Formulations to promote optimized workouts

Abstract

Provided herein are formulations to promote optimized workouts and enhance exercise results. The formulations provided herein can be in the form of a gummy and optionally can include stimulants, flavoring agents, bitter blocking agents, vitamins, and additional ingredients. Methods of making these formations are also provided herein. The formulations can be administered before a workout to enhance exercise performance.

Description

Attorney Docket No. 199237-707601FORMULATIONS TO PROMOTE OPTIMIZED WORKOUTSINCORPORATION BY REFERENCE

[0001] This application is a PCT Application, which claims priority to U.S. Provisional Patent Application No. 63 / 682,195, filed 08 / 12 / 2024, which is incorporated in full herein by reference.SUMMARY

[0002] Provided herein are semi-solid compositions for consumption before physical exertion to enhance physical performance, the semi-solid composition comprising: a purple tea extract and a vasodilator present at an amount to enhance physical performance; and a plurality of inactive ingredients that provide for formation of a semi-solid matrix. In some embodiments, the semi-solid composition is in the form of a gummy. In some embodiments, the semi-solid composition comprises: the purple tea extract in a concentration of about 1 wt% and the vasodilator in a concentration of about 1 wt%. In some embodiments, the semi-solid composition comprises: a plurality of active ingredients in a total concentration of about 1 wt% to about 5 wt%, the plurality of active ingredients comprising the purple tea extract in a concentration of about 1 wt% and the vasodilator in a concentration of about 1 wt%; and a plurality of inactive ingredients in a total concentration of about 95 wt% to about 99 wt%, wherein the plurality of inactive ingredients that provide for formation of a semi-solid matrix. In some embodiments, the semi-solid composition comprises: the purple tea extract in a concentration of about 1 wt%; the vasodilator in a concentration of about 1 wt%; a vitamin in a concentration of about 1 wt%; a L-theanine in a concentration of about 1 wt%; a stimulant in a concentration of about 1 wt%; an amino acid in a concentration of about 1 wt%; and the plurality of inactive ingredients that provide for formation of a semi-solid matrix. In some embodiments, the semi-solid composition comprises: the purple tea extract in a concentration of about 1 wt%; the vasodilator in a concentration of about 1 wt%; a vitamin in a concentration of about 1 wt%; a L-theanine in a concentration of about 1 wt%; a stimulant in a concentration of about 1 wt%; an amino acid in a concentration of about 1 wt%; and the plurality of inactive ingredients comprising water, sugar, pectin, glucose, pecmate, flavor, coloring, and citric acid. In some embodiments, the plurality of inactive ingredients further comprises bitter blocker, allulose, fiber and / or com fiber. In some embodiments, the vasodilator is selected from a group consisting of an angiotensin-converting enzyme (ACE) inhibitor, a milk-derived tripeptide, a casein-derived tripeptide, an Ile-Pro-Pro (IPP), a Val-Pro-Pro (VPP), an L-arginine, a L-citrulline, a beetroot extract, a hawthorn extract, a Ginkgo biloba extract, a cocoa flavanol, a garlic extract, a niacin, a magnesium, potassium, a theobromine, a resveratrol, a quercetin, a curcumin, a alpha-lipoic acid, an acetylcholine, a histamine, a prostacyclin, or combinations thereof. In some embodiments, the vasodilator is a milk-derived tripeptide. In some embodiments, the vitamin is vitamin B-12 or cyanocobalamin. In some embodiments, the stimulant is caffeine or coated caffeine. In some embodiments, the amino acid is Beta-phenylamine (PEA). In some embodiments, purple tea extract comprises antioxidants. In some embodiments, L-theanine is derived from green tea extract. In some embodiments, the plurality of inactive ingredients that provideAttorney Docket No. 199237-707601 for formation of a semi-solid matrix comprises a carbohydrate mixture and an aqueous component, the carbohydrate mixture comprising at least two of a sweetener, a non-reducing sugar, a food additive, or a fiber. In some embodiments, the plurality of inactive ingredients comprises the sweetener in a concentration of about 1 wt% to about 9 wt%. In some embodiments, the plurality of inactive ingredients comprises the non-reducing sugar in a concentration of about 1 wt% to about 22 wt%. In some embodiments, the plurality of inactive ingredients comprises the food additive in a concentration of about 1 wt%. In some embodiments, the plurality of inactive ingredients comprises the fiber in a concentration of about 1 wt% to about 8 wt%. In some embodiments, the sweetener is selected from the group consisting of a sucrose, a sugar, a pure cane granulated sugar, a glucose, a com syrup, a fructose, an isomalt, a high fructose com syrup, a tapioca symp, an agave symp, a honey, a maltose symp, a sucralose, an aspartame, a steviol glycosides, an acesulfame potassium, an erythritol, a xylitol, a mannitol, an isomalt, and a combination thereof. In some embodiments, the non-reducing sugar is selected from the group consisting of an allulose, a trehalose, a sucrose, a raffinose, a stachyose, a verbascose, a gentianose, and a combination thereof. In some embodiments, the food additive is a preservative, a flavor enhancer, a texture modifier, a gel strengthener. In some embodiments, the food additive is citric acid. In some embodiments, the fiber is selected from the group consisting of a com fiber, an acacia fiber, a psyllium husk, an inulin, a fmctooligosaccharides (FOS), a chicory root fiber, a tapioca fiber, and a combination thereof. In some embodiments, the plurality of inactive ingredients comprises the aqueous component in a concentration of about 1 wt% to about 25 wt %. In some embodiments, the aqueous component is water. In some embodiments, the plurality of inactive ingredients further comprises at least one of a hydrocolloid gelling ingredient and / or a gelling agent. In some embodiments, the hydrocolloid gelling ingredient is selected from the group consisting of a pectin, an alginate, a carrageenan, a gellan, a gelatin, an agar, a modified starch, a methyl cellulose, a hydroxypropylmethyl cellulose, and a combination thereof. In some embodiments, the hydrocolloid gelling ingredient is pectin. In some embodiments, the gelling agent is pecmate. In some embodiments, the gelling agent enhances controlled gelling. In some embodiments, the plurality of inactive ingredients comprises the hydrocolloid gelling ingredient in a range of greater than 0 wt % to 5 wt %? In some embodiments, the plurality of inactive ingredients further comprises a flavoring, a coloring, a bitter blocker, or a combination thereof.

[0003] Provided herein are semi-solid compositions for consumption before physical exertion to enhance physical performance, the semi-solid composition comprising: a lion’s mane and a vasodilator present at an amount to enhance physical performance; and a plurality of inactive ingredients that provide for formation of a semi-solid matrix. In some embodiments, the semi-solid composition is in the form of a gummy. In some embodiments, the semi-solid composition comprises: the lion’s mane in a concentration of about 2 wt% and the vasodilator in a concentration of about 1 wt%. In some embodiments, the semi-solid composition comprises: a plurality of active ingredients in a total concentration of about 1 wt% to about 8 wt%, the plurality of active ingredients comprising the lion’s mane in a concentration of about 2 wt% and the vasodilator in a concentration of about 1 wt%; and a plurality of inactive ingredients in a totalAttorney Docket No. 199237-707601 concentration of about 92 wt% to about 99 wt%, wherein the plurality of inactive ingredients that provide for formation of a semi-solid matrix. In some embodiments, the semi-solid composition comprises: the lion’s mane in a concentration of about 2 wt%; the vasodilator in a concentration of about 1 wt%; a vitamin in a concentration of about 1 wt%; a L-theanine in a concentration of about 1 wt%; an adaptogen in a concentration of about 2 wt%; a nootropic in a concentration of about 3 wt%; and the plurality of inactive ingredients that provide for formation of a semi-solid matrix. In some embodiments, the semi-solid composition comprises: the lion’s mane in a concentration of about 2 wt%; the vasodilator in a concentration of about 1 wt%; a vitamin in a concentration of about 1 wt%; a L-theanine in a concentration of about 1 wt%; an adaptogen in a concentration of about 2 wt%;a nootropic in a concentration of about 3 wt%; and the plurality of inactive ingredients comprising water, sugar, pectin, glucose, pecmate, flavor, coloring, and citric acid. In some embodiments, the plurality of inactive ingredients further comprises allulose, fiber and / or com fiber. In some embodiments, the vasodilator is selected from a group consisting of an angiotensin-converting enzyme (ACE) inhibitor, a milk-derived tripeptide, a casein-derived tripeptide, an Ile-Pro-Pro (IPP), a Val-Pro-Pro (VPP), an L-arginine, a L-citrulline, a beetroot extract, a hawthorn extract, a Ginkgo biloba extract, a cocoa flavanol, a garlic extract, a niacin, a magnesium, potassium, a theobromine, a resveratrol, a quercetin, a curcumin, a alpha-lipoic acid, an acetylcholine, a histamine, a prostacyclin, or combinations thereof. In some embodiments, the vasodilator is a milk-derived tripeptide. In some embodiments, the vitamin is vitamin B-12 or cyanocobalamin. In some embodiments, the adaptogen is cordyceps. In some embodiments, the nootropic is citicoline. In some embodiments, lion’s mane comprises hericenones and / or erinacines. In some embodiments, L-theanine is derived from green tea extract. In some embodiments, the plurality of inactive ingredients that provide for formation of a semi-solid matrix comprises a carbohydrate mixture and an aqueous component, the carbohydrate mixture comprising at least two of a sweetener, a non-reducing sugar, a food additive, or a fiber. In some embodiments, the plurality of inactive ingredients comprises the sweetener in a concentration of about 1 wt% to about 9 wt%. In some embodiments, the plurality of inactive ingredients comprises the non-reducing sugar in a concentration of about 1 wt% to about 22 wt%. In some embodiments, the plurality of inactive ingredients comprises the food additive in a concentration of about 1 wt%. In some embodiments, the plurality of inactive ingredients comprises the fiber in a concentration of about 1 wt% to about 8 wt%. In some embodiments, the sweetener is selected from the group consisting of a sucrose, a sugar, a pure cane granulated sugar, a glucose, a com syrup, a fructose, an isomalt, a high fructose com symp, a tapioca symp, an agave symp, a honey, a maltose symp, a sucralose, an aspartame, a steviol glycosides, an acesulfame potassium, an erythritol, a xylitol, a mannitol, an isomalt, and a combination thereof. In some embodiments, the non-reducing sugar is selected from the group consisting of an allulose, a trehalose, a sucrose, a raffinose, a stachyose, a verbascose, a gentianose, and a combination thereof. In some embodiments, the food additive is a preservative, a flavor enhancer, a texture modifier, a gel strengthener. In some embodiments, the food additive is citric acid. In some embodiments, the fiber is selected from the group consisting of a com fiber, an acacia fiber, a psyllium husk, an inulin, a fructooligosaccharides (FOS), a chicory root fiber, a tapioca fiber, and a combinationAttorney Docket No. 199237-707601 thereof. In some embodiments, the plurality of inactive ingredients comprises the aqueous component in a concentration of about 1 wt% to about 25 wt %. In some embodiments, the aqueous component is water. In some embodiments, the plurality of inactive ingredients further comprises at least one of a hydrocolloid gelling ingredient and / or a gelling agent. In some embodiments, the hydrocolloid gelling ingredient is selected from the group consisting of a pectin, an alginate, a carrageenan, a gellan, a gelatin, an agar, a modified starch, a methyl cellulose, a hydroxypropylmethyl cellulose, and a combination thereof. In some embodiments, the hydrocolloid gelling ingredient is pectin. In some embodiments, the gelling agent is pecmate. In some embodiments, the gelling agent enhances controlled gelling. In some embodiments, the plurality of inactive ingredients comprises the hydrocolloid gelling ingredient in a range of greater than 0 wt % to 5 wt %. In some embodiments, the plurality of inactive ingredients further comprises a flavoring, a coloring, or a combination thereof.

[0004] Provided herein are methods of enhancing physical performance in a human, the method comprising administering the semi-solid composition described herein prior to physical exertion. In some embodiments, enhancing physical performance is characterized by at least one measurable parameter selected from the group consisting of: (a) an increase in heart rate of at least 20% above resting baseline; (b) an increase in respiratory exchange ratio (RER) of at least 0.9; (c) an decrease in perceived exertion rating on the Borg scale; (d) an increase in peak oxygen uptake (VO2 max) of at least 20% above resting baseline; or (e) an increase in lactate threshold of at least 20% above resting baseline. In some embodiments, the semi-solid composition is administered within 60 minutes prior to the onset of physical exertion. In some embodiments, the semi-solid composition is administered orally prior to the onset of physical exertion.

[0005] Provided herein are formulations in the form of a gummy comprising the following ingredients: a glucose, an allulose, a fiber, a pectin, a sugar, a water, a malate salt, a citric acid or a salt thereof, a flavoring agent, a coloring agent, a bitter blocker agent, a vitamin or a salt thereof, an L-theanine or a salt thereof, a stimulant or a salt thereof, a valyl-prolyl-proline (VPP) peptide or a salt thereof, an iosoleucyl- prolylproline (IPP) peptide or a salt thereof, and a phenylethylamine or a salt thereof. In some embodiments, the fiber comprises a com fiber. In some embodiments, the fiber comprises a soluble fiber. In some embodiments, the com fiber comprises a soluble com fiber. In some embodiments, the sugar comprises a sucrose. In some embodiments, the composition further comprises the citric acid. In some embodiments, the composition further comprises the salt of the citric acid. In some embodiments, the composition further comprises the vitamin that comprises a vitamin B12. In some embodiments, the vitamin or the salt thereof comprises a vitamin B12 (methylcobalamin), a biotin, a pantothenic acid, a calcium pantothenate (vitamin B5), a folate, a pyridoxine HC1 and / or pyridoxal 5 ’phosphate (a vitamin Be), a niacin, a niacinamide, a riboflavin (vitamin B2), a thiamin and / or thiamin HC1 (a vitamin Bi), or any combination thereof. In some embodiments, the stimulant or the salt thereof comprises a caffeine or a salt thereof, a paraxanthine or a salt thereof, a theobromine or a salt thereof, or any combination thereof. In some embodiments, the stimulant or the salt thereof is in the form of particles In some embodiments, the particles are at least partially coated with a coating. In some embodiments, the coating comprises a cellulose or a derivative thereof, a celluloseAttorney Docket No. 199237-707601 acetate or a derivative thereof, a chitosan or a derivative thereof, a lignin or a derivative thereof, or any combination thereof. In some embodiments, the malate salt comprises potassium hydrogen malate. In some embodiments, the coloring agent imparts a red color to the gummy. In some embodiments, the coloring agent comprises FD&C Red Dye 40, a purple sweet potato extract, a black carrot extract, a purple carrot extract, a grape extract, an elderberry extract, a red cabbage extract, a red beet extract, or any combination thereof. In some embodiments, the coloring agent imparts a yellow coloring to the gummy. In some embodiments, the coloring agent comprises an amoretti or an extract thereof, a turmeric or an extract thereof, a beta carotene or an extract thereof, or any combination thereof. In some embodiments, the bitter blocker agent comprises two or three bitter blocker agents. In some embodiments, the bitter blocker agent comprises three bitter blocker agents. In some embodiments, the bitter blocker comprises a monoammonium glycyrrhizinate In some embodiments, the flavorant imparts a berry flavor to the gummy. In some embodiments, the composition further comprises at least one of an epigallocatechin (ECG), an epigallocatechin gallate (EGCG), a l,2-di-O-galloyl-4,6-O-(S)-hexahydroxydiphenoyl-P-D-glucose (GHG), or any combination thereof. In some embodiments, the pectin is a high methoxyl pectin, a low methoxyl pectin, a rapid set pectin, or any combination thereof. In some embodiments, each ingredient in the gummy is independently contained in an amount of from about 1% to about 99% by weight, based on the total weight of the gummy. In some embodiments, each ingredient in the gummy is independently contained an amount of from about: 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 31%, 32%,33%, 34%, 35%, 36%, 37%, 38%, 39%, 40%, 41%, 42%, 43%, 44%, 45%, 46%, 47%, 48%, 49%, 50%,51%, 52%, 53%, 54%, 55%, 56%, 57%, 58%, 59%, 60%, 61%, 62%, 63%, 64%, 65%, 66%, 67%, 68%,69%, 70%, 71%, 72%, 73%, 74%, 75%, 76%, 77%, 78%, 79%, 80%, 81%, 82%, 83%, 84%, 85%, 86%,87%, 88%, 89%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% by weight, based on the total weight of the gummy. In some embodiments, the ingredients are substantially homogeneously mixed in the gummy. In some embodiments, the composition is a dietary supplement. In some embodiments, the composition is in unit dose form.

[0006] Provided herein are methods of making a gummy, the method comprising contacting: a glucose, an allulose, a fiber, a pectin, a sugar, a water, a malate salt, a citric acid or a salt thereof, a flavoring agent, a coloring agent, a bitter blocker agent, a vitamin or a salt thereof, an L-theanine or a salt thereof, a stimulant or a salt thereof, a valyl-prolyl-proline (VPP) peptide or a salt thereof, an iosoleucyl- prolyl-proline (IPP) peptide or a salt thereof, and a phenylethylamine or a salt thereof, thereby forming a gummy.

[0007] Provided herein are formulations in the form of a gummy comprising the following ingredients: a glucose, an allulose, a fiber, a pectin, a sugar, a water, a malate salt, a citric acid or a salt thereof, a flavoring agent, a coloring agent, a vitamin or a salt thereof, an L-theanine or a salt thereof, a valyl-prolyl-proline (VPP) peptide or a salt thereof, an iosoleucyl- prolyl-proline (IPP) peptide or a salt thereof, a citicoline or a salt thereof, and a mushroom or an extract thereof. In some embodiments, the fiber comprises a com fiber. In some embodiments, the fiber comprises a soluble fiber. In some embodiments, the com fiber comprisesAttorney Docket No. 199237-707601 a soluble com fiber. In some embodiments, the sugar comprises a sucrose. In some embodiments, the composition further comprises a citric acid. In some embodiments, the composition further comprises the salt of the citric acid. In some embodiments, the composition further comprises the vitamin that comprises a vitamin B12. In some embodiments, the vitamin or the salt thereof comprises a vitamin B12 (methylcobalamin), a biotin, a pantothenic acid, a calcium pantothenate (vitamin B5), a folate, a pyridoxine HC1 and / or pyridoxal 5 ’phosphate (a vitamin Be), a niacin, a niacinamide, a riboflavin (vitamin B2), a thiamin and / or thiamin HC1 (a vitamin Bi), or any combination thereof. In some embodiments, the malate salt comprises potassium hydrogen malate. In some embodiments, the coloring agent imparts an orange color to the gummy. In some embodiments, the coloring agent comprises FD&C Red Dye 40, a purple sweet potato extract, a black carrot extract, a purple carrot extract, a grape extract, an elderberry extract, a red cabbage extract, a red beet extract, an amoretti or an extract thereof, a turmeric or an extract thereof, a beta carotene or an extract thereof, or any combination thereof In some embodiments, the flavorant imparts a mango flavor to the gummy. In some embodiments, the composition further comprises at least one of an epigallocatechin (ECG), an epigallocatechin gallate (EGCG), a l,2-di-O-galloyl-4,6-O-(S)- hexahydroxydiphenoyl-P-D-glucose (GHG), or any combination thereof. In some embodiments, the pectin is a high methoxyl pectin, a low methoxyl pectin, a rapid set pectin, or any combination thereof. In some embodiments, the mushroom or the extract thereof comprises a first mushroom or an extract thereof and a second mushroom or an extract thereof. In some embodiments, the first mushroom or the extract thereof comprises a lion’s mane or an extract thereof and the second mushroom or the extract thereof comprises a cordyceps or an extract thereof. In some embodiments, each ingredient in the gummy is independently contained in an amount of from about 1% to about 99% by weight, based on the total weight of the gummy. In some embodiments, each ingredient in the gummy is independently contained an amount of from about 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 31%, 32%, 33%, 34%, 35%, 36%, 37%, 38%,39%, 40%, 41%, 42%, 43%, 44%, 45%, 46%, 47%, 48%, 49%, 50%, 51%, 52%, 53%, 54%, 55%, 56%,57%, 58%, 59%, 60%, 61%, 62%, 63%, 64%, 65%, 66%, 67%, 68%, 69%, 70%, 71%, 72%, 73%, 74%,75%, 76%, 77%, 78%, 79%, 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%, 91%, 92%,93%, 94%, 95%, 96%, 97%, 98%, or 99% by weight based on the total weight of the gummy. In some embodiments, the ingredients are substantially homogeneously mixed in the gummy. In some embodiments, the composition is a dietary supplement. In some embodiments, the composition is in unit dose form.

[0008] Provided herein are kits comprising the formulation described herein and a container.

[0009] Provided herein are methods comprising orally administering the formulation described herein to a human about an hour to about a minute before the human engages in an exercise.

[0010] Provided herein are methods of making a gummy comprising contacting: a glucose, an allulose, a fiber, a pectin, a sugar, a water, a malate salt, a citric acid or a salt thereof, a flavoring agent, a coloring agent, a vitamin or a salt thereof, an L-theanine or a salt thereof, a valyl-prolyl-proline (VPP) peptide or aAttorney Docket No. 199237-707601 salt thereof, an iosoleucyl- prolyl-proline (IPP) peptide or a salt thereof, a citicoline or a salt thereof, and a mushroom or an extract thereof, thereby forming the gummy.

[0011] Provided herein are gummies made by the methods disclosed herein.BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The features of the disclosure are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the disclosure are utilized, and the accompanying drawings of which:

[0013] FIG. 1 shows an example of a stimulant gummy formulation that can be administered orally, according to the embodiments herein.

[0014] FIG. 2 shows an example non-stimulant gummy formulation that can be administered orally, according to the embodiments herein.

[0015] FIG. 3 shows an example of the process for producing a semi-solid composition according to the embodiments herein.

[0016] FIG. 4 shows an example of the transfer of the semi-solid composition to gummy form, according to the embodiments herein.

[0017] FIG. 5 shows an example of oral administration of a gummy before physical exertion to enhance physical performance, according to the embodiments herein.

[0018] FIG. 6 shows an example of more than one gummy in packaging, according to the embodiments herein.DETAILED DESCRIPTIONOverview

[0019] Provided herein are formulations for promoting optimized workouts by enhancing physical and / or mental performance. The compositions herein can be administered orally. The compositions herein can be provided in different forms such as in the form of gummies. In some cases, the gummies can comprise one or more of: sugars, fibers, pectins, water, malate, citric acid, flavorings, color agents, bitter blockers, vitamins, L-theanine, stimulants, peptides, and phenylethylamine. Also provided herein are methods of making formulations for promoting optimized workouts and kits comprising the formulations herein.Definitions

[0020] Throughout this application, various aspects may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the disclosure. Accordingly, the description of a rangeAttorney Docket No. 199237-707601 should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0021] As used herein, the term ‘about’ a number can refer to that number plus or minus 10% or plus or minus 5% of that number. The term ‘about’ a range can refer to that range minus 10% of its lowest value and plus 10% of its greatest value. The term ‘about’ a range can refer to that range minus 5% of its lowest value and plus 5% of its greatest value.

[0022] As used in the specification and claims, the singular forms “a”, “an” and “the” include plural references unless the context clearly dictates otherwise. For example, the term “a sample” includes a plurality of samples, including mixtures thereof.

[0023] Unless otherwise indicated, open terms for example “contain,” “containing,” “include,” “including,” and the like mean comprising.

[0024] The terms “composition” and “formulation” are used interchangeably herein.

[0025] The terms “determining”, “measuring”, “evaluating”, “assessing,” “assaying,” and “analyzing” are often used interchangeably herein to refer to forms of measurement and include determining if an element may be present or not (for example, detection). These terms may include quantitative and / or qualitative determinations. Assessing may be alternatively relative or absolute. “Detecting the presence of’ includes determining the amount of something present, as well as determining whether it may be present or absent.

[0026] The terms “subject,” “individual,” or “patient” are often used interchangeably herein. A “subject” may be a biological entity. The biological entity may be a plant, animal, or a microorganism. The subject may be tissues, cells and their progeny of a biological entity obtained in vivo or cultured in vitro. The subject may be a mammal. The mammal may be a human. The subject may be diagnosed or suspected of being at high risk for a disease. In some cases, the subject may not be necessarily diagnosed or suspected of being at high risk for the disease. In some cases, the subject may be healthy (e.g., the subject may not have a significant disease). In some cases, a subject can be a child or an adult. In some cases, a subject can be about 1 day of age to about 18 years of age, 1 day of age to about 120 years of age, 18 years of age to about 50 years of age, 18 years of age to about 120 years of age, 40 years to age to about 80 years of age, or 60 years of age to about 120 years of age.

[0027] The term “at least partially” may refer to a qualitative condition that exhibits a partial range or degree of a feature or characteristic of interest. For example, at least partially can comprise a partial range or degree of a feature or characteristic of interest that is at least about: 5%, 10%, 20%, 30%, 40%, 50%, 60%, 70%, 75%, 80%, 85%, 90%, 95%, 99%, or 100% of the feature or characteristic.Attorney Docket No. 199237-707601

[0028] As used herein, reference to a therapy, a compound, or a composition, includes reference to any salt, solvate, ester, or polymorph of the therapy, the compound, or the composition. A “salt” can include a pharmaceutically acceptable salt.

[0029] As used herein, the terms “treatment” or “treating” are used in reference to a pharmaceutical or other intervention regimen for obtaining beneficial or desired results in the recipient. Beneficial or desired results include but are not limited to a therapeutic benefit and / or a prophylactic benefit. Beneficial or desired results also include increasing the dietary health of an individual and / or increasing exercise performance of an individual. Treatment can include obtaining desired results such as increased energy, increased mental performance, increased exercise performance, or any combination thereof. A therapeutic benefit may refer to eradication or amelioration of symptoms or of an underlying disorder being treated. Also, a therapeutic benefit may be achieved with the eradication or amelioration of one or more of the physiological symptoms associated with the underlying disorder such that an improvement may be observed in the subject, notwithstanding that the subject may still be afflicted with the underlying disorder. A prophylactic effect includes delaying, preventing, or eliminating the appearance of a disease or condition, delaying or eliminating the onset of symptoms of a disease or condition, slowing, halting, or reversing the progression of a disease or condition, or any combination thereof. For a prophylactic benefit, a subject at risk of developing a particular disease, or to a subject reporting one or more of the physiological symptoms of a disease may undergo treatment, even though a diagnosis of this disease may not have been made.

[0030] A “therapeutically effective amount” refers to an amount of a composition as disclosed herein with or without additional agents that is effective to achieve its intended purpose, for example to enhance exercise performance. Individual patient needs may vary. Generally, the dosage required to provide an effective amount of the composition will vary, depending on the age, health, physical condition, sex, weight, extent of the disease of the recipient, frequency of treatment and the nature and scope of the disease or condition.

[0031] As used herein, the term “dose” can refer to a measured quantity of a therapeutic agent to be taken at one time.

[0032] As used herein, the term “unit dose” or “dosage form” may be used interchangeably and may be meant to refer to pharmaceutical drug products (or compositions) in the form in which they are marketed for use, with a specific mixture of active ingredients and inactive components or excipients, in a particular configuration, and apportioned into a particular dose to be delivered. The term “unit dose” may also sometimes encompass non-reusable packaging. More than one unit dose may refer to distinct pharmaceutical drug products packaged together, or to a single pharmaceutical drug product containing multiple drugs and / or doses. Types of unit doses may vary with the route of administration for drug delivery, and the substance(s) being delivered. A solid unit dose may be the solid form of a dose of a chemical compound used as a pharmaceutically acceptable drug or medication intended for administration or consumption.Attorney Docket No. 199237-707601

[0033] As used herein, the term “derivative” of a compound disclosed herein, can refer to a chemical substance related structurally to the compound disclosed. A derivative can be made from the structurally- related parent compound in one or more steps. The general physical and chemical properties of a derivative can be similar to the parent compound. A derivative can be, for example, an analog or a homolog.

[0034] As used herein, the term “substantially” or “essentially” can refer to a qualitative condition that exhibits an entire or nearly total range or degree of a feature or characteristic of interest. In some cases, substantially can refer to a total range or degree of a feature or characteristic of interest by about plus or minus: 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 31%, 32%, 33%, 34%, 35%, 36%, 37%,38%, 39%, 40%, 41%, 42%, 43%, 44%, 45%, 46%, 47%, 48%, 49%, 50%, 51%, 52%, 53%, 54%, 55%,56%, 57%, 58%, 59%, 60%, 61%, 62%, 63%, 64%, 65%, 66%, 67%, 68%, 69%, 70%, 71%, 72%, 73%,74%, 75%, 76%, 77%, 78%, 79%, 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%, 91%,92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, or 100%. In some cases, substantially can refer to at least about: 70%, 75%, 80%, 85%, 90%, 95%, 99%, or 100% of the total range or degree of a feature or characteristic of interest.

[0035] As used herein, the term “gummy” refers to a chewable, elastic, and cohesive confection or supplement composition that is formed from semi-solid composition comprising inactive ingredients (e.g., one or more gelling agents, carbohydrate components), that result in the formation of a semi-solid matrix. Optionally, inactive ingredients can also include ingredients such as sweeteners, flavorings, colorings, or other additives. A gummy can also comprise one or more active ingredients such as bioactive compounds (e.g., vitamins, minerals, dietary supplements, nootropics, botanicals, nutraceutical, pharmaceuticals) at different dosages. Structurally, the gummy is characterized by a soft, pliable, elastic, and resilient texture that allows it to be chewed and consumed orally, and may be provided in various shapes, sizes, and flavors.

[0036] As used herein, the term “purple tea extract”, refers to an extract obtained from the leaves, stems, flowers, or other parts of the Camellia sinensis plant variety known as purple tea, which is characterized by the presence of anthocyanins and other polyphenolic compounds that impart a purple coloration to the plant material. The extract may be prepared by any suitable method, including but not limited to aqueous, alcoholic, or supercritical fluid extraction, and may be provided in liquid, powder, or other forms. The term “purple tea extract” encompasses compositions containing one or more bioactive constituents derived from purple tea, such as anthocyanins, catechins, theaflavins, polyphenols, caffeine, amino acids, or combinations thereof, and may be used as a dietary supplement, food ingredient, or active agent in nutraceutical or pharmaceutical formulations.

[0037] As used herein, the terms “lion's mane" or "lions mane" refers to any material derived from the fungus Hericium erinacens. including but not limited to fruiting bodies, mycelium, spores, or extracts thereof. The term encompasses whole, powdered, or processed forms, as well as compositions containing one or more bioactive constituents naturally present in Hericium erinaceus. such as hericenones, erinacines,Attorney Docket No. 199237-707601 polysaccharides, beta-glucans, or combinations thereof. “Lion’s mane” may be used as a dietary supplement, food ingredient, or active agent in nutraceutical, pharmaceutical, or functional food formulations. Other terms for the fungus Hericium erinaceus include "bearded tooth fungus," "bearded hedgehog," "monkey head mushroom," or "yamabushitake."

[0038] As used herein, the term “nootropic” refers to any compound, substance, or composition that is capable of enhancing, supporting, or maintaining one or more aspects of cognitive function in a subject. Such aspects of cognitive function may include, but are not limited to, memory, learning, attention, focus, mental clarity, executive function, creativity, motivation, or mood. The term “nootropic” encompasses both naturally occurring and synthetic agents, including but not limited to vitamins, minerals, amino acids, botanical extracts, peptides, metabolites, pharmaceuticals, and combinations thereof, that exert their effects through any physiological, biochemical, or neurochemical mechanism.

[0039] As used herein, the term “adaptogen” refers any natural or synthetic substance, compound, or composition that is capable of supporting the body’s ability to adapt to physical, mental, or environmental stressors and to maintain or restore homeostasis. Adaptogens are characterized by their ability to help normalize physiological functions, enhance resistance to stress, and promote overall well-being without causing significant adverse effects. The term “adaptogen” encompasses, but is not limited to, botanical extracts, plant-derived compounds, fungi, minerals, and combinations thereof, as well as any agent that exerts adaptogenic effects through modulation of the neuroendocrine, immune, or other regulatory systems.

[0040] As used herein, the term “vasodilator,” refers to any compound, substance, or agent that causes dilation or widening of blood vessels by relaxing the smooth muscle cells within the vessel walls. Dilation or widening of blood vessels results in an increase in blood vessel diameter, improved blood flow, and a reduction in vascular resistance. The term “vasodilator” encompasses both naturally occurring and synthetic substances, including but not limited to pharmaceuticals, nutraceuticals, botanicals, metabolites, and combinations thereof, that directly or indirectly promote vasodilation through any physiological or biochemical mechanism. For example, the term “vasodilator” may refer to an angiotensin-converting enzyme (ACE) inhibitor, a milk-derived tripeptide, a casein-derived tripeptide, an Ile-Pro-Pro (IPP), or a Val-Pro-Pro (VPP).

[0041] As used herein, the term “physical exertion,” refers to any activity or process that requires voluntary muscular effort resulting in increased energy expenditure above resting levels. The term encompasses a wide range of activities, including but not limited to exercise, sports, manual labor, or any movement that elevates physiological parameters such as heart rate, respiratory rate, oxygen consumption, or perceived exertion. Physical exertion may be characterized or measured by objective criteria, including but not limited to an increase in heart rate, metabolic equivalents (METs), respiratory exchange ratio (RER), power output, or subjective scales such as the Borg Rating of Perceived Exertion. The term includes both aerobic and anaerobic activities, of any intensity or duration, performed by a human subject.Attorney Docket No. 199237-707601

[0042] The section headings used herein are for organizational purposes only and are not to be construed as limiting the subject matter described.Optimized Workout Formulations

[0043] Provided herein are compositions for providing optimized workouts. In some cases, the compositions can be used to enhance exercise performance. In some instances, the compositions can be in the form of a powder, a capsule, or a gummy. In some cases, the compositions herein can be in unit dose form. In some cases, a composition herein can be a dietary supplement. In some cases, a composition herein can be a pharmaceutical formulation.

[0044] In some cases, a composition herein can comprise a glucose, an allulose, a fiber, a pectin, a sugar, a water, a malate salt, a citric acid or a salt thereof, a flavoring agent, a coloring agent, a bitter blocker agent, a vitamin or a salt thereof, an L-theanine or a salt thereof, a stimulant or a salt thereof, a valyl-prolyl -proline (VPP) peptide or a salt thereof, an iosoleucyl- prolyl-proline (IPP) peptide or a salt thereof, a phenylethylamine or a salt thereof, or any combination thereof.

[0045] In some cases, a composition herein can comprise a glucose, an allulose, a fiber, a pectin, a sugar, a water, a malate salt, a citric acid or a salt thereof, a flavoring agent, a coloring agent, a vitamin or a salt thereof, an L-theanine or a salt thereof, a valyl -prolyl-proline (VPP) peptide or a salt thereof, an iosoleucyl - prolyl-proline (IPP) peptide or a salt thereof, a citicoline or a salt thereof, a mushroom or an extract thereof, or any combination thereof.

[0046] In some cases, a composition can comprise a fiber. In some cases, the fiber can comprise a com fiber, or a soluble fiber. In some cases, the com fiber can comprise a soluble com fiber. In some cases, a fiber can be an insoluble fiber. In some cases, a fiber can comprise a cellulose fiber, a hemicellulose fiber, an inulin fiber, an oligofructose fiber, a lignin fiber, a mucilage fiber, abeta-glucan fiber , a pectin, a gum, a polydextrose, a psyllium fiber, a resistant starch, a wheat dextrin, an acacia gum, a calcium polycarophil, a flaxseed, a methylcellulose, an arabinoxylan, a prebiotic fiber, or any combination thereof.

[0047] In some cases, a composition can comprise a glucose or a salt thereof. In some cases, a glucose can be a D-glucose, a L-glucose or both. In some cases, a glucose can be acyclic glucose, cyclic glucose, or a mixture of both. In some cases, glucose can be in the form of granules, crystals, a powder, or any combination thereof. In some cases, a glucose can be in the form of a liquid, a syrup, a solid, or a powder.

[0048] In some cases, a composition can comprise a L-theanine, or a salt thereof. In some cases, a composition can comprise a valyl-prolyl-proline (VPP) peptide or a salt thereof, an iosoleucyl- prolylproline (IPP) peptide or a salt thereof, a phenylethylamine or a salt thereof, a citicoline or a salt thereof, a derivative of any of these, or any combination thereof. In some cases, a phenylethylamine can comprise a Beta-phenylethylamine or a salt thereof. In some cases, a L-theanine, a VPP, an IPP, a phenylethylamine, a citicoline, a salt of any of these, or a derivative of any of these can be in the form of a liquid, a syrup, a solid, or a powder.Attorney Docket No. 199237-707601

[0049] In some cases, a composition can comprise an L-theanine or a salt thereof in an amount of about: 1 milligram (mg) to about 500 mg, 50 mg to about 250 mg, 50 mg to about 150 mg, or about 100 mg to about 300 mg. In some cases, a composition can comprise an L-theanine or a salt thereof in an amount of more than, less than, or equal to about: 50 mg, 55 mg, 60 mg, 65 mg, 70 mg, 75 mg, 80 mg, 85 mg, 90 mg, 95 mg, 100 mg, 105 mg, 110 mg, 115 mg, 120 mg, 125 mg, 130 mg, 135 mg, 140 mg, 145 mg, 150 mg, 155 mg, 160 mg, 165 mg, 170 mg, 175 mg, 180 mg, 185 mg, 190 mg, 195 mg, 200 mg, 205 mg, 210 mg, 215 mg, 220 mg, 225 mg, 230 mg, 235 mg, 240 mg, 245 mg, or 250 mg. In some cases, a composition can comprise a citicoline or a salt thereof in an amount of about: 1 mg to about 1000 mg, 50 mg to about 500 mg, 150 mg to about 750 mg, 100 mg to about 400 mg, or about 250 mg to about 500 mg. In some cases, a composition can comprise a citicoline or a salt thereof in an amount of more than, less than, or equal to about: 100 mg, 110 mg, 120 mg, 130 mg, 140 mg, 150 mg, 160 mg, 170 mg, 180 mg, 190 mg, 200 mg, 210 mg, 220 mg, 230 mg, 240 mg, 250 mg, 260 mg, 270 mg, 280 mg, 290 mg, 300 mg, 310 mg, 320 mg, 330 mg, 340 mg, 350 mg, 360 mg, 370 mg, 380 mg, 390 mg, 400 mg, 410 mg, 420 mg, 430 mg, 440 mg, 450 mg, 460 mg, 470 mg, 480 mg, 490 mg, 500 mg, 510 mg, 520 mg, 530 mg, 540 mg, 550 mg, 560 mg, 570 mg, 580 mg, 590 mg, or 600 mg. In some cases, a composition can comprise a beta-phenylethylamine or a salt thereof in an amount of about: 0.5 mg to about 500 mg, 50 mg to about 250 mg, 25 mg to about 150 mg, or about 1 mg to about 100 mg. In some cases, a composition can comprise a beta-phenylethylamine or a salt thereof in an amount of more than, less than, or equal to about: 1 mg, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, 40 mg, 45 mg, 50 mg, 55 mg, 60 mg, 65 mg, 70 mg, 75 mg, 80 mg, 85 mg, 90 mg, 95 mg, 100 mg, 105 mg, 110 mg, 115 mg, 120 mg, 125 mg, 130 mg, 135 mg, 140 mg, 145 mg, 150 mg,155 mg, 160 mg, 165 mg, 170 mg, 175 mg, 180 mg, 185 mg, 190 mg, 195 mg, 200 mg, 205 mg, 210 mg,215 mg, 220 mg, 225 mg, 230 mg, 235 mg, 240 mg, 245 mg, 250 mg, 260 mg, 270 mg, 280 mg, 290 mg,300 mg, 310 mg, 320 mg, 330 mg, 340 mg, 350 mg, 360 mg, 370 mg, 380 mg, 390 mg, 400 mg, 410 mg,420 mg, 430 mg, 440 mg, 450 mg, 460 mg, 470 mg, 480 mg, 490 mg, or 500 mg.

[0050] In some cases, IPP or a salt thereof and VPP or a salt thereof, individually or in combination, can be present in a composition in an amount of about: 1 milligram (mg) to about 500 mg, 50 mg to about 250 mg, 50 mg to about 150 mg, 75 mg to about 175 mg, 128 mg to about 300 mg, 125 mg to about 400 mg, or about 100 mg to about 300 mg. In some cases, IPP or a salt thereof and VPP or a salt thereof, individually or in combination, can be present in a composition in an amount of more than, less than, or equal to about: 50 mg, 55 mg, 60 mg, 65 mg, 70 mg, 75 mg, 80 mg, 85 mg, 90 mg, 95 mg, 100 mg, 105 mg, 110 mg, 115 mg, 116 mg, 117 mg, 118 mg, 119 mg, 120 mg, 121 mg, 122 mg, 123 mg, 124 mg, 125 mg, 126 mg, 127 mg, 128 mg, 129 mg, 130 mg, 131 mg, 132 mg, 133 mg, 134 mg, 135 mg, 136 mg, 137 mg, 138 mg, 139 mg, 140 mg, 145 mg, 150 mg, 155 mg, 160 mg, 165 mg, 170 mg, 175 mg, 180 mg, 185 mg, 190 mg, 195 mg, 200 mg, 205 mg, 210 mg, 215 mg, 220 mg, 225 mg, 230 mg, 235 mg, 240 mg, 245 mg, 250 mg, 260 mg, 270 mg, 280 mg, 290 mg, 300 mg, 310 mg, 320 mg, 330 mg, 340 mg, 350 mg, 360 mg, 370 mg, 380 mg, 390 mg, 400 mg, 410 mg, 420 mg, 430 mg, 440 mg, 450 mg, 460 mg, 470 mg, 480 mg, 490 mg, or 500 mg.Attorney Docket No. 199237-707601

[0051] In some embodiments, a composition herein can comprise a purple tea, or an extract thereof. In some cases, the purple tea can comprise a Kenyan purple tea extract. In some cases, a purple tea or an extract thereof can be present in an amount of about: 1 milligram (mg) to about 500 mg, 50 mg to about 250 mg, 50 mg to about 150 mg, or about 100 mg to about 300 mg. In some cases, a purple tea or an extract thereof can be present in an amount of more than, less than, or equal to about: 50 mg, 55 mg, 60 mg, 65 mg, 70 mg, 75 mg, 80 mg, 85 mg, 90 mg, 95 mg, 100 mg, 105 mg, 110 mg, 115 mg, 120 mg, 125 mg, 130 mg, 135 mg,140 mg, 145 mg, 150 mg, 155 mg, 160 mg, 165 mg, 170 mg, 175 mg, 180 mg, 185 mg, 190 mg, 195 mg,200 mg, 205 mg, 210 mg, 215 mg, 220 mg, 225 mg, 230 mg, 235 mg, 240 mg, 245 mg, 250 mg, 260 mg,270 mg, 280 mg, 290 mg, 300 mg, 310 mg, 320 mg, 330 mg, 340 mg, 350 mg, 360 mg, 370 mg, 380 mg,390 mg, 400 mg, 410 mg, 420 mg, 430 mg, 440 mg, 450 mg, 460 mg, 470 mg, 480 mg, 490 mg, or 500 mg.

[0052] In some cases, a composition can comprise an allulose or a salt thereof. In some cases, an allulose can be a D-psicose, an L-psicose or a mixture of both. In some cases, an allulose can be acyclic allulose, cyclic allulose, or a mixture of both. In some cases, allulose can be in the form of granules, crystals, a powder, or any combination thereof. In some cases, an allulose can be in the form of a liquid, a syrup, a solid, or a powder.

[0053] In some cases, a composition can comprise a pectin or a salt thereof. In some cases, a pectin can comprise a high methoxyl (HM) pectin, a low methoxyl (LM) pectin, a modified citrus pectin, an amidated pectin, an apple pectin, a rapid set pectin, a slow set pectin, a salt of any of these, or any combination thereof. In some cases, a HM pectin can comprise an extra slow-set HM pectin, a slow set HM pectin, a rapid set HM pectin or any combination thereof. In some cases, a pectin can comprise a pectin enhancer. In some cases, a pectin can be in the form of a liquid, a syrup, a solid, or a powder.

[0054] In some cases, a composition can comprise a sugar or a salt thereof. In some cases, a sugar can be a monosaccharide, a disaccharide, an oligosaccharide, a polysaccharide, or any combination thereof. In some cases, a sugar can comprise a sucrose. In some cases, a sugar can comprise a glucose, a fructose, a galactose, or any combination thereof. In some cases, a sugar can comprise a sucrose, a maltose, an isomaltose, a lactose, a trehalose, or any combination thereof. In some cases, a sugar can comprise a starch, a cellulose, an alginate, a pectin, an agar, a chitosan, a carrageenan, a glycogen, or any combination thereof. In some cases, a sugar can comprise a natural sugar or a synthetic sugar. In some cases, a sugar can comprise a sugar alcohol. In some cases, a sugar can be in the form of a liquid, a syrup, a solid, or a powder.

[0055] In some cases, a composition can comprise a citric acid or a salt thereof. In some cases, a citric acid can comprise as an anhydrous citric acid, a monohydrated citric acid, a salt of any of these, or any combination thereof. In some cases, a citric acid can be in the form of a liquid, a syrup, a solid, or a powder.

[0056] In some cases, a composition can comprise a vitamin or a salt thereof. In some cases, a vitamin can be a B vitamin. In some cases, a B vitamin can comprise a vitamin B12 (cyanocobalamin). In some cases, a B vitamin can comprise, thiamin (Bl), riboflavin (B2), niacin (B3), pantothenic acid (B5), pyridoxine (B6), biotin (B7), folate (B9), cyanocobalamin (B12), salt of any of these, or any combination thereof. InAttorney Docket No. 199237-707601 some cases, a vitamin can comprise a vitamin BI2(methylcobalamin), a biotin, a pantothenic acid, a calcium pantothenate (vitamin B5), a folate, a pyridoxine HC1 and / or pyridoxal 5 ’phosphate (a vitamin Be), a niacin, a niacinamide, a riboflavin (vitamin B2), a thiamin and / or thiamin HC1 (a vitamin Bi), a salt of any of these, or any combination thereof. In some cases, a vitamin can comprise a vitamin A, a thiamin, a riboflavin, a niacin, a pantothenic acid, a vitamin B6, a biotin, a vitamin C, a choline, a vitamin D, a vitamin E, a vitamin K, a folate, a salt of any of these, or any combination thereof. In some cases, a vitamin can be in the form of a liquid, a syrup, a solid, or a powder.

[0057] In some cases, a composition can comprise a vitamin or a salt thereof in an amount of about: 0.1 mg to about 1000 mg, 2 mg to about 20 mg, 1 mg to about 100 mg, 50 mg to about 150 mg, 25 mg to about 200 mg, 250 mg to about 500 mg, or about 500 mg to about 1000 mg. In some cases, a composition can comprise a vitamin or a salt thereof in an amount of more than, less than, or equal to about: 0.1 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7 mg, 8 mg, 9 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, 40 mg, 45 mg, 50 mg, 55 mg, 60 mg, 65 mg, 70 mg, 75 mg, 80 mg, 85 mg, 90 mg, 95 mg, 100 mg, 110 mg, 120 mg, 130 mg, 140 mg, 150 mg, 160 mg, 170 mg, 180 mg, 190 mg, 200 mg, 210 mg, 220 mg, 230 mg, 240 mg, 250 mg, 300 mg, 350 mg, 400 mg, 450 mg, 500 mg, 550 mg, 600 mg, 650 mg, 700 mg, 750 mg, 800 mg, 850 mg, 900 mg, 950 mg, or 1000 mg.

[0058] In some embodiments, a composition herein can comprise a water. In some cases, a water can be a purified water. In some cases, a water can be a spring water. In some cases, a water can be a distilled water. In some cases, a water can be a tap water.

[0059] In some embodiments, a composition can comprise a mineral, a salt thereof, or a chelated form thereof. In some cases, a mineral can comprise: a calcium, a phosphorus, a potassium, a sulfur, a sodium, a chloride, a magnesium, an iron, a zinc, a copper, a manganese, an iodine, a selenium, a molybdenum, a chromium, a fluoride, or any combination thereof. A chelated form of a mineral can comprise copper chelate, potassium iodine, di-magnesium malate, magnesium bisglycinate chelate, zinc bisglycinate chelate, selenium glycinate, copper bisglycinate chelate, manganese bisglycinate chelate, chromium chelate, molybdenum glycinate chelate, potassium glycinate chelate or any combination thereof. In some instances, a mineral can comprise sodium chloride. In some cases, a mineral can be in the form of a liquid, a syrup, a solid, or a powder.

[0060] In some embodiments, a composition can comprise a simulate or a salt thereof. In some cases, the stimulant can comprise a caffeine or a salt thereof, a paraxanthine or a salt thereof, a theobromine or a salt thereof, or any combination thereof. In some cases, a stimulant can comprise a Beta (P)-phenylethylamine, a phenethylamine, a salt of any of these, or any combination thereof. In some cases, caffeine or a salt thereof can be anhydrous caffeine or a salt thereof. In some cases, the stimulant can be in the form of particles. In some cases, the particles can be at least partially coated with a coating. In some cases, the coating can comprise a cellulose or a derivative thereof, a cellulose acetate or a derivative thereof, a chitosan or aAttorney Docket No. 199237-707601 derivative thereof, a lignin or a derivative thereof, a salt of any of these, or any combination thereof. In some cases, a simulate can be in the form of a liquid, a syrup, a solid, or a powder.

[0061] In some cases, a composition can comprise a simulate or a salt thereof in an amount of about: 1 milligram (mg) to about 500 mg, 50 mg to about 250 mg, 40 mg to about 180 mg, 50 mg to about 150 mg, or about 100 mg to about 300 mg. In some cases, a composition can comprise a stimulant or a salt thereof in an amount of more than, less than, or equal to about: 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, 40 mg, 45 mg, 50 mg, 55 mg, 60 mg, 65 mg, 70 mg, 75 mg, 80 mg, 85 mg, 90 mg, 95 mg, 100 mg, 105 mg, 110 mg, 115 mg, 120 mg, 125 mg, 130 mg, 135 mg, 140 mg, 145 mg, 150 mg, 155 mg, 160 mg, 165 mg,170 mg, 175 mg, 180 mg, 185 mg, 190 mg, 195 mg, 200 mg, 205 mg, 210 mg, 215 mg, 220 mg, 225 mg,230 mg, 235 mg, 240 mg, 245 mg, 250 mg, 260 mg, 270 mg, 280 mg, 290 mg, 300 mg, 310 mg, 320 mg,330 mg, 340 mg, 350 mg, 360 mg, 370 mg, 380 mg, 390 mg, 400 mg, 410 mg, 420 mg, 430 mg, 440 mg,450 mg, 460 mg, 470 mg, 480 mg, 490 mg, or 500 mg.

[0062] In some embodiments, a composition can comprise a malate salt. In some cases, a malate salt can comprise a potassium hydrogen malate. In some cases, a malate salt can comprise a (L)-malate salt, a (D)- malate salt, a (DL) malate salt, a sodium malate, a magnesium malate, or any combination thereof. In some cases, a malate salt can be in the form of a liquid, a syrup, a solid, or a powder.

[0063] In some embodiments, a composition can comprise a coloring agent. In some cases, a coloring agent can impart a red color, a yellow color, a blue color, a green color, an orange color, an indigo color, a violet color, or any combination thereof. In some cases, a coloring agent can impart a red color. In some cases, a coloring agent can impart a yellow color. In some cases, a coloring agent can impart an orange color. In some cases, a coloring agent can comprise a FD&C Red Dye 40, a purple sweet potato extract, a black carrot extract, a purple carrot extract, a grape extract, an elderberry extract, a red cabbage extract, a red beet extract, or any combination thereof. In some cases, a coloring agent can comprise an FD&C Red Dye 40, a purple sweet potato extract, a black carrot extract, a purple carrot extract, a grape extract, an elderberry extract, a red cabbage extract, a red beet extract, an amoretti or an extract thereof, a turmeric or an extract thereof, a beta carotene or an extract thereof, or any combination thereof. In some cases, a coloring agent can comprise an amoretti or an extract thereof, a turmeric or an extract thereof, a beta carotene or an extract thereof, or any combination thereof. In some cases, a coloring agent can comprise FD&C dye and lake colors, blue 1, blue 2, red 40, red 3, yellow 5, yellow 6, green 3, or any combination thereof. In some cases, a coloring agent can comprise annatto, a caramel coloring, a carmine, an elder berry juice, a lycopene, a paprika, a turmeric, a curcumin, a ponceu 4R, a carmoisine, an erythrosine, a tartrazine, a sunset yellow FCF, an indigo carmine, a brilliant blue FCF, a fast green FCF, or any combination thereof. In some cases, a coloring agent can be in the form of a liquid, a syrup, a solid, or a powder.

[0064] In some embodiments, a composition can comprise a bitter blocker. In some cases, a composition can comprise 1, 2, 3, 4, 5, or more than 5 bitter blocking agents. In some cases, a bitter blocker can comprise a monoammonium glycyrrhizinate. In some cases, a bitter blocking agent can comprise bb-020, bb-001,Attorney Docket No. 199237-707601 swe-089, P-cyclodextrin, homoeriodictyol sodium salt, zinc sulfate monohydrate, magnesium sulfate, and carboxymethylcellulose sodium salt, sodium acetate, sodium gluconate, glycyrrhizin, a bitter blocker peptide, a salt of any of these, or any combination thereof. In some cases, a bitter blocking agent can be in the form of a liquid, a syrup, a solid, or a powder.

[0065] In some embodiments, a composition can comprise a flavorant. In some cases, a flavorant can impart a berry flavor to the gummy, a tropical fruit flavor to the gummy, or both. In some cases, a flavorant can impart a mango flavor to the gummy. In some cases, a flavorant can comprise an artificial flavor, a natural flavor, or both. In some cases, a flavorant can comprise acai berry, almond, amaretto, anise, apple, apricot, banana, bacon, bavarian cream, berry cola, birch beer, black licorice, black cherry, black currant, black walnut, blackberry, blue raspberry, blueberry, bourbon, bubble gum, butter, butter almond, butter milk, butter pecan, butter rum, butter toffee, butterscotch, cake batter, candy com, caramel, caramel apple, caramel cream, carrot cake, champagne, cheesecake, cherry, cherry blossom, cherry cola, cherry cream spice, chocolate, chocolate cake, chocolate mint, cinnamon, cinnamon roll, coconut, coffee, cola, cookie dough, cotton candy, cranberry, cream soda, creme de menthe, cucumber, dill pickle, doughnut, elderberry, egg nog, eucalyptus, flan, fenugreek, fruity cereal, fruit punch, fuzzy navel, ginger ale, ginger beer, ginger lime, gingerbread, gingersnap, grand mariner, graham cracker, grape, grapefruit, green onion, hazelnut, honey, horchata, huckleberry, irish cream, irish whiskey, kettle com, key lime, kiwi, lemon, lemon bar, lemon custard, lemon lime, lemon meringue pie, lemonade, lime, long island tea, macadamia nut, malted milk, mango, mango orange pineapple, maple, margarita, marshmallow, melon, melon kiwi, mint, mixed berry, mocha, mocha irish cream, mojito, moscow mule, nutmeg, orange, orange brandy, orange cream, orange mandarin, orange mango, orange pineapple, papaya, passion fruit, peach, peanut, pear, pecan, pecan roll, peppermint, pina colada, pineapple, pink lemonade, pistachio, plantation punch, plum, pomegranate, prickly pear, pumpkin, pumpkin pie, punch, quinine, raspberry, raspberry ginger ale, rock and rye, root beer, rum, sarsaparilla, sassafras, smoke, sour, strawberry, strawberry kiwi, spice, spearmint, tangerine, tart lemon, tequila, toasted coconut, toffee, tonic, tropical punch, tutti frutti, vanilla, vanilla cream, watermelon, white chocolate, whipped cream, wild cherry cream, wintergreen, or any combination thereof. In some cases, a flavorant can be in the form of a liquid, a syrup, a solid, or a powder.

[0066] In some embodiments, a composition herein can comprise a mushroom. In some cases, a mushroom can comprise a portion of a mushroom, a mushroom extract, or any combination thereof. In some instances, a portion of a mushroom can comprise, a cap of a mushroom, a stem of a mushroom, a mycelium of a mushroom, the spores of a mushroom, the hyphae of a mushroom, or any combination thereof. In some cases, a composition can comprise a first mushroom, a portion of the first mushroom, or an extract of the first mushroom and a second mushroom, a portion of the second mushroom, or an extract of the second mushroom. In some cases, a composition can comprise 1, 2, 3, 4, 5, or more than 5 mushrooms, portions of mushrooms, or mushroom extracts. In some cases, a mushroom, a portion of a mushroom, or a mushroom extract can be from a lion’s mane mushroom, a cordyceps mushroom, a chaga mushroom, a reishi mushroom, a red reishi mushroom, a china root mushroom, an enokitake mushroom, a morel mushroom, aAttorney Docket No. 199237-707601 wood ear mushroom, a Lentinus mushroom, a tremella mushroom, a turkey tail mushroom, a shiitake mushroom, a maitake mushroom, an oyster mushroom, a buttom mushroom, or any combination thereof. In some cases, a mushroom, a portion of a mushroom, or a mushroom extract can be from a lion’s mane mushroom, a cordyceps mushroom, or both. In some cases, a mushroom (or portion thereof or extract thereof) can be in the form of a liquid, a syrup, a solid, or a powder.

[0067] In some cases, a composition can comprise a mushroom, a portion of a mushroom, or an extract of a mushroom in an amount of about: 1 mg to about 1000 mg, 50 mg to about 500 mg, 150 mg to about 750 mg, 200 mg to about 350 mg, 150 mg to about 600 mg, 400 mg to about 800 mg, 100 mg to about 400 mg, or about 250 mg to about 500 mg. In some cases, a composition can comprise a mushroom, a portion of a mushroom, or an extract of a mushroom in an amount of more than, less than, or equal to about: 100 mg, 110 mg, 120 mg, 130 mg, 140 mg, 150 mg, 160 mg, 170 mg, 180 mg, 190 mg, 200 mg, 210 mg, 220 mg,230 mg, 240 mg, 250 mg, 260 mg, 270 mg, 280 mg, 290 mg, 300 mg, 310 mg, 320 mg, 330 mg, 340 mg,350 mg, 360 mg, 370 mg, 380 mg, 390 mg, 400 mg, 410 mg, 420 mg, 430 mg, 440 mg, 450 mg, 460 mg,470 mg, 480 mg, 490 mg, 500 mg, 510 mg, 520 mg, 530 mg, 540 mg, 550 mg, 560 mg, 570 mg, 580 mg,590 mg, or 600 mg.

[0068] In some embodiments, a composition can comprise an epigallocatechin (ECG), an epigallocatechin gallate (EGCG), a l,2-di-O-galloyl-4,6-O-(S)-hexahydroxydiphenoyl-P-D-glucose (GHG), a salt of any of these, or any combination thereof. In some cases, an ECG, an EGCG, or a GHG can be in the form of a liquid, a syrup, a solid, or a powder.

[0069] In some embodiments, a composition herein can comprise each ingredient independently in an amount of from about: 1% to about 99% or 0.01% to about 99% by weight, based on the total weight of the gummy. In some cases, each ingredient in the gummy can be independently contained an amount of more than, less than, or equal to about: 0.01%, 0.05%, 0.1%. 0.5%, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%,29%, 30%, 31%, 32%, 33%, 34%, 35%, 36%, 37%, 38%, 39%, 40%, 41%, 42%, 43%, 44%, 45%, 46%,47%, 48%, 49%, 50%, 51%, 52%, 53%, 54%, 55%, 56%, 57%, 58%, 59%, 60%, 61%, 62%, 63%, 64%,65%, 66%, 67%, 68%, 69%, 70%, 71%, 72%, 73%, 74%, 75%, 76%, 77%, 78%, 79%, 80%, 81%, 82%,83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% by weight, based on the total weight of the gummy.

[0070] In some embodiments, the ingredients in a composition herein can be substantially homogenously mixed in the gummy. In some embodiments, the ingredients in a composition herein can be homogenously mixed in the gummy. In some cases, the ingredients in a composition herein can be substantially or at least partially heterogeneously mixed in the gummy.

[0071] Provided herein are semi-solid matrices comprising a plurality of inactive ingredients that collectively form a cohesive, chewable structure suitable for oral administration. The semi-solid matrix, which broadly encompasses the concept of a “gummy,” is formed by combining one or more carbohydrateAttorney Docket No. 199237-707601 sources, such as non-reducing sugars, sugar alcohols, and fibers, with at least one gelling agent, such as a hydrocolloid or gum. These inactive ingredients interact to create a pliable, elastic, and resilient matrix that maintains its shape while remaining soft enough to be chewed and swallowed. Additional optional inactive ingredients, including sweeteners, flavorings, colorings, acids, and water, may be incorporated to enhance palatability, stability, and appearance. The resulting semi-solid matrix serves as a delivery vehicle for active ingredients, providing a uniform and stable environment that facilitates controlled release, improved mouthfeel, and consumer acceptability.

[0072] In some embodiments, the compositions of the present disclosure are semi-solid compositions comprising a plurality of active ingredients in a total concentration of about 1 wt% to about 5 wt%, the plurality of active ingredients comprising purple tea extract in a concentration of about 1 wt% and a vasodilator in a concentration of about 1 wt%; and a plurality of inactive ingredients in a total concentration of about 95 wt% to about 99 wt%, wherein the plurality of inactive ingredients that provide for formation of a semi-solid matrix.

[0073] In some embodiments, the compositions of the present disclosure comprise semi-solid compositions for consumption before physical exertion to enhance physical performance, the semi-solid composition comprising: about 2 wt% lion’s mane and about 1 wt% vasodilator present to enhance physical performance; and about 92 wt% to about 97 wt% of a plurality of inactive ingredients that provide for formation of a semi-solid matrix.

[0074] In some embodiments, the compositions of the present disclosure comprise semi-solid compositions comprising: 2.1 wt% citicoline; 0.016 wt% vitamin B12 (cyanocobalamin); 0.8 wt% L-theanine; 1 wt% vasodilator; 1.6 wt% lion’s mane; and 1.6 wt% cordyceps. In some embodiments, the compositions of the present disclosure comprise semi-solid compositions comprising: 0.7 wt% purple tea extract; 0.015 wt% vitamin B12 (cyanocobalamin); 0.7 wt% L-theanine, 0.9 wt% vasodilator; 0.3 wt % coated caffeine, and 0.36 wt% beta-phenylethylamine (PEA). In some embodiments, the compositions of the present disclosure comprise semi-solid compositions comprising: 2.1 wt% citicoline; 0.016 wt% vitamin B12 (cyanocobalamin); 0.8 wt% L-theanine; 1 wt% vasodilator; 1.6 wt% lion’s mane; and 1.6 wt% cordyceps. In some embodiments, the compositions of the present disclosure comprise semi-solid compositions comprising: 0.85 wt% purple tea extract; 0.01 wt %vitamin B12 (cyanocobalamin; 1 wt% L-theanine; 1 wt% vasodilator; 0.3 wt% coated caffeine; and 0.4 wt% beta-phenylethylamine (PEA).

[0075] In some embodiments, the compositions of the present disclosure comprise non stimulant gummies comprising water; sugar; pectin; glucose; allulose syrup; com fiber; pecmate; flavor (- mango(ma-13313); color (such as sunset orange); citric acid; cognizing; vitamin B12; L-theanine; vasodrive; lion’s mane; and cordyceps.

[0076] In some embodiments, the compositions of the present disclosure comprise reduced sugar gummies comprising water; sugar; pectin (4420), glucose; allulose syrup; com fiber (e.g., fiber smart); pecmate;Attorney Docket No. 199237-707601 flavor (e.g., berry blast (be-20945); color (such as red); citric acid; blockers (e.g., bb-020, bb-001); swe- 089; purple force; vitamin B 12; 1- theanine; coated caffeine; pea; and vasodrive.Salts

[0077] As used herein reference to a composition, or a compound includes reference to any salt, solvate, ester, or polymorph of the composition or the compound. A “salt” can include a pharmaceutically acceptable salt.

[0078] In some embodiments, the pharmaceutically acceptable salts include, but are not limited to, metal salts such as sodium salt, potassium salt, cesium salt and the like; alkaline earth metals such as calcium salt, magnesium salt and the like; organic amine salts such as triethylamine salt, pyridine salt, picoline salt, ethanolamine salt, triethanolamine salt, dicyclohexylamine salt, N,N'-dibenzylethylenediamine salt and the like; inorganic acid salts such as hydrochloride, hydrobromide, phosphate, sulphate and the like; organic acid salts such as citrate, lactate, tartrate, maleate, fumarate, mandelate, acetate, dichloroacetate, trifluoroacetate, oxalate, formate and the like; sulfonates such as methanesulfonate, benzenesulfonate, p- toluenesulfonate and the like; and amino acid salts such as arginate, asparginate, glutamate and the like. In some instances, a salt of a polypeptide or derivative thereof or a compound can be a Zwitterionic salt.

[0079] In some embodiments, a pharmaceutical composition comprising the salt of the pharmaceutically active ingredient can comprise an organic salt or an inorganic salt. In some cases, an organic salt may comprise a phosphinate (e.g., sodium hypophosphite), a hydrazinium salt, a urate, a diazonium salt, an oxalate salt, a tartrate, a choline chloride. An example of an inorganic salt may be sodium chloride, calcium chloride, magnesium chloride, sodium bicarbonate, potassium chloride, sodium sulfate, calcium carbonate, calcium phosphate, or any combination thereof. In some cases, a salt comprises an HC1 salt, an ascorbic acid salt, a mandelic acid salt, an aspartic acid salt, a carbonic acid salt, a citric acid salt, a formic acid salt, a glutamic acid salt, a lactic acid salt, a lauric acid salt, a maleic acid salt, a borate salt, a bitartrate salt, a palmitic acid salt, a phosphoric acid salt, or any combination thereof.Excipients, carriers, and diluents

[0080] In some embodiments, a composition can comprise an excipient, a carrier, and / or a diluent. In some embodiments, an excipient, a carrier, and / or a diluent can be a pharmaceutically acceptable excipient, carrier, and / or diluent. In some embodiments, a composition herein can comprise one or more of the following excipients: acacia, acesulfame potassium, acetic acid-glacial, acetone, acetyltributyl citrate, acetyltriethyl citrate, adipic acid, agar, albumin, alcohol, alginic acid, aliphatic polyesters, alitame, almond oil, alpha tocopherol, aluminum hydroxide adjuvant, aluminum monostearate, aluminum oxide, aluminum phosphate adjuvant, ammonia solution, ammonium alginate, ammonium chloride, ascorbic acid, ascorbyl palmitate, aspartame, attapulgite, bentonite, benzalkonium chloride, benzethonium chloride, benzoic acid, benzyl alcohol, benzyl benzoate, boric acid, bronopol, butylated hydroxyanisole, butylated hydroxytoluene, butylene glycol, butylparaben, calcium acetate, calcium alginate, calcium carbonate, calcium chloride,Attorney Docket No. 199237-707601 calcium hydroxide, calcium lactate, calcium phosphate-dibasic anhydrous, calcium phosphate-dibasic dihydrate, calcium phosphate-tribasic, calcium silicate, calcium stearate, calcium sulfate, canola oil, carbomer, carbon dioxide, carboxymethylcellulose calcium, carboxymethylcellulose sodium, carrageenan, castor oil, castor oil-hydrogenated, cellulose-microcrystalline, cellulose-microcrystalline and carboxymethylcellulose sodium, cellulose-powdered, cellulose-silicified microcrystalline, cellulose acetate, cellulose acetate phthalate, ceratonia, ceresin, cetostearyl alcohol, cetrimide, cetyl alcohol, cetylpyridinium chloride, chitosan, chlorhexidine, chlorobutanol, chlorocresol, chlorodifluoroethane (hcfc), chlorofluorocarbons (cfc), chloroxylenol, cholesterol, citric acid monohydrate, coconut oil, colloidal silicon dioxide, coloring agents, copovidone, com oil, com starch and pregelatinized starch, cottonseed oil, cresol, croscarmellose sodium, crospovidone, cyclodextrins, cyclomethicone, denatonium benzoate, dextrates, dextrin, dextrose, dibutyl phthalate, dibutyl sebacate, diethanolamine, diethyl phthalate, difluoroethane (hfc), dimethicone, dimethyl ether, dimethyl phthalate, dimethyl sulfoxide, dimethylacetamide, disodium edetate, docusate sodium, edetic acid, erythorbic acid, erythritol, ethyl acetate, ethyl lactate, ethyl maltol, ethyl oleate, ethyl vanillin, ethylcellulose, ethylene glycol stearates, ethylene vinyl acetate, ethylparaben, fructose, fumaric acid, gelatin, glucose — liquid, glycerin, glyceryl behenate, glyceryl monooleate, glyceryl monostearate, glyceryl palmitostearate, glycine, glycofurol, guar gum, hectorite, heptafluoropropane (hfc), hexetidine, hydrocarbons (he), hydrochloric acid, hydrophobic colloidal silica, hydroxyethyl cellulose, hydroxyethylmethyl cellulose, hydroxypropyl betadex, hydroxypropyl cellulose, hydroxypropyl cellulose- low-substituted, hydroxypropyl starch, hypromellose, hypromellose acetate succinate, hypromellose phthalate, imidurea, inulin, iron oxides, isomalt, isopropyl alcohol, isopropyl myristate, isopropyl palmitate, kaolin, lactic acid, lactitol, lactose-anhydrous, lactose-inhalation, lactose-monohydrate, lactosemonohydrate and com starch, lactose-monohydrate and microcrystalline cellulose, lactose-monohydrate and povidone, lactose-monohydrate and powdered cellulose, lactose-spray-dried, lanolin, lanolin-hydrous, lanolin alcohols, lauric acid, lecithin, leucine, linoleic acid, macrogol 15 hydroxystearate, magnesium aluminum silicate, magnesium carbonate, magnesium oxide, magnesium silicate, magnesium stearate, magnesium trisilicate, maleic acid, malic acid, maltitol, maltitol solution, maltodextrin, maltol, maltose, mannitol, medium-chain triglycerides, meglumine, menthol, methionine, methylcellulose, methylparaben, mineral oil, mineral oil-light, mineral oil and lanolin alcohols, monoethanolamine, monosodium glutamate, monothioglycerol, myristic acid, myristyl alcohol, neohesperidin dihydrochalcone, neotame, nitrogen, nitrous oxide, octyldodecanol, oleic acid, oleyl alcohol, olive oil, palmitic acid, paraffin, peanut oil, pectin, pentetic acid, petrolatum, petrolatum and lanolin alcohols, phenol, phenoxyethanol, phenylethyl alcohol, phenylmercuric acetate, phenylmercuric borate, phenylmercuric nitrate, phospholipids, phosphoric acid, polacrilin potassium, poloxamer, polycarbophil, polydextrose, poly (dl-lactic acid), polyethylene glycol, polyethylene oxide, polymethacrylates, poly(methyl vinylether / maleic anhydride), polyoxyethylene alkyl ethers, polyoxyethylene castor oil derivatives, polyoxyethylene sorbitan fatty acid esters, polyoxyethylene stearates, polyoxylglycerides, polyvinyl acetate phthalate, polyvinyl alcohol, potassium alginate, potassium alum, potassium benzoate, potassium bicarbonate, potassium chloride, potassium citrate, potassiumAttorney Docket No. 199237-707601 hydroxide, potassium metabisulfite, potassium sorbate, povidone, propionic acid, propyl gallate, propylene carbonate, propylene glycol, propylene glycol alginate, propylparaben, propylparaben sodium, pyrrolidone, raffinose, saccharin, saccharin sodium, safflower oil, saponite, sesame oil, shellac, simethicone, sodium acetate, sodium alginate, sodium ascorbate, sodium benzoate, sodium bicarbonate, sodium borate, sodium carbonate, sodium chloride, sodium citrate dihydrate, sodium cyclamate, sodium formaldehyde sulfoxylate, sodium hyaluronate, sodium hydroxide, sodium lactate, sodium lauryl sulfate, sodium metabisulfite, sodium phosphate — dibasic, sodium phosphate — monobasic, sodium propionate, sodium starch glycolate, sodium stearyl fumarate, sodium sulfite, sodium thiosulfate, sorbic acid, sorbitan esters (sorbitan fatty acid esters), sorbitol, soybean oil, starch, starch-pregelatinized, starch — sterilizable maize, stearic acid, stearyl alcohol, sucralose, sucrose, sucrose octaacetate, sugar-compressible, sugar-confectioner's, sugar spheres, sulfobutylether b-cyclodextrin, sulfur dioxide, sulfuric acid, sunflower oil, suppository bases — hard fat, tagatose, talc, tartaric acid, tetrafluoroethane (hfc), thaumatin, thimerosal, thymol, titanium dioxide, tragacanth, trehalose, triacetin, tributyl citrate, tricaprylin, triethanolamine, triethyl citrate, triolein, vanillin, vegetable oil-hydrogenated, vitamin e polyethylene glycol succinate, water, wax-anionic emulsifying, waxcarnauba, wax-cetyl esters, wax-microcrystalline, wax-nonionic emulsifying, wax-white, wax-yellow, xanthan gum, xylitol, zein, zinc acetate, or zinc stearate.

[0081] In some cases, a composition herein can comprise a carrier and / or a diluent. In some cases, a carrier or a diluent can be a pharmaceutically acceptable carrier and / or diluent. In some instances, a carrier or diluent can comprise a water, an alcohol, a salt solution (e.g., saline), or a mixture thereof. In some instances, a carrier can comprise a carbohydrate (e.g., a sugar), a buffer, a salt, a pH adjuster, or any combination thereof. In some cases, sodium phosphate, citric acid, acetic acid, tromethamine, histidine, gluconic, lactic acid, tartaric acid, aspartic acid, glutamic acid, a citric acid cycle intermediate, or any combination thereof can be a buffer. In some cases, citrate can be used as a buffer. In some cases, a carrier can be a substrate used in the process of drug delivery. In some cases, a carrier can contribute a product’s attributes such as stability, biopharmaceutical profile, and / or appearance. In some cases, a carrier can be an organic excipient.Methods of making

[0082] The compositions herein can be made using a variety of methods. In some cases, the ingredients described herein can be contacted and / or mixed to form the formulations or compositions described herein. In some cases, the ingredients of the compositions can be mixed individually in separate groups and combined to make one composition. The methods herein can be used to make a gummy. Methods of making gummies are provided in Example 1 and Example 2. In some cases, the methods herein can be used to make a composition in the form of a gummy, a capsule, a powder, a tablet, a beverage, or a food. In some embodiments, a method for making can comprise use of an agitator, a mixer, devices for heating solutions (e.g., burners), buckets, scales, containers, or any combination thereof.

[0083] In some embodiments, a method of making a gummy can comprise making a gummy by contacting: a glucose, an allulose, a fiber, a pectin, a sugar, a water, a malate salt, a citric acid or a salt thereof, aAttorney Docket No. 199237-707601 flavoring agent, a coloring agent, a vitamin or a salt thereof, an L-theanine or a salt thereof, a valyl-prolyl- proline (VPP) peptide or a salt thereof, an iosoleucyl- prolyl-proline (IPP) peptide or a salt thereof, a citicoline or a salt thereof, and a mushroom or an extract thereof, thereby forming the gummy.

[0084] In some embodiments, a method of making a gummy can comprise making a gummy by contacting: a glucose, an allulose, a fiber, a pectin, a sugar, a water, a malate salt, a citric acid or a salt thereof, a flavoring agent, a coloring agent, a bitter blocker agent, a vitamin or a salt thereof, an L-theanine or a salt thereof, a stimulant or a salt thereof, a valyl-prolyl-proline (VPP) peptide or a salt thereof, an iosoleucyl- prolyl-proline (IPP) peptide or a salt thereof, and a phenylethylamine or a salt thereof, thereby forming a gummy.

[0085] In some embodiments, a method of making the semi-solid composition as described herein comprises preparing a mixture of a plurality of inactive ingredients, and adding one or more active ingredients.

[0086] In some embodiments, a method of making the semi-solid composition as described herein comprises different steps prepared in three temperature-controlled tanks: Tank #1 heated at 125 °C, Tank #2 heated at 128 °C, and Tank #3 heated at 95 °C. In some embodiments, inactive ingredients are added to water, mixed and heated. In some embodiments, two different temperature-controlled tanks are used to prepare two different mixtures of a plurality of inactive ingredients. In some embodiments, the two different mixtures are poured into a single tank prior to the addition of active ingredients. In some embodiments, the two different mixtures are poured into an empty tank, creating a third mixture of a plurality of inactive ingredients in a third tank prior to the addition of active ingredients. In some embodiments, a mixture of a plurality of inactive ingredients and active ingredients is mixed to a homogenous mixture before being poured into gummy molds (FIG. 4).Uses of the formulations

[0087] The compositions herein can be used to enhance exercise performance and workout potential. In some cases, the exercise can be an aerobic exercise or an anerobic exercise. In some cases, the exercise can be a sport. In some embodiments, a method herein can comprise orally administering a composition herein to a human about an hour to about a minute before the human engages in an exercise.

[0088] In some cases, enhanced exercise performance can comprise increased endurance of a subject who has taken a composition herein as compared to a comparable subject who has not received the composition. In some cases, enhanced exercise performance can comprise an increased oxygen level in the blood of a subject who has taken a composition herein as compared to a comparable subject who has not received the composition. In some cases, the oxygen level of a subject can increase by at least about: 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, or 10% after administration of a composition herein and exercising for at least about 10 min, 20 min, 30 min, 40 min, 50 min, 60 min, 2 hours, 3 hours, or 4 hours as compared to a comparable subject who did not receive the composition. In some cases, enhanced exercise performance can compriseAttorney Docket No. 199237-707601 a decreased respiratory rate of a subject who has taken a composition herein as compared to a comparable subject who has not received the composition. In some cases, the respiratory rate of subject can decrease by at least about: 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 15%, or 20% after administration of a composition herein and exercising for at least about 10 min, 20 min, 30 min, 40 min, 50 min, 60 min, 2 hours, 3 hours, or 4 hours as compared to a comparable subject who did not receive the composition. In some cases, enhanced exercise performance can comprise an increased number of repetitions during a weightlifting session of a subject who has taken a composition herein as compared to a comparable subject who has not received the composition and is doing a comparable exercise (e.g., lifting with the same amount of weight). In some cases, the number of repetitions of lifting a weight can increase by at least about: 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 15%, or 20% after administration of a composition herein as compared to a comparable subject who did not receive the composition. In some cases, the number of repetitions of lifting a weight can increase by at least about: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 after administration of a composition herein as compared to a comparable subject who did not receive the composition.

[0089] In some embodiments, an additional therapy (e.g., a second therapy) can be administered to a subject in a unit dose. In some cases, 1, 2, 3, 4, 5 or more therapies can be administered to a subject in need thereof. In some cases, the additional therapy can be administered consecutively or concurrently to a first therapy.

[0090] In some embodiments, a therapy can be administered to a subject in a unit dose. A unit dose that can be administered to a patient may comprise from about 0.0001 g (gram) - 500 g, 0.001 g - 250 g, 0.01 g - 100 g, 0.1 g - 50 g, 10 g - 25 g, 0.1 g - 5 g, 0.1 g - 1 g, or 1 g - 10 g of a composition of the current disclosure. In some embodiments, a composition comprises an amount of at least about, or equal to about: 0.0001 g, 0.001 g, 0.01 g, 0.1 g, 0.5 g, 1 g, 2 g, 3 g, 4 g, 5 g, 6 g, 7 g, 8 g, 9 g, 10 g, 11 g, 12 g, 13 g, 14 g, 15 g, 16 g, 17 g, 18 g, 19 g, 20 g, 21 g, 22 g, 23 g, 24 g, 25 g, 26 g, 27 g, 28 g, 29 g, 30 g, 31 g, 32 g, 33 g,34 g, 35 g, 36 g, 37 g, 38 g, 39 g, 40 g, 41 g, 42 g, 43 g, 44 g, 45 g, 46 g, 47 g, 48 g, 49 g, 50 g, 51 g, 52 g,53 g, 54 g, 55 g, 56 g, 57 g, 58 g, 59 g, 60 g, 61 g, 62 g, 63 g, 64 g, 65 g, 66 g, 67 g, 68 g, 69 g, 70 g, 71 g,72 g, 73 g, 74 g, 75 g, 76 g, 77 g, 78 g, 79 g, 80 g, 81 g, 82 g, 83 g, 84 g, 85 g, 86 g, 87 g, 88 g, 89 g, 90 g,91 g, 92 g, 93 g, 94 g, 95 g, 96 g, 97 g, 98 g, 99 g, 100 g, 125 g, 150 g, 175 g, 200 g, 250 g, 300 g, 350 g, 400 g, 450 g, 500 g, or more of an active ingredient of the current disclosure. In some embodiments, a treatment herein can comprise from 0.001 g - 2 g of an active ingredient of the current disclosure in a single dose. In some embodiments, an additional therapy can be an amount from about 0.1 g - 500 g of a therapeutic composition, a compound, or a salt thereof of the current disclosure. In some embodiments, an additional therapy comprises an amount between about 1 g - 15 g of an active ingredient of the current disclosure of the current disclosure. In some embodiments, an additional therapy can be an amount from about 0.1 g - 5 g of a therapeutic composition, a compound, or a salt thereof of the current disclosure.AdministrationAttorney Docket No. 199237-707601

[0091] A composition disclosed herein can be administered by any method. In some embodiments, a composition or an additional therapeutic can be administered orally, for example, in the form of a liquid, a tablet, a gummy, a pill, or a capsule. In some cases, a composition can be delivered by parenchymal injection, intra-thecal injection, intra-ventricular injection, intra-tumoral injection, intra-cistemal injection, or any combination thereof. In some cases, a method of administration can be by inhalation, intraarterial injection, intracerebroventricular injection, intracistemal injection, intramuscular injection, intraorbital injection, intraparenchymal injection, intraperitoneal injection, intraspinal injection, intrathecal injection, intravenous injection, intraventricular injection, stereotactic injection, subcutaneous injection, or any combination thereof. In some cases, delivery can comprise buccal administration, by infusion administration, nasal administration, otic administration, ophthalmic administration, sublingual administration, or transdermal administration. Delivery can include parenteral administration (including intravenous, subcutaneous, intrathecal, intraperitoneal, intramuscular, intravascular or infusion), oral administration, nasal administration, inhalation administration, anal administration, intraduodenal administration, rectal administration. In some cases, delivery can include delivery of a composition by a surgery, or by an injection. Delivery can include topical administration to an external surface of a surface, such as a skin. In some cases, a composition disclosed herein can be administered consecutively or concurrently to an additional composition and / or therapy.

[0092] In some instances, a composition may be in the form of a capsule, a tablet, a gummy, an oil, a syrup, a liquid, a tincture, a lotion, a cream, a balm, a food, a beverage, an oil, a suppository, a liquid for injection (which can be, for example, an intra venous liquid, an intra muscular liquid, a subcutaneous liquid), or any combination thereof. In some cases, the composition herein is in the form of a gummy.

[0093] In some embodiments, administering of a composition can be performed at least about: 1 time per day, 2 times per day, 3 times per day, 4 times per day, 5 times per day, 6 times per day, 7 times per day, or more than 7 times per day. In some cases, administering can be performed daily, weekly, monthly, or as needed. In some cases, administration can be performed at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 times a week. In some cases, administration can be performed at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, or 90 times a month.

[0094] Administration of a composition disclosed herein can be performed for a duration of at least about: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31,32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59,60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87,88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 150, 200, 250, 300, 350, 400, 450, 500, 550, 600, 650,700, 750, 800, 850, 900, 950 or 1000 days consecutive or nonconsecutive days. In some cases,Attorney Docket No. 199237-707601 administration of a composition disclosed herein can be performed as needed. In some cases, administration of a composition disclosed herein can be performed as needed, for example prior to when a subject is going to exercise. In some cases, a treatment duration can be from about: 1 to about 30 days, 1 to about 60 days, 1 to about 90 days, 30 days to about 90 days, 60 days to about 90 days, 30 days to about 180 days, from 90 days to about 180 days, or from 180 days to about 360 days. In some embodiments, administration herein can comprise administering the composition to a subject prior to a subject exercising. In some cases, administration of a composition herein can occur less than, more than, or equal to about: 1 minute (min), 2 min, 3 min, 4 min, 5 min, 6 min, 7 min, 8 min, 9 min, 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, or 6 hours prior to exercising. In some cases, administration of a composition herein can occur about: 1 min to about 12 hours, 1 min to about 2 hours, 1 min to about 1 hour, 1 min to about 30 min, 10 min to about 20 min, 5 min to about 15 min, 30 min to about 50 min, 20 min to about 40 min, 30 min to 1.5 hours, or 1 hour to about 3 hours prior to exercising.

[0095] In some cases, the composition may be administered as needed. In some embodiments, administration of a composition disclosed herein can be performed for a treatment duration of at least about 1 week, at least about 2 weeks, at least about 3 weeks, at least about 4 weeks, at least about 1 month, at least about 2 months, at least about 3 months, at least about 4 months, at least about 5 months, at least about 6 months, at least about 7 months, at least about 8 months, at least about 9 months, at least about 10 months, at least about 11 months, at least about 12 months, at least about 1 year, at least about 2 years, at least about 3 years, at least about 4 years, at least about 5 years, at least about 6 years, at least about 7 years, at least about 8 years, at least about 9 years, at least about 10 years, at least about 15 years, at least about 20 years, or for life. In some cases, administration can be performed repeatedly over a lifetime of a subject, such as once a month, once a week, or once a year for the lifetime of a subject. Administration can be performed repeatedly over a substantial portion of a subject’s life, such as once a month, once a week, or once a year for at least about 1 year, 5 years, 10 years, 15 years, 20 years, 25 years, 30 years, or more.

[0096] In some embodiments, a method of enhancing physical performance in a human, the method comprising: administering to the human, prior to physical exertion, an effective amount of a chewable or gummy composition, the composition comprising: a purple tea extract and a vasodilator present at an amount to enhance physical performance; and a plurality of inactive ingredients that provide for a chewable matrix; wherein enhance physical performance is characterized by at least one measurable parameter selected from the group consisting of: (a) an increase in heart rate of at least 20% above resting baseline, (b) an increase in respiratory exchange ratio (RER) of at least 0.9, (c) an decrease in perceived exertion rating on the Borg scale, (d) an increase in peak oxygen uptake (VO2 max) of at least 20% above resting baseline, or (e) an increase in lactate threshold of at least 20% above resting baseline.

[0097] In some embodiments, a method of enhancing physical performance in a human, the method comprising: administering to the human, prior to physical exertion, an effective amount of a chewable or gummy composition, the composition comprising: a lion’s mane and a vasodilator present at an amount toAttorney Docket No. 199237-707601 enhance physical performance; and a plurality of inactive ingredients that provide for a chewable matrix; wherein enhance physical performance is characterized by at least one measurable parameter selected from the group consisting of: (a) an increase in heart rate of at least 20% above resting baseline, (b) an increase in respiratory exchange ratio (RER) of at least 0.9, (c) an decrease in perceived exertion rating on the Borg scale, (d) an increase in peak oxygen uptake (VO2 max) of at least 20% above resting baseline, or (e) an increase in lactate threshold of at least 20% above resting baseline.Kits

[0098] In some embodiments, compositions and / or system components are assembled in a kit. In some embodiments, kits described herein are compatible with administration of the compositions described herein. In some embodiments, kits are compatible with methods for enhancing physical performance in a human.

[0099] In some embodiments, kits are compatible with methods of identifying the enhancing of physical performance in a human after the administration of a composition as described herein. Any of the kits described herein are compatible with any of the compositions, systems, kits, or methods disclosed herein. In some embodiments, kits are compatible with methods as disclosed herein, wherein a kit further comprises a detectable label or a nucleic acid encoding a detectable label. In some embodiments, the components of the kit are in same compriseer. In some embodiments, the components of the kit are in separate compriseers.

[0100] In some embodiments, a kit for performing a method as described herein, the kit comprising a structural component as well as a composition component. In some embodiments, kit components comprise structural components as well as sample components, including compositions and systems described herein. In some embodiments, kits comprise one or more containers compatible for containing the samples, compositions, and systems described herein. In some embodiments, components of the samples, compositions, and systems are contained in the same container or in separate containers. In some embodiments, a container is a bottles, chambers, channels, vials, bag or blister pack. In some embodiment, the containers are formed from a variety of materials such as glass, plastic, or polymers. The system or systems described herein comprise packaging materials. Examples of packaging materials comprise, but are not limited to, pouches, blister packs, bottles, tubes, bags, containers, bottles, and any packaging material suitable for intended mode of use.

[0101] In some embodiments, a kit comprises components, compositions, systems, and / or reagents for performing any methods disclosed herein.

[0102] In some embodiments, the kit comprises labels and / or instructions for performing a method as described herein. In some embodiments, the kit comprises labels and / or instructions for use. In some embodiments, labeling and / or instructions comprise, for example, information concerning the amount, frequency and method of introduction and / or administration of the compositions, systems, and / or nucleic acid constructs described herein. In some embodiments, a label is on a container when letters, numbers orAttorney Docket No. 199237-707601 other characters forming the label are attached, molded, or etched into the container itself; a label is associated with a container when it is present within a receptacle or carrier that also holds the container, e.g., as a package insert. In one embodiment, a label is used to indicate that the contents are to be used for a specific therapeutic application. The label also indicates directions for use of the contents, such as in the methods described herein. After packaging the formed product and wrapping or boxing to maintain a sterile barrier, in some embodiments, the product is terminally sterilized by heat sterilization, gas sterilization, gamma irradiation, or by electron beam sterilization. Alternatively, in some embodiments, the product is prepared and packaged by aseptic processing.

[0103] In some embodiments, the instructions for practicing the methods are recorded on a suitable recording medium. In some embodiments, the instructions are printed on a substrate, such as paper or plastic, etc. In some embodiments, the instructions are present in the kits as a package insert, in the labeling of the container of the kit or components thereof (i.e., associated with the packaging or subpackaging) etc. In some embodiments, the instructions are present as an electronic storage data file present on a suitable computer readable storage medium, e.g., CD-ROM, diskette, flash drive, etc. In some embodiments, the actual instructions are not present in the kit, but means for obtaining the instructions from a remote source (e.g. via the Internet), are provided. In some embodiments, the kit comprises a web address where the instructions are viewed and / or from which the instructions are downloaded.

[0104] In some embodiments, the compositions described herein can be in a kit. In some cases, a kit can comprise a container. In some cases, the container can be a glass container, a metal container, a plastic container, a wood container, or any combination thereof. In some cases, a kit can comprise a formulation in the form of a gummy comprising one or more of the following ingredients: a glucose, an allulose, a fiber, a pectin, a sugar, a water, a malate salt, a citric acid or a salt thereof, a flavoring agent, a coloring agent, a bitter blocker agent, a vitamin or a salt thereof, an L-theanine or a salt thereof, a stimulant or a salt thereof, a valyl-prolyl-proline (VPP) peptide or a salt thereof, an iosoleucyl- prolyl-proline (IPP) peptide or a salt thereof, and a phenylethylamine or a salt thereof and a container.ExamplesExample 1: Pre-Workout Non-Stimulant Formula Production1. SUBJECT:1.1. Provided in this example is a standard protocol for pre-workout non-stimulant gummy production.2. OBJECTIVE:2.1. The objective of this example is to establish a protocol that describes the process of making pre-workout non-stimulant gummies.Attorney Docket No. 199237-7076013. EQUIPMENT:The equipment for this protocol comprises:3.1. Scale for kilograms3.2. Scale for grams3.3. Buckets3.4. Small containers3.5. Hand drill with agitator3.6. Heavy-duty hand mixer3.7. Brix refractometer3.8. Electrical single burner4. PROCEDURE:4.1. NOTE: Mix tanks are fully heated (Tank #1 125 degrees; Tank #2 128 degrees: and Tank #3 95 degrees)4.2. The ingredients are weighed (80 kg batch. Refer to formula)4.2.1. In a bucket 9.7 kg of water is weighed.4.2.2. In a bucket 7.2 kg of sugar and 1.6 kg of pectin is weighed. The two dry ingredients thoroughly are thoroughly mixed using the hand drill with the agitator.4.2.3. In a bucket 30.4 kg of glucose is weighed.4.2.4. In a bucket 17.6 kg of Allulose Syrup is weighed.4.2.5. In a bucket 5.2 kg of Com Fiber and 4 kg of water is weighed. The two ingredients are mixed thoroughly until com fiber is fully dissolved.4.2.6. In a small container 280 Grams of pecmate and 1.2 kg of water are weighed. The two ingredients are mixed thoroughly.4.2.7. In a small container 240 Grams of Mango flavor (MA-13313) is weighed.4.2.8. In a small container 160 grams of Sunset orange color is weighed.4.2.9. In a pot 640 Grams of water and 640 Grams of Citric Acid are weighed. The two ingredients are mixed and stirred overheat until the citric acid is dissolved and the liquid is clear.Attorney Docket No. 199237-7076014.2.10. The active ingredients are weighed and put in a bucket except the VasoDrive which is weighed separately. (Refer To Formula)5. MIXING THE BATCH5.1. The water is poured into Tank #1. It is heated for at least 20 minutes.5.2. The glucose is poured into Tank #2, and the mixer is turned on for tank #2. The allulose and corn fiber mix is slowly pour in tank #2 with the mixer running.5.3. Once water is near boiling in tank #1, slowly add sugar / pectin mix, using agitator on drill to disperse and dissolved mixture in water.5.4. The mixer for Tank #1 is turned on and the lid is closed for about 30 min or until the solution reaches 180 degrees.5.5. Once Tank #1 and Tank #2 are fully dissolved and mixed, the contents of Tank #1 are transferred to Tank #2. The mixer is to remain running in Tank #2 for about 10 minutes.5.6. The flavor, color, and pecmate mixture is added.5.7. All active ingredients except VasoDrive are mixed until they reach 176-178 degrees Brix.5.8. A Brix Refractometer is used to test the degrees brix (a small sample of the mixture from Tank #2 is added to the meter).5.9. Once the solution reaches the 176 degrees brix, the VasoDrive is added and mixed for about 5 minutes.5.10. After mixture is fully mixed, the mixture of Tank #2 is transferred to Tank #3. The mixer for Tank #3 is turned on.5.11. The mixer for Tank #3 is turned off and the Citric Acid solution is slowly added into Tank #3 using the Heavy-duty mixer to disperse the solution into the mixture. The mixer for Tank #3 is turned back on.5.12. The mixture from Tank #3 is transferred to the hopper of the gummy machine to begin depositing the mixture in the molds.Example 2: Pre-Workout Gummy Formula Production Protocol1. SUBJECT:1.1. Provided in this example is a standard operation procedure for pre-workout gummy production.Attorney Docket No. 199237-7076012. OBJECTIVE:2.1. The objective of this example is to provide an example that describes the process of making Pre-workout Gummies.3. EQUIPMENT:The equipment for this protocol comprises:3.1. Scale for kilograms3.2. Scale for grams3.3. Buckets3.4. Small containers3.5. Hand drill with agitator3.6. Heavy-duty hand mixer3.7. Brix refractometer3.8. Electrical single burner4. PROCEDURE:4.1. The Mix tanks are fully heated (Tank #1 125 degrees; Tank #2 128 degrees: and Tank #3 95 degrees)4.2. The ingredients are weighed (80 kg batch. Refer to formula)4.2.1. In a bucket 9.7 kg of water is weighed.4.2.2. In a bucket 7.2 kg of sugar and 1.6 kg of pectin is weighed. The two dry ingredients thoroughly are thoroughly mixed using the hand drill with the agitator.4.2.3. In a bucket 30.4 kg of glucose is weighed.4.2.4. In a bucket 17.6 kg of Allulose Syrup is weighed.4.2.5. In a bucket 5.2 kg of Com Fiber and 4 kg of water is weighed. The two ingredients are mixed thoroughly until com fiber is fully dissolved.4.2.6. In a small container 280 Grams of pecmate and 1.2 kg of water are weighed. The two ingredients are mixed thoroughly.4.2.7. In a small container 240 Grams of berry Blast flavor (BE-20945) is weighed.Attorney Docket No. 199237-7076014.2.8. In a small container 160 grams of red color is weighed.4.2.9. In small container 40 Grams of Blocker BB-020 is weighed.4.2.10. In small container 12.8 Grams of Blocker BB-001 is weighed.4.2.11. In a small container 11.2 Grams of Blocker SWE-089 is weighed.4.2.12. In a pot 640 Grams of water and 640 Grams of Citric Acid are weighed. The two ingredients are mixed and stirred overheat until the citric acid is dissolved and the liquid is clear.4.2.13. The active ingredients are weighed and put in a bucket except the VasoDrive which is weighed separately. (Refer To Formula)5. MIXING THE BATCH5.1. The water is poured into Tank #1. It is heated for at least 20 minutes.5.2. The glucose is poured into Tank #2, and the mixer is turned on for tank #2. The allulose and corn fiber mix is slowly pour in tank #2 with the mixer running.5.3. Once water is near boiling in tank #1, slowly add sugar / pectin mix, using agitator on drill to disperse and dissolved mixture in water.5.4. The mixer for Tank #1 is turned on and the lid is closed for about 30 min or until the solution reaches 180 degrees.5.5. Once Tank #1 and Tank #2 are fully dissolved and mixed, the contents of Tank #1 are transferred to Tank #2. The mixer is to remain running in Tank #2 for about 10 minutes.5.6. The flavor, color, blockers and pecmate mixture is added.5.7. All active ingredients except VasoDrive are mixed until they reach 176-178 degrees Brix.5.8. A Brix Refractometer is used to test the degrees brix (a small sample of the mixture from Tank #2 is added to the meter).5.9. Once the solution reaches the 176 degrees brix, the VasoDrive is added and mixed for about 5 minutes.5.10. After mixture is fully mixed, the mixture of Tank #2 is transferred to Tank #3. The mixer for Tank #3 is turned on.5.11. The mixer for Tank #3 is turned off and the Citric Acid solution is slowly added into Tank #3 using the Heavy-duty mixer to disperse the solution into the mixture. The mixer for Tank #3 is turned back on.Attorney Docket No. 199237-7076015.12. The mixture from Tank #3 is transferred to the hopper of the gummy machine to begin depositing the mixture in the molds.Example 3: Pre-Workout Gummy Formula Sugar Reduced (80 kg Strawberry)

[0105] Provided below is a formula used to produce reduced sugar gummies:• water - 9.7 kg mix:• sugar - 7.2 kg• pectin (4420) - 1.6 kg• glucose - 30.4 kg• allulose syrup - 17.6 kg• com fiber (fiber smart) - 5.2 kg• water - 4kg (to dilute the fiber)• pecmate: water - 1.2kg• pecmate - 280grams• flavor - berry blast (be-20945) - 240 grams• color - red - 160 gram• citric acid: water - 640 grams• citric acid - 640 grams• blockers: bb-020 - 40 grams• bb-001 - 12.8 grams• swe-089 - 11.2 grams• active ingredients: purple force: 680 grams• vitamin b 12: 8 grams• 1- theanine: 800 g• coated caffeine - 240 grams• pea - 320 grams• vasodrive: 825.5 gExample 4: Pre-Workout Non- Stimulant Gummy Formula Sugar Reduced (80 KG, Mango)

[0106] Provided below is a formula used to produce non stimulant gummies:• Water - 9.7 kg• Mix:• Sugar - 7.2 kg• Pectin (4420) - 1.6 kg• Glucose - 30.4 kgAttorney Docket No. 199237-707601• Allulose syrup - 17.6 kg• Com fiber (fiber smart) - 5.2 kg• Water - 4kg (to dilute the fiber)• Pecmate: water - 1.2 kg• Pecmate - 280 gram• Flavor - mango(ma-13313) - 240 grams• Color - sunset orange - 160 gram• Citric acid: water - 640 grams• Citric acid - 640 grams• Active ingredients: cognizin: 1.7 kg• B12: 12.8 grams• L-theanine: 650 g• Vasodrive: 825.5 g• Lion’s mane: 1.3 kg• Cordyceps: 1.3 kgExample 5: Label of Stimulant Gummies

[0107] Stimulant pre-workout gummies were produced. The label of the stimulant pre-workout gummies is show in FIG. 1. The active ingredients comprise VasoDrive-AP® at a dose of 128 mg, PurpleForce® at a dose of 100 mg, caffeine (anhydrous) at a dose of 40 mg, vitamin B12 (cyanocobalamin) at a dose of 2 mg, L-theanine at a dose of 100 mg, and Beta-phenylethylamine at a dose of 50 mg.Example 6: Label of Non-Stimulant Gummies

[0108] Non-stimulant pre-workout gummies were produced. The label of the non-stimulant pre-workout gummies is show in FIG. 2. The active ingredients comprise VasoDrive-AP® at a dose of 128 mg, Cognizin® Citicoline at a dose of 250 mg, vitamin B12 (cyanocobalamin) at a dose of 2 mg, L-theanine at a dose of 100 mg, Lyon’s mane mushroom extract at a dose of 200 mg, and Cordyceps extract at a dose of 200 mg.Example 7 - Pre-Workout Stimulant Gummy Preparation

[0109] In the present example, a composition of a carbohydrate mixture including an aqueous component (e.g., water) and one or more active ingredients was prepared. The composition was prepared in three temperature-controlled tanks: Tank #1 is heated at 125 °C, Tank #2 is heated at 128 °C, and Tank #3 is heated at 95 °C, as depicted in at least FIG. 3.

[0110] Approximately 9.7 kg of water were poured into Tank #1 and heated to near boiling for at least 20 minutes. A dry mix of 7.2 kg of sugar and 1.6 kg of pectin was slowly added to the water, and a hand drillAttorney Docket No. 199237-707601 with agitator was used to disperse and dissolve the dry mixture in the water. The mixer for Tank # 1 was turned on and the lid was closed for about 30 min or until the solution reached 180 °C.[oni] In parallel, 30.4 kg of glucose (e.g., com syrup)] was poured into Tank #2. After the mixer for Tank #2 was tuned on, a mix of 17.6 kg of allulose and 5.2 kg of com fiber fully dissolved in 4 kg of water was slowly poured into Tank #2.

[0112] Once the mixture in Tank # 1 and the mixture in Tank #2 were homogeneous, the mixture in Tank #1 was poured into Tank #2 and mixed for about 10 minutes.

[0113] In parallel, 280 g of pecmate was fully dissolved in 1.2 kg of water, and mixed with 240 g of flavor (e.g., Berry Blast (BE-20945)), 160 g of coloring (e.g., Red color), 40 g of Blocker BB-020, 12.8 g of Blocker BB-001, and 11.2 g of Blocker SWE-089. The mixture was then added to Tank #2. Shortly afterwards, a mixture of all active ingredients, as detailed in TABLE 1, except the vasodilator (e.g., milk- derived tripeptide), was added to Tank #2, and mixed until reaching about 176-178 degrees Brix, as measured with a Brix refractometer. Shortly afterwards, approximately 825.5 g of vasodilator was added and mixed for about 5 minutes. Once the mixture in Tank #2 was homogeneous, it was transferred to Tank #3 and mixed. After the mixer for Tank #3 was turned off, a citric acid solution prepared with about 640 g citric acid and 640 g water was slowly added into Tank #3 and mixed using a heavy-duty hand mixer. The mixer for Tank #3 was turned back on until the total mixture, 80 kg, was homogeneous. The homogeneous mixture in Tank #3 was then transferred to the hopper of gummy machine to begin depositing the mixture into gummy molds, as depicted in FIG. 4.

[0114] Composition active components are shown in TABLE 1 below.TABLE 1:Example 8 - Pre-Workout Non-Stimulant Gummy Preparation

[0115] In the present example, a composition of a carbohydrate mixture including an aqueous component (e.g., water) and one or more active ingredients was prepared. The composition was prepared in threeAttorney Docket No. 199237-707601 temperature-controlled tanks: Tank #1 is heated at 125 °C, Tank #2 is heated at 128 °C, and Tank #3 is heated at 95 °C, as depicted in at least FIG. 3.

[0116] Approximately 9.7 kg of water were poured into Tank #1 and heated to near boiling for at least 20 minutes. A dry mix of 7.2 kg of sugar and 1.6 kg of pectin was slowly added to the water, and a hand drill with agitator was used to disperse and dissolve the dry mixture in the water. The mixer for Tank # 1 was turned on and the lid was closed for about 30 min or until the solution reached 180 °C.

[0117] In parallel, 30.4 kg of glucose (e.g., com syrup) was poured into Tank #2. After the mixer for Tank #2 was tuned on, a mix of 17.6 kg of allulose and 5.2 kg of com fiber fully dissolved in 4 kg of water was slowly poured into Tank #2.

[0118] Once the mixture in Tank # 1 and the mixture in Tank #2 were homogeneous, the mixture in Tank #1 was poured into Tank #2 and mixed for about 10 minutes.

[0119] In parallel, 280 g of pecmate was fully dissolved in 1.2 kg of water, and mixed with 240 g of flavor (e.g., Mango flavor (MA-13313)) and 160 g of coloring (e.g., Sunset orange color). The mixture was then added to Tank #2. Shortly afterwards, a mixture of all active ingredients, as detailed in TABLE 2, except the vasodilator (e.g., milk-derived tripeptide), was added to Tank #2, and mixed until reaching about 176- 178 degrees Brix, as measured with a Brix refractometer. Shortly afterwards, approximately 825.5 g of vasodilator was added and mixed for about 5 minutes. Once the mixture in Tank #2 was homogeneous, it was transferred to Tank #3 and mixed. After the mixer for Tank #3 was turned off, a citric acid solution prepared with about 640 g citric acid and 640 g water was slowly added into Tank #3 and mixed using a heavy-duty hand mixer. The mixer for Tank #3 was turned back on until the total mixture, 80 kg, was homogeneous. The homogeneous mixture in Tank #3 was then transferred to the hopper of gummy machine to begin depositing the mixture into gummy molds, as depicted in FIG. 4.

[0120] Composition active components are shown in TABLE 2 below.TABLE 2:Attorney Docket No. 199237-707601Example 9 - Pre-Workout Stimulant Gummy Preparation

[0121] In the present example, a composition of a carbohydrate mixture including an aqueous component (e.g., water) and one or more active ingredients was prepared. The composition was prepared in three temperature-controlled tanks: Tank #1 is heated at 125 °C, Tank #2 is heated at 128 °C, and Tank #3 is heated at 95 °C, as depicted in at least FIG. 3.

[0122] Approximately 13.5 kg of water were poured into Tank # 1 and heated to near boiling for at least 20 minutes. A dry mix of 32 kg of sugar and 1.92 kg of pectin was slowly added to the water, and a hand drill with agitator was used to disperse and dissolve the dry mixture in the water. The mixer for Tank # 1 was turned on and the lid was closed for about 30 min or until the solution reached 180 °C.

[0123] In parallel, 31.5 kg of glucose (e.g., com syrup) was poured into Tank #2. Once the mixture in Tank # 1 and the mixture in Tank #2 were homogeneous, the mixture in Tank # 1 was poured into Tank #2 and mixed for about 10 minutes.

[0124] In parallel, 280 g of pecmate was fully dissolved in 1.2 kg of water, and mixed with 240 g of flavor (e.g., Berry Blast (BE-20945)), 160 g of coloring (e.g., vegetable juice red (1003)), and three blockers (40 g of Blocker BB-020, 12.8 g of Blocker BB-001, and 11.2 g of Blocker SWE-089) fully dissolved in 64 g of water. The mixture was then added to Tank #2. Shortly afterwards, a mixture of all active ingredients, as detailed in TABLE 3, except the vasodilator (e.g., milk-derived tripeptide), was added to Tank #2, and mixed until reaching about 176-178 degrees Brix, as measured with a Brix refractometer. Shortly afterwards, approximately 825.5 g of vasodilator was added and mixed for about 5 minutes. Once the mixture in Tank #2 was homogeneous, it was transferred to Tank #3 and mixed. After the mixer for Tank #3 was turned off, a citric acid solution prepared with about 640 g - 1.04 kg citric acid and 640 g - 1.04 kg water was slowly added into Tank #3 and mixed using a heavy-duty hand mixer. The mixer for Tank #3 was turned back on until the total mixture, 90 kg, was homogeneous. The homogeneous mixture in Tank #3 was then transferred to the hopper of gummy machine to begin depositing the mixture into gummy molds, as depicted in FIG. 4.

[0125] Composition active components are shown in TABLE 3 below.TABLE 3:Attorney Docket No. 199237-707601Example 10 - Pre-Workout Non-Stimulant Gummy Preparation

[0126] In the present example, a composition of a carbohydrate mixture including an aqueous component (e.g., water) and one or more active ingredients was prepared. The composition was prepared in three temperature-controlled tanks: Tank #1 is heated at 125 °C, Tank #2 is heated at 128 °C, and Tank #3 is heated at 95 °C, as depicted in at least FIG. 3.

[0127] Approximately 13.5 kg of water were poured into Tank # 1 and heated to near boiling for at least 20 minutes. A dry mix of 32 kg of sugar and 1.92 kg of pectin was slowly added to the water, and a hand drill with agitator was used to disperse and dissolve the dry mixture in the water. The mixer for Tank # 1 was turned on and the lid was closed for about 30 min or until the solution reached 180 °C.

[0128] In parallel, 31.5 kg of glucose (e.g., com syrup) was poured into Tank #2. Once the mixture in Tank # 1 and the mixture in Tank #2 were homogeneous, the mixture in Tank # 1 was poured into Tank #2 and mixed for about 10 minutes.

[0129] In parallel, 280 g of pecmate was fully dissolved in 1.2 kg of water, and mixed with 240 g of flavor (e.g., Mango flavor (MA-13313)) and 160 g of coloring (e.g., B carotene). The mixture was then added to Tank #2. Shortly afterwards, a mixture of all active ingredients, as detailed in TABLE 4, except the vasodilator (e.g., milk-derived tripeptide), was added to Tank #2, and mixed until reaching about 176-178 degrees Brix, as measured with a Brix refractometer. Shortly afterwards, approximately 825.5 g of vasodilator was added and mixed for about 5 minutes. Once the mixture in Tank #2 was homogeneous, it was transferred to Tank #3 and mixed. After the mixer for Tank #3 was turned off, a citric acid solution prepared with about 640 g - 1.04 kg citric acid and 640 g - 1.04 kg water was slowly added into Tank #3 and mixed using a heavy-duty hand mixer. The mixer for Tank #3 was turned back on until the total mixture, 80 kg, was homogeneous. The homogeneous mixture in Tank #3 was then transferred to the hopper of gummy machine to begin depositing the mixture into gummy molds, as depicted in FIG. 4.

[0130] Composition active components are shown in TABLE 4 below.TABLE 4:Attorney Docket No. 199237-707601

[0131] While preferred embodiments of the present disclosure have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the disclosure. It should be understood that various alternatives to the embodiments of the disclosure described herein may be employed in practicing the disclosure. It is intended that the following claims define the scope of the disclosure and that methods and structures within the scope of these claims and their equivalents be covered thereby.

Claims

Attorney Docket No. 199237-707601CLAIMSWHAT IS CLAIMED IS:

1. A semi-solid composition for consumption before physical exertion to enhance physical performance, the semi-solid composition comprising: a purple tea extract and a vasodilator present at an amount to enhance physical performance; and a plurality of inactive ingredients that provide for formation of a semi-solid matrix.

2. The composition of claim 1, wherein the semi-solid composition is in the form of a gummy.

3. The composition of claim 1, wherein the semi-solid composition comprises: the purple tea extract in a concentration of about 1 wt% and the vasodilator in a concentration of about 1 wt%.

4. The composition of claim 1, wherein the semi-solid composition comprises: a plurality of active ingredients in a total concentration of about 1 wt% to about 5 wt%, the plurality of active ingredients comprising the purple tea extract in a concentration of about 1 wt% and the vasodilator in a concentration of about 1 wt%; and a plurality of inactive ingredients in a total concentration of about 95 wt% to about 99 wt%, wherein the plurality of inactive ingredients that provide for formation of a semi-solid matrix.

5. The composition of claim 1, wherein the semi-solid composition comprises: the purple tea extract in a concentration of about 1 wt%; the vasodilator in a concentration of about 1 wt%; a vitamin in a concentration of about 1 wt%; a L-theanine in a concentration of about 1 wt%; a stimulant in a concentration of about 1 wt%; an amino acid in a concentration of about 1 wt%; and the plurality of inactive ingredients that provide for formation of a semi-solid matrix.

6. The composition of claim 1, wherein the semi-solid composition comprises: the purple tea extract in a concentration of about 1 wt%; the vasodilator in a concentration of about 1 wt%; a vitamin in a concentration of about 1 wt%; a L-theanine in a concentration of about 1 wt%; a stimulant in a concentration of about 1 wt%; an amino acid in a concentration of about 1 wt%; and the plurality of inactive ingredients comprising water, sugar, pectin, glucose, pecmate, flavor, coloring, and citric acid.

7. The composition of claim 1, wherein the plurality of inactive ingredients further comprises bitter blocker, allulose, fiber and / or com fiber.

8. The composition of claim 1, wherein the vasodilator is selected from a group consisting of an angiotensin-converting enzyme (ACE) inhibitor, a milk-derived tripeptide, a casein-derivedAttorney Docket No. 199237-707601 tripeptide, an Ile-Pro-Pro (IPP), a Val-Pro-Pro (VPP), an L-arginine, a L-citrulline, a beetroot extract, a hawthorn extract, a Ginkgo biloba extract, a cocoa flavanol, a garlic extract, a niacin, a magnesium, potassium, a theobromine, a resveratrol, a quercetin, a curcumin, a alpha-lipoic acid, an acetylcholine, a histamine, a prostacyclin, or combinations thereof.

9. The composition of claim 5, wherein the vasodilator is a milk-derived tripeptide.

10. The composition of claim 5, wherein the vitamin is vitamin B-12 or cyanocobalamin.

11. The composition of claim 5, wherein the stimulant is caffeine or coated caffeine.

12. The composition of claim 5, wherein the amino acid is Beta-phenylamine (PEA).

13. The composition of claim 1, wherein purple tea extract comprises antioxidants.

14. The composition of claim 5, wherein L-theanine is derived from green tea extract.

15. The composition of claim 1, wherein the plurality of inactive ingredients that provide for formation of a semi-solid matrix comprises a carbohydrate mixture and an aqueous component, the carbohydrate mixture comprising at least two of a sweetener, a non-reducing sugar, a food additive, or a fiber.

16. The composition of claim 1, wherein the plurality of inactive ingredients comprises the sweetener in a concentration of about 1 wt% to about 9 wt%.

17. The composition of claim 1, wherein the plurality of inactive ingredients comprises the nonreducing sugar in a concentration of about 1 wt% to about 22 wt%.

18. The composition of claim 1, wherein the plurality of inactive ingredients comprises the food additive in a concentration of about 1 wt%.

19. The composition of claim 1, wherein the plurality of inactive ingredients comprises the fiber in a concentration of about 1 wt% to about 8 wt%.

20. The composition of claim 15, wherein the sweetener is selected from the group consisting of a sucrose, a sugar, a pure cane granulated sugar, a glucose, a com syrup, a fructose, an isomalt, a high fructose com symp, a tapioca symp, an agave symp, a honey, a maltose symp, a sucralose, an aspartame, a steviol glycosides, an acesulfame potassium, an erythritol, a xylitol, a mannitol, an isomalt, and a combination thereof.

21. The composition of claim 15, wherein the non-reducing sugar is selected from the group consisting of an allulose, a trehalose, a sucrose, a raffinose, a stachyose, a verbascose, a gentianose, and a combination thereof.

22. The composition of claim 15, wherein the food additive is a preservative, a flavor enhancer, a texture modifier, a gel strengthener.

23. The composition of claim 15, wherein the food additive is citric acid.

24. The composition of claim 15, wherein the fiber is selected from the group consisting of a com fiber, an acacia fiber, a psyllium husk, an inulin, a fructooligosaccharides (FOS), a chicory root fiber, a tapioca fiber, and a combination thereof.Attorney Docket No. 199237-70760125. The composition of claim 1, wherein the plurality of inactive ingredients comprises the aqueous component in a concentration of about 1 wt% to about 25 wt %.

26. The composition of claim 25, wherein the aqueous component is water.

27. The composition of claim 1, wherein the plurality of inactive ingredients further comprises at least one of a hydrocolloid gelling ingredient and / or a gelling agent.

28. The composition of claim 27, wherein the hydrocolloid gelling ingredient is selected from the group consisting of a pectin, an alginate, a carrageenan, a gellan, a gelatin, an agar, a modified starch, a methyl cellulose, a hydroxypropylmethyl cellulose, and a combination thereof.

29. The composition of claim 27, wherein the hydrocolloid gelling ingredient is pectin.

30. The composition of claim 27, wherein the gelling agent is pecmate.

31. The composition of claim 27, wherein the gelling agent enhances controlled gelling.

32. The composition of claim 27, wherein the plurality of inactive ingredients comprises the hydrocolloid gelling ingredient in a range of greater than 0 wt % to 5 wt %?33. The composition of claim 1, wherein the plurality of inactive ingredients further comprises a flavoring, a coloring, a bitter blocker, or a combination thereof.

34. A semi-solid composition for consumption before physical exertion to enhance physical performance, the semi-solid composition comprising: a lion’s mane and a vasodilator present at an amount to enhance physical performance; and a plurality of inactive ingredients that provide for formation of a semi-solid matrix.

35. The composition of claim 34, wherein the semi-solid composition is in the form of a gummy.

36. The composition of claim 34, wherein the semi-solid composition comprises: the lion’s mane in a concentration of about 2 wt% and the vasodilator in a concentration of about 1 wt%.

37. The composition of claim 34, wherein the semi-solid composition comprises: a plurality of active ingredients in a total concentration of about 1 wt% to about 8 wt%, the plurality of active ingredients comprising the lion’s mane in a concentration of about 2 wt% and the vasodilator in a concentration of about 1 wt%; and a plurality of inactive ingredients in a total concentration of about 92 wt% to about 99 wt%, wherein the plurality of inactive ingredients that provide for formation of a semi-solid matrix.

38. The composition of claim 34, wherein the semi-solid composition comprises: the lion’s mane in a concentration of about 2 wt%; the vasodilator in a concentration of about 1 wt%; a vitamin in a concentration of about 1 wt%; a L-theanine in a concentration of about 1 wt%; an adaptogen in a concentration of about 2 wt%; a nootropic in a concentration of about 3 wt%; and the plurality of inactive ingredients that provide for formation of a semi-solid matrix.Attorney Docket No. 199237-70760139. The composition of claim 34, wherein the semi-solid composition comprises: the lion’s mane in a concentration of about 2 wt%; the vasodilator in a concentration of about 1 wt%; a vitamin in a concentration of about 1 wt%; a L-theanine in a concentration of about 1 wt%; an adaptogen in a concentration of about 2 wt%; a nootropic in a concentration of about 3 wt%; and the plurality of inactive ingredients comprising water, sugar, pectin, glucose, pecmate, flavor, coloring, and citric acid.

40. The composition of claim 34, wherein the plurality of inactive ingredients further comprises allulose, fiber and / or com fiber.

41. The composition of claim 34, wherein the vasodilator is selected from a group consisting of an angiotensin-converting enzyme (ACE) inhibitor, a milk-derived tripeptide, a casein-derived tripeptide, an Ile-Pro-Pro (IPP), a Val-Pro-Pro (VPP), an L-arginine, a L-citrulline, a beetroot extract, a hawthorn extract, a Ginkgo biloba extract, a cocoa flavanol, a garlic extract, a niacin, a magnesium, potassium, a theobromine, a resveratrol, a quercetin, a curcumin, a alpha-lipoic acid, an acetylcholine, a histamine, a prostacyclin, or combinations thereof.

42. The composition of claim 34, wherein the vasodilator is a milk-derived tripeptide.

43. The composition of claim 34, wherein the vitamin is vitamin B-12 or cyanocobalamin.

44. The composition of claim 1, wherein the adaptogen is cordyceps.

45. The composition of claim 1, wherein the nootropic is citicoline.

46. The composition of claim 1, wherein lion’s mane comprises hericenones and / or erinacines.

47. The composition of claim 1, wherein L-theanine is derived from green tea extract.

48. The composition of claim 34, wherein the plurality of inactive ingredients that provide for formation of a semi-solid matrix comprises a carbohydrate mixture and an aqueous component, the carbohydrate mixture comprising at least two of a sweetener, a non-reducing sugar, a food additive, or a fiber.The composition of claim 34, wherein the plurality of inactive ingredients comprises the sweetener in a concentration of about 1 wt% to about 9 wt%.

49. The composition of claim 34, wherein the plurality of inactive ingredients comprises the nonreducing sugar in a concentration of about 1 wt% to about 22 wt%.

50. The composition of claim 34, wherein the plurality of inactive ingredients comprises the food additive in a concentration of about 1 wt%.

51. The composition of claim 34, wherein the plurality of inactive ingredients comprises the fiber in a concentration of about 1 wt% to about 8 wt%.

52. The composition of claim 48, wherein the sweetener is selected from the group consisting of a sucrose, a sugar, a pure cane granulated sugar, a glucose, a com syrup, a fructose, an isomalt, aAttorney Docket No. 199237-707601 high fructose com syrup, a tapioca syrup, an agave syrup, a honey, a maltose syrup, a sucralose, an aspartame, a steviol glycosides, an acesulfame potassium, an erythritol, a xylitol, a mannitol, an isomalt, and a combination thereof.

53. The composition of claim 48, wherein the non-reducing sugar is selected from the group consisting of an allulose, a trehalose, a sucrose, a raffinose, a stachyose, a verbascose, a gentianose, and a combination thereof.

54. The composition of claim 48, wherein the food additive is a preservative, a flavor enhancer, a texture modifier, a gel strengthener.

55. The composition of claim 48, wherein the food additive is citric acid.

56. The composition of claim 48, wherein the fiber is selected from the group consisting of a com fiber, an acacia fiber, a psyllium husk, an inulin, a fructooligosaccharides (FOS), a chicory root fiber, a tapioca fiber, and a combination thereof.

57. The composition of claim 34, wherein the plurality of inactive ingredients comprises the aqueous component in a concentration of about 1 wt% to about 25 wt %.

58. The composition of claim 57, wherein the aqueous component is water.

59. The composition of claim 34, wherein the plurality of inactive ingredients further comprises at least one of a hydrocolloid gelling ingredient and / or a gelling agent.

60. The composition of claim 59, wherein the hydrocolloid gelling ingredient is selected from the group consisting of a pectin, an alginate, a carrageenan, a gellan, a gelatin, an agar, a modified starch, a methyl cellulose, a hydroxypropylmethyl cellulose, and a combination thereof.

61. The composition of claim 59, wherein the hydrocolloid gelling ingredient is pectin.

62. The composition of claim 59, wherein the gelling agent is pecmate.

63. The composition of claim 59, wherein the gelling agent enhances controlled gelling.

64. The composition of claim 59, wherein the plurality of inactive ingredients comprises the hydrocolloid gelling ingredient in a range of greater than 0 wt % to 5 wt %.

65. The composition of claim 34, wherein the plurality of inactive ingredients further comprises a flavoring, a coloring, or a combination thereof.

66. A method of enhancing physical performance in a human, the method comprising administering the semi-solid composition of claim 1 prior to physical exertion.

67. A method of enhancing physical performance in a human, the method comprising administering the semi-solid composition of claim 34 prior to physical exertion.

68. A method of enhancing physical performance in a human, the method comprising administering the semi-solid composition of any one of claims 1-65 prior to physical exertion.

69. The method of claim 68, wherein enhancing physical performance is characterized by at least one measurable parameter selected from the group consisting of:(a) an increase in heart rate of at least 20% above resting baseline;(b) an increase in respiratory exchange ratio (RER) of at least 0.9;Attorney Docket No. 199237-707601(c) an decrease in perceived exertion rating on the Borg scale;(d) an increase in peak oxygen uptake (VO2 max) of at least 20% above resting baseline; or(e) an increase in lactate threshold of at least 20% above resting baseline.

70. The method of claim 68, wherein the semi-solid composition is administered within 60 minutes prior to the onset of physical exertion.

71. The method of claim 68, wherein the semi-solid composition is administered orally prior to the onset of physical exertion.

72. A formulation in the form of a gummy comprising the following ingredients: a glucose, an allulose, a fiber, a pectin, a sugar, a water, a malate salt, a citric acid or a salt thereof, a flavoring agent, a coloring agent, a bitter blocker agent, a vitamin or a salt thereof, an L-theanine or a salt thereof, a stimulant or a salt thereof, a valyl-prolyl-proline (VPP) peptide or a salt thereof, an iosoleucyl- prolyl-proline (IPP) peptide or a salt thereof, and a phenylethylamine or a salt thereof.

73. The formulation of claim 72, wherein the fiber comprises a com fiber.

74. The formulation of claim 72, wherein the fiber comprises a soluble fiber.

75. The formulation of claim 72, wherein the com fiber comprises a soluble com fiber.

76. The formulation of any one of claims 72-75, wherein the sugar comprises a sucrose.

77. The formulation of any one of claims 72-76, comprising the citric acid.

78. The formulation of any one of claims 72-77, comprising the salt of the citric acid.

79. The formulation of any one of claims 72-78, comprising the vitamin that comprises a vitamin BI2.

80. The formulation of any one of claims 72-79, wherein the vitamin or the salt thereof comprises a vitamin B12 (methylcobalamin), a biotin, a pantothenic acid, a calcium pantothenate (vitamin B5), a folate, a pyridoxine HC1 and / or pyridoxal 5 ’phosphate (a vitamin Be), a niacin, a niacinamide, a riboflavin (vitamin B2), a thiamin and / or thiamin HC1 (a vitamin Bi), or any combination thereof.

81. The formulation of any one of claims 72-80, wherein the stimulant or the salt thereof comprises a caffeine or a salt thereof, a paraxanthine or a salt thereof, a theobromine or a salt thereof, or any combination thereof.

82. The formulation of claim 72, wherein the stimulant or the salt thereof is in the form of particles.

83. The formulation of claim 82, wherein the particles are at least partially coated with a coating.

84. The formulation of claim 83, wherein the coating comprises a cellulose or a derivative thereof, a cellulose acetate or a derivative thereof, a chitosan or a derivative thereof, a lignin or a derivative thereof, or any combination thereof.

85. The formulation of any one of claims 72-84, wherein the malate salt comprises potassium hydrogen malate.

86. The formulation of any one of claims 72-85, wherein the coloring agent imparts a red color to the gummy.

87. The formulation of any one of claims 72-86, wherein the coloring agent comprises FD&C Red Dye 40, a purple sweet potato extract, a black carrot extract, a purple carrot extract, a grapeAttorney Docket No. 199237-707601 extract, an elderberry extract, a red cabbage extract, a red beet extract, or any combination thereof.

88. The formulation of any one of claims 72-87, wherein the coloring agent imparts a yellow coloring to the gummy.

89. The formulation of claim 72, wherein the coloring agent comprises an amoretti or an extract thereof, a turmeric or an extract thereof, a beta carotene or an extract thereof, or any combination thereof.

90. The formulation of any one of claims 72-89, wherein the bitter blocker agent comprises two or three bitter blocker agents.

91. The formulation of claim 72, wherein the bitter blocker agent comprises three bitter blocker agents.

92. The formulation of claim 72, wherein the bitter blocker comprises a monoammonium glycyrrhizinate.

93. The formulation of any one of claims 72-92, wherein the flavorant imparts a berry flavor to the gummy.

94. The formulation of any one of claims 72-93, further comprising at least one of an epigallocatechin (ECG), an epigallocatechin gallate (EGCG), a l,2-di-O-galloyl-4,6-O-(S)-hexahydroxydiphenoyl- P-D-glucose (GHG), or any combination thereof.

95. The formulation of any preceding claim, wherein the pectin is a high methoxyl pectin, a low methoxyl pectin, a rapid set pectin, or any combination thereof.

96. The formulation of any one of claims 72-95, wherein each ingredient in the gummy is independently contained in an amount of from about 1% to about 99% by weight, based on the total weight of the gummy.

97. The formulation of any one of claims 72-96, wherein each ingredient in the gummy is independently contained an amount of from about: 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%,27%, 28%, 29%, 30%, 31%, 32%, 33%, 34%, 35%, 36%, 37%, 38%, 39%, 40%, 41%, 42%,43%. 44%. 45%. 46%, 47%, 48%, 49%, 50%, 51%, 52%, 53%, 54%, 55%, 56%, 57%, 58%,59%, 60%, 61%, 62%, 63%, 64%, 65%, 66%, 67%, 68%, 69%, 70%, 71%, 72%, 73%, 74%,75%, 76%, 77%, 78%, 79%, 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%,91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% by weight, based on the total weight of the gummy.

98. The formulation of any one of claims 72-97, wherein the ingredients are substantially homogeneously mixed in the gummy.

99. The formulation of any one of claims 72-98, that is a dietary supplement.

100. The formulation of any one of claims 72-99, that is in unit dose form.

101. A kit comprising the formulation of any one of claims 72-100 and a container.Attorney Docket No. 199237-707601102. A method comprising orally administering the formulation of any one of claims 72-100 to a human about an hour to about a minute before the human engages in an exercise.

103. A method of making a gummy, the method comprising contacting: a glucose, an allulose, a fiber, a pectin, a sugar, a water, a malate salt, a citric acid or a salt thereof, a flavoring agent, a coloring agent, a bitter blocker agent, a vitamin or a salt thereof, an L-theanine or a salt thereof, a stimulant or a salt thereof, a valyl-prolyl-proline (VPP) peptide or a salt thereof, an iosoleucyl- prolyl-proline (IPP) peptide or a salt thereof, and a phenylethylamine or a salt thereof, thereby forming a gummy.

104. A formulation in the form of a gummy comprising the following ingredients: a glucose, an allulose, a fiber, a pectin, a sugar, a water, a malate salt, a citric acid or a salt thereof, a flavoring agent, a coloring agent, a vitamin or a salt thereof, an L-theanine or a salt thereof, a valyl-prolyl-proline (VPP) peptide or a salt thereof, an iosoleucyl- prolyl-proline (IPP) peptide or a salt thereof, a citicoline or a salt thereof, and a mushroom or an extract thereof.

105. The formulation of claim 104, wherein the fiber comprises a com fiber.

106. The formulation of claim 104, wherein the fiber comprises a soluble fiber.

107. The formulation of claim 105, wherein the com fiber comprises a soluble com fiber.

108. The formulation of any one of claims 104-107, wherein the sugar comprises a sucrose.

109. The formulation of any one of claims 104-107, comprising the citric acid.

110. The formulation of any one of claims 104-109, comprising the salt of the citric acid.

111. The formulation of any one of claims 104-110, comprising the vitamin that comprises a vitamin B12.

112. The formulation of any one of claims 104-111, wherein the vitamin or the salt thereof comprises a vitamin B12 (methylcobalamin), a biotin, a pantothenic acid, a calcium pantothenate (vitamin B5), a folate, a pyridoxine HC1 and / or pyridoxal 5 ’phosphate (a vitamin Be), a niacin, a niacinamide, a riboflavin (vitamin B2), a thiamin and / or thiamin HC1 (a vitamin Bi), or any combination thereof.

113. The formulation of any one of claims 104-112, wherein the malate salt comprises potassium hydrogen malate.

114. The formulation of any one of claims 104-113, wherein the coloring agent imparts an orange color to the gummy.

115. The formulation of any one of claims 104-125, wherein the coloring agent comprises FD&C Red Dye 40, a purple sweet potato extract, a black carrot extract, a purple carrot extract, a grape extract, an elderberry extract, a red cabbage extract, a red beet extract, an amoretti or an extract thereof, a turmeric or an extract thereof, a beta carotene or an extract thereof, or any combination thereof.

116. The formulation of any one of claims 104-115, wherein the flavorant imparts a mango flavor to the gummy.Attorney Docket No. 199237-707601117. The formulation of any one of claims 104-116, further comprising at least one of an epigallocatechin (ECG), an epigallocatechin gallate (EGCG), a l,2-di-O-galloyl-4,6-O-(S)- hexahydroxydiphenoyl-P-D-glucose (GHG), or any combination thereof.

118. The formulation of any one of claims 104-117, wherein the pectin is a high methoxyl pectin, a low methoxyl pectin, a rapid set pectin, or any combination thereof.

119. The formulation of any one of claims 104-118, wherein the mushroom or the extract thereof comprises a first mushroom or an extract thereof and a second mushroom or an extract thereof.

120. The formulation of claim 119, wherein the first mushroom or the extract thereof comprises a lion’s mane or an extract thereof and the second mushroom or the extract thereof comprises a cordyceps or an extract thereof.

121. The formulation of any one of claims 104-120, wherein each ingredient in the gummy is independently contained in an amount of from about 1% to about 99% by weight, based on the total weight of the gummy.

122. The formulation of any one of claims 104-121, wherein each ingredient in the gummy is independently contained an amount of from about 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%,27%, 28%, 29%, 30%, 31%, 32%, 33%, 34%, 35%, 36%, 37%, 38%, 39%, 40%, 41%, 42%,43%. 44%. 45%. 46%, 47%, 48%, 49%, 50%, 51%, 52%, 53%, 54%, 55%, 56%, 57%, 58%,59%, 60%, 61%, 62%, 63%, 64%, 65%, 66%, 67%, 68%, 69%, 70%, 71%, 72%, 73%, 74%,75%, 76%, 77%, 78%, 79%, 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%,91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% by weight based on the total weight of the gummy.

123. The formulation of any one of claims 104-122, wherein the ingredients are substantially homogeneously mixed in the gummy.

124. The formulation of any one of claims 104-123, that is a dietary supplement.

125. The formulation of any one of claims 104-124, that is in unit dose form.

126. A kit comprising the formulation of any one of claims 104-125 and a container.

127. A method comprising orally administering the formulation of any one of claims 104-125 to a human about an hour to about a minute before the human engages in an exercise.

128. A method of making a gummy comprising contacting: a glucose, an allulose, a fiber, a pectin, a sugar, a water, a malate salt, a citric acid or a salt thereof, a flavoring agent, a coloring agent, a vitamin or a salt thereof, an L-theanine or a salt thereof, a valyl-prolyl-proline (VPP) peptide or a salt thereof, an iosoleucyl- prolyl-proline (IPP) peptide or a salt thereof, a citicoline or a salt thereof, and a mushroom or an extract thereof, thereby forming the gummy.

129. A gummy made by the method of claim 103 or 128.

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