 1 to 11, wherein the composition is formulated as a sustained release formulation.

13. The method of claim 12, wherein the composition is formulated for once-daily administration.

14. The method of claim 12, wherein the sustained released formulation provides a reduction in glucose variability.

15. The method of any one of claims 1 to 11, wherein the composition is in a form of a capsule, gummy, table, functional beverage, and functional food.

16. The method of claim 15, wherein the capsule is a sustained release capsule.

17. The method of any one of claims 1 to 16, wherein the providing to the subject the composition provides sustained weight management.

18. The method of any one of claims 1 to 16, wherein the providing to the subject the composition provides visceral and abdominal fat loss.

19. The method of any one of claims 1 to 16, wherein the providing to the subject the composition provides visceral fat loss.

20. The method of any one of claims 1 to 16, wherein the providing to the subject the composition provides abdominal fat loss.

21. The method of any one of claims 1 to 16, wherein the providing to the subject the composition preserves lean body mass.

22. The method of any one of claims 1 to 16, wherein the providing to the subject the composition supports normal blood glucose regulation.

23. The method of any one of claims 1 to 16, wherein the providing to the subject the composition provides glucose level normalization followed by fat loss benefits.

24. The method of any one of claims 1 to 16, wherein the providing to the subject the composition provides normal blood glucose regulation followed by fat loss benefits.

25. The method of any one of claims 1 to 24, wherein the subject has a BMI ≥ 28.0 kg / m2.

26. The method of any one of claims 1 to 25, wherein the subject has a Total-C level of ≥ 200 mg / dL.

27. The method of any one of claims 1 to 26, wherein the subject has a HDL-C level of ≤ 40 mg / dL.

28. The method of any one of claims 1 to 27, wherein the subject has a triglyceride level of ≥ 150 mg / dL.

29. The method of any one of claims 1 to 28, wherein the subject has pre-diabetes.

30. The method of any one of claims 1 to 29, wherein the providing to the subject the composition comprises administering the composition once per day.

31. The method of claim 30, wherein the subject is administered the composition for at least 6 six months.

32. The method of any one of claims 1 to 31, wherein the composition is provided in combination with a dietary regimen designed to enhance a weight management in the subject.

33. The method of any one of claims 1 to 32, wherein the subject is advised to engage in a physical activity program in conjunction with the providing of the composition.

34. The method of any one of claims 1 to 33, wherein the composition provides improvement in metabolic rate.

35. The method of any one of claims 1 to 34, wherein the subject has a waist circumference reduction of at least 5% from baseline after administration of the composition for 3 months.

36. The method of any one of claims 1 to 35, wherein providing to the subject the composition improves insulin sensitivity.

37. The method of any one of claims 1 to 36, wherein the composition improves one or more biomarkers associated with inflammation and obesity.

38. The method of any one of claims 1 to 37, wherein the subject is administered the composition and is further instructed to answer a dietary questionnaire.

39. The method of any one of claims 1 to 38, wherein the subject is administered the composition before, concurrently, or after taking one or more of the following medical tests: Body Weight, Study Instructions / Query, Chemistry Profile, Urine Pregnancy Test, Lipid Panel, HbA1c, Glucose, Insulin, FGF-21, Archive Plasma / Serum Samples, Randomization, 3D Body Scan, and DEXA Scan.

40. The method of any one of claims 1 to 39, wherein a treatment outcome comprises a reduction in body fat mass by at least 5% to 15% from baseline measurements, as measured in kilograms (kg) or pounds (lbs).

41. The method of any one of claims 1 to 40, further comprising achieving a decrease in body weight of no less than 5% to 20% compared to initial measurements.

42. The method of any one of claims 1 to 41, wherein a treatment outcome comprises a reduction in visceral fat by a range of 10% to 30% from baseline measurements, quantified in cubic centimeters (cm³) or inches (in³).

43. The method of any one of claims 1 to 42, wherein a treatment outcome comprises a decrease in abdominal fat by a range of 5% to 25% from baseline measurements.

44. The method of any one of claims 1 to 43, further comprising maintaining fat loss within a range of ±3% to ±10% of the achieved reduction in body fat mass.

45. The method of any one of claims 1 to 44, wherein a treatment outcome comprises achieving controlled blood sugar levels within a target range of 70 to 120 milligrams per deciliter (mg / dL) or 3.9 to 6.7 millimoles per liter (mmol / L).

46. The method of any one of claims 1 to 45, wherein the N-trans-caffeoyltyramine and the N-trans-feruloyltyramine is in a ratio of 10:1 to 1:

10.

47. The method of claims 46, wherein the N-trans-caffeoyltyramine and the N-trans- feruloyltyramine is in a ratio of 5:1 to 1:

5.

48. The method of any one of claims 1 to 47, wherein the subject experiences a reduction in visceral fat mass, waist circumference, hip circumference, HbA1c level, or a combination thereof.

49. The method of any one of claims 1 to 48, wherein providing the composition significantly decreases overall total glucose, as measured by 24-hour AUC, 24-hour mean glucose, or both.

50. The method of any one of claims 1 to 49, wherein providing the composition results in one or more effects selected from the group consisting of: a decrease in time spent outsideof an ideal glucose range, a decrease in basal hyperglycemia, a decrease in peak glucose levels, and a decrease in postprandial glucose levels.

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