Compositions containing gamma-aminobutyric acid and methods for improving cognitive function, mood and alertness

Abstract

The present disclosure provides compositions and methods for improving cognitive function, mood and / or alertness in a person. In one embodiment, a method comprises administering an edible composition to a person in need of an improved condition, where the composition comprises a combination of gamma-aminobutyric acid and caffeine. The weight ratio of total gamma-aminobutyric acid to total caffeine of the edible composition is from about 1: 50 to about 10: 1.

Description

[0001] This application is being filed on March 1, 2024 as a PCT International Patent Application and claims priority to and the benefit of U.S. Provisional Patent Application Serial No. 63 / 488,267, filed March 3, 2023, the entire disclosure of which is incorporated by reference in its entirety. INTRODUCTION

[0002] The present disclosure relates generally to edible compositions, beverages, and methods for improving the condition or function or performance of a person.

[0003] Studies that have been conducted have shown that caffeine has a consistent effect on cognitive function, mood, and alertness in individuals. However, caffeine alone does not have an effect on all aspects of cognitive function, for example, caffeine has limited improvement on attention, and shows inconsistent effects on working memory.

[0004] Gamma-aminobutyric acid (GABA) is a well-known amino acid that acts as an inhibitory neurotransmitter in the central nervous system. It is known that gamma-aminobutyric acid reduces the ability of nerve cells to receive, produce, or send chemical messages to other nerve cells, which is associated with producing a calming effect in individuals. This neurotransmitter is believed to play an important role in controlling or reducing stress and anxiety in a person. Its induction of a sense of relaxation, stress reduction, cognitive effects, and alertness have been studied, however, meaningful results were obtained only by using high doses (e.g., 800 mg).

[0005] The presence of caffeine can have an inhibitory effect on the production of gamma-aminobutyric acid in the brain. Thus, while caffeine provides a positive effect on certain cognitive functions, it can inhibit the production of gamma-aminobutyric acid, which can reduce certain beneficial effects on cognitive tasks, mood, and alertness.

[0006] Therefore, there is a need to provide new compositions and beverages that can further improve cognitive function, mood, and / or alertness compared to conventional caffeinated products or decaffeinated products. There is also a need for methods of improving cognitive function and / or alertness with compositions or beverages for certain populations of subjects in need thereof. There is a further need for methods of improving cognitive function, mood, and / or alertness using compositions or beverages having defined ingredients and optimized amounts thereof.

[0007] The present disclosure proposes edible compositions, beverages, and methods that meet the needs described above.

[0008] In some aspects, the present disclosure relates to an edible composition comprising: gamma-aminobutyric acid and caffeine, wherein the weight ratio of total gamma-aminobutyric acid to total caffeine of the composition is from about 1 : 50 to about 10 : 1. In some embodiments, the edible composition is a processed food.

[0009] In some embodiments, the present compositions comprise gamma-aminobutyric acid or a functional analog, derivative, or variant thereof, and caffeine or a functional analog, derivative, metabolite, or variant thereof. While it is generally known that ingestion of caffeine has positive health effects on humans, such as improved performance, reduced fatigue, and reduced stimulation, over-ingestion of caffeine can cause caffeine poisoning (theobromine poisoning). It is first determined in the present disclosure that balanced doses of caffeine and gamma-aminobutyric acid have a synergistic effect in improving positive health benefits related to cognitive function, mood, and / or alertness when compared to caffeine alone or gamma-aminobutyric acid alone.

[0010] In some embodiments, the present compositions have a weight ratio of total gamma-aminobutyric acid to total caffeine from about 1 : 50 to about 10 : 1, or from about 1 : 40 to about 9 : 1, or from about 1 : 30 to about 8 : 1, or from about 1 : 20 to about 7 : 1, or from about 1 : 10 to about 6 : 1, or from about 1 : 5 to about 5 : 1, or from about 1 : 4 to about 4 : 1, or from about 1 : 3 to about 3 : 1, or from about 1 : 2 to about 2 : 1.

[0011] In some embodiments, the present compositions have a total caffeine content from about 0.001 wt% to about 5 wt%, or from about 0.05 wt% to about 4 wt%, or from about 0.1 wt% to about 3 wt%, or from about 0.5 wt% to about 2 wt%, or from about 1 wt% to about 1.5 wt%.

[0012] In some embodiments, the present compositions have a caffeine dose per serving from about 15 mg to about 250 mg, or from about 25 mg to about 200 mg, or from about 35 mg to about 150 mg, or from about 45 mg to about 100 mg, or from about 55 mg to about 80 mg, or from about 60 mg to about 75 mg.

[0013] In some embodiments, the present compositions have a gamma-aminobutyric acid content from 5 mg to about 150 mg, or from about 10 mg to about 120 mg, or from about 20 mg to about 100 mg, or from about 30 mg to about 80 mg, or from about 40 mg to about 70 mg, or from about 50 mg to about 60 mg.

[0014] In some embodiments, the present compositions have a total gamma-aminobutyric acid content from about 0.001 wt% to about 2.5 wt%, or from about 0.05 wt% to about 2.0 wt%, or from about 0.1 wt% to about 1.5 wt%, or from about 0.5 wt% to about 1 wt%.

[0015] In some embodiments, the present composition further comprises a sweetener. Examples of sweeteners include, but are not limited to, stevia and steviol glycosides, luo han guo and related mogroside compounds, monatin and its salts (monatin SS, RR, RS, SR), curculin, glycyrrhizic acid and its salts, thaumatin, monellin, mabinlin, brazzein, hernandulcin, phyllodulcin, glycofurol, phlorizin, phloridzin, trilobatin, baiyunoside, osladin, polypodoside A, pterocaryoside A, pterocaryoside B, mukurozi II, abrusoside A, cyclocarioside I, sugar alcohols such as erythritol, chloro sucrose, acesulfame potassium, acesulfame acid and its salts, aspartame, alitame, saccharin and its salts, neohesperidin dihydrochalcone, cyclamate, cyclamate salts, neotame, advantame, glycosylated steviol glycosides (GSG), and combinations thereof.

[0016] In some embodiments, the present composition further comprises at least one additive and / or at least one functional ingredient.

[0017] In some embodiments, the present composition is in a drinkable liquid form, a concentrate form, a dry form, or a semi-dry form. In some embodiments, the present composition is a chewing gum, a gel, a tablet, a capsule, a granule, a cube, or a dry powder.

[0018] In some embodiments, the present composition is a beverage selected from the group of non-carbonated beverages, carbonated beverages, juice beverages, juices, coffee beverages, tea beverages, milk beverages, dairy beverages, plant protein beverages, plant-based beverages, sports beverages, energy beverages.

[0019] In some embodiments, the present composition has a Brix value of about 3° to about 25°, or about 5° to about 20°, or about 7° to about 15°.

[0020] In some embodiments, the present composition comprises a coffee product selected from the group of coffee extract, coffee extract, coffee bean extract, coffee berry extract, coffee fruit skin extract, coffee berry juice, espresso, dried coffee, instant coffee, coffee oil, coffee essence, dried green coffee extract, wet green coffee extract, powdered coffee, ground coffee, roasted coffee, roasted and ground coffee, or any combination thereof.

[0021] In some embodiments, the present composition comprises a tea product selected from the group of instant tea product, tea extract, concentrated tea, dried tea, tea leaf, tea essence, green tea extract, concentrated green tea extract, or any combination thereof.

[0022] In some embodiments, the caffeine and / or gamma-aminobutyric acid is derived from a natural resource, wherein the natural resource is a plant selected from the group of coffee, tea, yerba mate, guayusa, yaupon, guarana, cacao, kola, green tea, white tea, oolong tea, black tea, or any combination thereof.

[0023] In some aspects, the disclosure relates to a beverage comprising gamma-aminobutyric acid and caffeine, wherein the beverage comprises from about 0.001 wt% to about 5 wt% caffeine; and from about 0.001 wt% to about 2.5 wt% gamma-aminobutyric acid, wherein the weight ratio of gamma-aminobutyric acid to caffeine is from about 1 : 50 to about 10 : 1.

[0024] In some aspects, the disclosure relates to a method for improving a condition in a person, the method comprising administering to a person in need of improvement in a condition any of the compositions or beverages described herein. Improving a condition in a person includes, but is not limited to, improving cognitive function; reducing mental fatigue, increasing alertness, increasing focus, increasing accuracy and / or speed of attention, increasing accuracy and / or speed of performance, increasing memory (e.g., speed and / or accuracy of working memory, episodic memory), improving mood, reducing stress, reducing anxiety, improving calmness, improving tranquility, improving relaxation, improving mental capacity, reducing headache, or any combination thereof.

[0025] In some embodiments of the methods of the invention, the condition is improved after a period of time after administration, wherein the period of time is at least about 5 minutes, or at least about 15 minutes, or at least about 30 minutes, or at least about 60 minutes, or at least about 90 minutes, or at least about 120 minutes, or at least about 150 minutes, or at least about 180 minutes, or at least about 210 minutes, or at least about 240 minutes, or at least about 270 minutes, or at least about 300 minutes.

[0026] The composition is administered to the person at one time or one or more times per day.

[0027] In some embodiments of the methods of the invention, the composition administered to the person comprises at least 15 mg, at least 25 mg, at least 50 mg, at least 75 mg, at least 100 mg, at least 125 mg, at least 150 mg, at least 175 mg, at least 200 mg, at least 250 mg of caffeine. In some embodiments, the composition administered to the person comprises at least 5 mg, at least 10 mg, at least 15 mg, at least 20 mg, at least 25 mg, at least 35 mg, at least 50 mg, at least 75 mg, at least 100 mg, at least 125 mg, at least 150 mg of gamma-aminobutyric acid.

[0028] Definitions and explanations of selected terms

[0029] As used herein, "weight percent," "wt%," "percent by weight," "% by weight," and variations thereof refer to the concentration of a substance as the weight of that substance divided by the total weight of the composition and multiplied by 100. It is understood that, as used in this disclosure, "percent," "%" and the like are intended to be synonymous with "weight percent," "wt%" and the like.

[0030] As used herein, "g" means gram; "L" means liter; "mg" means "milligram (10 -3 g)"; "mL" or "cc" means milliliter (10 -3 g). 1 "µL" is equivalent to 1 microliter (10 -6 g). The units "g / 100 g," "g / 100 mL," or "g / L" are units of concentration or content of a component in a composition. 1 "mg / L" is equivalent to 1 ppm (parts per million). "Da" refers to Daltons, which is a unit of molecular weight; 1 Da is equivalent to 1 g / mol. The units of temperature used herein are degrees Celsius (°C).

[0031] The term "about" is used in connection with a value to include normal variations that would be expected by persons of the art to occur in a measurement, and is understood to have the same meaning as "approximately" and to encompass typical error limits, such as ±15%, ±10%, ±5%, ±1%, ±0.5%, or even ±0.1% of the stated value. The term "about" also encompasses different amounts due to different equilibration conditions of the composition resulting from the particular initial composition. Whether modified by the term "about" or not, the claims encompass equivalent forms of a number.

[0032] It should be noted that, as used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. Thus, for example, reference to a composition containing "a compound" includes having two or more compounds the same or different from each other. It should also be noted that the term "or" is generally employed in its sense of "and / or" unless the content clearly dictates otherwise. As used herein, "and / or" means and encompasses any and all possible combinations of one or more of the associated listed items, as well as the lack of a combination when interpreted in the alternative ("or").

[0033] For brevity and conciseness, any range of values stated in the specification is to be construed as incorporating all values from the range and should be interpreted to support a claim to any sub-range having an end point that is a practical value within the specified range. By way of illustrative example, disclosure of a range from 1 to 5 in the specification should be considered to support a claim to any of the following ranges: 1-5; 1-4; 1-3; 1-2; 2-5; 2-4; 2-3; 3-5; 3-4; and 4-5.

[0034] The term "substantially" is used herein to denote an inherent degree of uncertainty that can be attributed to any quantitative comparison, value, measurement, or other representation that in its nature is subject to variation. The term "substantially" is also used herein to denote the degree by which a quantitative representation can vary from the stated reference without resulting in a change in the basic function of the subject matter at issue.

[0035] The term "substantially free of can refer to any component that is absent or predominantly absent from a composition of the disclosure. When referring to "substantially free of, it is intended that the component is not intentionally added to the composition of the disclosure. The use of the term "substantially free of a component allows for the inclusion of trace amounts of the component in the composition of the disclosure as they can exist in another component. However, it is recognized that when a composition is referred to as "substantially free of a component, only trace or minor amounts of the component will be allowed. Further, if a composition is referred to as "substantially free of a component, if the component is present in trace or minor amounts, it is understood that it will not affect the effectiveness of the composition. It is understood that if an ingredient is not expressly included in the present disclosure or stated herein that it can be included, the composition of the disclosure can be substantially free of the ingredient. Likewise, the express inclusion of an ingredient allows for its express exclusion, allowing the composition to be substantially free of the expressly stated ingredient.

[0036] The terms "comprise", "comprises" and "comprising" as used herein, specify the presence of stated features, integers, steps, operations, elements, and / or components but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0037] As used herein, the transitional phrase "consisting essentially of means the scope of a claim is interpreted to cover the specified materials or steps recited in the claim plus those that do not materially affect the basic and novel characteristics of the disclosed disclosure. Accordingly, the term "consisting essentially of, when used in the claims of the present disclosure, is not intended to be construed as equivalent to "comprising".

[0038] As used herein, the terms "increase," "increasing," "increased," "enhance," "enhanced," "enhancing," and "enhancement" (and grammatical variations thereof) describe an improvement of at least about 1%, 5%, 10%, 15%, 25%, 50%, 75%, 100%, 150%, 200%, 300%, 400%, 500% or more, as compared to a control.

[0039] As used herein, the terms "reduce," "reduced," "reducing," "reduction," "diminish," and "decrease" (and grammatical variations thereof) describe a decrease of, for example, at least about 1%, 5%, 10%, 15%, 20%, 25%, 35%, 50%, 75%, 80%, 85%, 90%, 95%, 97%, 98%, 99%, or 100% as compared to a control. In particular embodiments, a reduction can not produce or substantially not produce (i.e., not a significant amount, e.g., less than about 10% or even 5% or even 1%) a detectable activity or amount.

[0040] The term "beverage" as used herein means any drinkable liquid or semi-liquid, including, for example, water, flavored water, soft drinks, fruit drinks, tea-based drinks, juice-based drinks, gelatin drinks, carbonated or non-carbonated drinks, and alcoholic or non-alcoholic drinks. In some embodiments, the beverage powder can first be mixed with any drinkable liquid or semi-liquid to obtain a beverage.

[0041] As used herein, "gamma-aminobutyric acid" or "GABA" refers to the same compound and can be used interchangeably as a term throughout this disclosure. Gamma-aminobutyric acid refers to a naturally occurring amino acid that acts as an inhibitory neurotransmitter in the brain. It is synthesized in the brain and also found in some foods. More specifically, GABA is the product of decarboxylation of glutamate by glutamate decarboxylase (GAD). Gamma-aminobutyric acid, while naturally occurring in certain foods, can also be produced through known bioconversion processes, including through the use of specific bacterial strains to convert glutamate to gamma-aminobutyric acid, or other naturally occurring fermentation processes of certain foods.

[0042] As used herein, the term "cognitive function" or "cognition" generally refers to aspects of an individual's psychosocial performance. Cognitive function involves a variety of mental abilities, including learning, thinking, reasoning, memory, problem solving, decision making, focus, concentration, and attention.

[0043] As used herein, the term "attention" refers to the ability to direct and focus cognitive activity on a particular stimulus. It is the power or strength of concentration. Sustained attention refers to the state in which attention must be maintained over a period of time.

[0044] As used herein, the term "alertness" refers to the mental state of being attentive and vigilant, quick, or rapidly perceiving and / or acting. It is being alertly attentive, mentally responsive and perceptive, and quick.

[0045] As used herein, the term "mental fatigue" refers to a state of consciousness that describes a range of malaise associated with mental debilitation. This mental fatigue can manifest itself as a desire to sleep (reduced arousal) or a general decline in attention (not necessarily a desire to sleep). It can also be described as a reduction in level of consciousness. Mental fatigue can be caused by sustained mental effort and attention to a particular task, as well as high stress or emotional levels. Essentially, any mental process that goes into overdrive can lead to mental fatigue.

[0046] As used herein, the term "emotion" refers to a feeling state or quality at a particular time (emotional state). Emotions differ from simple feelings in that emotions are less specific, less intense, and less likely to be triggered by a specific stimulus or event. Emotions generally have a positive or negative valence. Emotions are internal, subjective states.

[0047] As used herein, the term "feeling of relaxation" refers to an act of mental relaxation or a state of mental relaxation.

[0048] As used herein, the term "juice product" refers to a beverage product made from juice or a combination of juice and water or other components for the purpose of nutrition, health maintenance, health improvement, and / or recreation of humans and / or animals. Particularly preferred juice products include those products that are consumed by humans. By "juice" is meant the liquid that occurs in nature in plant material, or a dilute form of such liquid. The juice as used herein is not produced by dissolving plant material. An "extract" is material that is drawn or forced out of plant material, including by means of heat, chemicals, or high pressure. While an extract can be in liquid form, it is not naturally occurring in the plant in liquid form, but rather is a combination of chemical components that are not naturally occurring in the liquid of the plant.

[0049] As used herein, the term "nutrient" refers to a compound or mixture of compounds that is ingested and provides a nutritional benefit to the ingesting person. Thus, the term nutrient as used herein specifically includes a compound or mixture of compounds that provides energy via metabolism of the compound or mixture of compounds (e.g., polysaccharides), interacts with the nervous system and / or immune system to modulate and preferably stimulate the nervous system and / or immune system (e.g., caffeine), or provides a protective function (e.g., polyphenols as antioxidants).

[0050] As used herein, the term "serving" encompasses "a serving", "serving size" or "serving per day" and "dose / dosage", "administration", "administration dose / dosage", "administration unit". A "serving" has its typical meaning as used in the art, and / or denotes the amount of the composition to be administered at a certain moment of ingestion, e.g. as a meal or before, during and / or after a meal, before going to sleep, etc. If the composition of the present disclosure is a powdered reconstitutable composition, or in concentrated form, it is preferred to mix a serving amount of the powdered or concentrated composition with about 50-500 ml, 100-400 ml, preferably 100-300 ml, more preferably 150-250 ml, e.g. about 240 ml of a carrier such as water. If the composition is provided in the form of a liquid ready-to-drink composition, a serving amount corresponds to the above indicated amounts of liquid and dry matter and preferred amounts, e.g. from about 120 ml to about 480 ml (about 4 oz to about 16 oz), or from about 180 ml to about 360 ml (about 6 oz to about 12 oz), or from about 240 ml to about 300 ml (about 8 oz to about 10 oz). A daily serving of the composition of the present disclosure encompasses at least one serving per day. For example, the daily administration amount can also be administered in two or more servings, or three or more servings. In this case, the amount of the servings is preferably adjusted accordingly. Furthermore, the amount of the composition that needs to be administered in order to achieve the beneficial effects according to the present disclosure can be adjusted depending on the particular subject that wishes to enjoy the beneficial effects described herein. For example, a serving of the composition can be consumed in the morning, and a serving of the composition is consumed in the afternoon, evening or before going to sleep. A serving can be taken at breakfast, and a serving is administered at dinner or after dinner, before going to sleep. A serving of the composition of the present disclosure can be part of or constitute the breakfast of a human subject. Similarly, the preferred weight, weight percent or weight percentage of dry matter of any component or ingredient of the composition can be determined based on the indication of the amount of said component or ingredient per serving and / or per daily serving, and vice versa, based on the indications in the present disclosure.

[0051] As used herein, the term "instant coffee" encompasses dehydrated coffee solids that are soluble in a liquid, e.g. water, and includes, but is not limited to, instant coffee solids, coffee powders and coffee crystals.

[0052] As used herein, the term "instant tea" encompasses dehydrated tea solids that are soluble in a liquid (e.g., water), and includes, but is not limited to, instant tea solids, tea powders, and tea crystals. BRIEF DESCRIPTION OF DRAWINGS

[0053] Figure 1 Example 1 is shown for evaluating the acute effects of example beverages on cognitive function and alertness in healthy adults.

[0054] Figure 2 Example 1 is shown for comparing the composite performance accuracy and performance speed of various example beverages.

[0055] Figure 3 Example 1 is shown for comparing the attention accuracy and attention speed of various example beverages.

[0056] Figure 4 Example 1 is shown for comparing the results related to working memory tasks of various example beverages.

[0057] Figure 5 Example 1 is shown for comparing the accuracy related to the RVIP task of various example beverages.

[0058] Figure 6 Example 1 is shown for comparing the results related to the VAS task of various example beverages. DETAILED DESCRIPTION

[0059] Compositions and Ingredients

[0060] In an aspect, the present disclosure relates to an edible composition comprising: gamma-aminobutyric acid and caffeine, wherein the weight ratio of total gamma-aminobutyric acid to total caffeine of the composition is from about 1 : 50 to about 10 : 1.

[0061] The present disclosure is based, at least in part, on the surprising discovery that administration of an edible composition or beverage having both gamma-aminobutyric acid and caffeine (in a ratio of about 1 : 50 to about 10 : 1) is effective in improving one or more of the following conditions or functions: improving cognitive function; reducing mental fatigue, increasing alertness, increasing focus, increasing accuracy and / or speed of attention, increasing accuracy and / or speed of performance, improving memory (e.g., speed and / or accuracy of working memory, episodic memory), improving mood, reducing stress, reducing anxiety, improving calmness, improving tranquility, improving relaxation, improving mental capacity, reducing headache, or any combination thereof.

[0062] Results from a randomized, double-blind, placebo-controlled, balanced crossover study (see Example 1) indicate that the compositions of the present invention are significantly superior to conventional caffeinated or decaffeinated beverages in various cognitive / mood / alertness tests in healthy humans.

[0063] Gamma-aminobutyric acid and caffeine

[0064] In some embodiments, the compositions of the present invention comprise gamma-aminobutyric acid or a functional analog, derivative, or variant thereof, and caffeine or a functional analog, derivative, metabolite, or variant thereof. While it is generally known that the ingestion of caffeine has positive health effects on humans, such as improved performance, reduced fatigue, and reduced stimulation, excessive ingestion of caffeine can cause caffeine poisoning (theophylline poisoning). It is first determined in the present disclosure that a balanced dose of caffeine and gamma-aminobutyric acid has a synergistic effect in improving positive health benefits related to cognitive function, mood, and / or alertness when compared to caffeine alone or gamma-aminobutyric acid alone.

[0065] In some embodiments, the weight ratio of total gamma-aminobutyric acid to total caffeine of the compositions of the present invention is from about 1 : 50 to about 10 : 1, or from about 1 : 40 to about 9 : 1, or from about 1 : 30 to about 8 : 1, or from about 1 : 20 to about 7 : 1, or from about 1 : 10 to about 6 : 1, or from about 1 : 5 to about 5 : 1, or from about 1 : 4 to about 4 : 1, or from about 1 : 3 to about 3 : 1, or from about 1 : 2 to about 2 : 1. In some embodiments, the total gamma-aminobutyric acid content is at least about 1 : 50, at least about 1 : 40, at least about 1 : 30, at least about 1 : 20, at least about 1 : 10, at least about 1 : 9, at least about 1 : 8, at least about 1 : 7, at least about 1 : 6, at least about 1 : 5, at least about 1 : 4, at least about 1 : 3, at least about 1 : 2, or at least about 1 : 1.5, than the total caffeine content.

[0066] In some embodiments, the weight ratio of total gamma-aminobutyric acid to total caffeine is at most about 10 : 1, or about at most about 9 : 1, or at most about 8 : 1, or at most about 7 : 1, or at most about 6 : 1, or at most about 5 : 1, or at most about 4 : 1, or at most about 3 : 1, or at most about 2 : 1, or at most 1 : 1, or at most 1 : 1.5.

[0067] In some embodiments, the total caffeine content of the present composition is from about 0.001 wt% to about 5 wt%, or from about 0.05 wt% to about 4 wt%, or from about 0.1 wt% to about 3 wt%, or from about 0.5 wt% to about 2 wt%, or from about 1 wt% to about 1.5 wt%. In some embodiments, the total caffeine content of the present composition is at least 0.01 wt%, at least 0.05 wt%, at least 0.1 wt%, at least 0.2 wt%, at least 0.3 wt%, at least 0.4 wt%, at least 0.5 wt%, at least 0.6 wt%, at least 0.7 wt%, at least 0.8 wt%, at least 0.9 wt%, at least 1 wt%, at least 1.1 wt%, at least 1.2 wt%, at least 1.3 wt%, at least 1.4 wt%, at least 1.5 wt%, at least 1.6 wt%, at least 1.7 wt%, at least 1.8 wt%, at least 1.9 wt%, at least 2.0 wt%, at least 2.1 wt%, at least 2.2 wt%, at least 2.3 wt%, at least 2.4 wt%, at least 2.5 wt%, at least 3 wt%, at least 3.5 wt%, at least 4 wt%, at least 4.5 wt%, or at least 5 wt%. In some embodiments, the total caffeine content of the present composition is at most 5 wt%, at most 4.5 wt%, at most 4 wt%, at most 3.5 wt%, at most 3 wt%, at most 2.5 wt%, at most 2 wt%, at most 1.5 wt%, at most 1 wt%.

[0068] In some embodiments, the caffeine dose of the present composition is from about 15 mg to about 250 mg, or from about 25 mg to about 200 mg, or from about 35 mg to about 150 mg, or from about 45 mg to about 100 mg, or from about 55 mg to about 80 mg, or from about 60 mg to about 75 mg per serving. In some embodiments, the caffeine dose of the present composition is at least 15 mg, at least 25 mg, at least 50 mg, at least 75 mg, at least 100 mg, at least 125 mg, at least 150 mg, at least 175 mg, at least 200 mg, at least 250 mg. In some embodiments, the caffeine dose of the present composition is at most 250 mg, at most 200 mg, at most 150 mg, at most 100 mg, at most 75 mg, at most 50 mg, at most 25 mg, or at most 15 mg.

[0069] In some embodiments, the content of gamma-aminobutyric acid in the composition is from 5 mg to about 150 mg, or from about 10 mg to about 120 mg, or from about 20 mg to about 100 mg, or from about 30 mg to about 80 mg, or from about 40 mg to about 70 mg, or from about 50 mg to about 60 mg.

[0070] In some embodiments, the dose of gamma-aminobutyric acid of the present composition is at least 5 mg, at least 10 mg, at least 15 mg, at least 20 mg, at least 25 mg, at least 35 mg, at least 50 mg, at least 75 mg, at least 100 mg, at least 125 mg, at least 150 mg. In some embodiments, the dose of gamma-aminobutyric acid of the present composition is at most 150 mg, at most 125 mg, at most 100 mg, at most 75 mg, at most 50 mg, at most 35 mg, at most 25 mg, at most 15 mg, at most 10 mg, or at most 5 mg for a serving.

[0071] In some embodiments, the total content of gamma-aminobutyric acid of the present composition is from about 0.001 wt% to about 2.5 wt%, or from about 0.05 wt% to about 2.0 wt%, or from about 0.1 wt% to about 1.5 wt%, or from about 0.5 wt% to about 1 wt%. In some embodiments, the total content of gamma-aminobutyric acid of the present composition is at least 0.01 wt%, at least 0.05 wt%, at least 0.1 wt%, at least 0.2 wt%, at least 0.3 wt%, at least 0.4 wt%, at least 0.5 wt%, at least 0.6 wt%, at least 0.7 wt%, at least 0.8 wt%, at least 0.9 wt%, at least 1 wt%, at least 1.1 wt%, at least 1.2 wt%, at least 1.3 wt%, at least 1.4 wt%, at least 1.5 wt%, at least 1.6 wt%, at least 1.7 wt%, at least 1.8 wt%, at least 1.9 wt%, at least 2.0 wt%, at least 2.1 wt%, at least 2.2 wt%, at least 2.3 wt%, at least 2.4 wt%, or at least 2.5 wt%. In some embodiments, the total content of gamma-aminobutyric acid of the present composition is at most 2.5 wt%, at most 2.0 wt%, at most 1.5 wt%, at most 1.0 wt%, at most.75 wt%, at most.5 wt%, at most.25 wt%, at most.1 wt%, at most.05 wt%, at most.01 wt%.

[0072] In some embodiments, the gamma-aminobutyric acid is derived from a natural resource, a biotransformation process, a fermentation process, an enzymatic process, a synthetic derivative, or any combination thereof.

[0073] In some embodiments, the gamma-aminobutyric acid is derived from a natural resource selected from a vegetable or fruit, a legume, a fermented product, a cereal, tea, or a combination thereof.

[0074] Additional / functional ingredients

[0075] The oral composition of the present application can contain additional typical beverage ingredients, such as at least one sweetener and / or at least one functional ingredient and / or at least one additive.

[0076] Sweeteners

[0077] The composition of the present application can optionally comprise a sweetener. The sweetener can be an artificial or synthetic sweetener, a natural sweetener, a natural high-potency sweetener. As used herein, the phrase "natural high-potency sweetener" (NHPS) refers to any sweetener that occurs naturally in nature and that characteristically has a sweetness potency greater than sucrose, fructose, or glucose and has fewer calories. The natural high-potency sweetener can be provided as a pure compound or, alternatively, as part of an extract. As used herein, the phrase "synthetic sweetener" refers to any composition that does not occur naturally in nature and that characteristically has a sweetness potency greater than sucrose, fructose, or glucose and has few calories.

[0078] Non-limiting examples of NHPSs include stevia and steviol glycosides, such as rebaudioside M, rebaudioside D, rebaudioside A, rebaudioside N, rebaudioside O, rebaudioside E, steviolmonoside, steviolbioside, rubusoside, dulcoside B, dulcoside A, rebaudioside B, rebaudioside G, stevioside, rebaudioside C, rebaudioside F, rebaudioside I, rebaudioside H, rebaudioside L, rebaudioside K, rebaudioside J, rebaudioside M2, rebaudioside D2, rebaudioside S, rebaudioside T, rebaudioside U, rebaudioside V, rebaudioside W, rebaudioside Zl, rebaudioside Z2, rebaudioside IX, enzymatically glycosylated steviol glycosides, and combinations thereof. Examples of high purity steviol glycosides and methods of making the same are provided in U.S. Patent Application No. 2021 / 0107933, which is hereby incorporated in its entirety.

[0079] In certain embodiments, the steviol glycoside blend comprises at least about 5% by weight of steviol glycosides, such as, for example, at least about 10%, at least about 20%, at least about 30%, at least about 40%, at least about 50%, at least about 60%, at least about 70%, at least about 80%, at least about 90%, at least about 95%, or at least about 97% of steviol glycosides. In exemplary embodiments, the steviol glycoside blend comprises at least about 50% by weight of steviol glycosides, such as, for example, from about 50% to about 90%, from about 50% to about 80%, from about 50% to about 70%, from about 50% to about 60%, from about 60% to about 90%, from about 60% to about 80%, from about 60% to about 70%, from about 70% to about 90%, from about 70% to about 80%, and from about 80% to about 90% of steviol glycosides.

[0080] Another exemplary NHPS is Momordica and related momordica glycoside compounds such as grosmogroside I, momordica glycoside IA, momordica glycoside IE, 11-oxomomordica glycoside IA, momordica glycoside II, momordica glycoside II A, momordica glycoside II B, momordica glycoside II E, 7-oxomomordica glycoside II E, momordica glycoside III, momordica glycoside HIE, 11-oxomomordica glycoside HIE, 11-deoxymomordica glycoside III, momordica glycoside IV, momordica glycoside IVA, 11-oxomomordica glycoside IV, 11-oxomomordica glycoside IVA, momordica glycoside V, isomomordica glycoside V, 11-deoxymomordica glycoside V, 7-oxomomordica glycoside V, 11-oxomomordica glycoside V, isomomordica glycoside V, momordica glycoside VI, momordin, 11-oxomomordin, siamenoside I, isomers of siamenoside I (e.g., those disclosed in U.S. Patent Application No. 20170119032; which is incorporated by reference in its entirety), (3β, 9β, 10α, 11α, 24R)-3-[(4-O-β-D-glucopyranosyl-6-O-β-D-glucopyranosyl]-25-hydroxy-9-methyl-19-norlathoster-5-ene-24-yl-[2-O-β-D-glucopyranosyl-6-O-β-D-glucopyranosyl]-β-D-glucopyranoside); (3β, 9β, 10α, 11α, 24R)-[(2-O-β-D-glucopyranosyl-6-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]-25-hydroxy-9-methyl-19-norlathoster-5-ene-24-yl-[2-O-β-D-glucopyranosyl-6-O-β-D-glucopyranosyl]-β-D-glucopyranoside); and (3β, 9β, 10α, 11α, 24R)-[(2-O-β-D-glucopyranosyl-6-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]-25-hydroxy-9-methyl-19-norlathoster-5-ene-24-yl-[2-O-β-D-glucopyranosyl-6-O-β-D-glucopyranosyl]-β-D-glucopyranoside).

[0081] In certain embodiments, the momordica glycoside blend comprises at least about 5% momordica glycoside by weight, such as, for example, at least about 10%, at least about 20%, at least about 30%, at least about 40%, at least about 50%, at least about 60%, at least about 70%, at least about 80%, at least about 90%, at least about 95%, or at least about 97% momordica glycoside.

[0082] Other exemplary NHPS include monatin and its salts (monatin SS, RR, RS, SR), curculin, glycyrrhizic acid and its salts, thaumatin, monellin, mabinlin, brazzein, hernandulcin, phylloducin, glycyphyllin, phlorizin, trilobatin, baiyunoside, osladin, polypodoside A, pterocaryoside A, pterocaryoside B, mukurozioside, phlomisoside I, periandrin I, abrusoside A, and cyclocarioside I.

[0083] In one embodiment, the sweetener is a carbohydrate sweetener. Suitable carbohydrate sweeteners include, but are not limited to, the group consisting of sucrose, glyceraldehyde, dihydroxyacetone, erythrose, threose, erythrulose, arabinose, lyxose, ribose, xylose, ribulose, xylulose, allose, altrose, galactose, glucose, gulose, idose, mannose, talose, fructose, psicose, sorbose, tagatose, mannoheptulose, sedoheptulose, octulosonate, fucose, rhamnose, arabinose, pinebrosulose, sialyllactose, and combinations thereof.

[0084] In certain embodiments, the present compositions are free or substantially free of carbohydrate sweeteners.

[0085] Other suitable sweeteners include siamenoside, monatin and its salts (monatin SS, RR, RS, SR), curculin, mogroside, glycyrrhizic acid and its salts, thaumatin, monellin, mabinlin, brazzein, hernandulcin, phylloducin, glycyphyllin, phlorizin, trilobatin, baiyunoside, osladin, polypodoside A, pterocaryoside A, pterocaryoside B, mukurozioside, phlomisoside I, periandrin I, abrusoside A, rebaudioside and cyclocarioside I, sugar alcohols such as erythritol, chloro sucrose, acesulfame potassium, advantame acid and its salts, aspartame, alitame, saccharin and its salts, neohesperidin dihydrochalcone, cyclamate, cyclamate and its salts, neotame, advantame, glycosylated steviol glycosides (GSG), and combinations thereof.

[0086] In one embodiment, the sweetener is a caloric sweetener or a mixture of caloric sweeteners. In another embodiment, the caloric sweetener is selected from the group consisting of sucrose, fructose, glucose, high fructose corn / starch syrup, beet sugar, cane sugar, and combinations thereof.

[0087] In certain embodiments, the present compositions are free or substantially free of caloric sweeteners.

[0088] In another embodiment, the sweetener is a rare sugar selected from the group consisting of allulose, gulose, kojibiose, sorbose, lyxose, ribulose, xylose, xylulose, D-arabinose, L-lyxose, D-tagatose, L-gulose, L-fucose, L-arabinose, pinebose, and combinations thereof.

[0089] The amount of sweetener in the present compositions depends on the identity of the sweetener and the desired level of sweetness. In preferred embodiments, the sweetener is present in a sweetening amount (i.e., a concentration at which sweetness is detectable).

[0090] As will be appreciated by those skilled in the art, high potency sweeteners are more effective and, therefore, require lower concentrations to achieve a particular sucrose equivalent value (SE). The sweetness of a non-sucrose sweetener can be measured relative to a sucrose reference by determining the sucrose equivalent value (SE) of the non-sucrose sweetener. Typically, a panel of taste experts is trained to detect the sweetness of a reference sucrose solution containing between 1% and 15% sucrose (w / v). Other non-sucrose sweeteners are then tasted at a range of dilutions to determine the concentration of the non-sucrose sweetener that is as sweet as a given percentage of the sucrose reference. For example, if a 1% solution of a non-sucrose sweetener is as sweet as a 10% sucrose solution, the sweetener is said to be 10 times as potent as sucrose and to have a sucrose equivalent value of 10%.

[0091] In one embodiment, the one or more sweeteners provide a sucrose equivalent value of about 1 wt% to the present compositions, such as, for example, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, about 10%, about 11%, about 12%, about 13%, about 14%, or any range between these values.

[0092] In another embodiment, the present compositions have a SE from about 2% to about 14%, such as, for example, from about 2% to about 10%, from about 2% to about 5%, from about 5% to about 15%, from about 5% to about 10%, or from about 10% to about 15%.

[0093] The amount of sucrose in a reference solution, and thus another measure of sweetness, can be described in terms of Brix (°Bx). One Brix is 1 gram of sucrose in 100 grams of solution and represents the strength of the solution as a weight percent (% w / w) (strictly speaking, by mass). In embodiments where the present composition is sweetened with a sweetener, the composition has a Brix value of about 3° to about 25°, or about 5° to about 20°, or about 7° to about 15°. In some embodiments, the composition can be at least about 1 °Bx, about 2 °Bx, about 3 °Bx, about 4 °Bx, about 5 °Bx, about 6 °Bx, about 7 °Bx, about 8 °Bx, about 9 °Bx, about 10 °Bx, about 11 °Bx, about 12 °Bx, about 13 °Bx, about 14 °Bx, about 15 °Bx, about 16 °Bx, about 17 °Bx, about 18 °Bx, about 19 °Bx, about 20 °Bx, about 21 °Bx, about 22 °Bx, about 23 °Bx, about 24 °Bx, about 25 °Bx, or any range between these values.

[0094] The present composition can optionally include a functional ingredient. Exemplary functional ingredients include, but are not limited to, electrolytes, saponins, antioxidants, dietary fiber sources, fatty acids, vitamins, glucosamine, minerals, preservatives, hydration agents, probiotics, prebiotics, weight management agents, osteoporosis management agents, terpenes or derivatives thereof, phytoestrogens, long chain aliphatic saturated primary alcohols, phytosterols, and combinations thereof.

[0095] Terpenes and Derivatives

[0096] In some embodiments, the present composition includes a terpene, diterpene, triterpene, or any derivative thereof. In some embodiments, the total content of terpenes in the present composition is from about 0.01 wt% to about 5 wt%, or from about 0.05 wt% to about 4 wt%, or from about 0.1 wt% to about 3 wt%, or from about 0.5 wt% to about 2 wt%, or from about 1 wt% to about 1.5 wt%.

[0097] In certain embodiments, the terpene derivative is at least one saponin. As used herein, the at least one saponin can include a single saponin or a plurality of saponins as the functional ingredient of the compositions provided herein. Saponins are glycoside natural plant products that include an aglycone ring structure and one or more sugar moieties. Non-limiting examples of specific saponins for use in particular embodiments of the disclosure include Group A acetyl saponins, Group B acetyl saponins, and Group E acetyl saponins. Several common sources of saponins include soybeans, soapwort plants (Saponaria, the roots of which have historically been used as soap) with about 5% saponin content by dry weight, as well as alfalfa, aloe, asparagus, grape, chickpea, yucca, and various other legumes and weeds. Saponins can be obtained from these sources by using extraction techniques well known to those of ordinary skill in the art. A description of conventional extraction techniques can be found in U.S. Patent Publication No. 20050123662.

[0098] In some embodiments, the total terpene content of the compositions of the present application is from about 0.01 wt% to about 5 wt%, or from about 0.05 wt% to about 4 wt%, or from about 0.1 wt% to about 3 wt%, or from about 0.5 wt% to about 2 wt%, or from about 1 wt% to about 1.5 wt%. In some embodiments, the total terpene dose of the compositions of the present application is from about 10 mg to about 1,000 mg, or from about 20 mg to about 800 mg, or from about 30 mg to about 600 mg, from about 40 mg to about 500 mg, from about 50 mg to about 400 mg, from about 60 mg to about 300 mg, from about 70 mg to about 250 mg, from about 80 mg to about 200 mg, or from about 90 mg to about 150 mg per serving.

[0099] Antioxidants

[0100] In certain embodiments, the functional ingredient is at least one antioxidant. As used herein, "antioxidant" refers to any substance that inhibits, suppresses, or reduces oxidative damage to cells and biomolecules.

[0101] Examples of suitable antioxidants for use in embodiments of the present disclosure include, but are not limited to, vitamins, vitamin cofactors, minerals, hormones, carotenoids, carotenoid terpenoids, non-carotenoid terpenoids, flavonoids, flavonoid polyphenols (e.g., bioflavonoids), flavonols, flavones, phenols, polyphenols, phenolic esters, polyphenolic esters, non-flavonoid phenols, isothiocyanates, and combinations thereof. In some embodiments, the antioxidant is vitamin A, vitamin C, vitamin E, ubiquinone, the mineral selenium, manganese, melatonin, oc-carotene, b-carotene, lycopene, lutein, zeaxanthin, crypoxanthin, resveratol, eugenol, quercetin, catechin, gossypol, hesperetin, epicatechin, curcumin, ferulic acid, thymol, hydroxytyrosol, turmeric, thyme, olive oil, lipoic acid, glutathinone, gutamine, oxalic acid, tocopherol-derived compounds, butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), ethylenediaminetetraacetic acid (EDTA), tertiary butylhydroquinone, acetic acid, pectin, tocotrienol, tocopherol, coenzyme Q10, zeaxanthin, astaxanthin, canthaxantin, saponins, limonin, kaempfedrol, myricetin, isorhamnetin, proanthocyanidins, quercetin, rutin, luteolin, apigenin, tangeritin, hesperetin, naringenin, erodictyol, flavan-3-ols (e.g., anthocyanidins), gallocatechin, epicatechin and its gallate forms, epigallocatechin and its gallate forms (ECGC), theaflavins and their gallate forms, thearubigins, isoflavones, phytoestrogens, genistein, daidzein, anthocyanins, cyaniding, delphinidin, malvidin, pelargonidin, procyanidins, ellagic acid, gallic acid, salicylic acid, rosmarinic acid, cinnamic acid and its derivatives (e.g., ferulic acid), chlorogenic acid, chicoric acid, gallotannins, ellagitannins, anthoxanthins, b- anthocyanins and other plant pigments, silymarin, citric acid, lignan, antinutrients, bilirubin, uric acid, R-oc-lipoic acid, N-acetyl cysteine, emblicanin, apple extract, apple peel extract (apple polyphenols), red rooibos extract, green rooibos extract,green), hawthorn berry extract, raspberry extract, green coffee antioxidant (GCA), aronia extract 20%, grape seed extract (i.e., VINOSEED), cocoa bean extract, hops extract, mangosteen extract, mangosteen hull extract, cranberry extract, pomegranate extract, pomegranate peel extract, pomegranate seed extract, hawthorn berry extract, pomella pomegranate extract, cassia bark extract, grape skin extract, blueberry extract, pine bark extract, bilberry extract, elderberry extract, mulberry root extract, gogi extract, blackberry extract, blueberry extract, blueberry leaf extract, raspberry extract, turmeric extract, citrus bioflavonoids, black currant, ginger, acai powder, green coffee bean extract, green tea extract, and phytic acid, or combinations thereof. In alternative embodiments, the antioxidant is a synthetic antioxidant, such as, for example, butylated hydroxytoluene or butylated hydroxyanisole. Other sources of suitable antioxidants for embodiments of the present disclosure include, but are not limited to, fruits, vegetables, tea, cocoa bean, chocolate, spices, herbs, rice, organ meat from domesticated animals, yeast, whole grains, or cereal grains.

[0102] Dietary Fiber

[0103] In certain embodiments, the functional ingredient is at least one dietary fiber. A wide variety of polymeric carbohydrates having significantly different structures in both composition and linkage fall within the definition of dietary fiber. Such compounds are well known to those skilled in the art, non-limiting examples of which include non-starch polysaccharides, lignin, cellulose, methylcellulose, hemicellulose, b-glucan, pectin, gum, mucilage, waxes, inulin, oligosaccharides, fructooligosaccharides, cyclodextrins, chitin, and combinations thereof. Although dietary fibers are generally derived from plant sources, indigestible animal products such as chitin are also classified as dietary fibers. Chitin is a polysaccharide composed of acetylglucosamine units linked by b(l-4) linkages similar to those of cellulose.

[0104] Fatty Acids

[0105] In certain embodiments, the functional ingredient is at least one fatty acid. As used herein, "fatty acid" refers to any straight-chain monocarboxylic acid and includes saturated fatty acids, unsaturated fatty acids, long-chain fatty acids, medium-chain fatty acids, short-chain fatty acids, fatty acid precursors (including omega-9 fatty acid precursors), and esterified fatty acids. As used herein, "long-chain polyunsaturated fatty acid" refers to any polyunsaturated carboxylic or organic acid having a long aliphatic tail. As used herein, "omega-3 fatty acid" refers to any polyunsaturated fatty acid having a first double bond as the third carbon-carbon bond from the terminal methyl end of its carbon chain. In particular embodiments, the omega-3 fatty acid can include a long-chain omega-3 fatty acid. As used herein, "omega-6 fatty acid" refers to any polyunsaturated fatty acid having a first double bond as the sixth carbon-carbon bond from the terminal methyl end of its carbon chain.

[0106] Suitable omega-3 fatty acids for use in embodiments of the present disclosure can be derived from, for example, algae, fish, animals, plants, or combinations thereof. Examples of suitable omega-3 fatty acids include, but are not limited to, linolenic acid, alpha-linolenic acid, eicosapentaenoic acid, docosahexaenoic acid, stearidonic acid, eicosatetraenoic acid, and combinations thereof. In some embodiments, suitable omega-3 fatty acids can be provided in fish oil (e.g., menhaden oil, tuna oil, salmon oil, bonito oil, and pollock oil), microalgal omega-3 oil, or combinations thereof. In particular embodiments, suitable omega-3 fatty acids can be derived from commercially available omega-3 fatty acid oils such as Microalgae DHA oil (from Martek, Columbia, MD), OmegaPure (from Omega Protein, Houston, TX), Marinol C-38 (from Lipid Nutrition, Channahon, IL), bonito oil and MEG-3 (from Ocean Nutrition, Dartmouth, NS), Evogel (from Symrise, Holzminden, Germany), marine oil from tuna or salmon (from Arista Wilton, CT), OmegaSource 2000, marine oil from menhaden, and marine oil from pollock (from OmegaSource, RTP, NC). Suitable omega-6 fatty acids include, but are not limited to, linoleic acid, gamma-linolenic acid, dihomo-gamma-linolenic acid, arachidonic acid, eicosadienoic acid, docosadienoic acid, adrenic acid, docosapentaenoic acid, and combinations thereof.

[0107] Suitable esterified fatty acids for use in embodiments of the disclosure include, but are not limited to, monoacylglycerols containing omega-3 and / or omega-6 fatty acids, diacylglycerols containing omega-3 and / or omega-6 fatty acids, or triacylglycerols containing omega-3 and / or omega-6 fatty acids, and combinations thereof.

[0108] Vitamins

[0109] In certain embodiments, the functional ingredient is at least one vitamin. Suitable vitamins include vitamin A, vitamin D, vitamin E, vitamin K, vitamin Bl, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B7, vitamin B9, vitamin B12, and vitamin C.

[0110] Various other compounds have been classified as vitamins by some authorities. These compounds can be referred to as pseudo-vitamins, and include, but are not limited to, compounds such as ubiquinone (coenzyme Q10), pantethine, dimethylglycine, taestrile, amygdalin, flavonoids, para-aminobenzoic acid, adenine, adenylic acid, and s-methylmethionine. As used herein, the term vitamin includes pseudo-vitamins. In some embodiments, the vitamin is a fat-soluble vitamin selected from the group consisting of vitamin A, vitamin D, vitamin E, vitamin K, and combinations thereof. In other embodiments, the vitamin is a water-soluble vitamin selected from the group consisting of vitamin Bl, vitamin B2, vitamin B3, vitamin B6, vitamin B12, folic acid, biotin, pantothenic acid, vitamin C, and combinations thereof.

[0111] Minerals

[0112] In certain embodiments, the functional ingredient is at least one mineral. In accordance with the teachings of the present disclosure, minerals include inorganic chemical elements required by living organisms. Minerals are composed of a wide range of compositions (e.g., elements, simple salts, and complex silicates) and crystal structures vary widely. They can occur naturally in foods and beverages, can be added as supplements, or can be consumed or administered separately from foods or beverages.

[0113] Minerals can be classified as bulk minerals, which are relatively large amounts needed, or trace minerals, which are relatively small amounts needed. The usual requirement for bulk minerals is greater than or equal to about 100 mg / day, and trace minerals are those with a requirement less than about 100 mg / day. In one embodiment, the minerals are selected from bulk minerals, trace minerals, or combinations thereof. Non-limiting examples of bulk minerals include calcium, chloride, magnesium, phosphorus, potassium, sodium, and sulfur. Non-limiting examples of trace minerals include chromium, cobalt, copper, fluoride, iron, manganese, molybdenum, selenium, zinc, and iodine. Although iodine is generally classified as a trace mineral, it is required in larger amounts than other trace minerals and is often classified as a bulk mineral.

[0114] In particular embodiments, the minerals are trace minerals that are considered essential for human nutrition, non-limiting examples of which include bismuth, boron, lithium, nickel, rubidium, silicon, strontium, tellurium, tin, titanium, tungsten, and vanadium.

[0115] The minerals presented herein can be in any form known to one of ordinary skill in the art. For example, in one embodiment, the minerals can be in ionic form, with a positive or negative charge. In another embodiment, the minerals can be in their molecular form. For example, sulfur and phosphorus are typically naturally occurring as sulfates, sulfides, and phosphates.

[0116] Preservatives

[0117] In certain embodiments, the functional ingredient is at least one preservative. In particular embodiments, the preservative is selected from an antimicrobial agent, an antioxidant, an anti-enzymatic agent, or a combination thereof. Non-limiting examples of antimicrobial agents include sulfites, propionates, benzoates, sorbates, nitrates, nitrites, bacteriocins, salts, sugars, acetic acid, dimethyl dicarbonate (DMDC), ethanol, and ozone. In one embodiment, the preservative is a sulfite. Sulfites include, but are not limited to, sulfur dioxide, sodium bisulfite, and potassium bisulfite. In another embodiment, the preservative is a propionate. Propionates include, but are not limited to, propionic acid, calcium propionate, and sodium propionate. In yet another embodiment, the preservative is a benzoate. Benzoates include, but are not limited to, sodium benzoate and benzoic acid. In still another embodiment, the preservative is a sorbate. Sorbates include, but are not limited to, potassium sorbate, sodium sorbate, calcium sorbate, and sorbic acid. In still another embodiment, the preservative is a nitrate and / or nitrite. Nitrates and nitrites include, but are not limited to, sodium nitrate and sodium nitrite. In another embodiment, the at least one preservative is a bacteriocin, such as, for example, nisin. In still another embodiment, the preservative is ethanol. In yet another embodiment, the preservative is ozone. Non-limiting examples of anti-enzymatic agents suitable for use as a preservative in particular embodiments of the present disclosure include ascorbic acid, citric acid, and metal chelators such as ethylenediaminetetraacetic acid (EDTA). In some embodiments, the present compositions are free or substantially free of preservatives.

[0118] Probiotic Bacteria

[0119] In certain embodiments, the functional ingredient is selected from at least one probiotic bacteria, a prebiotic, and combinations thereof. Probiotic bacteria are beneficial microorganisms that affect the naturally occurring microflora of the gastrointestinal tract of a human. Examples of probiotic bacteria include, but are not limited to, bacteria of the genus Lactobacilli, Bifidobacteria, Streptococci, or combinations thereof that confer a beneficial effect on a human. In particular embodiments of the present disclosure, the at least one probiotic bacteria is selected from the genus Lactobacilli. According to other particular embodiments of the present disclosure, the probiotic bacteria is selected from the genus Bifidobacteria. In particular embodiments, the probiotic bacteria is selected from the genus Streptococci.

[0120] Probiotic bacteria that can be used in accordance with the present disclosure are well known to those skilled in the art. Non-limiting examples of foods comprising probiotic bacteria include yogurt, sauerkraut, kefir, kimchi, fermented vegetables, and other foods containing microbial elements that beneficially affect a host animal by improving the intestinal microbalance.

[0121] In embodiments according to the present disclosure, prebiotics include, without limitation, mucopolysaccharides, oligosaccharides, polysaccharides, amino acids, vitamins, nutrient precursors, proteins, and combinations thereof. According to particular embodiments of the present disclosure, prebiotics are selected from dietary fibers, including, but not limited to, polysaccharides and oligosaccharides. Non-limiting examples of oligosaccharides classified as prebiotics according to particular embodiments of the present disclosure include fructooligosaccharides, inulin, isomalto- oligosaccharides, lactilol, lactulose, lactosucrose, pyrodextrin, soy oligosaccharides, transgalacto- oligosaccharides, and xylo-oligosaccharides. In other embodiments, prebiotics are amino acids. While many known prebiotics break down to provide carbohydrates for the prebiotic bacteria, some prebiotic bacteria also require amino acids to provide nutrients.

[0122] In some embodiments, the present compositions are free or substantially free of prebiotic bacteria.

[0123] Prebiotics

[0124] Prebiotics naturally occur in a variety of foods, including, without limitation, bananas, berries, asparagus, garlic, wheat, oats, barley (and other whole grains), flaxseed, tomatoes, Jerusalem artichokes, onions, and chicory, greens (e.g., dandelion greens, spinach, kale, beet greens, collard greens, mustard greens, turnip greens), and legumes (e.g., lentils, navy beans, chickpeas, navy beans, white beans, black beans). In some embodiments, the present compositions are free or substantially free of prebiotics.

[0125] Weight management agents

[0126] In certain embodiments, the functional ingredient is at least one weight management agent. As used herein, "weight management agent" includes appetite suppressants and / or thermogenic agents. As used herein, the phrases "appetite suppressant," "appetite satiation composition," "satiating agent," and "satiating ingredient" are synonymous. The phrase "appetite suppressant" describes macronutrients, herbal extracts, exogenous hormones, anorectics, anorexigenics, drugs, and combinations thereof that, when delivered in an effective amount, suppress, inhibit, reduce, or otherwise curtail a person's appetite. The phrase "thermogenic agent" describes macronutrients, herbal extracts, exogenous hormones, anorectics, anorexigenics, drugs, and combinations thereof that, when delivered in an effective amount, activate or otherwise enhance a person's thermogenesis or metabolism.

[0127] Suitable weight management agents include macronutrients selected from the group consisting of proteins, carbohydrates, dietary fats, and combinations thereof. Consumption of proteins, carbohydrates, and dietary fats stimulates the release of peptides that have appetite suppressant effects. For example, consumption of proteins and dietary fats stimulates the release of the gastrointestinal hormone cholecystokinin (CCK), while consumption of carbohydrates and dietary fats stimulates the release of glucagon-like peptide 1 (GLP-1).

[0128] Suitable macronutrient weight management agents also include carbohydrates. Carbohydrates generally include sugars, starches, celluloses, and gums that are converted by the body into glucose for energy. Carbohydrates are generally divided into two categories: digestible carbohydrates (e.g., monosaccharides, disaccharides, and starches) and indigestible carbohydrates (e.g., dietary fiber). Studies have shown that indigestible carbohydrates and complex polymeric carbohydrate with reduced absorption and digestibility within the small intestine stimulate physiological responses that inhibit food intake. Thus, the carbohydrates presented herein desirably include indigestible carbohydrates or carbohydrates with reduced digestibility. Non-limiting examples of such carbohydrates include polydextrose; inulin; monosaccharide-derived polyols such as erythritol, mannitol, xylitol, and sorbitol; disaccharide-derived alcohols such as isomaltitol, lactitol, and maltitol; and hydrogenated starch hydrolysates. Carbohydrates are described in more detail below.

[0129] Dietary Fats

[0130] In another particular embodiment, the weight management agent is a dietary fat. Dietary fats are lipids that comprise a combination of saturated and unsaturated fatty acids. Polyunsaturated fatty acids have been shown to have a greater satiety capacity than monounsaturated fatty acids. Accordingly, the dietary fats presented herein desirably include polyunsaturated fatty acids, non-limiting examples of which include triacylglycerols. In another particular embodiment, the weight management agent is a herbal extract. Extracts from multiple types of plants have been identified as having appetite suppressant properties. Non-limiting examples of plants whose extracts have appetite suppressant properties include plants of the genus Hoodia, the genus Trichocaulon, the genus Caralluma, the genus Stapelia, the genus Orbea, the genus Asclepias, and the genus Camelia. Other embodiments include extracts derived from Gymnema Sylvestre, Kola Nut, Citrus Auran tium, Yerba Mate, Griffonia Simplicifolia, guarana, myrrh, guggul Lipid, and black current seed oil.

[0131] In another embodiment, the weight management agent is a pharmaceutical. Non-limiting examples include phentenime, diethylpropion, benztropine, sibutramine, rimonabant, oxyntomodulin, fluoxetine hydrochloride, ephedrine, phenylalanine, or other stimulants.

[0132] Herbal Extracts

[0133] Herbal extracts can be prepared from any type of plant material or plant biomass. Non-limiting examples of plant material and biomass include stems, roots, leaves, dried powders obtained from plant material, and tree sap or dried tree sap. Herbal extracts are typically prepared by extracting tree sap from a plant and then spray drying the tree sap. Alternatively, solvent extraction procedures can be employed. Following initial extraction, it can be desirable to further fractionate the initial extract (e.g., by column chromatography) in order to obtain a herbal extract having enhanced activity. Such techniques are well known to those of ordinary skill in the art.

[0134] In one embodiment, the herbal extract is derived from a plant of the genus Opilia. The steroidal glycoside of the genus Opilia, referred to as P57, is believed to be responsible for the appetite suppressant effect of the Opilia species. In another embodiment, the herbal extract is derived from a plant of the genus Caralluma, non-limiting examples of which include caratuberside A, caratuberside B, bouceroside I, bouceroside II, bouceroside III, bouceroside IV, bouceroside V, bouceroside VI, bouceroside VII, bouceroside VIII, bouceroside IX, and bouceroside X. In another embodiment, the at least one herbal extract is derived from a plant of the genus Gymnogymnus. Gymnogymnus plants are succulents, native to South Africa, similar to Opilia, and include the species T. piliferum and T. officinale. In another embodiment, the herbal extract is derived from a plant of the genus Asclepias or Obeira. Without wishing to be bound by any theory, it is believed that the compounds that exhibit appetite suppressant activity are saponins, such as pregnane glycosides, which include stavaroside A, B, C, D, E, F, G, H, I, J, and K. In another embodiment, the herbal extract is derived from a plant of the genus Cynanchum. Without wishing to be bound by any theory, it is believed that these extracts contain steroidal compounds, such as pregnane glycosides and pregnane sapogenins, that have appetite suppressant effects. In another particular embodiment, the body weight management agent is an exogenous hormone that has a body weight management effect. Non-limiting examples of such hormones include CCK, peptide YY, ghrelin, bombesin, and gastrin-releasing peptide (GRP), enterostatin, apolipoprotein A-IV, GLP-1, amylin, somastatin, and leptin.

[0135] Osteoporosis management agent

[0136] In certain embodiments, the functional ingredient is at least one osteoporosis management agent. In certain embodiments, the osteoporosis management agent is at least one calcium source. According to particular embodiments, the calcium source is any compound containing calcium, including salt complexes, solubilizing substances, and other forms. Non-limiting examples of calcium sources include calcium amino acid chelate, calcium carbonate, calcium oxide, calcium hydroxide, calcium sulfate, calcium chloride, calcium phosphate, calcium phosphate dibasic, calcium phosphate monobasic, calcium citrate, calcium malate, calcium citrate malate, calcium gluconate, calcium tartrate, calcium lactate, solubilizing substances thereof, and combinations thereof.

[0137] According to particular embodiments, the osteoporosis management agent is a magnesium source. A magnesium source is any compound containing magnesium, including salt complexes, solubilizing agents, and other forms of magnesium. Non-limiting examples of magnesium sources include magnesium chloride, magnesium citrate, magnesium glucoheptonate, magnesium gluconate, magnesium lactate, magnesium hydroxide, magnesium picolate, magnesium sulfate, solubilizing agents thereof, and mixtures thereof. In another particular embodiment, the magnesium source includes an amino acid chelated magnesium or an amino acid formulation chelated magnesium.

[0138] In other embodiments, the osteoporosis agent is selected from the group consisting of vitamin D, vitamin C, vitamin K, precursors thereof, and / or beta-carotene, and combinations thereof.

[0139] A variety of plants and plant extracts have also been identified as effective for the prevention and treatment of osteoporosis. Non-limiting examples of suitable plants and plant extracts as osteoporosis management agents include species of Taraxacum and Amelanchier as disclosed in U.S. Patent Publication No. 2005 / 0106215, and species of the following genera: Lindera, Artemisia, Acorus, Carthamus, Carum, Cnidium, Curcuma, Cyperus, Juniperus, Prunus, Iris, Cichorium, Dodonaea, Epimedium, Erigonoum, Glycine, Mentha, Ocimum, thymus, Tanacetum, Plantago, Spearmint, Bixa, Vitis, Rosemarinus, Rhus, and Anethum as disclosed in U.S. Patent Application No. 2005 / 0079232.

[0140] Phytoestrogens

[0141] In certain embodiments, the functional ingredient is at least one phytoestrogen. Phytoestrogens are compounds that exist in plants, which can typically be delivered to the human body by ingesting plants or plant parts having phytoestrogens. As used herein, "phytoestrogen" means any substance that elicits any degree of estrogen-like effect when introduced into the body. For example, a phytoestrogen can bind to estrogen receptors in the body and have a small estrogen-like effect.

[0142] Examples of suitable phytoestrogens for use in embodiments of the present disclosure include, but are not limited to, isoflavones, stilbenes, lignans, resorcyclic acid lactones, coumestans, coumestrol, equol, and combinations thereof. Sources of suitable phytoestrogens include, but are not limited to, whole grains, cereals, fibers, fruits, vegetables, black cohosh, agave root, black currant, baneberry, chasteberries, cramp bark, dong quai root, devil's club root, false unicorn root, ginseng root, groundsel herb, licorice juice, liferoot, motherwort, peony root, raspberry leaf, rose family plants, sage leaf, sarsaparilla root, saw palmetto berry, wild yam root, yarrow flower, legumes, soybeans, soy products (e.g., miso, soy flour, soy milk, soy nuts, soy protein isolate, tempen, or tofu), chickpeas, nuts, lentils, seeds, clover, red clover, dandelion leaf, dandelion root, fenugreek seed, green tea, hops, red wine, flaxseed, garlic, onions, flaxseed, borage, butterfly weed, caraway, chastetree, vitex, dates, dill, fennel seed, goldenseal, milk thistle, monarda, pomegranate, wormwood, alfalfa, feverfew, and ginseng root (Panax ginseng), among others and combinations thereof.

[0143] Isoflavones belong to the polyphenol group as described above. Suitable phytoestrogen isoflavones according to embodiments of the present disclosure include genistein, daidzein, glycitein, biochanin A, formononetin, their respective naturally occurring glycosides and glycoside conjugates, martinusilanol, secoisolaricirecin, enterodiol, enterolactone, phytoestrogens, and combinations thereof. Suitable sources of isoflavones for use in embodiments of the present disclosure include, but are not limited to, soybeans, soy products, legumes, alfalfa sprouts, chickpeas, peanuts, and red clover.

[0144] Long chain aliphatic saturated primary alcohols

[0145] In some embodiments, the functional ingredient is at least one long-chain aliphatic saturated primary alcohol. Long-chain aliphatic saturated primary alcohols are organic compounds from a different group. The term alcohol refers to the fact that these compounds are characterized by a hydroxyl group (-OH) bonded to a carbon atom. Non-limiting examples of specific long-chain aliphatic saturated primary alcohols used in specific embodiments of this disclosure include 1-octanol (C8), 1-nonanol (C9), 1-decanol (C10), 1-dodecanol (C12), 1-tetradecanol (C14), 1-hexadecanol (C16), 1-octadecanol (C18), 1-eicosanool (C20), 1-docodecanol (C22), 1-tetracosanool (C24), 1-hexadecanol (C26), 1-heptadecanol (C27), 1-octanosol (C28), 1-nonadecanol (C29), 1-triacontanol (C30), 1-triadecanol (C32), and 1-triacontanol (C34).

[0146] In one embodiment, the long-chain aliphatic saturated primary alcohol is prilool. Prilool is a term relating to a mixture of long-chain aliphatic saturated primary alcohols consisting primarily of: 28-carbon 1-octacosanol and 30-carbon 1-triacontanol, as well as other alcohols in lower concentrations such as 22-carbon 1-docosahexacontanol, 24-carbon 1-tetracosanol, 26-carbon 1-hexacosanol, 27-carbon 1-heptacosanol, 29-carbon 1-nonacontanol, 32-carbon 1-trimosahexacontanol, and 34-carbon 1-trimosahexacontanol.

[0147] In some embodiments, the functional ingredient is at least one phytosterol, phytosterol, or a combination thereof. As used herein, the phrases “stand,” “plant stand,” and “phytostanol” are synonymous. Phytosterols and sterols are naturally found in small amounts in many fruits, vegetables, nuts, seeds, grains, legumes, vegetable oils, bark, and other plant sources. Sterols are a subgroup of steroidal compounds having a hydroxyl group at C-3. Typically, phytosterols have a double bond within the steroid nucleus, such as cholesterol; however, phytosterols may also contain a substituted side chain (R), such as an ethyl or methyl group, or an additional double bond at C-24. The structures of phytosterols are well known to those skilled in the art.

[0148] At least 44 naturally occurring phytosterols have been discovered and are typically derived from plants such as corn, soy, wheat, and tung oil; however, they can also be produced synthetically to form compositions identical to those found in nature or having properties similar to those of naturally occurring phytosterols. Non-limiting suitable phytosterols include, but are not limited to, 4-demethylsterols (e.g., b-sitosterol, campesterol, stigmasterol, brassicasterol, 22-dehydrobrassicasterol, and A5-avenasterol), 4-monomethylsterols, and 4,4-dimethylsterols (triterpenols) (e.g., cycloartanol, 24-methylene cycloartanol, and cyclobranol).

[0149] As used herein, the phrases "stanols," "plant stands," and "phytostanols" are synonymous. Phytostanols are saturated sterols that occur in nature only in trace amounts and can also be produced synthetically, such as by hydrogenation of phytosterols. Suitable phytostanols include, but are not limited to, b-sitostanol, campestanol, cycloartanol, and the saturated forms of other triterpenols.

[0150] As used herein, both phytosterols and phytostanols include a variety of isomers such as a and b isomers. The phytosterols and phytostanols of the present disclosure can also be in the form of their esters. Suitable methods for deriving esters of phytosterols and phytostanols are well known to those of ordinary skill in the art and are disclosed in U.S. Patent Nos. 6,589,588, 6,635,774, 6,800,317, and U.S. Patent Application No. 2003 / 0045473. Non-limiting examples of suitable esters of phytosterols and phytostanols include sitosteryl acetate, sitosteryl oleate, stigmasteryl oleate, and their corresponding phytostanol esters. The phytosterols and phytostanols of the present disclosure can also include derivatives thereof.

[0151] Other additives

[0152] Exemplary additives include, but are not limited to, carbohydrates, polyols, sugar acids and their corresponding salts, nucleotides, organic acids, inorganic acids, organic salts including organic acid salts and organic base salts, inorganic salts, bitter compounds, caffeine, flavorants and flavoring ingredients, astringent compounds, proteins or protein hydrolysates, surfactants, emulsifiers, plant extracts, flavonoids, alcohols, polymers, and combinations thereof.

[0153] In one embodiment, the composition further comprises one or more polyols. As used herein, the term "polyol" refers to a molecule containing more than one hydroxyl group. The polyol can be a diol, triol, or tetraol containing 2, 3, and 4 hydroxyl groups, respectively.

[0154] Polyols can also contain more than 4 hydroxyl groups, such as pentaols, hexaols, heptaols, etc., containing 5, 6, or 7 hydroxyl groups, respectively. Additionally, polyols can also be sugar alcohols, polyols, or polyols that are the reduced form of carbohydrates, where carbonyl groups (aldehyde or ketone, reducing sugars) have been reduced to primary or secondary hydroxyl groups. In some embodiments, non-limiting examples of polyols include maltitol, mannitol, sorbitol, lactitol, xylitol, isomalt, propylene glycol, glycerol (glycerin), threitol, galactitol, palatinose, reduced oligomeric isomaltulose, reduced oligomeric xylose, reduced oligomeric gentiobiose, reduced maltose syrup, reduced glucose syrup, and any other carbohydrate that is a sugar alcohol or can be reduced without adversely affecting taste.

[0155] Suitable sugar acid additives include, but are not limited to, aldonic acids, uronic acids, aldaric acids, alginic acid, gluconic acid, glucuronic acid, glucaric acid, galactaric acid, galacturonic acid, and salts thereof (e.g., sodium, potassium, calcium, magnesium, or other physiologically acceptable salts), and combinations thereof.

[0156] Suitable nucleotide additives include, but are not limited to, inosine monophosphate (IMP), guanosine monophosphate (GMP), adenosine monophosphate (AMP), cytosine monophosphate (CMP), uracil monophosphate (UMP), inosine diphosphate, guanosine diphosphate, adenosine diphosphate, cytosine diphosphate, uracil diphosphate, inosine triphosphate, guanosine triphosphate, adenosine triphosphate, cytosine triphosphate, uracil triphosphate, alkali metal or alkaline earth metal salts thereof, and combinations thereof. Nucleotides described herein can also include nucleotide-related additives, such as nucleosides or nucleic acid bases (e.g., guanine, cytosine, adenine, thymine, uracil).

[0157] Suitable organic acid additives include any compound comprising a -COOH moiety, such as, for example, C2-C30 carboxylic acids, substituted hydroxyl C2-C30 carboxylic acids, butyric acid (ethyl ester), substituted butyric acid (ethyl ester), benzoic acid, substituted benzoic acid (e.g., 2,4-dihydroxybenzoic acid), substituted cinnamic acid, hydroxyl acid, substituted hydroxyl benzoic acid, anisic acid substituted cyclohexyl carboxylic acid, tannic acid, aconitic acid, lactic acid, tartaric acid, citric acid, isocitric acid, gluconic acid, glucoheptonic acid, adipic acid, hydroxyl citric acid, malic acid, fruitaric acid (blend of malic acid, fumaric acid, and tartaric acid), fumaric acid, maleic acid, succinic acid, chlorogenic acid, salicylic acid, amino acid formulations, caffeic acid, bile acids, acetic acid, ascorbic acid, alginic acid, erythorbic acid, polyglutamic acid, gluconodeltalactone, and alkali or alkaline earth metal salt derivatives thereof. Additionally, the organic acid additives can be in either the D- or L-configuration. Suitable organic acid additive salts include, but are not limited to, sodium, calcium, potassium, and magnesium salts of all organic acids, such as citrate, malate, tartrate, fumarate, lactate (e.g., sodium lactate), alginates (e.g., sodium alginate), ascorbates (e.g., sodium ascorbate), benzoates (e.g., sodium or potassium benzoate), sorbates, and adipates. The examples of organic acid additives described can optionally be substituted with at least one group selected from hydrogen, alkyl, alkenyl, alkynyl, halogen, haloalkyl, carboxyl, acyl, acyloxy, amino, acylamino, carboxyl derivatives, alkylamino, dialkylamino, arylamino, alkoxy, aryloxy, nitro, cyano, sulfo, thiol, imine, sulfonyl, sulfenyl, sulfinyl, sulfamoyl, carboxalkoxy, carboxamido, phosphono, phosphinyl, phosphoryl, phosphino, thioester, thioether, anhydride, oximino, hydrazino, carbamoyl, phosphorus or phosphonate. In particular embodiments, the organic acid additive is present in the sweetener composition in an amount effective to provide a concentration of from about 10 ppm to about 5,000 ppm when present in a consumable, such as, for example, a beverage.

[0158] Suitable inorganic acid additives include, but are not limited to, phosphoric acid, phosphorous acid, polyphosphoric acid, hydrochloric acid, sulfuric acid, carbonic acid, sodium biphosphate, and alkali or alkaline earth metal salts thereof (e.g., myo-inositol hexaphosphate Mg / Ca).

[0159] Suitable bitter compound additives include, but are not limited to, caffeine, quinine, urea, bitter orange oil, naringin, quassia, and salts thereof.

[0160] Suitable flavoring agents and flavoring ingredient additives include, but are not limited to, vanillin, vanilla extract, mango extract, cinnamon, citrus, coconut, ginger, viridiflorol, almond, menthol (including menthol without mint), grape skin extract, and grape seed extract. "Flavoring agent" and "flavoring ingredient" are synonymous and can include natural or synthetic substances or combinations thereof. Flavoring agents also include any other substance that imparts flavor and can include natural or non-natural (synthetic) substances that are safe for use in humans or animals when used within generally accepted ranges. Non-limiting examples of proprietary flavoring agents include DOHLER™ natural flavoring sweetness enhancer K14323 (DOHLER™, Darmstadt, Germany), Symrise™ sweetness natural flavor masking agents 161453 and 164126 (SYMRISE™, Holzminden, Germany), Natural Advantage™ bitter blocking agents 1, 2, 9, and 10 (Natural Advantage™, Freehold, New Jersey, U.S.A.), and SUCRAMASK™ (Creative Research Management, Stockton, California, U.S.A.). Suitable polymeric additives include, but are not limited to, chitosan, pectin, pectic acid, pectinic acid, polyuronide, polygalacturonide, starch, food hydrocolloids or crude extracts thereof (e.g., FIBERGUM™, Senegalia senegal gum, carrageenan gum), poly-L-lysine (e.g., poly-L-a-lysine or poly-L-e-lysine), poly-L-ornithine (e.g., poly-L-a-ornithine or poly-L-e-ornithine), polypropylene glycol, polyethylene glycol, poly(ethylene glycol methyl ether), polyarginine, polyaspartic acid, polyglutamic acid, polyethyleneimine, alginic acid, sodium alginate, propylene glycol alginate, and polyethylene glycol sodium alginate, sodium hexametaphosphate and salts thereof, and other cationic and anionic polymers.

[0161] Suitable protein or protein hydrolysate additives include, but are not limited to, bovine serum albumin (BSA), whey protein (including fractions or concentrates thereof, such as 90% instant whey protein isolate, 34% whey protein, 50% hydrolyzed whey protein, and 80% whey protein concentrate), soluble rice protein, soy protein, protein isolates, protein hydrolysates, reaction products of protein hydrolysates, glycoproteins, and / or proteoglycans containing amino acids (e.g., glycine, alanine, serine, threonine, asparagine, glutamine, arginine, valine, isoleucine, leucine, norvaline, methionine, proline, tyrosine, hydroxyproline, etc.), collagen (e.g., gelatin), partially hydrolyzed collagen (e.g., hydrolyzed fish collagen), and collagen hydrolysates (e.g., porcine collagen hydrolysate).

[0162] Suitable surfactant additives include, but are not limited to, polysorbates (e.g., polyoxyethylene sorbitan monooleate (polysorbate 80), polysorbate 20, polysorbate 60), sodium dodecylbenzenesulfonate, dioctyl sulfosuccinate or sodium dioctyl sulfosuccinate, sodium dodecyl sulfate, cetylpyridinium chloride (cetylpyridinium hexadecylridinium chloride), cetyltrimethylammonium bromide, sodium cholate, camphoramide, choline chloride, sodium glycocholate, sodium taurodeoxycholate, lauroyl arginate, sodium stearyl fumarate, sodium taurocholate, lecithin, sucrose oleate, sucrose stearate, sucrose palmitate, sucrose laurate, and other emulsifiers, etc.

[0163] Suitable flavonoid additives are classified as flavonols, flavones, flavanones, flavan-3-ols, isoflavones, or anthocyanidins. Non-limiting examples of flavonoid additives include, but are not limited to, catechins (e.g., green tea extract, such as Polyphenon™ 60, Polyphenon™ 30, and Polyphenon™ 25 (Mitsui Norin Co., Ltd., Japan)), polyphenols, rutin (e.g., enzyme-modified rutin Sanmelin™ AO (San-fi Gen F.F.I., Inc., Osaka, Japan)), neohesperidin, naringin, neohesperidin dihydrochalcone, etc. Suitable alcohol additives include, but are not limited to, ethanol.

[0164] Suitable astringent compound additives include, but are not limited to, tannic acid, europium chloride (EuCl3), gadolinium chloride (GdCl3), terbium chloride (TbCl3), alum, tannic acid, and polyphenols (e.g., tea polyphenols).

[0165] Sources of selected ingredients

[0166] In general, the caffeine and gamma-aminobutyric acid of the present compositions can be derived from any source that exists in nature or synthetically. In some embodiments, the caffeine and / or gamma-aminobutyric acid introduced into the present compositions is extracted from a plant and exists in a relatively pure form. In other embodiments, the caffeine and / or gamma-aminobutyric acid is derived from a synthetic source that is food grade or equivalent thereof. Examples of methods for synthesizing, producing, extracting, purifying caffeine and / or gamma-aminobutyric acid are generally known in the art. In some embodiments, the source of caffeine and GABA can be the same. In other embodiments, the caffeine and GABA are derived from different sources.

[0167] Alternatively, the caffeine and / or gamma-aminobutyric acid can be introduced into the present compositions by incorporating a component containing the desired amount of caffeine and / or gamma-aminobutyric acid into the present compositions. Components containing caffeine, gamma-aminobutyric acid, or both include, but are not limited to, tea (such as green tea, white tea, oolong tea, black tea), cocoa, guarana, or any combination thereof.

[0168] In some embodiments, the present compositions comprise a plant, or a portion thereof, or a product thereof, or an extract or juice thereof, wherein the plant contains caffeine, or gamma-aminobutyric acid, or both.

[0169] In some embodiments, the gamma-aminobutyric acid is derived from a natural resource selected from the group consisting of a vegetable or fruit, a legume, a fermented product, a cereal, a tea, or a combination thereof.

[0170] Coffee and tea products

[0171] In some embodiments, the present compositions comprise a coffee product. Non-limiting examples of coffee products include: coffee extract, coffee extract, coffee bean extract, coffee berry extract, coffee pulp extract, coffee berry juice, espresso, dried coffee, instant coffee, coffee oil, coffee essence, dried green coffee extract, wet green coffee extract, powdered coffee, ground coffee, roasted coffee, roasted and ground coffee, or any combination thereof.

[0172] In one particular embodiment, the present compositions comprise a coffee fruit (also known as coffee berry or coffee cherry), or a portion thereof, product thereof, extract thereof, or juice thereof. In some embodiments, the coffee fruit is selected from the group consisting of Arabica coffee or a derivative thereof, Canephora coffee or a derivative thereof, or any combination thereof. Products of coffee fruit are a natural source of both caffeine and phenolic acids, including chlorogenic acid, caffeic acid, ferulic acid, isoferulic acid, dihydroferulic acid, quinic acid, or a combination thereof.

[0173] Coffee fruit products for use in the compositions of the present application include, but are not limited to, liquid coffee fruit extract, dried coffee fruit, coffee fruit powder, concentrated coffee fruit juice, non-concentrated (non-concentrate) coffee fruit juice, full-press coffee berry juice. Examples of coffee fruit extract and coffee fruit juice and methods of making the same can be found in WO 2021055757, which is incorporated by reference herein in its entirety.

[0174] In some embodiments, the coffee fruit juice product has a caffeine content from about 0.002 wt% to about 5 wt%, or from about 0.05 wt% to about 4 wt%, or from about 0.1 wt% to about 3 wt%, or from about 0.5 wt% to about 2 wt%, or from about 1 wt% to about 1.5 wt%. In some embodiments, the coffee fruit juice product has a gamma-aminobutyric acid content of about 0.001 wt% to about 0.1 wt%, or from about 0.005 wt% to about 0.05 wt%, or from about 0.01 wt% to about 0.02 wt%.

[0175] In some embodiments, the composition of the present application comprises a tea product selected from the group of instant tea product, fermented tea, tea extract, concentrated tea, dried tea, tea leaf, tea essence, white tea, black tea, oolong tea, green tea or extract thereof, or any combination thereof.

[0176] Beverage

[0177] In some embodiments, the composition is a beverage selected from the group of non-carbonated beverage, carbonated beverage, juice beverage, juice, coffee beverage, tea beverage, milk beverage, dairy beverage, plant protein drink, plant-based beverage, sports drink, energy drink.

[0178] As used herein, a “beverage” is a ready-to-drink beverage. Suitable ready-to-drink beverages include carbonated beverages and non-carbonated beverages. Carbonated beverages include, but are not limited to, soft drinks, colas, lemon-lime flavored sparkling beverages, orange flavored sparkling beverages, grape flavored sparkling beverages, strawberry flavored sparkling beverages, pineapple flavored sparkling beverages, ginger ales, soft drinks, root beers, and malt beverages.

[0179] Non-carbonated beverages include, but are not limited to, juices, fruit-flavored juices, juice drinks, nectars, vegetable juices, vegetable-flavored juices, sports drinks, energy drinks, protein drinks, enhanced waters with vitamins, near water drinks (e.g., water with natural or synthetic flavorings), coconut water, tea types (e.g., black tea, green tea, red tea, oolong tea), coffee, cocoa drinks, beverages containing dairy components (e.g., milk beverages, coffee with dairy components, café au lait, milk tea, fruit milk beverages), beverages containing cereal extracts, smoothies, and combinations thereof.

[0180] The beverage contains a liquid base, i.e., a base ingredient in which these ingredients, including the caffeine and gamma-aminobutyric acid of the present disclosure, are dissolved. In one embodiment, the liquid base is water of beverage quality, such as, for example, deionized water, distilled water, reverse osmosis water, carbonated water, purified water, softened water, and combinations thereof can be used. Additional suitable liquid bases include, but are not limited to, phosphoric acid, phosphate buffer, citric acid, citrate buffer, and carbonated water.

[0181] In one embodiment, the beverage contains inclusions, i.e., fruit pieces, seeds, chunks, and the like.

[0182] The beverage can further comprise additives including, but not limited to, carbohydrates, polyols, amino acids and their corresponding salts, polyamino acids and their corresponding salts, sugar acids and their corresponding salts, nucleotides, organic acids, inorganic acids, organic salts (including organic acid salts and organic base salts), inorganic salts, bitter compounds, caffeine, flavorants and flavoring ingredients, astringent compounds, proteins or protein hydrolysates, surfactants, emulsifiers, weight agents, juices, dairy products, cereal and other plant extracts, flavonoids, alcohols, polymers, and combinations thereof. Any suitable additive described herein can be used.

[0183] The beverage can further contain one or more additives and / or functional ingredients described above. Functional ingredients include, but are not limited to, vitamins, minerals, antioxidants, preservatives, glucosamine, and combinations thereof. Any suitable functional ingredient described herein can be used.

[0184] It is contemplated that the pH of the beverage does not substantially or adversely affect the cognitive / alertness enhancement. Non-limiting examples of a pH range of the beverage can be from about 1.8 to about 10. Another example includes a pH range of from about 2 to about 5. In particular embodiments, the pH of the beverage can be from about 2.5 to about 4.2. Those skilled in the art will appreciate that the pH of the beverage can vary based on the type of beverage. For example, a dairy beverage can have a pH greater than 4.2.

[0185] The titratable acidity of the beverage can be, for example, in the range of from about 0.01 wt% to about 1.0 wt% by weight of the beverage.

[0186] In one embodiment, the sparkling beverage product has an acidity of from about 0.01 wt% to about 1.0 wt% by weight of the beverage, such as, for example, from about 0.05 wt% to about 0.25 wt% by weight of the beverage.

[0187] The carbonation of the sparkling beverage product has from 0 to about 2% (w / w), such as, for example, from about 0.1% to about 1.0% (w / w) carbon dioxide or its equivalent.

[0188] The temperature of the beverage can be, for example, in the range from about 4°C to about 100°C, such as, for example, from about 4°C to about 25°C.

[0189] The beverage can be a full calorie beverage having up to about 120 calories per 8 ounce serving. The beverage can be a medium calorie beverage having up to about 60 calories per 8 ounce serving. The beverage can be a low calorie beverage having up to about 40 calories per 8 ounce serving. The beverage can be a zero calorie beverage having less than about 5 calories per 8 ounce serving.

[0190] In some embodiments, the disclosure relates to a beverage comprising gamma-aminobutyric acid and caffeine: wherein the beverage comprises from about 0.002 wt% to about 5 wt% caffeine; and from about 0.01 wt% to about 2.5 wt% gamma-aminobutyric acid, wherein the weight ratio of gamma-aminobutyric acid to caffeine of the beverage is from about 1 : 50 to about 10 : 1.

[0191] Edible gel mixtures and edible gel compositions

[0192] In one embodiment, the composition of the present invention is an edible gel or an edible gel mixture.

[0193] An edible gel is a gel that can be eaten. A gel is a colloidal system in which a network of particles spans the volume of a liquid medium. Although a gel is primarily composed of a liquid and thus exhibits a density similar to a liquid, a gel has the structural coherence of a solid due to the network of particles spanning the liquid medium. For this reason, a gel often appears to be a solid, jelly-like material. Gels can be used in a variety of applications. For example, gels can be used in food, pigments, and adhesives.

[0194] Non-limiting examples of edible gel compositions for particular embodiments include gelatin desserts, puddings, jellies, pastes, cakes, aspics, marshmallows, gummy candies, and the like. The edible gel mixture is typically a powdery or granular solid to which a fluid can be added to form the edible gel composition. Non-limiting examples of fluids for use in particular embodiments include water, dairy fluid, dairy analog fluid, fruit juice, alcohol, alcoholic beverage, and combinations thereof. Non-limiting examples of dairy fluids that can be used in particular embodiments include milk, yogurt, cream, fluid whey, and mixtures thereof. Non-limiting examples of dairy analog fluids that can be used in particular embodiments include, for example, soy milk and non-dairy coffee whitener. Because edible gel products visible in the market are typically sweetened with sucrose, it is desirable to sweeten edible gels with alternative sweeteners in order to provide low calorie or calorie free alternatives.

[0195] As used herein, the term "gelling ingredient" means any material that can form a colloidal system within a liquid medium. Non-limiting examples of gelling ingredients for use in particular embodiments include gelatin, alginate, carrageenan, gum, pectin, konjac gum, agar, food acid, rennet, starch, starch derivatives, and combinations thereof. It is well known to one of ordinary skill in the art that the amount of gelling ingredient used in an edible gel mixture or an edible gel composition is appropriately varied depending on a variety of factors, such as the particular gelling ingredient used, the particular base liquid used, and the desired gel properties.

[0196] Non-limiting examples of other ingredients for use in particular embodiments include a food acid, a food acid salt, a buffering system, an expanding agent, a chelating agent, a cross-linking agent, one or more flavoring agents, one or more colorants, and combinations thereof. Non-limiting examples of food acids for use in particular embodiments include citric acid, adipic acid, fumaric acid, lactic acid, malic acid, and combinations thereof. Non-limiting examples of food acid salts for use in particular embodiments include sodium salts of food acids, potassium salts of food acids, and combinations thereof. Non-limiting examples of expanding agents for use in particular embodiments include raftilose, isomaltitol, sorbitol, polydextrose, maltodextrin, and combinations thereof. Non-limiting examples of chelating agents for use in particular embodiments include calcium disodium ethylenediaminetetraacetate, glucono delta-lactone, sodium gluconate, potassium gluconate, ethylenediaminetetraacetic acid (EDTA), and combinations thereof. Non-limiting examples of cross-linking agents for use in particular embodiments include calcium ions, magnesium ions, sodium ions, and combinations thereof.

[0197] Confectionery

[0198] In one embodiment, the composition of the present application is a confectionery.

[0199] As referred to herein, a "confectionery" can mean a candy, lollie, bakery confectionery, or similar term. Confectionery typically contains a base composition component and a sweetener component. Confectionery can be in the form of any food that is typically considered to be sugar-rich or typically sweet. According to particular embodiments of the present disclosure, confectionery can be a baked good, such as a bakery confectionery; a dessert, such as a yogurt, a jelly, a drinkable jelly, a pudding, a Bavarian cream, a custard, a cake, a brownie, a mousse, and the like, a sweetened food product that is consumed at tea time or after a meal; a frozen food; a cold confectionery, for example, an ice cream type, such as ice cream, ice milk, lacto-ice, and the like (a food product in which a sweetener and various other types of ingredients are added to a dairy product and the resulting mixture is agitated and frozen), and a frozen confectionery, such as a sherbet, a dessert ice, and the like (a food product in which various other types of ingredients are added to a sugar-containing liquid and the resulting mixture is agitated and frozen); a general confectionery, for example, a baked confectionery or a steamed confectionery, such as a biscuit, a cookie, a muffin with a jam filling, a sesame candy, an alfajor, and the like; a rice cake and a snack; a table top product; a general sugar confectionery, such as a chewing gum (for example, including a composition containing a substantially water-insoluble, chewable gum base, such as chicle or a substitute thereof, including jetulong, guttakay rubber, or some edible natural synthetic resin or wax), a hard candy, a soft candy, a mint, a nougat, a praline, a fudge, a cream fudge, a butter cream, a toffee, a Swiss tablet, a liquorice, a chocolate, a jelly, a marshmallow, a divinity, a fondant, and the like; a sauce, including a fruit-flavored sauce, a chocolate sauce, and the like; an edible gel; a dairy cream, including a butter cream, a flour paste, a whipped cream, and the like; a jam, including a strawberry jam, an orange marmalade, and the like; and a bread, including a sweet bread and the like or other starch products, and combinations thereof.

[0200] As referred to herein, a "base composition" means any composition that can be a food and provides a matrix for carrying a sweetener component.

[0201] Suitable base compositions for use in embodiments of the present disclosure can include flour, yeast, water, salt, butter, eggs, milk, milk powder, spirits, gelatin, nuts, chocolate, citric acid, tartaric acid, fumaric acid, natural flavoring, artificial flavoring, color, polyol, sorbitol, isomalt, maltitol, lactitol, malic acid, magnesium stearate, lecithin, hydrogenated glucose syrup, glycerol, natural or synthetic gum, starch, and the like, and combinations thereof. Such components are generally regarded as safe (GRAS) and / or approved by the U.S. Food and Drug Administration (FDA). According to particular embodiments of the present application, the base composition is present in the confectionery in an amount ranging from about 0.1 wt% to about 99 wt% by weight of the confectionery.

[0202] The base composition of the confectionery can optionally include other artificial or natural sweeteners, bulking sweeteners, or combinations thereof. Bulking sweeteners include both caloric and non-caloric compounds. Non-limiting examples of bulking sweeteners include sucrose, dextrose, maltose, dextrin, dried invert sugar, fructose, high fructose corn syrup, levulose, galactose, corn syrup solids, tagatose, polyols (e.g., sorbitol, mannitol, xylitol, lactitol, erythritol, and maltitol), hydrogenated starch hydrolysate, isomalt, trehalose, and mixtures thereof. Generally, the amount of bulking sweetener present in the confectionery varies widely depending on the particular embodiment of the confectionery and the desired sweetness. One of ordinary skill in the art will readily determine the appropriate amount of bulking sweetener.

[0203] Condiment composition

[0204] In one embodiment, the present composition is a condiment. In another embodiment, the condiment comprises a composition of the present disclosure. As used herein, a condiment is a composition used to enhance or improve the flavor of a food or beverage. Non-limiting examples of condiments include ketchup (catsup); mustard; barbecue sauce; butter; chili sauce; hot sauce; cocktail sauce; curry; dip; fish sauce; horseradish; hot sauce; jelly, jam, marmalade, or preserve; mayonnaise; peanut butter; relish; remoulade; salad dressing (e.g., vinaigrette, Caesar dressing, French dressing, ranch dressing, blue cheese dressing, Russian dressing, Thousand Island dressing, Italian dressing, and Italian black dressing), salsa; sauerkraut; soy sauce; steak sauce; syrup; tarragon sauce; and Worcestershire sauce.

[0205] Seasoning bases typically comprise a mixture of different ingredients, non-limiting examples of which include vehicles (e.g., water and vinegar); spices or seasonings (e.g., salt, pepper, garlic, mustard seed, onion, chili pepper, turmeric, and combinations thereof); fruits, vegetables, or products thereof (e.g., tomato or tomato-based products (pastes, purees), fruit juices, fruit juice peels, and combinations thereof); oils or oil emulsions, particularly vegetable oils; thickening agents (e.g., xanthan gum, food starch, other hydrocolloids, and combinations thereof); and emulsifiers (e.g., egg yolk solids, proteins, gum arabic, gum karaya, guar gum, gum karite, gum tragacanth, carrageenan, pectin, propylene glycol esters of alginic acid, sodium carboxymethylcellulose, polysorbate esters, and combinations thereof). Formulations of seasoning bases and methods of preparing seasoning bases are well known to those of ordinary skill in the art.

[0206] Typically, seasonings also comprise caloric sweeteners, such as sucrose, high fructose corn syrup, molasses, honey, or brown sugar. In exemplary embodiments of the seasonings provided herein, the compounds of the present application or compositions comprising the compounds of the present application are used in place of traditional caloric sweeteners. Thus, the seasoning compositions desirably comprise the compounds of the present application or compositions comprising the compounds of the present application and a seasoning base.

[0207] The seasoning compositions can optionally comprise other natural and / or synthetic high-potency sweeteners, bulk sweeteners, pH modifiers (e.g., lactic acid, citric acid, phosphoric acid, hydrochloric acid, acetic acid, and combinations thereof), fillers, functional agents (e.g., pharmaceutical agents, nutrients, or components of food or plants), flavorants, colorants, or combinations thereof.

[0208] Chewing gum compositions

[0209] In one embodiment, the compositions of the present application are chewing gums. In another embodiment, the chewing gum compositions comprise the compositions of the present application. Chewing gum compositions typically comprise a water-soluble portion and a water-insoluble chewy gum base portion. The water-soluble portion, which typically comprises the compositions of the present application, dissipates over time during mastication with a portion of the flavoring agent while the insoluble gum base portion remains in the mouth. The insoluble gum base typically determines whether the gum is considered a chewing gum, bubble gum, or functional chewing gum.

[0210] The insoluble gum base is typically present in the chewing gum composition in an amount ranging from about 15 wt% to about 35 wt% of the chewing gum composition, which typically comprises a combination of elastomers, softeners (plasticizers), emulsifiers, resins, and fillers. Such components are typically considered food grade, Generally Recognized as Safe (GRAS) and / or approved by the U.S. Food and Drug Administration (FDA).

[0211] Elastomers (the primary component of the gum base) provide the gum with rubbery cohesive properties and can include one or more of natural rubbers (e.g., smoked latex, liquid latex, or guayule); natural gums (e.g., jelutong, perillo, sorva, chicle, chocolate chicle, nispero, rosindinha, sugar gum, and maleic latex); or synthetic elastomers (e.g., butadiene-styrene copolymer, isobutylene-isoprene copolymer, polybutadiene, polyisobutylene, and vinyl polymer elastomers). In particular embodiments, the elastomers are present in the gum base in an amount in the range of about 3 wt% to about 50 wt% of the gum base.

[0212] Resins are used to alter the firmness of the gum base and help soften the elastomer component of the gum base. Non-limiting examples of suitable resins include rosin esters, terpene resins (e.g., terpene resins from a-pinene, b-pinene, and / or d-limonene), polyvinyl acetate, polyvinyl alcohol, ethylene vinyl acetate, and vinyl acetate-ethylene laurate copolymer. Non-limiting examples of rosin esters include glycerol esters of partially hydrogenated rosin, glycerol esters of polymerized rosin, glycerol esters of partially dimerized rosin, gum rosin, pentaerythritol esters of partially hydrogenated rosin, methyl esters of rosin, or methyl esters of partially hydrogenated rosin. In particular embodiments, the resins are present in the gum base in an amount in the range of about 5 wt% to about 75 wt% of the gum base.

[0213] Softeners, also known as plasticizers, are used to alter chewability and / or mouthfeel of the chewing gum composition. Generally, softeners include oils, fats, waxes, and emulsifiers. Non-limiting examples of oils and fats include tallow, hydrogenated tallow, large hydrogenated or partially hydrogenated vegetable oils (e.g., soybean oil, rapeseed oil, cottonseed oil, sunflower oil, palm oil, coconut oil, corn oil, safflower oil, or palm kernel oil), cocoa butter, glycerol monostearate, glyceryl triacetate, gum rosin, leithin, monoglycerides, diglycerides, triglycerides, acetylated monoglycerides, and free fatty acids. Non-limiting examples of waxes include polypropylene / polyethylene / Fischer-Tropsch wax, paraffin wax, and microcrystalline wax and natural waxes (e.g., candelilla wax, beeswax, and palm wax). Microcrystalline waxes, especially those with high crystallinity and high melting points, can also be considered as thickening agents or structure modifiers. In particular embodiments, the softeners are present in the gum base in an amount in the range of about 0.5 wt% to about 25 wt% of the gum base.

[0214] Emulsifiers are used to form a uniform dispersion of the insoluble and soluble phases of the chewing gum composition and also have plasticizing properties. Suitable emulsifiers include glycerol monostearate (GMS), lecithin (phosphatidylcholine), polyglycerol polyricinoleic acid (PPGR), mono- and di-glycerides of fatty acids, glycerol distearate, triacetin, acetylated monoglycerides, glycerol triacetate, and magnesium stearate. In particular embodiments, the emulsifier is present in the gum base in an amount ranging from about 2 wt% to about 30 wt% of the gum base.

[0215] The chewing gum composition can also include an adjuvant or bulking agent in the gum base and / or soluble portion of the chewing gum composition. Suitable adjuvants and bulking agents include lecithin, inulin, polydextrose, calcium carbonate, magnesium carbonate, magnesium silicate, limestone powder, aluminum hydroxide, aluminum silicate, talc, clay, aluminum oxide, titanium dioxide, and calcium phosphate. In particular embodiments, lecithin can be used as an inert bulking agent to reduce the viscosity of the chewing gum composition. In other particular embodiments, lactic acid copolymer, protein (e.g., gluten and / or zein), and / or guar gum can be used to produce a more biodegradable chewing gum. The adjuvant or bulking agent is typically present in the gum base in an amount up to about 20 wt% of the gum base. Other optional ingredients include colorants, whitening agents, preservatives, and flavoring agents.

[0216] In particular embodiments of the chewing gum composition, the gum base comprises from about 5 wt% to about 95 wt% of the chewing gum composition, more desirably from about 15 wt% to about 50 wt% of the chewing gum composition, and even more desirably from about 20 wt% to about 30 wt% of the chewing gum composition.

[0217] The soluble portion of the chewing gum composition can optionally include other artificial or natural sweeteners, bulk sweeteners, softening agents, emulsifiers, flavoring agents, colorants, adjuvants, bulking agents, functional agents (e.g., pharmaceutical or nutritional agents), or combinations thereof. Examples of suitable softening agents and emulsifiers are described above.

[0218] Bulk sweeteners include both caloric and non-caloric compounds. Non-limiting examples of bulk sweeteners include sucrose, dextrose, maltose, dextrin, dried invert sugar, fructose, high fructose corn syrup, levulose, galactose, corn syrup solids, tagatose, polyols (e.g., sorbitol, mannitol, xylitol, lactitol, erythritol, and maltitol), hydrogenated starch hydrolysate, isomalt, trehalose, and mixtures thereof. In particular embodiments, the bulk sweetener is present in the chewing gum composition in an amount ranging from about 1 wt% to about 75 wt% of the chewing gum composition.

[0219] Flavoring agents can be used in the insoluble gum base or soluble portion of the chewing gum composition. Such flavoring agents can be natural or artificial flavorings. In particular embodiments, the flavoring agents include essential oils, such as oils derived from plants or fruits, peppermint oil, spearmint oil, other mint oils, clove oil, cinnamon oil, wintergreen oil, bay oil, thyme oil, cedar leaf oil, mace, allspice, sage oil, mace oil, and almond oil. In another particular embodiment, the flavoring agents include plant extracts or fruit essences, such as apple, banana, watermelon, pear, peach, grape, strawberry, raspberry, cherry, plum, pineapple, apricot, and mixtures thereof. In yet another particular embodiment, the flavoring agents include citrus flavoring, such as extracts, essences, or oils of lemon, lime, orange, tangerine, grapefruit, quince, or kumquat.

[0220] Cereal composition

[0221] In one embodiment, the composition of the present application is a cereal composition. In another embodiment, the present disclosure relates to a cereal composition comprising a composition comprising gamma-aminobutyric acid and caffeine. Cereal compositions are typically consumed as a main meal or as a snack. Non-limiting examples of cereal compositions for use in particular embodiments include ready-to-eat cereals and hot cereals. Ready-to-eat cereals are cereals that can be consumed without further processing by the consumer (i.e., cooking). Examples of ready-to-eat cereals include breakfast cereals and snack bars. Breakfast cereals are typically processed to produce a shredded, flaked, puffed, or extruded form. Breakfast cereals are usually eaten cold and are often mixed with milk and / or fruit. Snack bars include, for example, energy bars, rice cakes, granola bars, and nutrition bars. Hot cereals are usually cooked in milk or water before consumption. Non-limiting examples of hot cereals include rolled oats, porridge, polenta, rice, and oatmeal.

[0222] Cereal compositions typically comprise at least one cereal ingredient. As used herein, the term "cereal ingredient" refers to materials such as whole or partial grains, whole or partial seeds, and whole or partial grasses. Non-limiting examples of cereal ingredients for use in particular embodiments include corn, wheat, rice, barley, bran, bran endosperm, bulgur, sorghum, millet, oats, rye, triticale, buckwheat, fonio, quinoa, beans, soybeans, amaranth, teff, spelt, and kaniwa.

[0223] In particular embodiments, the cereal composition comprises gamma-aminobutyric acid and caffeine according to the present disclosure, or comprises a composition comprising gamma-aminobutyric acid and caffeine and at least one cereal ingredient. The composition comprising gamma-aminobutyric acid and caffeine can be added to the cereal composition in a variety of ways, for example as a coating, as a glaze, as a syrup, or as a base blend (i.e., as an ingredient to a cereal formulation prior to preparation of the final cereal product).

[0224] Thus, in particular embodiments, the gamma-aminobutyric acid and caffeine or the composition comprising gamma-aminobutyric acid and caffeine is added to the cereal composition as a base blend. In one embodiment, the gamma-aminobutyric acid and caffeine or the composition comprising gamma-aminobutyric acid and caffeine is blended with the cereal prior to cooking to provide a cereal product. In another embodiment, the gamma-aminobutyric acid and caffeine or the composition comprising gamma-aminobutyric acid and caffeine is blended with the cereal base prior to extruding the cereal.

[0225] In another particular embodiment, the gamma-aminobutyric acid and caffeine or the composition comprising gamma-aminobutyric acid and caffeine is added to the cereal composition as a coating, for example like by combining the gamma-aminobutyric acid and caffeine or the composition comprising gamma-aminobutyric acid and caffeine with a food grade oil and applying the mixture to the cereal. In different embodiments, the gamma-aminobutyric acid and caffeine or the composition comprising gamma-aminobutyric acid and caffeine and the food grade oil can be applied separately to the cereal by first applying the oil or sweetener. Non-limiting examples of food grade oils for particular embodiments include vegetable oils, such as corn oil, soybean oil, cottonseed oil, peanut oil, coconut oil, rapeseed oil, olive oil, sesame seed oil, palm oil, palm kernel oil, and mixtures thereof. In yet another embodiment, a food grade fat can be used in place of these oils, provided that the fat is melted prior to applying the fat to the cereal.

[0226] In another embodiment, the gamma-aminobutyric acid and caffeine or the composition comprising gamma-aminobutyric acid and caffeine is added to the cereal composition as a syrup. Non-limiting examples of glazes for particular embodiments include corn syrup, honey syrup and honey syrup solids, maple syrup and maple syrup solids, sucrose, isomaltulose, polydextrose, polyol, hydrogenated starch hydrolysate, aqueous solutions thereof, and mixtures thereof. In another such embodiment, the gamma-aminobutyric acid and caffeine or the composition comprising gamma-aminobutyric acid and caffeine is added as a syrup by combining with a glaze and a food grade oil or fat and applying the mixture to the cereal. In yet another embodiment, a gum system (for example like gum arabic, carboxymethyl cellulose, or algin) can be added to the syrup to provide structural support. Additionally, the syrup can also comprise a colorant, and can also comprise a flavoring.

[0227] In another embodiment, the caffeine and gamma-aminobutyric acid or composition comprising caffeine and gamma-aminobutyric acid are added to the cereal composition as a cream. In one such embodiment, the gamma-aminobutyric acid and caffeine or composition comprising gamma-aminobutyric acid and caffeine are combined with water and a creaming agent and then applied to the cereal. Non-limiting examples of creaming agents for use in particular embodiments include maltodextrin, sucrose, starch, polyols, and mixtures thereof. The cream can also comprise a food grade oil, a food grade fat, a colorant, and / or a flavoring.

[0228] Dairy products

[0229] In one embodiment, the composition of the present disclosure is a dairy product comprising the caffeine and gamma-aminobutyric acid described herein. In another embodiment, the composition of the present disclosure is a dairy product comprising a composition comprising caffeine and gamma-aminobutyric acid. Dairy products suitable for use in the present invention and methods for preparing dairy products are well known to those of ordinary skill in the art. As used herein, a dairy product includes milk or a food product produced from milk. Non-limiting examples of dairy products suitable for use in embodiments of the present invention include milk, cream, sour cream, creme fraiche, buttermilk, fermented buttermilk, milk powder, condensed milk, evaporated milk, butter, cheese, cottage cheese, cream cheese, yogurt, ice cream, custard, frozen yogurt, gelato, vial, piima, filmjolk, kajmak, kefir, viili, kumiss, airag, ice milk, casein, ayran, lassi, khoa, or combinations thereof.

[0230] Milk is a fluid secreted by the mammary glands of female mammals for the nourishment of their young. The ability of females to produce milk is one of the defining characteristics of mammals and provides a primary source of nutrients for newborns until they are able to digest more diverse foods. In particular embodiments of the present invention, these dairy products are derived from raw milk of cows, goats, sheep, horses, donkeys, camels, water buffalo, yaks, reindeer, moose, or humans.

[0231] In particular embodiments of the present invention, processing dairy products from raw milk generally includes the steps of pasteurization, creaming, and homogenization. Although raw milk can be consumed without pasteurization, it is typically pasteurized to destroy harmful microorganisms, such as bacteria, viruses, protozoa, molds, and yeasts. Pasteurization generally includes heating the milk to a high temperature for a short period of time to substantially reduce the number of microorganisms, thereby reducing the risk of disease.

[0232] Creaming has traditionally been after the pasteurization step and involves separating the milk into a higher fat cream layer and a lower fat milk layer. The milk will separate into a cream layer and a milk layer after being left to stand for twelve to twenty-four hours. The cream rises to the top of the milk layer and can be skimmed off and used as a separate dairy product. Alternatively, centrifugation can be used to separate the cream from the milk. The remaining milk is classified according to its fat content, non-limiting examples of which include whole milk, 2% milk, 1% milk, and skim milk.

[0233] After the desired amount of fat is removed from the milk by creaming, the milk is often homogenized. Homogenization prevents the cream from separating from the milk and typically involves pumping the milk under high pressure through a narrow tube in order to break up the fat globules in the milk. Pasteurization, creaming, and homogenization of the milk are common, but are not necessary to produce consumable dairy product. Thus, suitable dairy products for use in embodiments of the present invention can not undergo a processing step, undergo a single processing step, or undergo a combination of the processing steps described herein. Suitable dairy products for use in embodiments of the present invention can also undergo processing steps in addition to the processing steps described herein.

[0234] Particular embodiments of the present invention include dairy products produced from milk by additional processing steps. As described above, cream can be skimmed from the top of the milk or separated from the milk using a mechanical centrifuge. In a particular embodiment, the dairy product includes sour cream, which is a fatty-rich dairy product obtained using bacterial cultures to ferment the cream. The bacteria produce lactic acid during the fermentation, which acidifies and thickens the cream. In another particular embodiment, the dairy product includes crème fraiche, which is a slightly acidified, high-fat cream that is acidified in a similar manner to sour cream using bacterial cultures. Crème fraiche is typically not as thick or as sour as sour cream. In yet another particular embodiment, the dairy product includes fermented buttermilk. Fermented buttermilk is obtained by adding bacteria to milk. The resulting fermentation, in which the bacterial cultures convert lactose to lactic acid, produces the sour fermented buttermilk. Fermented buttermilk is typically similar to traditional buttermilk, which is a byproduct of butter manufacture, although it is produced in a different manner.

[0235] According to other specific embodiments of the present application, the dairy product includes powdered milk, condensed milk, evaporated milk, or combinations thereof. Powdered milk, condensed milk, and evaporated milk are typically produced by removing water from milk. In a specific embodiment, the dairy product comprises powdered milk containing dry milk solids having a low moisture content. In another specific embodiment, the dairy product includes condensed milk. Condensed milk typically comprises milk with reduced water content and added sweetener, resulting in a thick, sweet product with a long shelf life. In yet another specific embodiment, the dairy product includes evaporated milk. Evaporated milk typically includes fresh homogenized milk from which about 60% of the water has been removed, which has been cooled, fortified with additives such as vitamins and stabilizers, packaged, and finally sterilized. According to another specific embodiment of the present application, the dairy product comprises dry creamer, and a combination of gamma-aminobutyric acid and caffeine or a composition comprising gamma-aminobutyric acid and caffeine.

[0236] In another specific embodiment, the dairy product provided herein includes butter. Butter is typically prepared by churning fresh or fermented cream or milk. Butter typically comprises milk fat around small droplets comprising most of the water and milk proteins. The churning process damages the membrane around the tiny globules of milk fat, allowing the milk fat to coalesce and separate from the rest of the cream. In yet another specific embodiment, the dairy product includes buttermilk, which is the sour liquid that remains after butter is produced from whole milk by the churning process.

[0237] In yet another particular embodiment, the dairy product includes cheese, which is a solid food product produced using rennet or a rennet substitute in combination with acidification to coagulate milk. Rennet is a natural enzyme complex produced in the stomach of a mammal that digests milk and is used in cheese production to coagulate milk, thereby causing it to separate into solids called curd and liquids called whey. Typically, rennet is obtained from the stomach of young ruminants such as calves; however, alternative sources of rennet include some plants, microbial organisms, and genetically modified bacteria, fungi, or yeast. Additionally, milk can be coagulated by the addition of an acid such as citric acid. Typically, a combination of rennet and / or acidification is used to coagulate milk. After the separation of milk into curd and whey, some cheeses are made by simply draining, salting, and packaging these curds. However, for most cheeses, more processing is required. Many different methods can be used to produce the hundreds of cheese varieties available. Processing methods include heating the cheese, cutting it into small pieces to drain, salting, stretching, forming cheddar cheese, washing, molding, ripening, and aging. Some cheeses such as blue cheese have additional bacteria or molds introduced into them before or during ripening, which impart flavor and aroma to the final product. Cottage cheese is a cheese curd product with a mild flavor that is drained but not pressed, leaving some whey. The curd is typically washed to remove acidity. Cream cheese is a soft, mildly flavored white cheese with a high fat content that is produced by adding cream to milk and then coagulating it to form rich curds. Alternatively, cream cheese can be made from skim milk, with cream added to the curds. It should be understood that cheese, as used herein, includes all solid food products produced by coagulating milk.

[0238] In another particular embodiment of the present application, the dairy product includes yogurt. Yogurt is typically produced by bacterial fermentation of milk. Fermentation of lactose produces lactic acid, which acts on the proteins in the milk to produce a gel-like texture and a sour taste of yogurt. In particularly desirable embodiments, the yogurt can be sweetened with a sweetener and / or flavored. Non-limiting examples of flavorings include, but are not limited to, fruits (e.g., peach, strawberry, banana), vanilla, and chocolate. As used herein, yogurt also includes yogurt varieties with different consistencies and viscosities, such as dahi, dadih or dadiah, labneh or labaneh, bulgarian, kefir, and matsoni. In another particular embodiment, the dairy product includes a yogurt-based beverage, which is also known as drinkable yogurt or yogurt smoothie. In particularly desirable embodiments, the yogurt-based beverage can include a sweetener, a flavoring, other ingredients, or a combination thereof.

[0239] In certain embodiments of the application, other dairy products can be used in addition to those described herein. Such dairy products are well known to those of ordinary skill in the art, and non-limiting examples thereof include milk, milk and juice, coffee, tea, milk shake, health yogurt, yogurt, kefir, koumiss, whey, kumiss, ayran, ice milk, casein, salted yogurt, lassi, and doenjang.

[0240] According to certain embodiments of the application, the dairy composition can also include other additives. Non-limiting examples of suitable additives include sweeteners and flavorings, such as chocolate, strawberry, and banana. Certain embodiments of the dairy composition provided herein can also include additional nutrient supplements such as vitamins (e.g., vitamin D) and minerals (e.g., calcium) to improve the nutrient composition of the milk.

[0241] In some embodiments, the inventive composition is a non-dairy milk, a plant-based drink, a plant protein drink, a plant milk such as soy milk, almond milk, rice milk, bean milk, coconut milk, workpiece plant milk, and the like.

[0242] Tabletop functional sweetener composition

[0243] In some embodiments, the inventive composition is a tabletop functional sweetener composition comprising caffeine and gamma-aminobutyric acid and: (i) at least one functional ingredient; (ii) at least one filler; and (iii) optionally at least one sweet taste improving composition having improved temporal and / or flavor profile and / or an anti-caking agent. According to certain embodiments, suitable "fillers" include maltodextrin (10 DE, 18 DE, or 5 DE), corn syrup solids (20 or 36 DE), sucrose, fructose, glucose, invert sugar, sorbitol, xylose, ribulose, mannose, xylitol, mannitol, galactitol, erythritol, maltitol, lactitol, isomalt, maltose, tagatose, lactose, inulin, glycerol, propylene glycol, polyols, polydextrose, fructooligosaccharides, cellulose and cellulose derivatives, and the like, and mixtures thereof. Additionally, according to still other embodiments of the application, granulated sugar (sucrose) or other caloric sweeteners such as crystalline fructose, other carbohydrates, or sugar alcohols can be used as fillers due to their providing good content uniformity without adding a large amount of calories. In one embodiment, the filler can be used as the sweet taste improving composition.

[0244] As used herein, the phrases "anti-caking agent" and "flow agent" refer to any composition that prevents, reduces, inhibits, or retards the adherence, binding, or contact of at least one natural and / or synthetic high-potency sweetener molecule to another natural and / or synthetic high-potency sweetener molecule. Alternatively, an anti-caking agent can refer to any composition that aids in content uniformity and uniform dissolution. According to particular embodiments, non-limiting examples of anti-caking agents include tartaric acid, calcium silicate, silicon dioxide, microcrystalline cellulose (Avicel (FMC BioPolymer, Philadelphia, Pa.), and tricalcium phosphate. In one embodiment, the anti-caking agent is present in the tabletop functional sweetener composition in an amount from about 0.001% to about 3% by weight of the tabletop functional sweetener composition.

[0245] The tabletop functional sweetener compositions are presented and packaged in a variety of different forms, and it is contemplated that the tabletop functional sweetener compositions of the present application can be in any form known in the art. According to particular embodiments, non-limiting examples include a powder form, a granular form, a packet, a tablet, a caplet, a pellet, a cube, a solid, and a liquid.

[0246] In embodiments, the tabletop functional sweetener composition comprises a single serving (serving controlled) packet containing a dry blend of a functional sweetener formulation. The dry blend formulation can generally include a powder or granules. Although the tabletop functional sweetener packet can be of any size, an illustrative non-limiting example of a conventional serving controlled tabletop sweetener packet is approximately 2.5 x 1.5 inches and holds approximately 1 gram of sweetener composition that is equivalent in sweetness to 2 teaspoons of granulated sugar (about 8 g). The amount of natural and / or synthetic high-potency sweetener in the dry blend tabletop functional sweetener formulation will vary due to the different potencies of different natural and / or synthetic high-potency sweeteners. In particular embodiments, the dry blend tabletop functional sweetener formulation can comprise a natural and / or synthetic high-potency sweetener in an amount from about 1% (w / w) to about 10% (w / w) of the tabletop functional sweetener composition.

[0247] Solid tabletop functional sweetener embodiments include cubes and tablets. A non-limiting example size of a common cube is equivalent to a standard cube of granulated sugar, which is approximately 2.2 x 2.2 x 2.2 cm 3 and weighs approximately 8 g. In one embodiment, the solid tabletop sweetener is in the form of a tablet or any other form known to one skilled in the art.

[0248] In one embodiment, tabletop functional sweetener compositions can also be formulated for the intended use, e.g., for beverages, foodstuffs, pharmaceuticals, cosmetics, herbal / vitamins, tobacco, and any other product that can be sweetened. For example, a tabletop functional sweetener composition for baking can be formulated with additional protective agents such as encapsulants. Other forms will be apparent to those skilled in the art of tabletop sweeteners.

[0249] Methods commonly used to manufacture powdered or granulated functional sweetener formulations for use in sachets include fluid bed agglomeration. Other methods of making tabletop sweetener compositions are well known to those of ordinary skill in the art.

[0250] Methods

[0251] In another aspect, the present disclosure relates to a method for improving a condition in a person, the method comprising: administering to a person in need of an improved condition an edible composition described anywhere herein. In a particular embodiment, the composition comprises: caffeine and / or a derivative thereof; and gamma-aminobutyric acid, wherein the weight ratio of total gamma-aminobutyric acid to total caffeine of the composition is from about 1 : 50 to about 10 : 1. Improving a condition in a person includes, but is not limited to, improving cognitive function; reducing mental fatigue, increasing alertness, increasing focus, increasing accuracy and / or speed of attention, increasing accuracy and / or speed of performance, increasing memory (e.g., speed and / or accuracy of working memory, episodic memory), improving mood, reducing stress, reducing anxiety, improving sedation, improving calmness, improving relaxation, improving mental capacity, reducing headache, or any combination thereof.

[0252] In some embodiments, the composition is administered orally by having the person ingest the composition. The composition can be administered at one time, or alternatively more than one time per day. Administration can continue for at least 1 day, at least 1 week, at least 1 month, at least 1 year. In some embodiments, the methods include applying a time interval between any two administrations per day, wherein the time interval is at least about 1 hour, at least about 2 hours, at least about 3 hours, at least about 4 hours, at least about 5 hours, or at least about 6 hours.

[0253] In some embodiments, the dose of caffeine of the composition administered to a human is at least about 15 mg, at least about 25 mg, at least about 35 mg, at least about 55 mg, at least about 75 mg, at least about 100 mg, at least about 125 mg, at least about 150 mg, at least about 175 mg, at least about 200 mg, at least about 225 mg, or at least about 250 mg. In some embodiments, the dose of gamma-aminobutyric acid of the composition administered to a human is at least about 5 mg, at least about 25 mg, at least about 75 mg, at least about 100 mg, at least about 125 mg, or at least about 150 mg.

[0254] In some embodiments, the composition of the present application begins to exert an improvement in condition after a period of time after administration, wherein the period of time is at least about 5 minutes, or at least about 15 minutes, or at least about 30 minutes, or at least about 60 minutes, or at least about 90 minutes, or at least about 120 minutes, or at least about 150 minutes, or at least about 180 minutes, or at least about 210 minutes, or at least about 240 minutes, or at least about 270 minutes, or at least about 300 minutes.

[0255] All publications, patents, and patent applications mentioned in the specification are indicative of the level of those skilled in the art to which this disclosure pertains.

[0256] The following examples illustrate preferred but non-limiting embodiments of the present disclosure. Example

[0257] Example 1 - Study of the acute effects of a combination of caffeine and gamma-aminobutyric acid on cognitive function, mood, and alertness in healthy adults.

[0258] Background

[0259] Many studies have demonstrated consistent effects of caffeine on cognitive function and alertness 1 However, caffeine alone does not have effects on all aspects of cognitive function, for example, it has modest improvements on attention 2-4 Effects on working memory are inconsistent 5-7 GABA exhibits mood benefits, such as relaxation, anti-stress. It has been reported to have cognitive function at high dose levels.

[0260] Explanation and rationale for conducting the trial

[0261] In light of the above, and based on our previous research, many ingredients can provide enhanced or additional benefits when combined with caffeine than caffeine alone.

[0262] This study assessed the effects of two low doses of GABA in combination with caffeine on mood and a number of cognitive domains (attention, working memory, episodic memory, executive function) and during performance on tasks with high cognitive demand compared to placebo and / or a positive (caffeine) control.

[0263] These assessments were conducted 60 minutes, 180 minutes and 300 minutes post-administration in order to characterise the time course of any effects compared to the positive control intervention containing caffeine.

[0264] Benefit / Risk Assessment

[0265] The ingredients of the study product are not associated with any significant negative effects. Therefore, the risk of balancing significant benefits is low in terms of understanding the efficacy of extending GABA in combination with caffeine.

[0266] Objectives

[0267] The aim of the proposed randomised, double-blind, placebo-controlled, balanced crossover approach was to assess the effects of acute supplementation of two doses of GABA (14 mg, 28 mg) in combination with 75 mg caffeine on cognitive function and alertness. The trial used the COMPASS cognitive assessment system. Primary cognitive / mood assessments were conducted pre-administration and 60 min, 180 min and 300 min post-administration, on six separate test days with a minimum of 7 days between intervals.

[0268] Study Population

[0269] A total of 54 participants (n = 54 per condition) were recruited for the study. Responders were recruited using inclusion and exclusion criteria via telephone or web survey.

[0270] Inclusion Criteria

[0271] • Participants volunteered for the trial

[0272] • Participants must have self-assessed as being in good health

[0273] • Aged 18 to 45 years at the time of consent

[0274] Exclusion Criteria

[0275] Participants were not able to participate if they had:

[0276] • Any pre-existing medical condition / disease that would affect participation in the study (i.e. if the participant had a condition / disease that would not interact with the active treatment or impede performance, they could be allowed into the screening).

[0277] • Currently taking prescription medication

[0278] Note: The explicit exception to this is: contraceptive treatment for female participants, and "as needed" medication for the treatment of asthma and hay fever. There can be other medication use situations where there will be no interaction with the active treatment and which are not expected to have any influence on brain function, and participants can enter the screening.

[0279] • Has high blood pressure (systolic blood pressure above 159 mm Hg, or diastolic blood pressure above 99 mm Hg); or has low blood pressure (systolic blood pressure below 90 mm Hg, or diastolic blood pressure below 60 mm Hg)

[0280] • Body mass index (BMI) between 18.5-30 kg / m 2 outside the range

[0281] • Is pregnant, planning to become pregnant, or breastfeeding.

[0282] • Has learning and / or behavioral difficulties, such as dyslexia or ADHD

[0283] • Has a visual impairment that cannot be corrected with glasses or contact lenses (including color blindness)

[0284] • Smokes or uses nicotine or nicotine replacement products

[0285] • Consumes excessive amounts of caffeine (> 500 mg / day)

[0286] • Has relevant food intolerances / sensitivities

[0287] • Has taken antibiotics in the past 4 weeks

[0288] • Has taken dietary supplements, such as vitamins, omega 3 fish oil, etc. in the past 4 weeks (Note: Participants can participate after a 4-week washout of supplements prior to participation and during the duration of the study, provided that the supplements they take are not elective but are on a medical prescription or recommendation)

[0289] • Has any health condition that would interfere with meeting the requirements of the study (this includes conditions that are undiagnosed, not on medication)

[0290] • Cannot complete all study assessments

[0291] • Is currently participating in, or has participated in, other clinical or nutritional intervention studies in the past 4 weeks

[0292] • Has been diagnosed with alcohol or drug abuse in the past 12 months / is receiving treatment for alcohol or drug abuse

[0293] • Has been diagnosed with a psychiatric disorder in the past 12 months / is receiving treatment for a psychiatric disorder

[0294] • Frequent migraine requiring medication (more than or equal to 1 per month)

[0295] • Sleep disorders or taking sleep-aid medication

[0296] • Any known active infection

[0297] • Non-compliance in terms of treatment intake (see 4.3)

[0298] • Refusal to drink beverages containing artificial sweeteners (e.g. aspartame, sucralose, acesulfame potassium, etc.)

[0299] • Not being native English speaker or at least not being fluent in English

[0300] All participants who are excluded after screening are kept in the records with the reason for exclusion.

[0301] Example beverages to be evaluated for the study

[0302] The beverages will contain one of the following:

[0303] • 14 mg GABA with 75 mg caffeine (plus vehicle)

[0304] • 28 mg GABA with 75 mg caffeine (plus vehicle)

[0305] • 75 mg caffeine (plus vehicle)

[0306] or

[0307] • Vehicle (placebo)

[0308] The products are non-commercialized carbonated beverages. All ingredients are food grade. The vehicle contains potassium benzoate; potassium sorbate; citric acid; malic acid; sucralose; acesulfame potassium; trisodium citrate; natural flavors. The ingredients present in the vehicle are at the same level in all products. No ingredient information will be provided on the label (under item "4.1.2") considering that the study is double-blind. The product label is interpreted as follows: "Fizzy beverage, code number, manufacturing date, not for sale".

[0309] Participants are randomly assigned to a balanced schedule that dictates the order in which they receive the four interventions.

[0310] Product dosage schedule

[0311] Participants drink one of the four interventions during each day of their evaluation day (Day 1 / Day 2 / Day 3 / Day 4) in the laboratory, with the order of the interventions balanced across participants (via random assignment to a balanced schedule - example above).

[0312] Packaging, labelling and resupply

[0313] A 3-digit code was assigned to each intervention. The computerized balancing schedule was generated by a third party not involved in the study. According to the balancing schedule, the beverages were prepared and pre-packaged at a GMP trial factory by a third party not involved in the study. The packaging / labelling displayed only "fizzy drink, code number, manufacture date, and non-merchandise".

[0314] Emergency unblinding information was held by the third party who labelled the treatment envelopes, for use as required by the investigators.

[0315] Storage conditions

[0316] Beverages were stored at 4°C until consumption. No dietary supplements or prescription pharmaceutical products (excluded according to exclusion criteria) were allowed during the trial period, including OTC dietary supplements / products.

[0317] Product compliance

[0318] During the laboratory testing, product was consumed in the presence of the investigator, ensuring 100% compliance.

[0319] Observations

[0320] Efficacy

[0321] This was intended as an exploratory placebo-controlled study to investigate the acute effects of the GABA / caffeine combination on cognitive performance and alertness compared to placebo. Efficacy was assessed based on the comparison of the following measures after a single dose of study product (vs. placebo and caffeine-containing control) effects:

[0322] • Cognitive function - executive function, attention, working memory, episodic memory (baseline pre-dose and 60, 180 and 300 min post-dose) - see Figure 1 .

[0323] • Cognitive function and mental fatigue during prolonged performance of tasks with high cognitive demand (cognitive demand test battery [series 3 s / 7 s, RVIP, mental fatigue VAS] (baseline pre-dose and 60, 180 and 300 min post-dose).

[0324] • Alertness, stress and calmness as assessed by VAMS at 60, 180 and 300 min post-dose.

[0325] Safety

[0326] All products are manufactured in GMP trial factories and cleared for microbiological testing. The ingredients of the beverages are not associated with any significant adverse effects. Several published clinical trials used doses of GABA that were 10-28 times higher than the doses used in this study. There were no issues with subject autonomy. However, participants were encouraged to report any adverse effects during the trial period. A medical professional was on site from 8:00 to 10:00 am daily to conduct physical examinations. Any medical issues arising after 10:00 am could be addressed by contacting a medical assistant at a given phone number. If any study-related injury occurred, medical treatment and compensation for the participant would be provided according to the liability insurance of the site and the study sponsor.

[0327] Investigation

[0328] Study design and plan

[0329] The study followed a randomized, double-blind, placebo-controlled, balanced, crossover design.

[0330] Study procedures

[0331] Testing was conducted in a set of testing facilities in Tokyo, Japan, where participants were visually isolated from each other. Participants arrived at the laboratory at five different times, one introductory visit and four testing days (Testing Day 1, Testing Day 2, Testing Day 3, Testing Day 4). The four-day testing schedule was conducted every 7 days, and in exceptional cases, an additional 7-day leeway was acceptable.

[0332] The introductory visit to the laboratory included: introduction to study requirements, obtaining informed consent, health screening, completion of the Caffeine Consumption Questionnaire (CCQ), training in cognitive and emotional measures, and collection of demographic data. Information detailing demographics and confirming all activities completed would be recorded on the individual participant’s Case Report Form (CRF).

[0333] For the following four laboratory-based testing periods (Testing Day 1, Testing Day 2, Testing Day 3, Testing Day 4), participants were to arrive at the laboratory no later than 8:00 am, in a fasted (water allowed), alcohol- free (24 hours), and caffeine-free (overnight) state. The methods during these visits were the same, with the exception that participants would consume a different treatment during each visit. Upon arrival each day, participants consumed a standardized breakfast, after which continued compliance with study inclusion / exclusion criteria was confirmed by completion of a CRF. One hour after eating breakfast, participants completed a 60-minute computerized cognitive assessment (COMPASS - including the Cognitive Demand Test Battery). The tasks in this assessment were as follows: Figure 1The tasks are shown in Figure 1 and are described in Appendices I (General Tasks) and II (CDB). After the initial cognitive assessment, participants consumed their treatment drink of the day (within 20 min) and were assessed on the same cognitive / emotional tasks as above at 60, 180 and 300 min post-dose. To eliminate the effects of different colours and aromas of all samples, the drinks were transferred into pre-labelled opaque cups with lids and straws prior to serving. The labels were identical to those on the original packaging.

[0334] At the 180 min post-dose assessment (i.e. 14:00), participants were provided with a standardized lunch and, after completing the 60 min post-dose assessment (i.e. 12:00), participants were offered a snack choice (hot decaffeinated tea or decaffeinated coffee and digestive biscuits). No other snacks and lunches were available.

[0335] Stopping criteria and rules for participant treatment

[0336] An individual participant will be withdrawn from the trial if:

[0337] • the participant withdraws their consent without proof of the rationality of the decision

[0338] • the participant no longer meets the inclusion / exclusion criteria

[0339] • the participant has to take any concomitant prescription medication or any other substance which would constitute a reason for exclusion (per the exclusion criteria) and the participant cannot be rescheduled

[0340] • the participant is no longer able to participate due to other medical reasons (including adverse reactions)

[0341] Statistics

[0342] Pre-analysis

[0343] Treatment pre-baseline difference analysis between treatments was assessed using one-way ANOVA (treatment). For tasks with multiple repetitions (CDB tasks), the mean of the repetitions was used. Post-hoc tests were performed using Tukey's multiple comparison test.

[0344] Repeated measures analysis

[0345] Mixed effects models were fitted with covariates, assessment points and treatment as fixed effects and subjects as random effects. Interaction terms were fitted as treatment Post-dose assessments. The full model was fitted, including the interaction terms, irrespective of significance. For tasks with multiple repetitions (CDB tasks), the mean of the repetitions was used. This was considered a sensible approach given the complexity of the model and simplified the interpretation of the results.

[0346] • Covariate = Baseline covariate term (cognitive function at time zero).

[0347] • Assessment = Time of assessment after 3 administrations (60, 180, and 300 min).

[0348] • Treatment = The 6 different products under study.

[0349] • Subject = Responder identifier.

[0350] • Visit = Number of visits (days) for each subject.

[0351] For each cognitive performance measure, 4 models with different covariance structures were run. The following structures were considered:

[0352] • un = Unstructured

[0353] • cs = Compound Symmetry

[0354] • ar(l) = Autoregressive (1)

[0355] • arh(l) = Heterogeneous Autoregressive (1)

[0356] The analyses were run twice, once using unadjusted p-values for both main effects and interactions (as detailed in the SAS code version 1 below) for the pre-planned comparisons due to the exploratory nature of the trial. The second method used adjusted p-values (as detailed in the SAS code version 2). The Proc Mixed method of SAS was used for both analyses. To produce adjusted p-values for both main effects and interactions, Dunnett’s test was applied for main effects and Tukey’s test for interactions to ensure that the adjustments were appropriate for repeated measures analysis.

[0357] The results report overall p-values for all measures and provide an understanding of the strength of evidence against the null hypothesis, as well as confidence intervals, estimates, and relevant mean comparisons. If interactions are significant, extra care is needed in the interpretation process to describe the product effects as well as the interaction effects. For interactions, only those comparisons within the same assessment time point are reported.

[0358] Randomization

[0359] During the introductory visit, participants were randomly assigned to receive one of four treatments (represented by a 3-digit product code) according to a blinding schedule that used a computer-generated random number list.

[0360] Sample size issues

[0361] The cross-over design and proposed sample size of 48 participants delivers good power (>90%) to detect a medium effect size that has been seen previously with similar interventions. The G Power 3.0 computing power.

[0362] Ethics

[0363] Independent Ethics Committee

[0364] The trial will not be initiated until the protocol and informed consent and participant information forms have been reviewed and approved / endorsed by an appropriate ethics committee (or institutional review board). If protocol amendments require ethics committee approval, the protocol change will not be implemented until the amendment and the amended informed consent form (if appropriate) have been reviewed and approved / endorsed by the ethics committee.

[0365] Informed Consent and Participant Information

[0366] A written informed consent will be obtained from each participant prior to their participation in the trial. Each signature must be dated by each signatory and the informed consent and any other participant information forms must be retained by the investigator as part of the study records. A signed copy of the informed consent and any other participant information must be provided to each participant.

[0367] Records

[0368] Drug Accountability

[0369] Treatment supplies are kept in a secure, limited access storage area under the temperature conditions defined by the manufacturer.

[0370] Emergency Unblinding

[0371] A third party has the information necessary to perform emergency unblinding. This unblinding is performed only in the event of an emergency when the investigator must know the identity of the study drug to provide appropriate medical treatment. The reason for the unblinding must be documented and all parties involved are notified of the unblinding.

[0372] Case Report Forms

[0373] Case Report Forms are retained at the study site.

[0374] Source Documents

[0375] Source documents providing evidence of the participant's existence and the integrity of the data collected are archived at the investigator site.

[0376] The following data are included in the source documents:

[0377] Participant identity information (initials, gender, date of birth, and race)

[0378] Participant participation in trial (subject identification number, date of informed consent given).

[0379] Participant visit dates

[0380] Adverse reactions (description, onset and end)

[0381] Results

[0382] The study was conducted in Tokyo, Japan, in accordance with the guidelines of the 1975 Declaration of Helsinki. All documents were prepared in English and Japanese. All procedures were reviewed and approved by the scientific and regulatory affairs team of the Coca-Cola company and an external ethics committee (Maebashi Hirosegawa Ethics Committee, Japan). Written informed consent was obtained from all participants.

[0383] Two participants withdrew from the study, they were not replaced. A total of 52 data sets were entered for analysis.

[0384] Caffeine, GABA / caffeine combination (14 / 75 mg; 28 / 75 mg) significantly improved performance speed (p = 0.004, 0.0002, 0.018) at the combined level compared to placebo; although no significance was observed, all 3 treatments numerically tended to improve performance accuracy; this suggests that the improvement in performance speed was not associated with a decrease in accuracy (see Figures 2-6 ).

[0385] GABA / caffeine combination (14 / 75 mg) significantly improved working memory at the combined level compared to placebo (p = 0.009).

[0386] GABA / caffeine combination (28 / 75 mg) significantly improved RVIP (% correct) compared to placebo (p = 0.022).

[0387] Caffeine, GABA / caffeine combination (14 / 75 mg; 28 / 75 mg) significantly reduced mental fatigue (p = 0.0004, 0.0003, < 0.001) compared to placebo.

[0388] Caffeine, GABA / caffeine combination (14 / 75 mg; 28 / 75 mg) significantly reduced mental fatigue (p = 0.0004, 0.0003, < 0.001) compared to placebo.

[0389] The above results provide evidence to support the synergistic effect of caffeine and GABA in improving cognitive function and alertness in subjects when administered in the optimal ratio and dosage.

[0390] Cognitive assessment

[0391] Cognitive function will be assessed using the Computerized Measures of Psychological Performance Assessment System (COMPASS). This test system provides customised collections of tasks, with a fully randomised parallel version of each task provided at each assessment for each individual. It has previously been shown to be sensitive to a wide range of nutritional interventions [1-4]. The test battery has been used in our own laboratory for over 10 years and is now commercially available to other research institutions and is currently used in a number of universities and research institutions in the UK, New Zealand and Australia. The selection of tasks employed here includes a number of standard and ‘classic’ tasks assessing memory (working, episodic, spatial), attention and executive function. One potential advantage of the COMPASS test battery is the possibility of breaking down task results into ‘factors’, which can be useful in determining whether a treatment has a global effect on a given cognitive domain, which can not be meaningful for individual tasks. Factor scores are calculated by averaging the reaction times (milliseconds) or % accuracies of all tasks contributing to these factors (as shown in Figure 1 Two additional global scores are also calculated using Z-scores - Performance Speed - including reaction time (milliseconds) data from all tasks returning this data (except pegs and balls); and Performance Accuracy - including accuracy data from all tasks returning this data. Tasks are described below, and the task order and contribution to factors are shown in Figure 1

[0392] Proposed COMPASS tasks:

[0393] Mood / Alertness

[0394] Visual Analogue Mood Scale (VAMS): Participants complete 18 visual analogue scales, each anchored by adjectives describing opposite emotional states. Data from the scales are broken down into three factors previously determined by factor analysis: ‘Alertness’, ‘Stress’, ‘Feeling Calm’.

[0395] ‘Episodic’ long-term memory task:

[0396] Picture Presentation: Fifteen colour photographic images of objects are presented in sequence on the screen at a rate of 1 per 3 s for the participant to memorise, with a stimulus duration of one second.

[0397] ​Word Presentation: A unique set of fifteen words is presented. The words are randomly selected from a large word bank (MRC Psycholinguistic Database) that is matched for word length, frequency, familiarity, and concreteness. The stimulus duration is one second, as is the inter-stimulus duration.

[0398] Immediate and Delayed Word Recall: Participants write down as many of the 15 words they were presented with as possible during the stimulus presentation period immediately following this time period and during the delayed recall / recognition period. This task is scored only for accuracy.

[0399] Delayed Picture Recognition: A series of pictures is displayed on the screen, one at a time. The number of pictures, the rate at which the pictures are displayed, and the inter-stimulus interval can be varied. All of the target pictures shown during the picture presentation period, plus an equal number of foils, are displayed on the screen, one at a time. For each stimulus, the participant selects 'yes' or 'no' to indicate whether they have seen the picture before. Task outcomes include accuracy and reaction time.

[0400] Attention:

[0401] Number Vigilance Task: A target number is randomly selected and displayed constantly on the right side of the computer screen. A series of numbers is then presented in the center of the screen at a rate of 80 per minute, and the participant is asked to press the YES button as fast as possible each time a number in the series matches the target number. The task lasts 2 minutes and there are 30 stimulus-target matches. Task outcomes are accuracy, average reaction time, and number of false alarms.

[0402] Choice Reaction Time: An arrow pointing left or right appears on the screen. The participant presses the left or right key to respond corresponding to the direction of the arrow. There are random variations in the inter-stimulus interval between 1 and 3 seconds for a total of fifty stimuli. Task outcomes are accuracy of correct responses and average reaction time.

[0403] Simple Reaction Time: An arrow pointing up appears on the screen each time, and the participant presses a single key to respond. There are random variations in the inter-stimulus interval between 1 and 3 seconds for a total of fifty stimuli. Task outcomes are accuracy and average reaction time.

[0404] Working Memory:

[0405] 'Sternberg' Number Working Memory Task: A series of five single-digit numbers is displayed on the screen, one at a time. The participant is asked to try to remember the numbers that appear. Once the series is complete, 30 single-digit numbers are displayed, one at a time, and the participant responds to indicate whether each number was presented in the previous list. The task is repeated three times with different numbers. Task outcomes include accuracy and reaction time.

[0406] ‘Corsi Block’ : Spatial working memory task. Nine blue squares are displayed on the screen on a black background. Some of the blue squares turn red in order and turn back to blue again. Participants are asked to remember this order. The task is repeated five times at each level of difficulty, with the order span increasing from 4 upwards until the participant can no longer correctly recall the order. The task outcome is the ‘span score’ and this is calculated as the mean of the last 3 trials completed correctly. For example, if a participant makes correct replies for all five 4-level trials and only one 5-level trial, their span score will be 4.3 [(4 + 4 + 5) / 3].

[0407] Executive function

[0408] Nuts and Bolts: Two configurations are displayed on the screen. In each configuration, there are three coloured balls (blue, green, red) on one of the 3 pegs. The configuration at the top of the screen is the target configuration and the participant must arrange the balls on the starting configuration (shown in the centre of the screen) to match the position of the balls in the target configuration. They must do this with the minimum number of moves possible. The task outcomes include mean thinking time, completion time and errors.

[0409] Cognitive Demand Test Battery

[0410] The aim of this test battery is to assess the impact of treatment on speed / accuracy and mental fatigue during sustained performance of tasks that are high in cognitive demand.

[0411] Participants complete the test battery task for 10 minutes immediately, consecutively, three times (i.e. for 30 minutes in total). The application of this test battery has been shown to reliably elevate self-rated scores of ‘mental fatigue’ and is sensitive to a range of herbal and natural interventions. Of particular relevance here, it has been shown to be sensitive to performance enhancement induced by a single dose of cocoa-flavanols (520mg / 920mg) and a caffeine-containing product.

[0412] The 10-minute test battery includes:

[0413] Series 3 s subtraction task (2 min): A computerised version of the series subtraction task will be performed using a 2-minute duration test. Participants are asked to count backwards from a given number, entering each reply as quickly and accurately as possible using the number keys. A random starting number between 800 and 999 is presented on the computer screen, which is cleared by entering the first reply. The task is scored according to the number of correct replies and the number of errors. In the case of an incorrect reply, a score is given if the subsequent reply is scored as correct relative to the new number.

[0414] Series 7 s subtraction task (2 min): This is the same as the series three task, except that it involves seven's series subtraction.

[0415] Rapid visual information processing task (RVIP - 5 min): Participants were asked to monitor successive series of digits to find numbers that were three consecutive odd numbers or three consecutive even numbers. The digits were presented at a rate of 100 per minute and participants responded to the detection of target strings by pressing a response button as quickly as possible. The task was continuous and lasted 5 minutes, with 8 correct target strings presented per minute. The task was scored in terms of the percentage of correctly detected target strings, the mean reaction time to correctly detected target strings, and the number of false alarms.

[0416] ‘Mental fatigue’ visual analogue scale; participants rated their current subjective ‘mental fatigue’ state by marking on a 100 mm line with endpoints labelled ‘not at all’ (left-hand end) and ‘very much so’ (right-hand end).

[0417] References:

[0418] 1. T. M. McLellan; J. A. Caldwell; H. R. Lieberman. A review of caffeine’s effects on cognitive, physical and occupational performance. Neurosci. Biobehav. Rev. 2016, 71, 294-312.

[0419] 2. C. Brice; A. Smith. The effects of caffeine on simulated driving, subjective alertness and sustained attention. Hum. Psychopharmacol. 2001, 16, 523-531.

[0420] 3. E. Childs; H. de Wit. Subjective, behavioral, and physiological effects of acute caffeine in light, nondependent caffeine users. Psychopharmacology (Berlin) 2006, 185, 514-523.

[0421] 4. P. J. Durlac; R. Edmunds; L. Howard; S. P. Tipper. A rapid effect of caffeinated beverages on two choice reaction time tasks. Nutr. Neurosci. 2002, 5, 433-442.

[0422] 5. H. R. Lieberman. The effects of ginseng, ephedrine, and caffeine on cognitive performance, mood and energy. Nutr Rev 2001, 59, 91-102.

[0423] 6. H. R. Lieberman. Nutrition, brain function and cognitive performance. Appetite 2003, 40, 245-254.

[0424] 7. A. Nehlig. Is caffeine a cognitive enhancer? J. Alzheimers Dis. 2010, 20, 85-94.

[0425] All of the compositions and methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure. While the compositions and methods of the present disclosure have been described in terms of the embodiments outlined above, and as illustrative of its principles and application, those skilled in the art will recognize that variations, changes, modifications, and alterations in the compositions, methods, and steps or steps sequences of the methods described herein can be made without departing from the true concept, spirit, and scope of the present disclosure. More particularly, it will be apparent to those skilled in the art that certain agents, additives, and ingredients, which are physically, chemically, physiologically, and / or gustatorily similar, can be substituted for the agents, additives, and ingredients described herein, while still obtaining the same or similar results. All such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the spirit, scope, and concept of the present disclosure as defined by the appended claims below.

[0426] The following numbered clauses define further example aspects and features of the present disclosure:

[0427] 1. An edible composition comprising:

[0428] gamma-aminobutyric acid; and

[0429] caffeine;

[0430] wherein the weight ratio of total gamma-aminobutyric acid to total caffeine of the composition is from about 1 : 50 to about 10 : 1.

[0431] 2. The composition of clause 1, wherein the caffeine dose of the composition is from about 15 mg to about 250 mg, or from about 25 mg to about 200 mg, or from about 35 mg to about 150 mg, or from about 45 mg to about 100 mg, or from about 55 mg to about 80 mg, or from about 60 mg to about 75 mg for a serving.

[0432] 3. The composition of any of clauses 1 or 2, wherein the total content of gamma- aminobutyric acid of the composition is from about 0.001 wt% to about 2.5 wt%, or from about 0.05 wt% to about 2.0 wt%, or from about 0.1 wt% to about 1.5 wt%, or from about 0.5 wt% to about 1 wt%.

[0433] 4. The composition of any of clauses 1-3, wherein the gamma-aminobutyric acid dose of the composition is from 5 mg to about 150 mg, or from about 10 mg to about 120 mg, or from about 20 mg to about 100 mg, or from about 30 mg to 80 mg, or from about 40 mg to 70 mg, or from about 50 mg to about 60 mg.

[0434] 5. The composition of any one of clauses 1-4, wherein the weight ratio of total gamma-aminobutyric acid to total caffeine is from about 1 : 40 to about 9 : 1, or from about 1 : 30 to about 8 : 1, or from about 1 : 20 to about 7: 1, or from about 1 : 10 to about 6 : 1, or from about 1 : 5 to about 5 : 1, or from about 1 : 4 to about 4 : 1, or from about 1 : 3 to about 3: 1, or from about 1 : 2 to about 2 : 1.

[0435] 6. The composition of any one of clauses 1-5, wherein the weight ratio of total gamma-aminobutyric acid to total caffeine is from about 1 : 6 to about 2 : 1.

[0436] 7. The composition of any one of clauses 1-6, wherein the total caffeine content of the composition is from about 0.002 wt% to about 5 wt%, or from about 0.05 wt% to about 4 wt%, or from about 0.1 wt% to about 3 wt%, or from about 0.5 wt% to about 2 wt%, or from about 1 wt% to about 1.5 wt%.

[0437] 8. The composition of clause 1-7, wherein the gamma-aminobutyric acid is derived from a natural resource, a biotransformation process, a fermentation process, an enzymatic process, a synthetic derivative, or any combination thereof.

[0438] 9. The composition of any one of clauses 1-8, wherein the caffeine and / or gamma-aminobutyric acid is derived from a natural resource, wherein the natural resource is a plant selected from the group of coffee, tea, green tea, white tea, black tea, oolong tea, mate tea, yaupon holly tea, yaupon holly, guarana, cocoa, kolanut, or any combination thereof.

[0439] 10. The composition of any one of clauses 1-9, wherein the caffeine and / or gamma-aminobutyric acid is each derived from the same or different natural resource.

[0440] 11. The composition of any one of clauses 1-10, wherein the gamma-aminobutyric acid is derived from a natural resource selected from a vegetable or fruit, a legume, a fermented product, a cereal, tea, or a combination thereof.

[0441] 12. The composition of any one of clauses 1-11, further comprising a sweetener.

[0442] 13. The composition of clause 12, wherein the sweetener is selected from the group comprising: stevia and steviol glycosides, luo han guo and related mogroside compounds, monatin and its salts (monatin SS, RR, RS, SR), curculin, glycyrrhizic acid and its salts, thaumatin, monellin, mabinlin, brazzein, hernandulin, phyllodulcin, phlorizin, phloridzin, trilobatin, baiyunoside, osladin, polypodoside A, swingle glycosides A and B, mukurozi II, brazzein I, abrusoside A, and cyclocarioside I, sugar alcohols such as erythritol, sucralose, acesulfame potassium, advantame acid and its salts, aspartame, alitame, saccharin and its salts, neohesperidin dihydrochalcone, cyclamates, cyclamate salts, neotame, advantame, glycosylated steviol glycosides (GSG), and combinations thereof.

[0443] 14. The composition of any one of clauses 1-13, further comprising at least one additive.

[0444] 15. The composition of any one of clauses 1-14, further comprising at least one functional ingredient.

[0445] 16. The composition of any one of clauses 1-5, wherein the composition is in a drinkable liquid form, a concentrate form, a dry form, or a semi-dry form.

[0446] 17. The composition of any one of clauses 1-16, wherein the composition is a chewing gum, a gel, a tablet, a capsule, a granule, a cube, or a dry powder.

[0447] 18. The composition of any one of clauses 1-17, wherein the composition is a beverage selected from the group of a non-carbonated beverage, a carbonated beverage, a juice beverage, a juice, a coffee beverage, a tea beverage, a milk beverage, a dairy beverage, a protein drink, a plant-based beverage, a sports drink, an energy drink.

[0448] 19. The composition of any one of clauses 1-18, wherein the composition has a Brix value of about 3° to about 25°, or about 5° to about 20°, or about 7° to about 15°.

[0449] 20. The composition of any one of clauses 1-19, further comprising a coffee product selected from the group of a coffee extract, a coffee bean extract, a coffee berry extract, a coffee fruit peel extract, a coffee berry juice, an espresso, a dried coffee, an instant coffee, a coffee oil, a coffee essence, a dried green coffee extract, a wet green coffee extract, a powdered coffee, a ground coffee, a roasted coffee, a roasted and ground coffee, or any combination thereof.

[0450] 21. The composition of any one of clauses 1-20, further comprising a tea product selected from the group of instant tea products, tea extracts, tea concentrates, dry tea, tea leaves, tea flavoring, green tea extract, concentrated green tea extract, or any combination thereof.

[0451] 22. The composition of any one of clauses 1-21, wherein the composition is a processed food.

[0452] 23. A beverage comprising:

[0453] gamma-aminobutyric acid; and

[0454] caffeine;

[0455] wherein the weight ratio of total gamma-aminobutyric acid to total caffeine of the composition is from about 1 : 50 to about 10 : 1.

[0456] 24. The composition or beverage of any one of clauses 1-23, wherein the caffeine dose of the composition is from about 15 mg to about 250 mg, or from about 25 mg to about 200 mg, or from about 35 mg to about 150 mg, or from about 45 mg to about 100 mg, or from about 55 mg to about 80 mg for a serving.

[0457] 25. The composition or beverage of any one of clauses 1-24, wherein the total content of gamma-aminobutyric acid of the composition is from about 0.001 wt% to about 2.5 wt%, or from about 0.05 wt% to about 2.0 wt%, or from about 0.1 wt% to about 1.5 wt%, or from about 0.5 wt% to about 1 wt%.

[0458] 26. The composition or beverage of any one of clauses 1-25, wherein the gamma-aminobutyric acid dose of the composition is from 5 mg to about 150 mg, or from about 10 mg to about 120 mg, or from about 20 mg to about 100 mg, or from about 30 mg to 80 mg, or from about 40 mg to 70 mg, or from about 50 mg to about 60 mg.

[0459] 27. The composition or beverage of any one of clauses 1-26, wherein the weight ratio of total the gamma-aminobutyric acid to total the caffeine is from about 1 : 40 to about 9 : 1, or from about 1 : 30 to about 8 : 1, or from about 1 : 20 to about 7 : 1, or from about 1 : 10 to about 6 : 1, or from about 1 : 5 to about 5 : 1, or from about 1 : 4 to about 4 : 1, or from about 1 : 3 to about 3 : 1, or from about 1 : 2 to about 2 : 1.

[0460] 28. The composition or beverage of any one of clauses 1-27, wherein the weight ratio of total gamma-aminobutyric acid to total caffeine is from about 1 : 6 to about 2 : 1.

[0461] 29. The composition or beverage of any one of clauses 1-28, wherein the total caffeine content of the composition is from about 0.001 wt% to about 5 wt%, or from about 0.05 wt% to about 4 wt%, or from about 0.1 wt% to about 3 wt%, or from about 0.5 wt% to about 2 wt%, or from about 1 wt% to about 1.5 wt%.

[0462] 30. The composition or beverage of clauses 1-29, wherein the gamma-aminobutyric acid is derived from a natural resource, a biotransformation process, a fermentation process, an enzymatic process, a synthetic derivative, or any combination thereof.

[0463] 31. The composition or beverage of any one of clauses 1-30, wherein the caffeine and / or gamma-aminobutyric acid is derived from a natural resource, wherein the natural resource is a plant selected from the group of coffee, tea, green tea, white tea, black tea, oolong tea, mate tea, piu piu tea, yaupon holly, guarana, cacao, kolanut, or any combination thereof.

[0464] 32. The composition or beverage of any one of clauses 1-31, wherein the caffeine and / or gamma-aminobutyric acid is each derived from the same or different natural resource.

[0465] 33. The composition or beverage of any one of clauses 1-32, wherein the gamma-aminobutyric acid is derived from a natural resource selected from a vegetable or fruit, a legume, a fermented product, a cereal, tea, or a combination thereof.

[0466] 34. The composition or beverage of any one of clauses 1-33, further comprising a sweetener.

[0467] 35. The composition or beverage of clause 34, wherein the sweetener is selected from the group comprising: stevia and steviol glycosides, luo han guo and related mogroside compounds, monatin and its salts (monatin SS, RR, RS, SR), curculin, glycyrrhizic acid and its salts, thaumatin, monellin, mabinlin, brazzein, hernandulin, phyllodulcin, phlorizin, phloridzin, trilobatin, baiyunoside, osladin, polypodoside A, rebaudioside A, rebaudioside B, mukurozi II, brazzein I, cyclocarioside I, sugar alcohols such as erythritol, sucralose, acesulfame potassium, advantame acid and its salts, aspartame, alitame, saccharin and its salts, neohesperidin dihydrochalcone, cyclamates, cyclamate salts, neotame, advantame, glycosylated steviol glycosides (GSG), and combinations thereof.

[0468] 36. The composition or beverage of any one of clauses 1-35, further comprising at least one additive.

[0469] 37. The composition or beverage of any one of clauses 1-36, further comprising at least one functional ingredient.

[0470] 38. The composition or beverage of any one of clauses 1-37, wherein the beverage is selected from the group of: non-carbonated beverages, carbonated beverages, juice beverages, juices, coffee beverages, tea beverages, milk beverages, dairy beverages, protein drinks, plant-based beverages, sports drinks, energy drinks.

[0471] 39. The composition or beverage of any one of clauses 1-38, wherein the beverage has a Brix value of about 3° to about 25°, or about 5° to about 20°, or about 7° to about 15°.

[0472] 40. The composition or beverage of any one of clauses 1-39, further comprising a coffee product selected from the group of: coffee extract, coffee bean extract, coffee berry extract, coffee fruit peel extract, coffee berry juice, espresso, dried coffee, instant coffee, coffee oil, coffee essence, dried green coffee extract, wet green coffee extract, powdered coffee, ground coffee, roasted coffee, roasted and ground coffee, or any combination thereof.

[0473] 41. The composition or beverage of any one of clauses 1-40, further comprising a tea product selected from the group of: instant tea product, tea extract, concentrated tea, dried tea, tea leaves, tea essence, green tea extract, concentrated green tea extract, or any combination thereof.

[0474] 42. The composition or beverage of any one of clauses 1-41, wherein administration of the composition or beverage to a human elicits one or more effects in the human: improving cognitive function, reducing mental fatigue, increasing alertness, increasing focus, increasing accuracy and / or speed of attention, increasing accuracy and / or speed of performance, improving memory (e.g., speed and / or accuracy of working memory, episodic memory), improving mood, reducing stress, reducing anxiety, improving calmness, improving peacefulness, improving relaxation, improving mental capacity, reducing headache, or any combination thereof.

[0475] 43. The composition or beverage of any one of clauses 1-42, wherein the composition exerts an effect after a period of time after administration, wherein the period of time is about 5 minutes, or about 15 minutes, or about 30 minutes, or about 60 minutes, or about 90 minutes, or about 180 minutes, or about 210 minutes, or about 240 minutes, or about 270 minutes, or about 300 minutes.

[0476] 44. A method for improving a condition in a human, the method comprising:

[0477] administering to a human in need of an improved condition a consumable composition, wherein the composition comprises:

[0478] gamma-aminobutyric acid; and

[0479] caffeine;

[0480] wherein the weight ratio of total gamma-aminobutyric acid to total caffeine of the composition is from about 1 : 50 to about 10 : 1.

[0481] 45. The method of clause 44, wherein the caffeine dose of the composition is from about 15 mg to about 250 mg, or from about 25 mg to about 200 mg, or from about 35 mg to about 150 mg, or from about 45 mg to about 100 mg, or from about 55 mg to about 80 mg for a serving.

[0482] 46. The method of any one of clauses 44 or 45, wherein the total content of gamma- aminobutyric acid of the composition is from about 0.001 wt% to about 2.5 wt%, or from about 0.05 wt% to about 2.0 wt%, or from about 0.1 wt% to about 1.5 wt%, or from about 0.5 wt% to about 1 wt%.

[0483] 47. The method of any one of clauses 44-46, wherein the composition has a gamma-aminobutyric acid dose of from 5 mg to about 150 mg, or from about 10 mg to about 120 mg, or from about 20 mg to about 100 mg, or from about 30 mg to 80 mg, or from about 40 mg to 70 mg, or from about 50 mg to about 60 mg.

[0484] 48. The method of any one of clauses 44-47, wherein the weight ratio of total gamma-aminobutyric acid to total caffeine is from about 1 : 40 to about 9 : 1, or from about 1 : 30 to about 8 : 1, or from about 1 : 20 to about 7 : 1, or from about 1 : 10 to about 6 : 1, or from about 1 : 5 to about 5 : 1, or from about 1 : 4 to about 4 : 1, or from about 1 : 3 to about 3 : 1, or from about 1 : 2 to about 2 : 1.

[0485] 49. The method of any one of clauses 44-48, wherein the weight ratio of total gamma-aminobutyric acid to total caffeine is from about 1 : 5 to about 2 : 1.

[0486] 50. The method of any one of clauses 44-49, wherein the composition has a total caffeine content of from 0.001 wt% to about 5 wt%, or from about 0.05 wt% to about 4 wt%, or from about 0.1 wt% to about 3 wt%, or from about 0.5 wt% to about 2 wt%, or from about 1 wt% to about 1.5 wt%.

[0487] 51. The method of clauses 44-50, wherein the gamma-aminobutyric acid is derived from a natural resource, a biotransformation process, a fermentation process, an enzymatic process, a synthetic derivative, or any combination thereof.

[0488] 52. The method of any one of clauses 44-51, wherein the caffeine and / or gamma-aminobutyric acid is derived from a natural resource, wherein the natural resource is a plant selected from the group of coffee, tea, green tea, white tea, black tea, oolong tea, mate tea, yaupon holly tea, yaupon holly, guarana, cocoa, kolanut, or any combination thereof.

[0489] 53. The method of any one of clauses 44-52, wherein the caffeine and / or gamma-aminobutyric acid is each derived from the same or different natural resource.

[0490] 54. The method of any one of clauses 44-53, wherein the gamma-aminobutyric acid is derived from a natural resource selected from a vegetable or fruit, a legume, a fermented product, a cereal, tea, or a combination thereof.

[0491] 55. The method of any one of clauses 44-54, wherein the composition further comprises a sweetener.

[0492] 56. The method of clause 55, wherein the sweetener is selected from the group comprising: stevia and steviol glycosides, luo han guo and related mogroside compounds, monatin and its salts (monatin SS, RR, RS, SR), curculin, glycyrrhizic acid and its salts, thaumatin, monellin, mabinlin, brazzein, hernandulin, phylloducin, phlorizin, trilobatin, baiyunoside, osladin, polypodoside A, rebaudioside A, rebaudioside B, mukuroziiko VI, pseudoionoside I, periandrin I, abrusoside A, and cyclocarioside I, sugar alcohols such as erythritol, chloro sucrose, acesulfame potassium, advantame acid and its salts, aspartame, alitame, saccharin and its salts, neohesperidin dihydrochalcone, cyclamate, cyclamates, neotame, advantame, glycosylated steviol glycosides (GSG), and combinations thereof.

[0493] 57. The method of any one of clauses 44-56, wherein the composition further comprises at least one additive.

[0494] 58. The method of any one of clauses 44-57, wherein the composition further comprises at least one functional ingredient.

[0495] 59. The method of any one of clauses 44-58, wherein the composition is in a form of a drinkable liquid, a concentrate, a dry form, or a semi-dry form.

[0496] 60. The method of any one of clauses 44-59, wherein the composition is a chewing gum, a gel, a tablet, a capsule, a granule, a cube, or a dry powder.

[0497] 61. The method of any one of clauses 44-60, wherein the composition is a beverage selected from the group of non-carbonated beverages, carbonated beverages, juice beverages, juices, coffee beverages, tea beverages, milk beverages, dairy beverages, protein drinks, plant-based beverages, sports drinks, energy drinks.

[0498] 62. The method of any one of clauses 44-61, wherein the composition has a Brix value of about 3° to about 25°, or about 5° to about 20°, or about 7° to about 15°.

[0499] 63. The method of any one of clauses 44-62, wherein the composition further comprises a coffee product selected from the group of coffee extract, coffee bean extract, coffee berry extract, coffee fruit peel extract, coffee berry juice, espresso, dried coffee, instant coffee, coffee oil, coffee essence, dried green coffee extract, wet green coffee extract, powdered coffee, ground coffee, roasted coffee, roasted and ground coffee, or any combination thereof.

[0500] 64. The method of any one of clauses 44-63, wherein the composition further comprises a tea product selected from the group of instant tea product, tea extract, concentrated tea, dried tea, tea leaf, tea essence, green tea extract, concentrated green tea extract, or any combination thereof.

[0501] 65. The method of any one of clauses 44-64, wherein the composition is a processed food.

[0502] 66. The method of any one of clauses 44-65, wherein the improvement in the condition of the person is selected from the group of improving cognitive function; reducing mental fatigue, increasing alertness, increasing focus, increasing accuracy and / or speed of attention, increasing accuracy and / or speed of performance, improving memory (e.g., speed and / or accuracy of working memory, episodic memory), improving mood, reducing stress, reducing anxiety, improving calmness, improving peacefulness, improving relaxation, improving mental capacity, reducing headache, or any combination thereof.

[0503] 67. The method of any one of clauses 44-66, wherein the condition is improved after a period of time after administration, wherein the period of time is at least about 5 minutes, or at least about 15 minutes, or at least about 30 minutes, or at least about 60 minutes, or at least about 90 minutes, or at least about 120 minutes, or at least about 150 minutes, or at least about 180 minutes, or at least about 210 minutes, or at least about 240 minutes, or at least about 270 minutes, or at least about 300 minutes.

[0504] 68. The method of any one of clauses 44-67, wherein the composition is administered to the person at one time.

[0505] 69. The method of clause 44-68, comprising administering the composition to the person one or more times per day.

[0506] 70. A method for improving a condition of a person, the method comprising:

[0507] administering to a person in need of improvement in a condition a beverage comprising:

[0508] from about 5 mg to about 150 mg of gamma-aminobutyric acid; and

[0509] from about 15 mg to about 200 mg of caffeine

[0510] wherein the weight ratio of total gamma-aminobutyric acid to total caffeine is from about 1 : 50 to about 10 : 1.

[0511] 71. The method of clause 70, wherein the improvement in the condition of the person is selected from the group of: improving cognitive function; reducing mental fatigue, increasing alertness, increasing focus, increasing accuracy and / or speed of attention, increasing accuracy and / or speed of performance, increasing memory (e.g., speed and / or accuracy of working memory, episodic memory), improving mood, reducing stress, reducing anxiety, improving calmness, improving tranquility, improving relaxation, improving mental capacity, reducing headache, or any combination thereof.

[0512] 72. The method of any one of clauses 70-71, wherein the condition is improved after a period of time after administration, wherein the period of time is at least about 5 minutes, or at least about 15 minutes, or at least about 30 minutes, or at least about 60 minutes, or at least about 90 minutes, or at least about 120 minutes, or at least about 150 minutes, or at least about 180 minutes, or at least about 210 minutes, or at least about 240 minutes, or at least about 270 minutes, or at least about 300 minutes.

[0513] 73. The method of any one of clauses 70-72, comprising administering the beverage to the person one or more times per day.

Claims

1. An edible composition comprising: γ-aminobutyric acid; and caffeine; The weight ratio of total γ-aminobutyric acid to total caffeine in the composition is from about 1:50 to about 10:

1.

2. The composition of claim 1, wherein, The caffeine dosage of the composition for one part is from about 15 mg to about 250 mg, or from about 25 mg to about 200 mg, or from about 35 mg to about 150 mg, or from about 45 mg to about 100 mg, or from about 55 mg to about 80 mg, or from about 60 mg to about 75 mg.

3. The composition of claim 2, wherein, The total content of γ-aminobutyric acid in the composition is from about 0.001 wt% to about 2.5 wt%, or from about 0.05 wt% to about 2.0 wt%, or from about 0.1 wt% to about 1.5 wt%, or from about 0.5 wt% to about 1 wt%.

4. The composition of claim 1, wherein, The dosage of γ-aminobutyric acid in the composition is from about 5 mg to about 150 mg, or from about 10 mg to about 120 mg, or from about 20 mg to about 100 mg, or from about 30 mg to 80 mg, or from about 40 mg to 70 mg, or from about 50 mg to about 60 mg.

5. The composition of claim 3, wherein, The total weight ratio of the γ-aminobutyric acid to the total caffeine is from about 1:40 to about 9:1, or from about 1:30 to about 8:1, or from about 1:20 to about 7:1, or from about 1:10 to about 6:1, or from about 1:5 to about 5:1, or from about 1:4 to about 4:1, or from about 1:3 to about 3:1, or from about 1:2 to about 2:

1.

6. The composition of claim 5, wherein, The total weight ratio of the γ-aminobutyric acid to the total caffeine is from about 1:6 to about 2:

1.

7. The composition of claim 1, wherein, The total caffeine content of the composition is from about 0.002 wt% to about 5 wt%, or from about 0.05 wt% to about 4 wt%, or from about 0.1 wt% to about 3 wt%, or from about 0.5 wt% to about 2 wt%, or from about 1 wt% to about 1.5 wt%.

8. The composition of claim 6, wherein, The γ-aminobutyric acid is derived from natural resources, biotransformation processes, fermentation processes, enzymatic processes, synthetic derivatives, or any combination thereof.

9. The composition of claim 6, wherein, The caffeine and / or γ-aminobutyric acid are derived from natural resources, wherein the natural resources are plants selected from the group consisting of: coffee, tea, green tea, white tea, black tea, oolong tea, mate tea, holly tea, guarana, cocoa, kola nut, or any combination thereof.

10. The composition of claim 9, wherein, The caffeine and / or γ-aminobutyric acid are derived from the same or different natural resources.

11. The composition of claim 6, wherein, The γ-aminobutyric acid is derived from natural resources, which are selected from vegetables or fruits, legumes, fermented products, grains, tea, or combinations thereof.

12. The composition of claim 11, further comprising a sweetener.

13. The composition of claim 12, wherein, The sweetener is selected from the group consisting of: stevia and steviol glycosides, monk fruit and related monk fruit glycosides, monosaccharide and its salts (monasaccharide SS, RR, RS, SR), curculigoside, glycyrrhizic acid and its salts, kiwifruit glycoside, monellin, areca oleracea glycoside, blazienin, horny saccharin, lecithin, phloroglucinol, phloroglucinol, trifolin, sennain, porphyrin, pterostilbene glycoside A, and decacaridine. Glycoside A, pectin B, Sapindus mukorossi sesquiterpene glycoside, pseudogentianin I, glycyrrhizin I, abrin A, and cyclocarya glycoside I, sugar alcohols such as erythritol, sucralose, acetylsupan potassium, acesulfame K and its salts, aspartame, alitane, saccharin and its salts, neohesperidin dihydrochalcone, cyclohexylsulfamic acid salt, cyclohexylsulfamic acid and its salts, neotame, adventitia, glycosylated steviol glycosides (GSG), and combinations thereof.

14. The composition of claim 12, further comprising at least one additive.

15. The composition of claim 14, further comprising at least one functional ingredient.

16. The composition of claim 15, wherein, The composition is available in drinkable liquid form, concentrate form, dry form, or semi-dry form.

17. The composition of claim 15, wherein, The composition is chewing gum, gel, tablet, capsule, granules, cubes, or dry powder.

18. The composition of claim 15, wherein, The composition is a beverage selected from the group consisting of: non-carbonated beverages, carbonated beverages, fruit juice beverages, fruit juice, coffee beverages, tea beverages, milk beverages, dairy beverages, protein drinks, plant-based beverages, sports drinks, and energy drinks.

19. The composition of claim 18, wherein, The composition has a Brix value of about 3° to about 25°, or about 5° to about 20°, or about 7° to about 15°.

20. The composition of claim 6, further comprising a coffee product selected from the group consisting of: coffee extract, coffee bean extract, coffee berry extract, coffee pericarp extract, coffee berry juice, espresso, dried coffee, instant coffee, coffee oil, coffee flavoring, dried green coffee extract, wet green coffee extract, powdered coffee, ground coffee, roasted coffee, roasted and ground coffee, or any combination thereof.

21. The composition of claim 6, further comprising a tea product selected from the group consisting of: instant tea products, tea extracts, concentrated tea, dried tea, tea leaves, tea flavorings, green tea extracts, concentrated green tea extracts, or any combination thereof.

22. The composition of claim 1, wherein, The composition is a processed food.

23. A beverage comprising: γ-aminobutyric acid; and caffeine; The weight ratio of total γ-aminobutyric acid to total caffeine in the composition is from about 1:50 to about 10:

1.

24. The beverage as claimed in claim 23, wherein, The caffeine dosage of the composition is from about 15 mg to about 250 mg, or from about 25 mg to about 200 mg, or from about 35 mg to about 150 mg, or from about 45 mg to about 100 mg, or from about 55 mg to about 80 mg per serving.

25. The beverage as claimed in claim 24, wherein, The total content of γ-aminobutyric acid in the composition is from about 0.001 wt% to about 2.5 wt%, or from about 0.05 wt% to about 2.0 wt%, or from about 0.1 wt% to about 1.5 wt%, or from about 0.5 wt% to about 1 wt%.

26. The beverage as claimed in claim 23, wherein, The dosage of γ-aminobutyric acid in the composition is from about 5 mg to about 150 mg, or from about 10 mg to about 120 mg, or from about 20 mg to about 100 mg, or from about 30 mg to 80 mg, or from about 40 mg to 70 mg, or from about 50 mg to about 60 mg.

27. The beverage as claimed in claim 25, wherein, The total weight ratio of the γ-aminobutyric acid to the total caffeine is from about 1:40 to about 9:1, or from about 1:30 to about 8:1, or from about 1:20 to about 7:1, or from about 1:10 to about 6:1, or from about 1:5 to about 5:1, or from about 1:4 to about 4:1, or from about 1:3 to about 3:1, or from about 1:2 to about 2:

1.

28. The beverage as claimed in claim 27, wherein, The total weight ratio of the γ-aminobutyric acid to the total caffeine is from about 1:6 to about 2:

1.

29. The beverage as claimed in claim 23, wherein, The total caffeine content of the composition is from about 0.001 wt% to about 5 wt%, or from about 0.05 wt% to about 4 wt%, or from about 0.1 wt% to about 3 wt%, or from about 0.5 wt% to about 2 wt%, or from about 1 wt% to about 1.5 wt%.

30. The beverage as claimed in claim 28, wherein, The γ-aminobutyric acid is derived from natural resources, biotransformation processes, fermentation processes, enzymatic processes, synthetic derivatives, or any combination thereof.

31. The beverage as claimed in claim 27, wherein, The caffeine and / or γ-aminobutyric acid are derived from natural resources, wherein the natural resources are plants selected from the group consisting of: coffee, tea, green tea, white tea, black tea, oolong tea, mate tea, holly tea, guarana, cocoa, kola nut, or any combination thereof.

32. The beverage as claimed in claim 31, wherein, The caffeine and / or γ-aminobutyric acid are derived from the same or different natural resources.

33. The beverage as claimed in claim 32, wherein, The γ-aminobutyric acid is derived from natural resources, which are selected from vegetables or fruits, legumes, fermented products, grains, tea, or combinations thereof.

34. The beverage of claim 33, further comprising a sweetener.

35. The beverage as claimed in claim 34, wherein, The sweetener is selected from the group consisting of: stevia and steviol glycosides, monk fruit and related monk fruit glycosides, monosaccharide and its salts (monasaccharide SS, RR, RS, SR), curculigoside, glycyrrhizic acid and its salts, kiwifruit glycoside, monellin, areca oleracea glycoside, blazienin, horny saccharin, lecithin, phloroglucinol, phloroglucinol, trifolin, sennain, porphyrin, pterostilbene glycoside A, and decacaridine. Glycoside A, pectin B, Sapindus mukorossi sesquiterpene glycoside, pseudogentianin I, glycyrrhizin I, abrin A, and cyclocarya glycoside I, sugar alcohols such as erythritol, sucralose, acetylsupan potassium, acesulfame K and its salts, aspartame, alitane, saccharin and its salts, neohesperidin dihydrochalcone, cyclohexylsulfamic acid salt, cyclohexylsulfamic acid and its salts, neotame, adventitia, glycosylated steviol glycosides (GSG), and combinations thereof.

36. The beverage of claim 34, further comprising at least one additive.

37. The beverage of claim 36, further comprising at least one functional ingredient.

38. The beverage as claimed in claim 37, wherein, The beverage is selected from the group consisting of: non-carbonated beverages, carbonated beverages, fruit juice beverages, fruit juice, coffee beverages, tea beverages, dairy beverages, dairy product beverages, protein drinks, plant-based beverages, sports drinks, and energy drinks.

39. The beverage as claimed in claim 38, wherein, The beverage has a Brix value of about 3° to about 25°, or about 5° to about 20°, or about 7° to about 15°.

40. The beverage of claim 28, further comprising a coffee product selected from the group consisting of: coffee extract, coffee bean extract, coffee berry extract, coffee pericarp extract, coffee berry juice, espresso, dried coffee, instant coffee, coffee oil, coffee flavoring, dried green coffee extract, wet green coffee extract, powdered coffee, ground coffee, roasted coffee, roasted and ground coffee, or any combination thereof.

41. The beverage of claim 28, further comprising a tea product selected from the group consisting of: instant tea products, tea extracts, concentrated tea, dried tea, tea leaves, tea flavorings, green tea extracts, concentrated green tea extracts, or any combination thereof.

42. The beverage as claimed in claim 40, wherein, The administration of the composition or beverage to a person may cause one or more effects on the person: improved cognitive function, reduced mental fatigue, increased alertness, improved concentration, improved accuracy and / or speed of attention, improved accuracy and / or speed of performance, improved memory (e.g., speed and / or accuracy of working memory, episodic memory), improved mood, reduced stress, reduced anxiety, improved calmness, improved tranquility, improved relaxation, improved mental capacity, reduced headache, or any combination thereof.

43. The beverage as claimed in claim 40, wherein, The composition takes effect after a certain period of time following application, wherein the period of time is about 5 minutes, or about 15 minutes, or about 30 minutes, or about 60 minutes, or about 90 minutes, or about 180 minutes, or about 210 minutes, or about 240 minutes, or about 270 minutes, or about 300 minutes.

44. A method for improving a person's condition, the method comprising: Administering an edible composition to a person whose condition requires improvement, wherein the composition comprises: γ-aminobutyric acid; and caffeine; The weight ratio of total γ-aminobutyric acid to total caffeine in the composition is from about 1:50 to about 10:

1.

45. The method of claim 44, wherein, The caffeine dosage of the composition is from about 15 mg to about 250 mg, or from about 25 mg to about 200 mg, or from about 35 mg to about 150 mg, or from about 45 mg to about 100 mg, or from about 55 mg to about 80 mg per serving.

46. ​​The method of claim 45, wherein, The total content of γ-aminobutyric acid in the composition is from about 0.001 wt% to about 2.5 wt%, or from about 0.05 wt% to about 2.0 wt%, or from about 0.1 wt% to about 1.5 wt%, or from about 0.5 wt% to about 1 wt%.

47. The method of claim 45, wherein, The dosage of γ-aminobutyric acid in the composition is from about 5 mg to about 150 mg, or from about 10 mg to about 120 mg, or from about 20 mg to about 100 mg, or from about 30 mg to 80 mg, or from about 40 mg to 70 mg, or from about 50 mg to about 60 mg.

48. The method of claim 47, wherein, The total weight ratio of the γ-aminobutyric acid to the total caffeine is from about 1:40 to about 9:1, or from about 1:30 to about 8:1, or from about 1:20 to about 7:1, or from about 1:10 to about 6:1, or from about 1:5 to about 5:1, or from about 1:4 to about 4:1, or from about 1:3 to about 3:1, or from about 1:2 to about 2:

1.

49. The method of claim 48, wherein, The total weight ratio of the γ-aminobutyric acid to the total caffeine is from about 1:5 to about 2:

1.

50. The method of claim 49, wherein, The total caffeine content of the composition is from about 0.001 wt% to about 5 wt%, or from about 0.05 wt% to about 4 wt%, or from about 0.1 wt% to about 3 wt%, or from about 0.5 wt% to about 2 wt%, or from about 1 wt% to about 1.5 wt%.

51. The method of claim 49, wherein, The γ-aminobutyric acid is derived from natural resources, biotransformation processes, fermentation processes, enzymatic processes, synthetic derivatives, or any combination thereof.

52. The method of claim 49, wherein, The caffeine and / or γ-aminobutyric acid are derived from natural resources, wherein the natural resources are plants selected from the group consisting of: coffee, tea, green tea, white tea, black tea, oolong tea, mate tea, holly tea, guarana, cocoa, kola nut, or any combination thereof.

53. The method of claim 52, wherein, The caffeine and / or γ-aminobutyric acid are derived from the same or different natural resources.

54. The method of claim 53, wherein, The γ-aminobutyric acid is derived from natural resources, which are selected from vegetables or fruits, legumes, fermented products, grains, tea, or combinations thereof.

55. The method of claim 54, wherein, The composition further comprises a sweetener.

56. The method of claim 55, wherein, The sweetener is selected from the group consisting of: stevia and steviol glycosides, monk fruit and related monk fruit glycosides, monosaccharide and its salts (monasaccharide SS, RR, RS, SR), curculigoside, glycyrrhizic acid and its salts, kiwifruit glycoside, monellin, areca oleracea glycoside, blazienin, horny saccharin, lecithin, phloroglucinol, phloroglucinol, trifolin, sennain, porphyrin, pterostilbene glycoside A, and decacaridine. Glycoside A, pectin B, Sapindus mukorossi sesquiterpene glycoside, pseudogentianin I, glycyrrhizin I, abrin A, and cyclocarya glycoside I, sugar alcohols such as erythritol, sucralose, acetylsupan potassium, acesulfame K and its salts, aspartame, alitane, saccharin and its salts, neohesperidin dihydrochalcone, cyclohexylsulfamic acid salt, cyclohexylsulfamic acid and its salts, neotame, adventitia, glycosylated steviol glycosides (GSG), and combinations thereof.

57. The method of claim 55, wherein, The composition further comprises at least one additive.

58. The method of claim 57, wherein, The composition further comprises at least one functional ingredient.

59. The method of claim 58, wherein, The composition is available in drinkable liquid form, concentrate form, dry form, or semi-dry form.

60. The method of claim 58, wherein, The composition is chewing gum, gel, tablet, capsule, granules, cubes, or dry powder.

61. The method of claim 59, wherein, The composition is a beverage selected from the group consisting of: non-carbonated beverages, carbonated beverages, fruit juice beverages, fruit juice, coffee beverages, tea beverages, milk beverages, dairy beverages, protein drinks, plant-based beverages, sports drinks, and energy drinks.

62. The method of claim 61, wherein, The composition has a Brix value of about 3° to about 25°, or about 5° to about 20°, or about 7° to about 15°.

63. The method of claim 53, wherein, The composition further comprises a coffee product selected from the group consisting of: coffee extract, coffee bean extract, coffee berry extract, coffee pericarp extract, coffee berry juice, espresso, dried coffee, instant coffee, coffee oil, coffee flavoring, dried green coffee extract, wet green coffee extract, powdered coffee, ground coffee, roasted coffee, roasted and ground coffee, or any combination thereof.

64. The method of claim 53, wherein, The composition further comprises a tea product selected from the group consisting of: instant tea products, tea extracts, concentrated tea, dried tea, tea leaves, tea flavorings, green tea extracts, concentrated green tea extracts, or any combination thereof.

65. The method of claim 44, wherein, The composition is a processed food.

66. The method of claim 61, wherein, Improving the condition of the person is selected from the group consisting of: improving cognitive function; reducing mental fatigue; increasing alertness; improving concentration; improving the accuracy and / or speed of attention; improving the accuracy and / or speed of performance; improving memory (e.g., speed and / or accuracy of working memory, episodic memory); improving mood; reducing stress; reducing anxiety; improving calmness; improving tranquility; improving relaxation; improving mental capacity; reducing headache; or any combination thereof.

67. The method of claim 66, wherein, The condition improves after a period of time following application, wherein the time period is at least about 5 minutes, or at least about 15 minutes, or at least about 30 minutes, or at least about 60 minutes, or at least about 90 minutes, or at least about 120 minutes, or at least about 150 minutes, or at least about 180 minutes, or at least about 210 minutes, or at least about 240 minutes, or at least about 270 minutes, or at least about 300 minutes.

68. The method of claim 67, wherein, The composition is applied to the person in a single application.

69. The method of claim 68, wherein the method comprises administering the composition to the person once or more daily.

70. A method for improving a person's condition, the method comprising: Administering a beverage to a person whose condition needs improvement, said beverage comprising: From approximately 5 mg to approximately 150 mg of γ-aminobutyric acid; and Caffeine from approximately 15 mg to approximately 200 mg The total weight ratio of the γ-aminobutyric acid to the total caffeine is from about 1:50 to about 10:

1.

71. The method of claim 70, wherein, Improving the condition of the person is selected from the group consisting of: improving cognitive function; reducing mental fatigue; increasing alertness; improving concentration; improving the accuracy and / or speed of attention; improving the accuracy and / or speed of performance; improving memory (e.g., speed and / or accuracy of working memory, episodic memory); improving mood; reducing stress; reducing anxiety; improving calmness; improving tranquility; improving relaxation; improving mental capacity; reducing headache; or any combination thereof.

72. The method of claim 71, wherein, The condition improves after a period of time following application, wherein the time period is at least about 5 minutes, or at least about 15 minutes, or at least about 30 minutes, or at least about 60 minutes, or at least about 90 minutes, or at least about 120 minutes, or at least about 150 minutes, or at least about 180 minutes, or at least about 210 minutes, or at least about 240 minutes, or at least about 270 minutes, or at least about 300 minutes.

73. The method of claim 72, wherein the method comprises administering the beverage to the person once or more per day.

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