Rapid hydration preparations and methods

Abstract

To provide an oral composition and rehydration method for fast hydration, fast rehydration, long lasting hydration, and / or long lasting rehydration.SOLUTION: The oral composition comprises a first active ingredient and a second active ingredient, where the first active ingredient comprises a mixture of sodium salts including at least two selected from among sodium chloride, sodium lactate, trisodium citrate, and sodium bicarbonate, the second active ingredient comprises a mixture of potassium salts including at least one selected from monopotassium phosphate, potassium chloride and potassium citrate, the concentration of sodium in the oral composition is 23 mmol / L to 28 mmol / L, the concentration of potassium in the oral composition is 1.2 mmol / L to 7.7 mmol / L, and the oral composition increases the D2O percentage in human plasma by at least 4.5%, or at least 5%, or at least 5.5%, or at least 6%, within 15 minutes after administration of the oral composition.SELECTED DRAWING: Figure 1B

Description

Background Art

[0001] This application was filed on May 30, 2023 as a PCT international patent application, and claims the benefit and priority of U.S. Provisional Patent Application No. 63 / 346,470, filed on May 27, 2022, the entire disclosure of which is incorporated herein by reference.

[0002] Introduction The present disclosure generally relates to compositions and methods for rapid hydration, rapid water replenishment, long-term hydration, and / or long-term water replenishment.

[0003] Humans often experience dehydration or hypohydration under stressful conditions such as excessive exposure to high temperatures, intense or prolonged exercise, strenuous physical activity in water-scarce conditions, climbing high mountains, or prolonged water deficiency due to diarrhea, vomiting, or sweating. Negative physiological effects such as electrolyte imbalance or protein loss often accompany dehydration. It would be beneficial to provide a composition for rapid and effective hydration or water replenishment that can quickly restore body water and extremely important elements to avoid any potential harmful health problems associated with dehydration.

[0004] Attempts have previously been made to prepare hydration compositions, particularly beverages and sports drinks, that provide an energy source, electrolytes, and water for water replenishment. These beverages may contain a mixture of proteins, sugars such as glucose, fructose, maltose, salts, and other additives such as citric acid, glycerol, triacylglycerol, sodium bisulfate, etc., and are claimed to be beneficial for water replenishment. These beverages and compositions are generally disclosed in, for example, Patent Document 1, Patent Document 2, Patent Document 3, Patent Document 4, Patent Document 5, Patent Document 6, Patent Document 7, and Patent Document 8, Patent Document 9, Patent Document 10, Patent Document 11.

[0005] However, many of the disclosed compositions could be made more effective. For example, many compositions do not result in rapid recovery of D2O percent in body fluids and plasma, and the duration of their hydration effect is often relatively short. In particular, fluid retention after ingesting these compositions does not last long, and the total body water content quickly drops to the level before hydration (Non-Patent Literature 1). Furthermore, prior disclosures do not clearly show the effective components of the hydration compositions and / or direct evidence of their hydration effect. In addition, many existing compositions contain a large amount of carbohydrates and / or other high-calorie ingredients that are not very popular with consumers. Also, when consuming carbohydrate-containing drinks, there is a trade-off between the objective of rapid fluid recovery and the objective of energy replenishment. The higher the carbohydrate concentration of the drink, the higher its energy density and gravimetric osmolality, which reduces its gastric emptying rate. Consequently, the effect of fluid recovery is weakened.

[0006] Therefore, despite the above disclosures, there is still a great need for novel rapid hydration, rapid rehydration, long-lasting hydration, and / or long-lasting rehydration compositions and beverages that provide a rapid and effective solution to dehydration and dehydration, long-lasting hydration or rehydration, compensation and long-term retention of total body water, long-term restoration of electrolyte balance, and / or improved taste and palatability profiles. [Prior art documents] [Patent Documents]

[0007] [Patent Document 1] U.S. Patent No. 4,853,237 [Patent Document 2] U.S. Patent No. 5,447,730 [Patent Document 3] U.S. Patent No. 6,221,910 [Patent Document 4] U.S. Patent No. 6,485,764 [Patent Document 5] U.S. Patent No. 7,001,612 [Patent Document 6] U.S. Patent No. 7,160,565 [Patent Document 7] U.S. Patent No. 8,993,032 [Patent Document 8] U.S. Patent Application Publication No. 2005 / 0100637 [Patent Document 9] U.S. Patent Application Publication No. 2005 / 0048136 [Patent Document 10] U.S. Patent Application Publication No. 2009 / 0117224 [Patent Document 11] U.S. Patent Application Publication No. 2012 / 0128815 [Non-patent literature]

[0008] [Non-Patent Document 1] Jeukendrup, Nutr. Metab. 2009 [Overview of the Initiative]

[0009] This disclosure provides rapid hydration, rapid rehydration, long-term hydration, and / or long-term rehydration compositions and methods that satisfy the above-mentioned needs.

[0010] In one embodiment, the disclosure relates to an orally administered composition comprising at least one or at least two active ingredients. In some embodiments, the composition may be an amino acid-free formulation and / or the composition may be substantially free of nutritional sweeteners. In some embodiments, the oral composition is a ready-to-drink hydration beverage. A specific example is a sports drink or sports beverage. In some embodiments, the concentration of the active ingredients in the beverage is about 1 g / L to about 50 g / L, or about 2 g / L to about 30 g / L, or about 3 g / L to about 30 g / L, or about 4 g / L to about 20 g / L, or about 5 g / L to about 10 g / L, or about 0.05 g / L to about 1 g / L, relative to the total volume of the beverage. In some embodiments, the concentration of at least one active ingredient in the oral composition, which is composed of a mixture of sodium salts, is about 15 mmol / L to about 35 mmol / L, or about 17 mmol / L to about 30 mmol / L, or about 20 mmol / L to about 30 mmol / L, or about 23 mmol / L to about 28 mmol / L, or about 25 mmol / L to about 26 mmol / L, or about 25.9 mmol / L. In some embodiments, the concentration of at least one active ingredient in the oral composition, which is composed of a mixture of potassium salts, is about 15 mmol / L to about 35 mmol / L, or about 17 mmol / L to about 30 mmol / L, or about 23 mmol / L to about 29 mmol / L, or about 25 mmol / L to about 28 mmol / L, or about 27.8 mmol / L. In a particular embodiment, at least two active ingredients are a first active ingredient, a sodium salt having a concentration of about 10 mmol / L to about 28 mmol / L, or about 13 mmol / L to about 25 mmol / L, or about 16 mmol / L to about 20 mmol / L, or about 17 mmol / L to about 19 mmol / L, or about 18.3 mmol / L, and a second active ingredient, a potassium salt having a concentration of about 10 mmol / L to about 28 mmol / L, or about 13 mmol / L to about 25 mmol / L, or about 16 mmol / L to about 22 mmol / L, or about 18 mmol / L to about 21 mmol / L, or about 20.5 mmol / L.

[0011] In some embodiments, the oral composition is in a dry or semi-dry form. A specific example is a water-soluble dry powder. In some embodiments, a drinking solution of the dry powder can be easily prepared by dissolving the dry powder in a drinking medium, where the solution has an amino acid-free concentration. In some embodiments, the composition further comprises at least one electrolyte. Examples of electrolytes include sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate, and combinations thereof.

[0012] In some embodiments, the composition further comprises at least one sweetener. The sweetener may be a carbohydrate, a peptide-based sweetener, a non-nutrient sweetener, an artificial sweetener, a commercially available sweetener or sweetening composition, or a "natural high potency sweetener" (NHPS). In one particular embodiment, the composition contains a low-calorie or zero-calorie sweetener. In another particular embodiment, the composition does not contain or substantially contains non-nutrient sweeteners and / or nutrient sweeteners.

[0013] In some embodiments, the composition further comprises at least one additive, at least one functional component, or both.

[0014] In some embodiments, the weight osmolality of the composition is approximately 250 mOsm / kg to approximately 350 mOsm / kg, or approximately 260 mOsm / kg to approximately 340 mOsm / kg, or approximately 270 mOsm / kg to approximately 330 mOsm / kg, or approximately 280 mOsm / kg to approximately 320 mOsm / kg, or approximately 290 mOsm / kg to approximately 310 mOsm / kg, or approximately 290 mOsm / kg to approximately 300 mOsm / kg.

[0015] In another embodiment, the Disclosure relates to a method of hydration or rehydration. In this method, the compositions described herein are used for at least one of the following purposes: to have a rapid effect on the recovery of total body water volume during rehydration; to reduce or reverse the effects of dehydration or dehydration; to mitigate other adverse effects of exercise, high temperature or other activity that causes fluid loss; to have a positive effect on subsequent physical performance; to extend the duration of fluid retention; to rapidly increase total body water volume; to maintain the increased total body water volume over a long period of time; to restore and maintain electrolyte balance; to provide an energy source; to balance or control calorie intake; and to stimulate thirst and drinking.

[0016] In some embodiments, the Disclosure provides a method for providing rapid hydration, rapid rehydration, prolonged hydration, and / or prolonged rehydration to a human, comprising administering an effective amount of an oral composition described herein. In some embodiments of the Method, the oral composition is in a dry or semi-dry form. The form of the oral composition may be a concentrated beverage, a gel, a dry powder, a tablet, or a capsule. In one embodiment, the oral composition is a dry powder readily soluble in a drinking medium. In some embodiments, the Method comprises preparing a drinking solution containing the dry powder by dissolving the dry powder in a drinking medium containing water, and administering the drinking solution orally.

[0017] In other embodiments, the method comprises taking / ingesting a drinking medium comprising an oral composition and water. The taking of the oral composition and the drinking medium can be carried out in parallel, simultaneously, separately, or sequentially. In some embodiments, the ratio of the oral composition to the drinking medium is such that the content of the active ingredient in the formulation is about 1 g / L to about 50 g / L, or about 2 g / L to about 30 g / L, or about 3 g / L to about 30 g / L, or about 4 g / L to about 20 g / L, or about 5 g / L to about 10 g / L, or about 0.05 g / L to about 1 g / L with respect to the total volume of the drinking medium. In some embodiments, the concentration of at least one active ingredient composed of a mixture of sodium salts in the oral composition is about 15 mmol / L to about 35 mmol / L, or about 17 mmol / L to about 30 mmol / L, or about 20 mmol / L to about 30 mmol / L, or about 23 mmol / L to about 28 mmol / L, or about 25 mmol / L to about 26 mmol / L, or about 25.9 mmol / L. In some embodiments, the concentration of at least one active ingredient composed of a mixture of potassium salts in the oral composition is about 15 mmol / L to about 35 mmol / L, or about 17 mmol / L to about 30 mmol / L, or about 23 mmol / L to about 29 mmol / L, or about 25 mmol / L to about 28 mmol / L, or about 27.8 mmol / L. In certain embodiments, the at least two active ingredients are a first active ingredient, a sodium salt having a concentration of about 10 mmol / L to about 28 mmol / L, or about 13 mmol / L to about 25 mmol / L, or about 16 mmol / L to about 20 mmol / L, or about 17 mmol / L to about 19 mmol / L, or about 18.3 mmol / L, and a second active ingredient, a potassium salt having a concentration of about 10 mmol / L to about 28 mmol / L, or about 13 mmol / L to about 25 mmol / L, or about 16 mmol / L to about 22 mmol / L, or about 18 mmol / L to about 21 mmol / L, or about 20.5 mmol / L.

[0018] In some embodiments of the method, the human plasma volume increases by at least about 2.5%, or at least about 3%, or at least about 4% within 10 minutes after administration of the oral composition.

[0019] In some embodiments, the percent D2O in human plasma increases by at least about 4.5%, or at least about 5%, or at least about 5.5%, or at least about 6% within 15 minutes after administration of the oral composition.

[0020] In some embodiments, the percent D2O in human plasma increases by at least about 5%, or at least about 5.5%, or at least about 6%, or at least about 6.5%, or at least about 7% within 30 minutes after administration of the oral composition.

[0021] In some embodiments, the percent D2O in human plasma increases by at least about 3%, or at least about 3.5%, or at least about 4%, or at least about 5%, or at least about 6% within 45 minutes after administration of the oral composition.

[0022] In some embodiments, the percent D2O in human plasma increases by at least about 3%, or at least about 3.5%, or at least about 4%, or at least about 5%, or at least about 6% within 60 minutes after administration of the oral composition.

[0023] In some embodiments, the percent D2O in human plasma measured 30 minutes after administration of the oral composition remains substantially unchanged for at least about 15 minutes, or at least about 30 minutes, or at least about 1 hour thereafter.

[0024] In some embodiments, the decrease in the percent D2O in human plasma measured 30 minutes after administration of the oral composition over at least about 30 minutes is less than about 1%, or less than about 2%, or less than about 3%, or less than about 4%, or less than about 5%, or less than about 6%, or less than about 7%, or less than about 8%, or less than about 9%, or less than about 10%.

[0025] In some embodiments, the human plasma weight osmolality is maintained within the range of approximately 270 mOsm / kg to approximately 330 mOsm / kg, or approximately 280 mOsm / kg to approximately 320 mOsm / kg, or approximately 290 mOsm / kg to approximately 310 mOsm / kg, or approximately 290 mOsm / kg to approximately 300 mOsm / kg for at least 60 minutes after administration of the oral composition.

[0026] In some embodiments, the change in human plasma weight osmolality at least 60 minutes after administration of the oral composition is 3 mOsm / kg or less.

[0027] Definitions and interpretations of selected terms As used herein, "weight percent," "wt%," "percent by weight," "weight %," and variations thereof refer to the concentration of a substance obtained by dividing its weight by the total weight of the composition and multiplying by 100. As used herein, "percent," "%," etc., are intended to be synonymous with "weight percent," "wt%," etc.

[0028] As used herein, "g" represents grams, "kg" represents kilograms or 1,000 grams, "L" represents liters, and "mg" represents milligrams (10 -3 "mL" or "cc" represents milliliters (10 -3 The unit "g / 100g", "g / 100mL", or "g / L" represents the concentration or content of a component in a composition. 1 mg / L is equal to 1 ppm (parts per million). "Da" refers to Dalton, which is a unit of molecular weight, and 1 Da is equal to 1 g / mol. The unit of temperature used herein is degrees Celsius (°C).

[0029] The term “approximately” is used in conjunction with numerical values ​​to include the normal variation in measurements that can be predicted by those skilled in the art, and is understood to have the same meaning as “about,” encompassing typical tolerances, such as ±15%, ±10%, ±5%, ±1%, ±0.5%, or even ±0.1% of the stated value. The term “approximately” also encompasses different quantities resulting from different equilibrium conditions of compositions derived from a particular initial composition. Equivalent quantities of those quantities, whether modified by the term “approximately,” are included in the claims.

[0030] It should be noted that, as used herein and in the appended claims, the singular forms “a,” “an,” and “the” encompass multiple references unless it is evident from the context. For example, a reference to a composition containing “a compound” encompasses having two or more compounds that are either the same or different from each other. It should also be noted that the term “or” is generally used to mean “and / or” unless it is evident from the context. As used herein, “and / or” means and encompasses all possible combinations of one or more of the related enumerated items, and the absence of any combination where it is interpreted as a binary choice ("or").

[0031] For brevity and conciseness, any range of values ​​described herein is intended to encompass all values ​​within that range and should be interpreted as supporting any subranges enumerating any subrange having real numerical endpoints within the specified range. As a hypothetical example, the disclosure of ranges 1 through 5 herein shall be deemed to support a claim for 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.

[0032] The term “substantially” is used herein to describe the degree of inherent uncertainty that may be attributable to any quantitative comparison, value, measurement, or other representation. The term “substantially” is also used herein to describe the extent to which a quantitative representation may vary from an express reference without altering the fundamental function of the subject matter in question.

[0033] The term “substantially absent” may refer to any component that is absent or nearly absent in the compositions of this disclosure. When “substantially absent” is used, it is assumed that the component has not been intentionally added to the compositions of this disclosure. In using the term “substantially absent” for a component, its presence in trace amounts in the compositions of this disclosure is permissible because it is present in other components. However, when a composition says it “substantially absent” a component, it is understood that only trace or minute amounts of that component are permissible. Furthermore, when a composition says it “substantially absent” a component when it is present in trace or minute amounts, it is understood that the component does not affect the effect of the composition. If a component is not expressly included herein or its possibility of inclusion is not expressly indicated herein, it is understood that the compositions of this disclosure may also substantially absent that component. Similarly, the express inclusion of a component may allow for its express exclusion, thereby making the composition substantially absent from the explicitly stated components.

[0034] When used herein, the terms “comprise,” “comprises,” and “comprising” indicate the presence of a specified feature, integer, process, operation, element, and / or component, but do not exclude the presence or addition of one or more other features, integers, processes, operations, elements, components, and / or groups thereof.

[0035] Where used herein, the transitional phrase "consisting essentially of" means that any materials or processes that do not substantially affect the specified materials or processes described in the claims, as well as any basic and novel features(if any) of the claimed disclosure, should be construed as being included in the claims. Accordingly, where used in the claims of this disclosure, the term "consisting essentially of" shall not be construed as equivalent to "comprising."

[0036] As used herein, the terms “increase,” “increasing,” “increased,” “enhance,” “enhanced,” “enhancing,” and “enhancement” (and their grammatical variations) describe an increase of at least about 1%, 5%, 10%, 15%, 25%, 50%, 75%, 100%, 150%, 200%, 300%, 400%, 500%, or greater than that compared to a control.

[0037] As used herein, the terms “reduce,” “reduced,” “reducing,” “reduction,” “diminish,” and “decrease” (and their grammatical variations) 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% compared to a control. In certain embodiments, the reduction results in the absence or complete absence of detectable activity or amount (i.e., a small amount, e.g., less than about 10%, or even 5%, or even 1%).

[0038] "Capacitive osmolality" is defined as the number of particles dissolved in a unit volume of aqueous solution. "Gross osmolality" is defined as the number of particles dissolved in a unit weight of aqueous solution. In practice, within the scope of this disclosure, the values ​​of capacitive osmolality and gravimetric osmolality are very close, and therefore, they are used interchangeably. A solution with a dissolved osmole of 1 / 1000 per kilogram has a concentration of 1 milliosmolality ("mOs") per kilogram. An osmole is the number of particles in 1 gram of undissociated solute molecular weight. Tonicity is a measure of the osmotic pressure of a solution compared to the osmotic pressure of blood fluids. It should be understood that the osmotic pressure of the body varies somewhat from person to person. Hypotonic solutions are solutions with lower osmotic pressure or tonicity than blood. The gravimetric osmolality of hypotonic solutions typically falls within the range of approximately 80 mOs / kg to 250 mOs / kg. Isotonic solutions have the same tonicity as blood. Here, the gravimetric osmolality typically falls within the range of approximately 280 mOs / kg to 310 mOs / kg. Hypertonic solutions are solutions with higher tonicity than blood. Their typical gravimetric osmolality ranges from approximately 310 mOs / kg to 440 mOs / kg. The gravimetric osmolality of water is approximately 10 mOs / kg to 20 mOs / kg.

[0039] As used herein, the term "beverage" means any drinking liquid or semi-liquid, including, for example, water, flavored water, soft drinks, fruit drinks, tea-based drinks, juice-based drinks, gel drinks, carbonated or non-carbonated drinks, and alcoholic or non-alcoholic drinks. In some embodiments, a beverage can be obtained by first mixing a beverage powder with any drinking liquid or semi-liquid.

[0040] As used herein, dehydration is defined as a condition resulting from the excessive loss of water and other fluids normally necessary for movement. Dehydration is usually caused by severe diarrhea and vomiting, but can also be caused by insufficient intake of water or other fluids, excessive sweating, fever, excessive urination, taking certain medications, or physical exercise. Rehydration is the process of replenishing the water and electrolytes lost due to dehydration. Rapid rehydration (or rapid fluid replacement) is the process of replenishing water and electrolytes within 30 minutes.

[0041] As used herein, “amino acid” refers to an organic compound or unit containing an amino(-NH2) functional group and a carboxyl(-COOH) functional group. “Amino acid” in this disclosure broadly encompasses any compound having at least one amino acid unit. “Amino acid-free formulation” as used herein refers to a formulation in which a molecule, compound, complex, oligomer, polymer, mixture, or composition having at least one amino acid unit is not physically (by non-covalent bonds) or chemically (by covalent bonds, hydrogen bonds, or coordination bonds). Amino acids, amino acid compounds, and non-limiting examples of amino acids used herein include aspartic acid, alanine, glycine, glutamic acid, proline, threonine, theanine, cysteine, cystine, alanine, valine, tyrosine, leucine, arabinose, trans-4-hydroxyproline, isoleucine, asparagine, serine, lysine, histidine, ornithine, methionine, carnitine, aminobutyric acid (α-, β-, and / or γ-isomers), glutamine, hydroxyproline, taurine, norvaline, sarcosine, and their salt forms, such as sodium or potassium salts or acidic salts. Amino acids may also be in a D-configuration or an L-configuration, and may be mono-, di-, or tri-forms of the same or different amino acids. Furthermore, amino acids may, where appropriate, be α-isomers, β-isomers, and / or γ-isomers. In some embodiments, combinations of the aforementioned amino acids and their corresponding salts (e.g., sodium, potassium, calcium, magnesium, or other alkali metal or alkaline earth metal salts, or acidic salts) are also suitable additives. Amino acids may be natural or synthetic. Amino acids may also be modified. Modified amino acids are any amino acids to which at least one atom has been added, removed, substituted, or any combination thereof (e.g., N-alkyl amino acids, N-acyl amino acids, or N-methyl amino acids). Non-limiting examples of modified amino acids include amino acid derivatives, such as trimethylglycine, N-methylglycine, and N-methylalanine.As used herein, modified amino acids include both modified and unmodified amino acids. As used herein, amino acids include peptides, oligopeptides, and polypeptides (e.g., dipeptides, tripeptides, tetrapeptides, and pentapeptides), such as glutathione and L-alanyl-L-glutamine. Suitable polyamino acids include poly-L-aspartic acid, poly-L-lysine (e.g., poly-L-α-lysine or poly-L-ε-lysine), poly-L-ornithine (e.g., poly-L-α-ornithine or poly-L-ε-ornithine), poly-L-alanine, other polymeric forms of amino acids, and their salt forms (e.g., calcium salts, potassium salts, sodium salts, or magnesium salts, such as monosodium L-glutamate). Polyamino acid adducts may also be in a D-configuration or an L-configuration. Furthermore, polyamino acids may be α-isomers, β-isomers, γ-isomers, δ-isomers, and ε-isomers, as appropriate. In some embodiments, combinations of the aforementioned polyamino acids and their corresponding salts (e.g., sodium, potassium, calcium, magnesium, or other alkali metal salts, alkaline earth metal salts, or acidic salts) are also suitable adducts. The polyamino acids described herein may include copolymers of different amino acids. The polyamino acids described herein may include copolymers of different amino acids. The polyamino acids may be natural or synthetic. The polyamino acids may also be modified, and therefore may have at least one atom added, removed, substituted, or a combination thereof (e.g., N-alkyl polyamino acids or N-acyl polyamino acids). As used herein, polyamino acids include both modified and unmodified polyamino acids. For example, modified polyamino acids are not limited to these, but include polyamino acids with various molecular weights (MW), such as poly-L-α-glycine with MWs of approximately 100 Daltons (Da), approximately 200 Da, approximately 300 Da, approximately 500 Da, approximately 1000 Da, approximately 1500 Da, approximately 6000 Da, approximately 25200 Da, approximately 63000 Da, approximately 83000 Da, or approximately 300000 Da. [Brief explanation of the drawing]

[0042] [Figure 1A] Figure 1A shows the Faster Hydration Benefit in three different examples of the present disclosure and in a human test group using water (control) after dehydration induced by high temperature and exercise. [Figure 1B] Figure 1B shows the Faster Hydration Benefit in three different examples of the present disclosure and in human test groups using water (control) after dehydration induced by high temperature and exercise. [Figure 2A] Figure 2A shows the longer-lasting hydration in human test groups using three different examples of the disclosure and water (control) after dehydration induced by high temperature and exercise. [Figure 2B] Figure 2B shows the longer-lasting hydration in human test groups using three different examples of the disclosure and water (control) after dehydration induced by high temperature and exercise. [Modes for carrying out the invention]

[0043] This disclosure is based on the finding that, in at least part, formulations comprising at least one active ingredient, and in certain particular embodiments, at least two active ingredients, can rapidly improve plasma D2O percentage after exercise and hydration. Better and sustained replenishment of plasma D2O percentage after hydration results in potential thermoregulation and performance benefits during subsequent exercise-high temperature stress.

[0044] This disclosure advantageously provides compositions that are effective for improving rapid hydration and retention of hydration, including long-term hydration and / or prolonged rehydration.

[0045] In some embodiments, the composition is amino acid-free and / or substantially free of nutritional sweeteners. In some embodiments, the composition contains active ingredients. These active ingredients in the oral composition include beverage-compatible components, such as at least one electrolyte and / or at least one sweetener and / or at least one functional ingredient and / or at least one additive.

[0046] electrolyte This composition may contain at least one electrolyte. Examples of non-limiting electrolytes include sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate, and combinations thereof. The electrolytes and ionic components of this disclosure can, but are not necessarily, usually be obtained from their corresponding water-soluble and non-toxic salts. Unless otherwise defined, the amount of electrolyte or ionic component in a composition is based on the electrolyte or ionic component present in the final edible form. The concentration of an electrolyte is the concentration of ions only, and not the concentration of salts.

[0047] The concentration of the total electrolyte contained in the composition is preferably at least about 200 mg / L, at least about 300 mg / L, at least about 400 mg / L, at least about 500 mg / L, at least about 600 mg / L, at least about 700 mg / L, or at least about 800 mg / L. In certain embodiments, the concentration of the electrolyte contained in the composition is about 400 mg / L to about 1000 mg / L, about 400 mg / L to about 900 mg / L, about 400 mg / L to about 800 mg / L, about 400 mg / L to about 700 mg / L, about 400 mg / L to about 600 mg / L, about 400 mg / L to about 500 mg / L, or about 500 mg / L to about 1000 mg / L.

[0048] Potassium ion components can be derived from any salt, including chlorides, carbonates, sulfates, acetates, bicarbonates, citrates, phosphates, hydrogen phosphates, tartrates, sorbates, or combinations thereof. Potassium ions are preferably present in the compositions of this disclosure in amounts of at least 0.0025% to about 0.08% by weight, about 0.0075% to about 0.06% by weight, or about 0.0075% to about 0.015% by weight.

[0049] The composition may contain potassium in an amount of about 5 mg / L to about 1000 mg / L, more preferably about 50 mg / L to about 300 mg / L, for example, about 100 mg / L to about 300 mg / L, about 200 mg / L to about 300 mg / L, about 50 mg / L to about 200 mg / L, about 100 mg / L to about 200 mg / L, or about 100 mg / L to about 200 mg / L. In some embodiments, the concentration of at least one active ingredient in the oral composition, which consists of a mixture of potassium salts, is about 15 mmol / L to about 35 mmol / L, or about 17 mmol / L to about 30 mmol / L, or about 23 mmol / L to about 29 mmol / L, or about 25 mmol / L to about 28 mmol / L, or about 27.8 mmol / L.

[0050] The sodium ion component can be derived from any salt, such as chloride, carbonate, sulfate, acetate, bicarbonate, citrate, phosphate, hydrogen phosphate, tartrate, sorbate, or a combination thereof. It is preferable that sodium ions are present in the composition in an amount of at least about 0.005% to about 0.1% by weight, about 0.0075% to about 0.075% by weight, or about 0.015% to about 0.05% by weight.

[0051] This composition contains sodium in an amount of approximately 5 mg / L to approximately 1000 mg / L, more preferably approximately 300 mg / L to approximately 800 mg / L, for example, approximately 300 mg / L to approximately 700 mg / L, approximately 300 mg / L to approximately 600 mg / L, approximately 300 mg / L to approximately 500 mg / L, approximately 300 mg / L to approximately 400 mg / L, approximately 400 mg / L to approximately 800 mg / L, and approximately 400 mg The composition may contain approximately 600 mg / L to 700 mg / L, approximately 400 mg / L to 600 mg / L, approximately 400 mg / L to 500 mg / L, approximately 500 mg / L to 800 mg / L, approximately 500 mg / L to 700 mg / L, approximately 500 mg / L to 600 mg / L, approximately 600 mg / L to 800 mg / L, approximately 600 mg / L to 700 mg / L, and approximately 700 mg / L to 800 mg / L. In a particular embodiment, the composition contains approximately 600 mg / L to 700 mg / L of sodium. In some embodiments, the concentration of at least one active ingredient in the oral composition, which is composed of a mixture of sodium salts, is about 15 mmol / L to about 35 mmol / L, or about 17 mmol / L to about 30 mmol / L, or about 20 mmol / L to about 30 mmol / L, or about 23 mmol / L to about 28 mmol / L, or about 25 mmol / L to about 26 mmol / L, or about 25.9 mmol / L.

[0052] The calcium ion component can be obtained from any salt such as chloride, carbonate, sulfate, acetate, bicarbonate, citrate, phosphate, hydrogen phosphate, tartrate, sorbate, or a combination thereof. It is preferable that calcium ions are present in the composition in an amount of at least about 0.0005% to about 0.010% by weight.

[0053] This composition may contain calcium in an amount of about 5 mg / L to about 1000 mg / L, more preferably about 1 mg / L to about 50 mg / L, for example, about 5 mg / L to about 10 mg / L. The magnesium ion component can be obtained from any salt such as chloride, carbonate, sulfate, acetate, bicarbonate, citrate, phosphate, hydrogen phosphate, tartrate, sorbate, or a combination thereof. Magnesium ions are preferably present in this composition in an amount of at least about 0.0005% to about 0.010% by weight.

[0054] This composition may contain magnesium in an amount of approximately 5 mg / L to approximately 1000 mg / L, more preferably approximately 1 mg / L to approximately 50 mg / L, for example, approximately 5 mg / L to approximately 20 mg / L.

[0055] This composition may contain chloride ions in amounts of approximately 0.005% to approximately 0.20% by weight, approximately 0.01% to approximately 0.15% by weight, or approximately 0.02% to approximately 0.075% by weight. The chloride ion components can be obtained from salts of sodium chloride, potassium chloride, or combinations thereof.

[0056] In certain embodiments, the beverage of the Disclosure contains at least one electrolyte selected from the group consisting of sodium, potassium, magnesium, calcium, and combinations thereof. In another particular embodiment, the beverage of the Disclosure contains at least one electrolyte selected from the group consisting of sodium, potassium, magnesium, calcium, and combinations thereof, wherein the amount of each electrolyte is as described above. In a particular embodiment, at least two active ingredients are a first active ingredient, a sodium salt having a concentration of about 10 mmol / L to about 28 mmol / L, or about 13 mmol / L to about 25 mmol / L, or about 16 mmol / L to about 20 mmol / L, or about 17 mmol / L to about 19 mmol / L, or about 18.3 mmol / L, and a second active ingredient, a potassium salt having a concentration of about 10 mmol / L to about 28 mmol / L, or about 13 mmol / L to about 25 mmol / L, or about 16 mmol / L to about 22 mmol / L, or about 18 mmol / L to about 21 mmol / L, or about 20.5 mmol / L.

[0057] sweetener This composition may optionally contain a sweetener. The sweetener may be an artificial or synthetic sweetener, a natural sweetener, or a natural high-intensity sweetener. As used herein, the phrase “natural high-intensity sweetener” (NHPS) refers to any sweetener found naturally in nature and characterized by having a higher sweetness than sucrose, fructose, or glucose, yet having a lower calorie content. Natural high-intensity sweeteners may be provided as a pure compound, or instead, as part of an extract. As used herein, the phrase “synthetic sweetener” refers to any composition not found naturally in nature and characterized by having a higher sweetness than sucrose, fructose, or glucose, yet having a lower calorie content. In certain embodiments, the oral composition may be sweetener-free. In certain embodiments, the oral composition may be completely and / or substantially free of nutritional sweeteners and / or non-nutritional sweeteners.

[0058] Non-limiting examples of NHPS include stevia and steviol glycosides, e.g., rebaudioside M, rebaudioside D, rebaudioside A, rebaudioside N, rebaudioside O, rebaudioside E, steviol monoside, steviol bioside, rubusoside, dulcoside B, dulcoside A, rebaudioside B, rebaudioside G, stevioside, rebaudioside C, rebaudioside F, rebaudioside Examples include dioside I, rebaudioside H, rebaudioside L, rebaudioside K, rebaudioside J, rebaudioside M2, rebaudioside D2, rebaudioside S, rebaudioside T, rebaudioside U, rebaudioside V, rebaudioside W, rebaudioside Z1, rebaudioside Z2, rebaudioside IX, enzymatically glucosylated steviol glycosides, and combinations thereof. Examples of high-purity steviol glycosides and methods for producing them are presented in U.S. Patent Application Publication No. 2021 / 0107933, which is incorporated herein by reference in its entirety.

[0059] In a particular embodiment, the steviol glycoside mixture contains at least about 5% by weight, 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 an exemplary embodiment, the steviol glycoside mixture contains at least about 50% by weight, for example, about 50% to about 90%, about 50% to about 80%, about 50% to about 70%, about 50% to about 60%, about 60% to about 90%, about 60% to about 80%, about 60% to about 70%, about 70% to about 90%, about 70% to about 80%, and about 80% to about 90% of steviol glycosides.

[0060] Another exemplary NHPS is Luo Han Guo and related mogroside compounds, e.g., Grossmogroside I, Mogroside IA, Mogroside IE, 11-Oxomogroside IA, Mogroside II, Mogroside II A, Mogroside II B, Mogroside II E, 7-Oxomogroside II E, Mogroside III, Mogroside HIE, 11-Oxomogroside HIE, 11-Deoxymogroside III, Mogroside IV, Mogroside IVA 11-Oxomogloside IV, 11-Oxomogloside IVA, Mogloside V, Isomogloside V, 11-Deoxymogloside V, 7-Oxomogloside V, 11-Oxomogloside V, Isomogloside V, Mogloside VI, Mogrol, 11-Oxomogrol, Siamenoside I, Isomers of Siamenoside I (e.g., the whole is incorporated by reference in the U.S. Patent Application) (Disclosed in Publication No. 20170119032), (3β,9β,10α,11α,24R)-3-[(4-O-β-D-glucopyranosyl-6-O-β-D-glucopyranosyl]-25-hydroxyl-9-methyl-19-norlanosto-5-en-24-yl-[2-O-β-D-glucopyranosyl-6-O-β-D-glucopyranosyl]-β-D-glucopy Lanoside; (3β,9β,10α,11α,24R)-[(2-O-β-D-glucopyranosyl-6-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]-25-hydroxy-9-methyl-19-norlanosto-5-en-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-norlanosto-5-en-24-yl-[2-O-β-D-glucopyranosyl-6-O-β-D-glucopyranosyl]-β-D-glucopyranoside).

[0061] In a particular embodiment, the mogroside mixture contains at least about 5% by weight of mogrosides, 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%.

[0062] Other exemplary NHPSs include monatin and its salts (monatin SS, RR, RS, SR), curculin, glycyrrhizinate and its salts, thaumatin, monellin, mavinlin, blazein, hernandulcin, phylodulcin, glycifylin, phlorizin, trilobatin, bayunoside, osrazine, polypodoside A, pterocarioside A, pterocarioside B, muclodioside, flomisoside I, periandrin I, abrusoside A, and cyclocarioside I.

[0063] In one embodiment, the sweetener is a carbohydrate sweetener. Suitable carbohydrate sweeteners include, but are not limited to, sucrose, glyceraldehyde, dihydroxyacetone, erythrose, threose, erythrolose, arabinose, lyxose, ribose, xylose, ribulose, xylulose, allose, altrose, galactose, glucose, iodose, mannose, talose, fructose, psicose, sorbose, tagatose, mannoheptulose, sedoheptulose, octolose, fucose, rhamnose, arabinose, turanose, sialose, and combinations thereof.

[0064] In certain embodiments, the composition is free of or substantially free of carbohydrate sweeteners.

[0065] Other suitable sweeteners include siamenoside, monatin and its salts (monatin SS, RR, RS, SR), curculin, mogroside, glycyrrhizic acid and its salts, thaumatin, monelin, mavinrin, blazein, hernandulcin, phyllodulcin, glycifylline, phlorizin, trilobatin, bayunoside, osrazine, polypodoside A, pterocarioside A, pterocarioside B, muclodioside, flomisoside I, and periand Examples include phosphorus I, abrusoside A, steviol bioside and cyclocarioside I, sugar alcohols such as erythritol, sucralose, acesulfame potassium, acesulfame acid and its salts, aspartame, alitarm, saccharin and its salts, neohesperidin dihydrochalcone, cyclamate, cyclamic acid and its salts, neotame, advantame, glucosylated steviol glycoside (GSG), and combinations thereof.

[0066] In one embodiment, the sweetener is a caloric sweetener or a mixture of caloric sweeteners. In another embodiment, the caloric sweetener is selected from sucrose, fructose, glucose, high-fructose corn / starch syrup, beet sugar, sucrose, and combinations thereof.

[0067] In certain embodiments, the composition is free of or substantially free of caloric sweeteners.

[0068] In another embodiment, the sweetener is a rare sugar selected from allulose, gross, korgibiose, sorbose, lyxose, ribulose, xylose, xylulose, D-allose, L-ribose, D-tagatose, L-glucose, L-fucose, L-arabinose, turanose, and combinations thereof.

[0069] The amount of sweetener in this composition depends on the identity of the sweetener and the desired level of sweetness. In a preferred embodiment, the sweetener is present in an amount that imparts sweetness, i.e., at a concentration in which sweetness is detectable.

[0070] As those skilled in the art will understand, high-intensity sweeteners are stronger and therefore require lower concentrations to achieve a particular sucrose equivalent sweetness (SE). The sweetness of a non-sucrose sweetener can be measured by determining its sucrose equivalent sweetness (SE) relative to a sucrose reference. Generally, taste testers are trained to detect the sweetness of a reference sucrose solution containing 1% to 15% sucrose (w / v). Then, other non-sucrose sweeteners are tasted at a series of dilutions to determine the concentration of the non-sucrose sweetener that is as sweet as a given percentage of sucrose reference. For example, if a 1% solution of a non-sucrose sweetener is as sweet as a 10% sucrose solution, then the sweetener is said to be 10 times stronger than sucrose and has a 10% sucrose equivalent sweetness.

[0071] In one embodiment, one or more sweeteners provide the composition with a sucrose equivalent sweetness of about 1% (w / v), 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.

[0072] In another embodiment, the composition has about 2% to about 14%, for example, about 2% to about 10%, about 2% to about 5%, about 5% to about 15%, about 5% to about 10%, or about 10% to about 15%.

[0073] The amount of sucrose in the reference solution, and therefore another measure of sweetness, can be expressed in Brix degrees (°Bx). One Brix degree is one gram of sucrose in 100 grams of solution, and the intensity of the solution is expressed as a percentage by weight (%w / w) (strictly speaking, by mass). In embodiments of sweetening the composition with sucrose, the beverage may be about 1 Brix degree, about 2 Brix degrees, about 3 Brix degrees, about 4 Brix degrees, about 5 Brix degrees, about 6 Brix degrees, about 7 Brix degrees, about 8 Brix degrees, about 9 Brix degrees, about 10 Brix degrees, about 11 Brix degrees, about 12 Brix degrees, about 13 Brix degrees, about 14 Brix degrees, or any range between these values.

[0074] Functional components / ingredients This composition may optionally contain functional ingredients. Examples of functional ingredients, but not limited to, include saponins, antioxidants, sources of dietary fiber, fatty acids, vitamins, glucosamine, minerals, preservatives, hydrating agents, probiotics, prebiotics, weight management agents, osteoporosis management agents, phytoestrogens, long-chain aliphatic saturated primary alcohols, phytosterols, and combinations thereof.

[0075] In certain embodiments, the functional component is at least one saponin. As used herein, at least one saponin may be a single saponin or multiple saponins as the functional component for the compositions presented herein. Saponins are naturally occurring plant-produced glycosides comprising an aglycone ring structure and one or more sugar moieties. Non-limiting examples of specific saponins for use in certain embodiments of this disclosure include group A acetylsaponins, group B acetylsaponins, and group E acetylsaponins. Some common sources of saponins include soybeans, which have a saponin content of approximately 5% by dry weight; the soapwort plant (Saponaria), whose roots have historically been used as soap; and alfalfa, aloe, asparagus, grapes, chickpeas, yucca, and various other legumes and herbs. Saponins can be obtained from these sources by using extraction techniques known to those skilled in the art. A description of conventional extraction techniques can be found in U.S. Patent Application Publication No. 2005 / 0123662.

[0076] In certain embodiments, the functional component is at least one antioxidant. As used herein, “antioxidant” means any substance that inhibits, suppresses, or reduces oxidative damage to cells and biomolecules.

[0077] Examples of suitable antioxidants for 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, phenol esters, polyphenol esters, non-flavonoid phenols, isothiocyanates, and combinations thereof. In some embodiments, antioxidants include vitamin A, vitamin C, vitamin E, ubiquinone, the minerals selenium, manganese, melatonin, oc-carotene, β-carotene, lycopene, lutein, zeaxanthin, cryptoxanthin, resveratrol, eugenol, quercetin, catechin, gossypol, hesperetin, curcumin, ferulic acid, thymol, hydroxytyrosol, turmeric, thyme, olive oil, lipoic acid, glutathione, glutamine, oxalic acid, tocopherol-derived compounds, butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), ethylenediaminetetraacetic acid (EDTA), tert-butylhydroquinone, acetic acid, pectin, tocotrienol, tocopherol, coenzyme Q10, zeaxanthin, astaxanthin, canthaxanthin, saponin, limonoid, kaempferol, myricetin, and isorhamne. Tin, proanthocyanidins, quercetin, rutin, luteolin, apigenin, tangeretin, hesperetin, naringenin, eriodictyol, flavan-3-ol (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 Glycitein, anthocyanins, cyanidin, delphinidin, malvidin, pelargonidin, peonidin, petunidin, ellagic acid, gallic acid, salicylic acid, rosmarinic acid, cinnamic acid and its derivatives (e.g., ferulic acid), chlorogenic acid, chicoric acid, gallotannin, ellagitannin, anthoxanthin, betacyanin and other plant pigments, silymarin, citric acid, lignan, antitrophic factors, bilirubin, uric acid, R-oc-lipoic acid,N-acetylcysteine, emblicanin, apple extract, apple peel extract (applephenone), red rooibos extract, green rooibos extract, hawthorn extract, red raspberry extract, green coffee antioxidant (GCA), 20% aronia extract, grape seed extract (VinOseed), cocoa extract, hop extract, mangosteen extract, mangosteen peel extract, cranberry extract, pomegranate extract, pomegranate peel extract, pomegranate seed extract, hawthorn extract, pomella extract, cinnamon extract, grape peel extract, bilberry extract, pine bark extract, pycnogenol, elderberry extract, mulberry root extract, wolfberry (gogi) extract, blackberry extract, blueberry extract, blueberry leaf extract, raspberry extract, turmeric extract, citrus bioflavonoids, blackcurrant, ginger, acai powder, green coffee bean extract, green tea extract, and phytic acid, or a combination thereof. In alternative embodiments, the antioxidant is a synthetic antioxidant such as butylated hydroxytoluene or butylated hydroxyanisole. Other suitable sources of antioxidants for embodiments of this disclosure include, but are not limited to, fruits, vegetables, tea, cocoa, chocolate, spices, herbs, rice, animal offal, yeast, whole grains, or cereals.

[0078] Certain antioxidants belong to a class of plant nutrients called polyphenols (also known as "polyphenols"), which are chemical substances found in plants and characterized by having two or more phenolic groups per molecule. Suitable polyphenols for embodiments of this disclosure include catechins, proanthocyanidins, procyanidins, anthocyanins, quercetin, rutin, resveratrol, isoflavones, curcumin, punicalagin, ellagitannins, hesperidin, naringin, citrus flavonoids, chlorogenic acid, other similar materials, and combinations thereof.

[0079] In one embodiment, the antioxidant is a catechin, such as epigallocatechin gallate (EGCG). In another embodiment, the antioxidant is selected from proanthocyanidins, procyanidins, or a combination thereof. In a particular embodiment, the antioxidant is anthocyanin. In yet another embodiment, the antioxidant is selected from quercetin, rutin, or a combination thereof. In one embodiment, the antioxidant is resveratrol. In another embodiment, the antioxidant is isoflavone. In yet another embodiment, the antioxidant is curcumin. In yet another embodiment, the antioxidant is selected from punicalazine, ellagitannin, or a combination thereof. In yet another embodiment, the antioxidant is chlorogenic acid.

[0080] In certain embodiments, the functional component is at least one type of dietary fiber. Numerous polymeric carbohydrates with structures that differ significantly in both composition and linkage fall within the definition of dietary fiber. Such compounds are known to those skilled in the art, and non-limiting examples include non-starch polysaccharides, lignin, cellulose, methylcellulose, hemicellulose, β-glucan, pectin, gum, mucus, wax, inulin, oligosaccharides, fructooligosaccharides, cyclodextrin, chitin, and combinations thereof. Dietary fiber generally originates from plant sources, but indigestible animal products such as chitin are also classified as dietary fiber. Chitin is a polysaccharide composed of acetylglucosamine units linked by β(1-4) linkages similar to those of cellulose.

[0081] In certain embodiments, the functional component 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 acid or organic acid having a long aliphatic tail. As used herein, “omega-3 fatty acid” refers to any polyunsaturated fatty acid having its first double bond as a third carbon-carbon bond from the terminal methyl group of its carbon chain. In certain embodiments, the omega-3 fatty acid may include a long-chain omega-3 fatty acid. As used herein, “omega-6 fatty acid” refers to any polyunsaturated fatty acid having its first double bond as a sixth carbon-carbon bond from the terminal methyl group of its carbon chain.

[0082] Suitable omega-3 fatty acids for use in the embodiments of this disclosure may be derived, for example, from algae, fish, animals, plants, or combinations thereof. Examples of suitable omega-3 fatty acids, but not limited to, include linolenic acid, alpha-linolenic acid, eicosapentaenoic acid, docosahexaenoic acid, stearidonic acid, eicosatetraenoic acid, and combinations thereof. In some embodiments, suitable omega-3 fatty acids may be found in fish oils (e.g., herring oil, tuna oil, salmon oil, bonito oil, and cod oil), microalgae omega-3 oils, or combinations thereof. In certain embodiments, suitable omega-3 fatty acids may be derived from commercially available omega-3 fatty acid oils, such as Microalgae DHA oil (Martek, Columbia, MD), OmegaPure (Omega Protein, Houston, TX), Marinol C-38 (Lipid Nutrition, Channahon, IL), Bonito oil and MEG-3 (Ocean Nutrition, Dartmouth, NS), Evogel (Symrise, Holzminden, Germany), Marine Oil from Tuna or Salmon (Arista Wilton, CT), OmegaSource 2000, Marine Oil from Herring and Marine Oil from Cod (OmegaSource, RTP, NC). Appropriate 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, adrenaline, docosapentaenoic acid, and combinations thereof.

[0083] Suitable esterified fatty acids for embodiments of the present 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, triacylglycerols containing omega-3 and / or omega-6 fatty acids, and combinations thereof.

[0084] In certain embodiments, the functional component is at least one vitamin. Suitable vitamins include vitamin A, vitamin D, vitamin E, vitamin K, vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B7, vitamin B9, vitamin B12, and vitamin C.

[0085] Various other compounds are classified as vitamins by some authorities. These compounds are sometimes referred to as pseudovitamins and include, but are not limited to, ubiquinone (coenzyme Q10), pangamic acid, dimethylglycine, taestrile, amygdalin, flavanoids, para-aminobenzoic acid, adenine, adenylic acid, and s-methylmethionine. As used herein, the term vitamin encompasses pseudovitamins. In some embodiments, the vitamin is a fat-soluble vitamin selected from vitamins A, D, E, K and combinations thereof. In other embodiments, the vitamin is a water-soluble vitamin selected from vitamin B1, vitamin B2, vitamin B3, vitamin B6, vitamin B12, folic acid, biotin, pantothenic acid, vitamin C and combinations thereof.

[0086] In certain embodiments, the functional component is glucosamine, and optionally further contains chondroitin sulfate.

[0087] In certain embodiments, the functional component is at least one mineral. Minerals include inorganic chemical elements required by living organisms, as taught in this disclosure. Minerals consist of a wide range of compositions (e.g., elements, monosaltes, and complex silicates), and their crystalline structures also vary widely. Minerals may be naturally occurring in foods and beverages, added as dietary supplements, or ingested or administered separately from foods or beverages.

[0088] Minerals can be classified into either bulk minerals, which are required in relatively large quantities, or trace minerals, which are required in relatively small quantities. Generally, bulk minerals are required in amounts of approximately 100 mg or more per day, while trace minerals are required in amounts of less than approximately 100 mg per day. In one embodiment, minerals are selected from bulk minerals, trace minerals, or a combination thereof. Non-limiting examples of bulk minerals include calcium, chlorine, magnesium, phosphorus, potassium, sodium, and sulfur. Non-limiting examples of trace minerals include chromium, cobalt, copper, fluorine, iron, manganese, molybdenum, selenium, zinc, and iodine. While iodine is generally classified as a trace mineral, it is often required in larger quantities than other trace minerals and is frequently classified as a bulk mineral.

[0089] In certain embodiments, the minerals are trace minerals considered necessary for human nutrition, and non-limiting examples include bismuth, boron, lithium, nickel, rubidium, silicon, strontium, tellurium, tin, titanium, tungsten, and vanadium.

[0090] The minerals embodied herein may be in any form known to those skilled in the art. For example, in one embodiment, the minerals may be in their ionic form, having either a positive or negative charge. In another embodiment, the minerals may be in their molecular form. For example, sulfur and phosphorus are often found in nature as sulfates, sulfides, and phosphates.

[0091] In certain embodiments, the functional component is at least one preservative. In certain embodiments, the preservative is selected from antimicrobial agents, antioxidants, anti-enzyme agents, or combinations 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. Examples of sulfites, but not limited to, include sulfur dioxide, sodium bisulfite, and potassium bisulfite. In another embodiment, the preservative is a propionate. Examples of propionates, but not limited to, include propionic acid, calcium propionate, and sodium propionate. In yet another embodiment, the preservative is a benzoate. Examples of benzoates, but not limited to, include sodium benzoate and benzoic acid. In yet another embodiment, the preservative is a sorbate. Examples of sorbates, but not limited to, include potassium sorbate, sodium sorbate, calcium sorbate, and sorbic acid. In yet another embodiment, the preservative is a nitrate and / or nitrite. Examples of nitrates and nitrites, but not limited to, include sodium nitrate and sodium nitrite. In yet another embodiment, at least one preservative is a bacteriocin, such as nisin. In yet another embodiment, the preservative is ethanol. In yet another embodiment, the preservative is ozone. Non-limiting examples of suitable anti-enzyme agents for use as preservatives in certain embodiments of this disclosure include ascorbic acid, citric acid, and metal chelating agents such as ethylenediaminetetraacetic acid (EDTA).

[0092] In certain embodiments, the functional component is an additional hydrating agent to an amino acid-free formulation. The additional hydrating agent may be a synergistic agent that, when combined with an amino acid-free formulation, further enhances the hydrating or rehydrating effect of the composition. In one particular embodiment, the additional hydrating agent is a carbohydrate to replenish energy stores burned by muscles. Suitable carbohydrates for use in certain embodiments of this disclosure are described in U.S. Patent No. 4,312,856, Patent Document 1, U.S. Patent No. 5,681,569, and U.S. Patent No. 6,989,171. Non-limiting examples of suitable carbohydrates include monosaccharides, disaccharides, oligosaccharides, complex polysaccharides, or combinations thereof. Non-limiting examples of suitable monosaccharide types for use in certain embodiments include trioses, tetroses, pentoses, hexoses, heptoses, octoses, and nonoses. Non-limiting examples of specific types of suitable monosaccharides include glyceraldehyde, dihydroxyacetone, erythrose, threose, erythrolose, arabinose, lyxose, ribose, xylose, ribulose, xylulose, allose, altrose, galactose, glucose, glucose, idose, mannose, talose, fructose, psicose, sorbose, tagatose, mannoheptulose, sedoheptulose, octorose, and siarose. Non-limiting examples of suitable disaccharides include sucrose, lactose, and maltose. Non-limiting examples of suitable oligosaccharides include saccharose, maltotriose, and maltodextrin. In other specific embodiments, carbohydrates may be provided by corn syrup, beet sugar, sucrose, juice, or tea.

[0093] In another specific embodiment, the additional hydrating agent is a flavanol, which provides cellular hydration. Flavanols are a type of naturally occurring substance found in plants and generally contain a phenylbenzopyrone molecular skeleton bound to one or more chemical moieties. Non-limiting examples of suitable flavanols for use in the specific embodiments of this disclosure include catechin, epicatechin, gallocatechin, epigallocatechin, epicatechin gallate, epigallocatechin 3-gallate, theaflavin, theaflavin 3-gallate, theaflavin 3'-gallate, theaflavin 3,3'-gallate, thearubigin, or combinations thereof. Some common sources of flavanols include tea plants, fruits, vegetables, and flowers. In a preferred embodiment, the flavanol is extracted from green tea.

[0094] In certain embodiments, the additional hydration supplement is a glycerol solution for improving exercise endurance. It has been shown that taking a glycerol-containing solution results in beneficial physiological effects such as increased blood volume, decreased heart rate, and decreased rectal temperature.

[0095] In certain embodiments, the functional ingredient is selected from at least one probiotic, prebiotic, or combination thereof. Probiotics are beneficial microorganisms that affect the naturally occurring gastrointestinal microflora of the human body. Examples of probiotics, but not limited to, include bacteria of the genera Lactobacillus, Bifidobacteria, Streptococci, or combination thereof that confer beneficial effects to humans. In certain embodiments of this disclosure, at least one probiotic is selected from the genus Lactobacillus. According to other certain embodiments of this disclosure, the probiotic is selected from the genus Bifidobacteria. In certain embodiments, the probiotic is selected from the genus Streptococcus.

[0096] Probiotics that can be used in accordance with this disclosure are known to those skilled in the art. Non-limiting examples of food products containing probiotics include yogurt, sauerkraut, kefir, kimchi, fermented vegetables, and other food products containing microbial elements that have a beneficial effect on the host animal by improving the intestinal microbalance.

[0097] Prebiotics according to embodiments of the present disclosure include, but are not limited to, mucopolysaccharides, oligosaccharides, polysaccharides, vitamins, nutrient precursors, proteins, and combinations thereof. According to certain embodiments of the present disclosure, prebiotics are selected from dietary fiber, including polysaccharides and oligosaccharides, but are not limited to these. Non-limiting examples of oligosaccharides classified as prebiotics according to certain embodiments of the present disclosure include fructooligosaccharides, inulin, isomaltoligosaccharides, lactitol, lactulose, pyrodextrin, soybean oligosaccharides, transgalactooligosaccharides, and xylooligosaccharides.

[0098] Prebiotics are found naturally in a variety of foods, not limited to these, including bananas, berries, asparagus, garlic, wheat, oats, barley (and other whole grains), flaxseed, tomatoes, Jerusalem artichokes, onions and chicory, leafy vegetables (e.g., dandelion leaves, spinach, collard greens, chard, kale, mustard greens, turnip greens), and legumes (e.g., lentils, kidney beans, chickpeas, white beans, white beans, black beans).

[0099] 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 compositions,” “satiety agents,” and “satiety ingredients” are synonymous. The phrase “appetite suppressant” refers to a major nutrient, herbal extract, exogenous hormone, appetite suppressant, appetite stimulant, compound, and combination thereof that, when delivered in an effective amount, suppress, inhibit, reduce, or otherwise deprive a person of their appetite. The phrase “thermogenic agent” refers to a major nutrient, herbal extract, exogenous hormone, appetite suppressant, appetite stimulant, compound, and combination thereof that, when delivered in an effective amount, activate or otherwise enhance a person's heat generation or metabolism.

[0100] Appropriate weight management aids include macronutrients selected from the group consisting of proteins, carbohydrates, dietary fats, and combinations thereof. Intake of proteins, carbohydrates, and dietary fats stimulates the release of peptides that have an appetite-suppressing effect. For example, intake of proteins and dietary fats stimulates the release of cholecystokinin (CCK), a gastrointestinal hormone, while intake of carbohydrates and dietary fats stimulates the release of glucagon-like peptide-1 (GLP-1).

[0101] Carbohydrates are also listed as appropriate macronutrient weight management agents. Carbohydrates generally include sugars, starches, celluloses, and gums, which are converted by the body into glucose for energy. Carbohydrates are often classified into two categories: easily digestible carbohydrates (e.g., monosaccharides, disaccharides, and starches) and poorly digestible carbohydrates (e.g., dietary fiber). Multiple studies have shown that poorly digestible carbohydrates and complex polymer carbohydrates, which are poorly absorbed and digested in the small intestine, stimulate physiological responses that inhibit food intake. Therefore, it is desirable that the carbohydrates embodied herein include poorly digestible or poorly digestible carbohydrates. Non-limiting examples of such carbohydrates include polydextrose; inulin; monosaccharide-derived polyols, e.g., erythritol, mannitol, xylitol, and sorbitol; disaccharide-derived alcohols, e.g., isomalt, lactitol, and maltitol; and hydrolyzed hydrogenated starch. Carbohydrates are described in detail below herein.

[0102] In another specific embodiment, the weight management agent is dietary fat. Dietary fat is a lipid composed of a combination of saturated and unsaturated fatty acids. Polyunsaturated fatty acids have been shown to be more satiating than monounsaturated fatty acids. Therefore, the dietary fat embodied herein is preferably to contain polyunsaturated fatty acids, a non-limiting example of which is triacylglycerol. In another specific embodiment, the weight management agent is a herbal extract. Extracts from numerous types of plants have been identified as having appetite-suppressing properties. Non-limiting examples of plants whose extracts have appetite-suppressing properties include plants of the genera Hoodia, Trichocaulon, Caralluma, Stapelia, Orbea, Asclepias, and Camellia. Other embodiments include extracts derived from Gymnema sylvestre, cola nut, Citrus aurantium, Yerba mate, Griffonia simplicifolia, guarana, myrrh, guggul lipids, and blackcurrant seed oil.

[0103] Herbal extracts can be prepared from any type of plant material or plant biomass. Non-limiting examples of plant materials and biomass include stems, roots, leaves, dried powders obtained from plant materials, and sap or dried sap. Herbal extracts are generally prepared by extracting sap from plants and then spray-drying the sap. Alternatively, solvent extraction procedures can be used. After the initial extraction, it is desirable to further fractionate the initial extract (e.g., by column chromatography) to obtain a herbal extract with improved activity. Such techniques are known to those skilled in the art.

[0104] In one embodiment, the herbal extract is derived from plants of the genus Hoodia. The sterol glycoside of Hoodia is known as P57 and is thought to be involved in the appetite-suppressing effect of Hoodia species. In another embodiment, the herbal extract is derived from plants of the genus Caralluma, and non-limiting examples 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 yet another embodiment, at least one herbal extract is derived from plants of the genus Trichocaulon. Trichocaulon plants are generally succulent plants native to South Africa, similar to Hoodia, and include the species T. piliferum and T. officinale. In another embodiment, the herbal extract is derived from plants of the genus Stapelia or Orbea. While we do not wish to be bound by any theory, the compounds exhibiting appetite-suppressing activity are thought to be saponins, such as pregnane glycosides including stabolosides A, B, C, D, E, F, G, H, I, J, and K. In another embodiment, the herbal extract is derived from plants of the genus Asclepias. While we do not wish to be bound by any theory, this extract is thought to contain steroidal compounds having appetite-suppressing effects, such as pregnane glycosides and pregnane aglycones. In another specific embodiment, the weight management agent is an exogenous hormone having weight management effects. Non-limiting examples of such hormones include CCK, peptide YY, ghrelin, bombesin and gastrin-releasing peptide (GRP), enterostatin, apolipoprotein A-IV, GLP-1, amylin, somatostatin, and leptin.

[0105] In another embodiment, the weight management agent is a compound. Non-limiting examples include phentenime, diethylpropion, fendimethrazine, sibutramine, limonabant, oxytomodulin, fluoxetine hydrochloride, ephedrine, phenethylamine, or other stimulants.

[0106] In certain embodiments, the functional component is at least one osteoporosis management agent. In certain embodiments, the osteoporosis management agent is at least one calcium source. According to certain embodiments, the calcium source is any compound containing calcium, including calcium complex salts, solubilized species, and other forms. Non-limiting examples of calcium sources include calcium carbonate, calcium oxide, calcium hydroxide, calcium sulfate, calcium chloride, calcium phosphate, calcium hydrogen phosphate, calcium dihydrogen phosphate, calcium citrate, calcium malate, calcium citrate-malate, calcium gluconate, calcium tartrate, calcium lactate, solubilized species thereof, and combinations thereof.

[0107] According to certain embodiments, the osteoporosis management agent is a magnesium source. The magnesium source is any compound containing magnesium, including magnesium complex salts, solubilized species, and other forms. Non-limiting examples of magnesium sources include magnesium chloride, magnesium citrate, magnesium gluceptate, magnesium gluconate, magnesium lactate, magnesium hydroxide, magnesium picolate, magnesium sulfate, its solubilized species, and mixtures thereof.

[0108] In other embodiments, the osteoporosis management agent is selected from vitamins D, C, K, their precursors and / or beta-carotene and combinations thereof.

[0109] Numerous plants and plant extracts have also been identified as effective in the prevention and treatment of osteoporosis. Non-limiting examples of plants and plant extracts suitable as osteoporosis management agents include species of the genera Taraxacum and Amelanchier disclosed in U.S. Patent Application Publication 2005 / 0106215, and species of Lindera, Artemisia, Acorus, Carthamus, Carum, Cnidium, Curcuma, Cyperus, Juniperus, and Prunus (P) disclosed in U.S. Patent Application 2005 / 0079232. Species from the genera *runus*, *Iris*, *Cichorium*, *Dodonaea*, *Epimedium*, *Erigonoum*, *rioya*, *Mentha*, *Ocimum*, *thymus*, *Tanacetum*, *Plantago*, *Spearmint*, *Bixa*, *Vitis*, *Rosemarinus*, *Rhus*, and *Anethum* are examples.

[0110] In certain embodiments, the functional component is at least one phytoestrogen. Phytoestrogens are compounds found in plants and can generally be delivered to the human body by ingesting plants or parts of plants containing phytoestrogens. As used herein, “phytoestrogen” refers to any substance that, when introduced into the body, produces estrogen-like effects to varying degrees. For example, a phytoestrogen may be one that can bind to estrogen receptors in the body and has a small estrogen-like effect.

[0111] Examples of suitable phytoestrogens for embodiments of the present disclosure include, but are not limited to, isoflavones, stilbenes, lignans, resorcylate lactones, coumestan, coumestrol, ecol, and combinations thereof. Suitable sources of phytoestrogens include, but are not limited to, whole grains, cereals, fiber, fruits, vegetables, black cohosh, agave root, blackcurrant, black hoe, chasteberry, crumple bark, angelica root, American holly root, false unicorn root, Korean ginseng root, ragwort herb, licorice, fleabane herb, motherwort herb, peony root, raspberry leaf, rose family plants, sage leaf, sarsaparilla root, saw palmetto fruit, wild yam root, yarrow flower, legumes, soybeans, soybean products (e.g., miso, dama). Examples include soy flour, soy milk, roasted soybeans, soy protein isolate, tempeh, or tofu, chickpeas, nuts, lentils, seeds, clover, red clover, dandelion leaves, dandelion roots, fenugreek seeds, green tea, hops, red wine, flaxseed, garlic, onions, flaxseed, borage, willow sedge, caraway, chaste tree, vitex, dates, dill, fennel seeds, gotu kola, milk thistle, pennyroyal mint, pomegranate, southernwood, soy flour, tansy, and kudzu root (pueraria root), etc., and combinations thereof.

[0112] Isoflavones belong to a group of plant nutrients called polyphenols. Generally, polyphenols (also known as "polyphenols") are a group of chemical substances found in plants that are characterized by having two or more phenol groups per molecule.

[0113] Suitable phytoestrogens and isoflavones according to embodiments of the present disclosure include genistein, daidzein, glycitein, biochanin A, formononetin, their respective naturally occurring glycosides and glycoside conjugates, matairesinol, secoisolariciresinol, enterolactone, enterodiol, textured plant proteins, and combinations thereof. Suitable sources of isoflavones for embodiments of the present disclosure include, but are not limited to, soybeans, soybean products, legumes, alfalfa sprouts, chickpeas, peanuts, and red clover.

[0114] In certain embodiments, the functional component is at least one long-chain aliphatic saturated primary alcohol. Long-chain aliphatic saturated primary alcohols are a diverse group of organic compounds. 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 for use in specific embodiments of this disclosure include 1-octanol (8 carbon atoms), 1-nonanol (9 carbon atoms), 1-decanol (10 carbon atoms), 1-dodecanol (12 carbon atoms), 1-tetradecanol (14 carbon atoms), 1-hexadecanol (16 carbon atoms), 1-octadecanol (18 carbon atoms), 1-eicosanol (20 carbon atoms), 1-docosanol (22 carbon atoms), 1-tetracosanol (24 carbon atoms), 1-hexacosanol (26 carbon atoms), 1-heptacosanol (27 carbon atoms), 1-octacosanol (28 carbon atoms), 1-nonacosanol (29 carbon atoms), 1-triacontanol (30 carbon atoms), 1-dotriacontanol (32 carbon atoms), and 1-tetracontanol (34 carbon atoms).

[0115] In one embodiment, the long-chain aliphatic saturated primary alcohol is policosanol. Policosanol is a term for a mixture of long-chain aliphatic saturated primary alcohols, mainly consisting of 1-octacosanol (28 carbon atoms) and 1-triacontanol (30 carbon atoms), as well as other alcohols at lower concentrations, such as 1-docosanol (22 carbon atoms), 1-tetracosanol (24 carbon atoms), 1-hexacosanol (26 carbon atoms), 1-heptacosanol (27 carbon atoms), 1-nonacosanol (29 carbon atoms), 1-dotriacontanol (32 carbon atoms), and 1-tetracontanol (34 carbon atoms).

[0116] In certain embodiments, the functional component is at least one phytosterol, phytostanol, or a combination thereof. As used herein, the terms “stanol,” “plant stanol,” and “phytostanol” are synonymous. Plant sterols and stanols are naturally present in small numbers in many fruits, vegetables, nuts, seeds, cereals, legumes, vegetable oils, tree bark, and other plant sources. Sterols are a subgroup of steroids having a hydroxyl group at C3. Generally, phytosterols, like cholesterol, have a double bond in the steroid nucleus. However, phytosterols may also contain a substituted side chain (R) at C24, for example, an ethyl or methyl group, or an additional double bond. The structures of phytosterols are known to those skilled in the art.

[0117] At least 44 naturally occurring phytosterols have been discovered, generally derived from plants such as maize, soybeans, wheat, and wood oil. However, these phytosterols can also be synthesized to have the same composition as those found in nature, or to possess similar properties to those found in nature. Suitable phytosterols, though not limited to these, include, but are not limited to, 4-desmethylsterols (e.g., β-sitosterol, campesterol, stigmasterol, brassicasteol, 22-dehydrobrassicasterol, and A5-avenasterol), 4-monomethylsterol, and 4,4-dimethylsterols (triterpene alcohols) (e.g., cycloartenol, 24-methylenecycloartanol, and cyclobranol).

[0118] As used herein, the terms “stanol,” “plant stanol,” and “phytostanol” are synonymous. Phytostanols are saturated sterol alcohols that exist in nature only in trace amounts, and can also be synthesized, for example, by hydrogenation of phytosterols. Suitable phytostanols include, but are not limited to, β-sitostanol, campestanol, cycloartanol, and saturated forms of other triterpene alcohols.

[0119] Both phytosterols and phytostanols, as used herein, encompass various isomers, including α-isomers and β-isomers. The phytosterols and phytostanols of this disclosure may also be in their ester forms. Suitable methods for deriving esters from phytosterols and phytostanols are known to those skilled in the art and are disclosed in U.S. Patents 6,589,588, 6,635,774, 6,800,317, and U.S. Patent Application Publication 2003 / 0045473. Non-limiting examples of suitable phytosterol and phytostanol esters include sitosterol acetate, sitosterol oleate, stigmasterol oleate, and their corresponding phytostanol esters. The phytosterols and phytostanols of this disclosure may also include their derivatives.

[0120] Examples of additives, but not limited to, include carbohydrates, polyols, sugar acids and their corresponding salts, nucleotides, organic acids, inorganic acids, organic acidic salts and organic basic salts, organic salts, inorganic salts, bitter compounds, caffeine, flavorings and flavor components, astringent compounds, proteins or protein hydrolysates, surfactants, emulsifiers, plant extracts, flavonoids, alcohols, polymers, and combinations thereof.

[0121] In one embodiment, the composition further comprises one or more polyols. As used herein, the term "polyol" refers to a molecule containing two or more hydroxyl groups. The polyols may be diols, triols, or tetravalent polyols, each containing two, three, and four hydroxyl groups, respectively.

[0122] The polyol may contain five or more hydroxyl groups, for example, pentavalent polyols, hexaols, heptaols, etc., each containing five, six, or seven hydroxyl groups. Furthermore, the polyol may be a sugar alcohol, polyhydric alcohol, or polyalcohol, which is a reduced form of carbohydrate, in which a carbonyl group (aldehyde or ketone, reducing sugar) is reduced to a primary or secondary hydroxyl group. In some embodiments, non-limiting examples of polyols include maltitol, mannitol, sorbitol, lactitol, xylitol, isomalt, propylene glycol, glycerol (glycerin), treitol, galactitol, palatinose, reduced isomaltoligosaccharide, reduced xylooligosaccharide, reduced gentiooligosaccharide, reduced maltose syrup, reduced glucose syrup, and sugar alcohols, or any other carbohydrate that can be reduced without adversely affecting taste.

[0123] Suitable sugar and acid additives include, but are not limited to, aldonic acid, uronic acid, aldaric acid, alginic acid, gluconic acid, glucuronic acid, glucanic acid, galactaric acid, galacturonic acid, and their salts (e.g., sodium salts, potassium salts, calcium salts, magnesium salts, or other physiologically acceptable salts), and combinations thereof.

[0124] 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, their alkali metal salts or alkaline earth metal salts, and combinations thereof. The nucleotides described herein may also include nucleotide-related additives such as nucleosides or nucleic acid bases (e.g., guanine, cytosine, adenine, thymine, uracil).

[0125] Suitable organic acid additives include any compound containing an α-COOH moiety, such as 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, hydroxy acids, substituted hydroxybenzoic 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, hydroxycitric acid, malic acid, and fruit acids. Examples of organic acid additives include (a mixture of malic acid, fumaric acid, and tartaric acid), fumaric acid, maleic acid, succinic acid, chlorogenic acid, salicylic acid, caffeic acid, bile acids, acetic acid, ascorbic acid, alginic acid, erythorbic acid, polyglutamic acid, glucono delta-lactone, and derivatives of their alkali metal or alkaline earth metal salts. Furthermore, the organic acid additive may be in either the D or L stereoconfiguration. Suitable organic acid additive salts, but are not limited to these, include sodium, calcium, potassium, and magnesium salts of all organic acids, such as salts of citric acid, malic acid, tartaric acid, fumaric acid, lactic acid (e.g., sodium lactate), alginic acid (e.g., sodium alginate), ascorbic acid (e.g., sodium ascorbate), benzoic acid (e.g., sodium benzoate or potassium benzoate), sorbic acid, and adipic acid. Examples of organic acid additives described may be optionally substituted with at least one group selected from hydrogen, alkyl, alkenyl, alkynyl, halo, haloalkyl, carboxyl, acyl, acyloxy, amino, amide, carboxyl derivative, alkylamino, dialkylamino, arylamino, alkoxy, aryloxy, nitro, cyano, sulfo, thiol, imine, sulfonyl, sulfenyl, sulfumyl, sulfamyl, carboxyalkoxy, carboxyamide, phosphonyl, phosphinyl, phosphoryl, phosphino, thioester, thioether, anhydride, oxyimino, hydrazino, carbamyl, phosphoro, or phosphonato.In certain embodiments, the organic acid additive is present in the sweetener composition in an amount effective to yield a concentration of about 10 ppm to about 5000 ppm when present in an ingested substance such as a beverage.

[0126] Suitable inorganic acid additives include, but are not limited to, phosphoric acid, phosphorous acid, polyphosphate, hydrochloric acid, sulfuric acid, carbonic acid, sodium dihydrogen phosphate, and their alkali metal salts or alkaline earth metal salts (e.g., inositol hexaphosphate Mg / Ca).

[0127] Suitable bittering compound additives include, but are not limited to, caffeine, quinine, urea, bitter orange oil, naringin, thorny brown sugar, and their salts.

[0128] Suitable flavorings and flavor additives include, but are not limited to, vanillin, vanilla extract, mango extract, cinnamon, citrus fruits, palm, ginger, viridiflorol, almond, menthol (including menthol without mint), grape skin extract, and grape seed extract. "Flavoring" and "flavoring" are synonymous and may include natural substances, synthetic substances, or combinations thereof. Flavorings also include any other substances that impart flavor and may include natural or non-natural (synthetic) substances that are safe for humans or animals when used in generally accepted amounts. Non-exclusive examples of trademarked flavorings include DOHLER® Natural Flavoring Sweetness Enhancer K14323 (DOHLER®, Darmstadt, Germany), Symrise® Natural Flavor Mask for Sweeteners 161453 and 164126 (SYMRISE®, Holzminden, Germany), Natural Advantage® Bitterness Blockers 1, 2, 9 and 10 (Natural Advantage®, Freehold, New Jersey, USA), and SUCRAMASK® (Creative Research Management, Stockton, California, USA).Suitable polymer additives include, but are not limited to, chitosan, pectin, pectic acid, pectinic acid, polyuronic acid, polygalacturonic acid, starch, food hydrocolloids or their crude extracts (e.g., Senegalese gum arabic (FIBERGUM®), Seyal gum arabic, carrageenan), poly-L-lysine (e.g., poly-L-α-lysine or poly-L-ε-lysine), poly-L-ornithine (e.g., poly-L-α-ornithine or poly-L-ε-ornithine), polypropylene glycol, polyethylene glycol, poly(ethylene glycol methyl ether), polyarginine, polyaspartic acid, polyglutamic acid, polyethyleneimine, alginic acid, sodium alginate, propylene glycol alginate, and sodium polyethylene glycol alginate, sodium hexametaphosphate and its salts, as well as other cationic and anionic polymers.

[0129] In some embodiments, the oral composition for hydration or rehydration may contain a protein hydrolysate additive. In related embodiments, the composition may contain the protein hydrolysate additive as a substitute for components such as amino acids.

[0130] 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 (hexadecylpyridinium chloride), hexadecyltrimethylammonium bromide, sodium cholate, carbamoyl, choline chloride, sodium glycocholate, sodium taurodeoxycholate, alginate laurate, sodium stearoyl lactylate, sodium taurocholate, lecithin, sucrose oleate, sucrose stearate, sucrose palmitate, sucrose laurate, and other emulsifiers.

[0131] Suitable flavonoid additives are classified as flavonols, flavones, flavanones, flavan-3-ols, isoflavones, or anthocyanidins. Non-exclusive examples of flavonoid additives include, but are not limited to, catechins (e.g., green tea extract, e.g., Polyphenon® 60, Polyphenon® 30, and Polyphenon® 25 (Mitsui Norin Co., Ltd., Japan)), polyphenols, rutin (e.g., enzyme-treated rutin Sanmelin® AO (San-Ei Gen F.F.I. Co., Ltd., Osaka, Japan)), neohesperidin, naringin, and neohesperidin dihydrochalcone. Suitable alcohol additives include, but are not limited to, ethanol.

[0132] Suitable astringent compound additives include, but are not limited to, tannic acid, europium chloride (EuCl3), gadolinium chloride (GdCl3), terbium chloride (TbCl3), arum, tannic acid, and polyphenols (e.g., tea polyphenols).

[0133] Compositions and methods The composition may generally be in any edible form, such as liquid, semi-liquid, solid, or semi-solid. In some embodiments, the composition is a beverage or beverage product. One example of a beverage is a ready-to-drink beverage. Ready-to-drink beverages include carbonated and non-carbonated beverages. Examples of carbonated beverages, but not limited to, include frozen carbonated beverages, highly carbonated beverages, cola, fruit-flavored carbonated beverages (e.g., lemon-lime, orange, grape, strawberry, and pineapple), ginger ale, soft drinks, and root beer. Non-carbonated beverages include, but are not limited to, fruit juices, fruit-flavored juices, juice drinks, nectars, vegetable juices, vegetable-flavored juices, sports drinks, energy drinks, fortified water drinks, fortified water with vitamins, water-like drinks (e.g., water with natural or synthetic flavorings), coconut water, tea-based drinks (e.g., black tea, green tea, rooibos tea, oolong tea), coffee, cocoa drinks, beverages containing dairy components (e.g., dairy beverages, coffee containing dairy components, café au lait, milk tea, fruit milk beverages), beverages containing grain extracts, and smoothies.

[0134] In certain embodiments, this disclosure relates to sports drinks or fortified water drinks.

[0135] The beverage may be a full-calorie beverage with a maximum of approximately 120 calories per 226.8g (8oz) serving. The beverage may be a medium-calorie beverage with a maximum of approximately 60 calories per 226.8g (8oz) serving. The beverage may be a low-calorie beverage with a maximum of approximately 40 calories per 226.8g (8oz) serving. The beverage may be zero-calorie, with less than approximately 5 calories per 226.8g (8oz) serving.

[0136] In another specific embodiment, the beverage does not contain milk and / or dairy components.

[0137] In some embodiments, the plasma gravimetric osmolality of the beverage falls within the range of approximately 250 mOsm / kg to approximately 350 mOsm / kg, or approximately 270 mOsm / kg to approximately 330 mOsm / kg, or approximately 290 mOsm / kg to approximately 310 mOsm / kg, or approximately 290 mOsm / kg to approximately 300 mOsm / kg.

[0138] The Disclosure also provides a method for preparing a ready-to-drink beverage, comprising (i) preparing a beverage base, and (ii) adding the beverage components described herein to the beverage base to thereby produce a ready-to-drink beverage. The method optionally includes a further mixing step in which the beverage components and the base are mixed to promote dissolution. The method also optionally includes a heating step in which the beverage components and the base are heated to promote dissolution.

[0139] Beverage components are dissolved in a beverage base. Examples of beverage bases include beverage-quality water, such as tap water, deionized water, distilled water, reverse osmosis water, carbonized water, purified water, demineralized water, and combinations thereof. Additional suitable bases, but not limited to these, include phosphoric acid, phosphate buffer, citric acid, citrate buffer, and carbonized water.

[0140] This method can be carried out at any temperature necessary for formulating ready-to-drink beverages. For example, with respect to temperature-sensitive components, this method can be carried out at temperatures below 70°C. Similarly, beverage components can be added to the beverage base in any order.

[0141] In some embodiments, the composition is in a dry or semi-dry form, such as a dry powder, concentrated beverage, tablet, capsule, gel, or gum. The dry composition can be easily ingested or easily and quickly dissolved in a drinking medium such as water.

[0142] In one particular embodiment, the composition may be prepared in the form of a concentrate or powder, which is reconstituted by adding water or any other suitable liquid depending on the subject for use. Such reconstitution may be carried out using the amount of water / liquid necessary to ensure that the beverage to be consumed contains the active components in the proportions previously described. In another embodiment, the composition may be dissolved in water / liquid and then frozen to produce, for example, a flavored ice pop on a stick, such as those known under the trade name or trademark "Popsicle".

[0143] In one embodiment, a method for preparing a ready-to-drink solution includes mixing the oral composition described herein with a drinking medium in a weight ratio such that the concentration of the active ingredient in the formulation is about 1 g / L to about 50 g / L, or about 2 g / L to about 30 g / L, or about 3 g / L to about 30 g / L, or about 4 g / L to about 20 g / L, or about 5 g / L to about 10 g / L, or about 0.05 g / L to about 1 g / L relative to the total volume of the ready-to-drink solution. In certain embodiments, the concentration of at least one active ingredient in the oral composition, which is composed of a mixture of sodium salts, is about 15 mmol / L to about 35 mmol / L, or about 17 mmol / L to about 30 mmol / L, or about 20 mmol / L to about 30 mmol / L, or about 23 mmol / L to about 28 mmol / L, or about 25 mmol / L to about 26 mmol / L, or about 25.9 mmol / L. In some embodiments, the concentration of at least one active ingredient in the oral composition, which is composed of a mixture of potassium salts, is about 15 mmol / L to about 35 mmol / L, or about 17 mmol / L to about 30 mmol / L, or about 23 mmol / L to about 29 mmol / L, or about 25 mmol / L to about 28 mmol / L, or about 27.8 mmol / L. In a particular embodiment, at least two active ingredients are a first active ingredient, a sodium salt having a concentration of about 10 mmol / L to about 28 mmol / L, or about 13 mmol / L to about 25 mmol / L, or about 16 mmol / L to about 20 mmol / L, or about 17 mmol / L to about 19 mmol / L, or about 18.3 mmol / L, and a second active ingredient, a potassium salt having a concentration of about 10 mmol / L to about 28 mmol / L, or about 13 mmol / L to about 25 mmol / L, or about 16 mmol / L to about 22 mmol / L, or about 18 mmol / L to about 21 mmol / L, or about 20.5 mmol / L. Examples of drinking media include drinking-quality water, such as tap water, deionized water, distilled water, reverse osmosis water, carbonized water, purified water, demineralized water, and combinations thereof. The beverage medium may also be an existing beverage such as sparkling water, juice, tea, milk, or coffee.

[0144] In some embodiments, the composition can be prepared as a dry powder mixture. The dry powder mixture is combined with a support for dispersion in water / liquid, such as maltodextrin having a non-glucose sweetening base, like neohesperidin dihydrochalcone, at a level not exceeding 120 kcal / L when reconstituted, and optionally flavored with fruit extracts or aromas such as orange, lemon, strawberry, or others. One dose is intended to be dissolved in 591 ml of drinking water / liquid (one standard sports bottle). The concentration is shown only, and more concentrated drinks may be prepared based on the same formulation.

[0145] The above powder mixture may be added to a suitable tableting support having good sensory stimulation properties, such as sorbitol and magnesium stearate. The tablets may be sweetened, if applicable, with known natural sweeteners such as neohesperidin dihydrochalcone, and the total energy content should not exceed an average of 120 kcal per day. The product may be flavored with any selected fruit or other flavor, such as orange, lemon, menthol, eucalyptol, etc. Compressed tablets (or equivalent solid forms having the same composition) are intended to be consumed in an average of 5 to 10 tablets per day.

[0146] In some embodiments, the disclosure relates to methods for rapid hydration, rapid rehydration, prolonged hydration, and / or prolonged rehydration. These methods generally involve administering any oral composition described herein.

[0147] In this method, the compositions described herein are generally used for at least one of the following purposes: to have a rapid effect on the recovery of plasma D2O percent during the rehydration phase; to reduce or reverse the effects of dehydration or dehydration; to mitigate other adverse effects of exercise, high temperature or other activities that cause fluid loss; to have a positive effect on subsequent physical performance; to prolong the duration of fluid retention; to rapidly increase plasma D2O percent; to maintain the increased plasma D2O percent over a long period; to restore electrolyte balance; to provide an energy source; to improve physical performance; and to limit or reduce calorie intake.

[0148] In some embodiments, the Disclosure provides a method for providing to a human being rapid hydration, rapid rehydration, prolonged hydration, and / or prolonged rehydration, comprising administering an effective amount of an oral composition described herein, wherein the oral composition is free of nutritional sweeteners. The administration of the oral composition may be before, during, or after dehydration or fluid loss.

[0149] In some embodiments, the method comprises administering a sports drink to a person as described herein, wherein the sports drink is further configured to improve the person's sports performance, reduce lactic acid production, reduce fatigue, reduce muscle soreness (actual muscle damage and perceived pain), improve time to fatigue, improve time trial performance, improve power output, reduce lactic acid production, and reduce net fluid loss observed with exercise. As used herein, “improved sports performance” refers to the improvement in sports performance associated with the intake of the sports drink of the embodiments presented herein, compared to sports performance without intake of the sports drink or water. Intake of the sports drink may be before, during, or after sports performance. As used herein, “sports performance” refers to both endurance and non-endurance exercise. Endurance exercise includes aerobic activity over a long period (e.g., more than about 30 minutes), while non-endurance exercise includes aerobic activity over a short period (e.g., less than about 30 minutes).

[0150] In one particular embodiment, the Disclosure relates to a method for improving athletic performance, comprising administering / ingesting a sports drink before, during, or after endurance exercise, wherein the sports drink comprises an aqueous solution as described herein, and the formulation contains an active ingredient in an amount of about 1 g / L to about 50 g / L, or about 2 g / L to about 30 g / L, or about 3 g / L to about 30 g / L, or about 4 g / L to about 20 g / L, or about 5 g / L to about 10 g / L, or about 0.05 g / L to about 1 g / L, relative to the total volume of the sports drink. In some embodiments, the concentration of at least one active ingredient in the oral composition, which is composed of a mixture of sodium salts, is about 15 mmol / L to about 35 mmol / L, or about 17 mmol / L to about 30 mmol / L, or about 20 mmol / L to about 30 mmol / L, or about 23 mmol / L to about 28 mmol / L, or about 25 mmol / L to about 26 mmol / L, or about 25.9 mmol / L. In some embodiments, the concentration of at least one active ingredient in the oral composition, which is composed of a mixture of potassium salts, is about 15 mmol / L to about 35 mmol / L, or about 17 mmol / L to about 30 mmol / L, or about 23 mmol / L to about 29 mmol / L, or about 25 mmol / L to about 28 mmol / L, or about 27.8 mmol / L. In a particular embodiment, at least two active ingredients are a first active ingredient, a sodium salt having a concentration of about 10 mmol / L to about 28 mmol / L, or about 13 mmol / L to about 25 mmol / L, or about 16 mmol / L to about 20 mmol / L, or about 17 mmol / L to about 19 mmol / L, or about 18.3 mmol / L, and a second active ingredient, a potassium salt having a concentration of about 10 mmol / L to about 28 mmol / L, or about 13 mmol / L to about 25 mmol / L, or about 16 mmol / L to about 22 mmol / L, or about 18 mmol / L to about 21 mmol / L, or about 20.5 mmol / L.

[0151] In some embodiments, the method comprises preparing a drinking solution by dissolving a dry powder composition containing the formulation in a drinking medium containing water, and administering the drinking solution orally. In some embodiments, the concentration of the active ingredient in the amino acid-free formulation is about 1 g / L to about 50 g / L, or about 2 g / L to about 30 g / L, or about 3 g / L to about 30 g / L, or about 4 g / L to about 20 g / L, or about 5 g / L to about 10 g / L, or about 0.05 g / L to about 1 g / L, relative to the total volume of the drinking solution.

[0152] In other embodiments, the method includes taking / ingesting a drinking medium containing an oral composition and water. The oral composition and the drinking medium may be taken in parallel, simultaneously, separately, or sequentially. In some embodiments, the ratio of the oral composition to the drinking medium is such that the content of the active ingredient in the formulation is about 1 g / L to about 50 g / L, or about 2 g / L to about 30 g / L, or about 3 g / L to about 30 g / L, or about 4 g / L to about 20 g / L, or about 5 g / L to about 10 g / L, or about 0.05 g / L to about 1 g / L, relative to the total volume of the drinking medium. In some embodiments, the concentration of at least one active ingredient in the oral composition, which is composed of a mixture of sodium salts, is about 15 mmol / L to about 35 mmol / L, or about 17 mmol / L to about 30 mmol / L, or about 20 mmol / L to about 30 mmol / L, or about 23 mmol / L to about 28 mmol / L, or about 25 mmol / L to about 26 mmol / L, or about 25.9 mmol / L. In some embodiments, the concentration of at least one active ingredient in the oral composition, which is composed of a mixture of potassium salts, is about 15 mmol / L to about 35 mmol / L, or about 17 mmol / L to about 30 mmol / L, or about 23 mmol / L to about 29 mmol / L, or about 25 mmol / L to about 28 mmol / L, or about 27.8 mmol / L. In a particular embodiment, at least two active ingredients are a first active ingredient, a sodium salt having a concentration of about 10 mmol / L to about 28 mmol / L, or about 13 mmol / L to about 25 mmol / L, or about 16 mmol / L to about 20 mmol / L, or about 17 mmol / L to about 19 mmol / L, or about 18.3 mmol / L, and a second active ingredient, a potassium salt having a concentration of about 10 mmol / L to about 28 mmol / L, or about 13 mmol / L to about 25 mmol / L, or about 16 mmol / L to about 22 mmol / L, or about 18 mmol / L to about 21 mmol / L, or about 20.5 mmol / L.

[0153] The methods described herein provide rapid and effective hydration and fluid retention in humans. In some embodiments, the percentage of D2O in human plasma increases by at least about 2.5%, at least about 3%, or at least about 4% within about 10 minutes after administration of the oral composition.

[0154] In some embodiments, the percentage of D2O in human plasma increases by at least about 4.5%, at least about 5%, at least about 5.5%, or at least about 6% about 15 minutes after administration of the oral composition.

[0155] In some embodiments, the percentage of D2O in human plasma increases by at least about 5%, or at least about 5.5%, or at least about 6%, or at least about 6.5%, or at least about 7% about 30 minutes after administration of the oral composition.

[0156] In some embodiments, the percentage of D2O in human plasma increases by at least about 3%, or at least about 3.5%, or at least about 4%, or at least about 5%, or at least about 6% about 45 minutes after administration of the oral composition.

[0157] In some embodiments, the percentage of D2O in human plasma increases by at least about 3%, or at least about 3.5%, or at least about 4%, or at least about 5%, or at least about 6% about 60 minutes after administration of the oral composition.

[0158] In some embodiments, the percentage of D2O in human plasma, measured 30 minutes after administration of the oral composition, remains substantially unchanged thereafter for at least about 15 minutes, at least about 30 minutes, or at least about 1 hour.

[0159] In some embodiments, the decrease in the percentage of D2O in human plasma measured 30 minutes after administration of the oral composition over at least about 30 minutes is less than about 1%, or less than about 2%, or less than about 3%, or less than about 4%, or less than about 5%, or less than about 6%, or less than about 7%, or less than about 8%, or less than about 9%, or less than about 10%.

[0160] In some embodiments of this method, the human plasma weight osmolality is maintained within the range of approximately 270 mOsm / kg to approximately 330 mOsm / kg, or approximately 280 mOsm / kg to approximately 320 mOsm / kg, or approximately 290 mOsm / kg to approximately 310 mOsm / kg, or approximately 290 mOsm / kg to approximately 300 mOsm / kg for at least 60 minutes after administration of the oral composition.

[0161] In some embodiments, the change in human plasma weight osmolality at least 60 minutes after administration of the oral composition is 3 mOsm / kg or less. [Examples]

[0162] Example 1 Human studies using examples of the beverages described herein were conducted to evaluate the benefits of more rapid hydration (assessing the speed of absorption into the bloodstream by measuring plasma heavy water (D2O) accumulation) and more prolonged hydration (assessing the volume of beverage consumed by measuring net fluid balance (subtracting urine volume from body weight over time)) (Maughan et al, 2016). In this study, the effectiveness of three test beverages for more rapid and prolonged hydration during a 3-hour rehydration period after exercise-induced dehydration in high temperatures was evaluated compared to water intake (water as a control). Healthy men (n=12) completed four dehydration / rehydration studies in which they consumed different beverages during the rehydration period.

[0163] method The study group consisted of 12 clearly healthy men aged 18 to 40 years. Participants were randomly assigned to one of four intervention trials (water and three test beverages) in a crossover, double-blind design. To maintain the double-blind study design, each test beverage was assigned an alphanumeric code. All beverages contained no nutrients, flavors, or colors; only the electrolyte content differed.

[0164] Each participant underwent a dehydration phase in a room where temperature and humidity levels could be maintained within approximately 95°F / 35°C and 40%RH (relative humidity) ±2°C and ±3%RH. Prior to the dehydration phase, a butterfly needle was inserted, and after the participant remained seated for 15 minutes, a blood sample was collected without cessating blood flow (Pre-D: pre-dehydration phase). After fasting blood collection, participants were provided with a light meal (Clif Bar, 250kcal-260kcal; 130mg-230mg sodium), which they ate in front of the research staff. Immediately before the start of the dehydration phase, the participant's weight was measured naked (after eating the Clif Bar and after blood collection).

[0165] During the dehydration period, participants engaged in an intermittent cycling protocol (a series of 20-minute exercise sessions followed by 5-minute rest periods) at approximately 95°F and 40% RH to induce weight loss (dehydration period). The workload of the cycling exercise was set to a predetermined intensity from the baseline assessment (approximately 50% HRR). Participant weight was measured during each 5-minute rest period to obtain net fluid loss from baseline.

[0166] Following the dehydration phase, participants entered the rehydration phase. Once the target weight loss was achieved, participants were transferred back to the laboratory, entered a mild environment (approximately 20°C-22°C), and rested in a seated position for 15 minutes. After 15 minutes of rest, an intravenous catheter was inserted, and after participants continued to rest in a seated position for another 15 minutes, a pre-rehydration (Pre-R) blood sample was collected without cessating blood flow. After collecting the Pre-R blood sample, a total urine sample was collected, and the participant's weight was measured undressed and compared to the Pre-D level to calculate the total weight loss (% dehydration = % fluid loss). After this transitional rest period (approximately 40 minutes), participants began the rehydration / recovery phase of the protocol.

[0167] During the hydration phase, participants drank equal amounts of assigned beverages (water or test beverages) every 15 minutes for 60 minutes (a total of 5 bolus drinks) to restore 150% of the weight lost during the dehydration phase. During the hydration phase of the protocol, participants were asked to remain seated to limit fluid movement. During the recovery phase of the protocol, participants remained seated quietly for 3 hours in a mild environment (approximately 20°C to 22°C).

[0168] More rapid hydration (accumulation of D2O in plasma) The appearance of beverages in the bloodstream was compared across beverages using the deuterium dilution method according to the technique of Davis et al. (1987). Venous blood samples for D2O analysis were collected without cessation of blood flow from a Teflon indwelling catheter placed before the rehydration period. After maintaining a seated position for at least 20 minutes, a baseline blood sample (3 ml EDTA) was obtained immediately before the last drink bolus to control for any background D2O. Participants then ingested the last bolus of the D2O-containing test beverage within 5 minutes (timed to be consistent across the study). The last 50 ml of the beverage was then used as a rinse to ensure all D2O was ingested. Additional venous blood (3 ml) was obtained at 5 min (5 min-R), 10 min (10 min-R), 15 min (15 min-R), 20 min (20 min-R), 25 min (25 min-R), 30 min (30 min-R), and 45 min (45 min-R) after the start of hydration, after hydration (Post-R), 20 min (20 Post-R), 40 min (40 Post-R), and 60 min (60 Post-R). Blood samples were centrifuged at 3000 rpm, and the plasma was stored at -80°C. Plasma D2O enrichment was measured in an independent laboratory. While D2O enrichment in the blood does not provide quantitative measurements of the amount of fluid absorbed in the intestines after leaving the stomach, it can estimate relative differences in volume and delivery rate (Non-patent document 1, Hill et al. 2008).

[0169] Figure 1A discloses the following timeframes for each of the three examples of the present disclosure and water: pre-hydration (Pre-R), 5 minutes (5min-R), 10 minutes (10min-R), 15 minutes (15min-R), 20 minutes (20min-R), 25 minutes (25min-R), 30 minutes (30min-R), and 45 minutes (45min-R); post-hydration (Post-R), 20 minutes (20Post-R) after the last fluid bolus, 40 minutes (40Post-R) after the last fluid bolus, and 60 minutes (60Post-R) after the last fluid bolus, as well as the beverage intake (D2O, in PPM units) at each time. Example 228 is a 25.9 mmol / L sodium admixture containing sodium lactate, sodium chloride, trisodium citrate, and sodium bicarbonate. Example 460 is a potassium mixture of 27.8 mmol / L containing monopotassium phosphate and potassium citrate. Example 351 is a mixture of 18.3 mmol / L sodium and 20.5 mmol / L potassium containing sodium lactate, sodium chloride, trisodium citrate, sodium bicarbonate, monopotassium phosphate, and potassium citrate. Example 741 is water. Examples 228, 460, 351, and 741 are the same throughout the experiment.

[0170] Longer-term hydration (net fluid balance) Body weight was measured before dehydration (Pre-D), before / after rehydration (Post-D), immediately after the last fluid bolus (Post-R), and every 60 minutes after the last fluid bolus (60Post-R, 120Post-R, and 180Post-R). Body weight was measured naked after urination and towel wiping, using a 10-gram accuracy electronic scale in double-barreled measurements. Fluid loss due to the dehydration protocol was calculated from the rapid change in body weight from Pre-D to Pre-R (corrected for fecal reduction if necessary) and expressed as a percentage of baseline body weight (Cheuvront et al. 2004, 2010). For all calculations, water and body weight loss due to sweat and urine were considered equivalent (1L = 1kg).

[0171] Figure 2A discloses the net body fluid balance (in kg) for each group and time interval after dehydration (Post-D), after rehydration (Post-R), 60 minutes after the last fluid bolus (60Post-R), 120 minutes after the last fluid bolus (120Post-R), and 180 minutes after the last fluid bolus (180Post-R) for each of the three examples of the present disclosure and water.

[0172] result More frequent hydration Figure 1B shows a graph of the data from Figure 1A. Both the sodium admixture (228) and the sodium-potassium admixture (351) showed a more rapid hydration benefit compared to water (741), beginning at 45 minutes (45 min-R) after the start of hydration. In the case of the sodium admixture (228), a more rapid hydration benefit compared to the potassium admixture (460) was shown at 20 minutes (20 Post-R) after the last fluid bolus, while in the case of the sodium-potassium admixture (351), a more rapid hydration benefit compared to the potassium admixture (460) began to be shown from 20 minutes (20 Min-R) after the start of hydration.

[0173] Longer-term hydration Figure 2B is a graph of the data from Figure 2A, further including pre-dehydration (Pre-D) as a zero measurement. In the sodium admixture (228), longer-term hydration benefits were observed compared to water at 120 and 180 minutes post-hydration, while in the sodium + potassium admixture (351), longer-term hydration benefits were observed compared to water at 180 minutes post-hydration. In both the sodium admixture (228) and the sodium + potassium admixture (351), longer-term hydration benefits were demonstrated compared to the potassium admixture (460) at 120 and 180 minutes post-hydration. In the sodium admixture (228), longer-term hydration benefits were also observed compared to the sodium + potassium admixture (351) at 180 minutes post-hydration.

[0174] Non-patent references Siamak, A. Adibi, Leucine absorption rate and net movements of sodium and water in human jejunum, Journal of Applied Physiology, 1970, 28(6), 753-757. Kazunobu Okazaki, Yoshi-Ichiro Kamijo, Yoshiaki Takeno, Tadashi Okumoto, Shizue Masuki, Hiroshi Nose, Effects of exercise training on thermoregulatory responses and blood volume in older men, Journal of Applied Physiology, 2002, 93, 1630-1637. Chih-Yin Tai, Jordan M Joy, Paul H Falcone, Laura R Carson, Matt M Mosman, Justen L Straight, Susie L Oury, Carlos Mendez Jr, Nick J Loveridge, Michael P Kim & Jordan R Moon, An amino acid-electrolyte beverage may increase cellular rehydration relative to carbohydrate-electrolyte and flavored water beverages. Nutrition Journal, 2014 (13), 47. Kurt J Sollanek, Matthew Tsurumoto, Sadasivan Vidyasagar, Robert W Kenefick, Samuel N Cheuvront, Neither body mass nor sex influences beverage hydration index outcomes during randomized trial when comparing 3 commercial beverages. The American Journal of Clinical Nutrition, 2018, 107(4), 544-549. Samuel N. Cheuvront, Robert W. Kenefick, Nisha Charkoudian, Katherine M. Mitchell, Adam J. Luippold, Karleigh E. Bradbury, Sadasivan Vidyasagar, Efficacy of Glucose or Amino Acid-Based Commercial Beverages in Meeting Oral Rehydration Therapy Goals After Acute Hypertonic and Isotonic Dehydration, J Parenter Enteral Nutr, 2018, 42(7), 1185-1193. S. M. Shirreffs, A. J. Taylor, J. B. Leiper, R. J. Maughan, Post-exercise rehydration in man: effects of volume consumed and drink sodium content. Medicine and Science in Sports and Exercise, 1996, 28(10):1260-1271. SN Cheuvront, R. Carter 3rd, SJ Montain, MN Sawka, Daily body mass variability and stability in active men undergoing exercise-heat stress. Int J Sport Nutr Exerc Metab. 2004, 14(5):532-40. SN Cheuvront, BR Ely, RW Kenefick, MN Sawka, Biological variation and diagnostic accuracy of dehydration assessment markers. Am J Clin Nutr. 2010, 92(3):565-73. LB Baker, Sweating Rate and Sweat Sodium Concentration in Athletes: A Review of Methodology and Intra / Interindividual Variability. Sports Med. 2017, 47(Suppl 1):111-128.

[0175] All publications, patents, and patent applications referenced herein represent the level of skill of those skilled in the art to which this disclosure pertains.

[0176] All compositions and methods disclosed and claimed herein can be produced and performed without undue experimentation in light of this disclosure. While the compositions and methods of this disclosure are described in relation to the exemplary embodiments described herein, it will be apparent to those skilled in the art that the compositions, methods, and steps or sets of steps of the methods described herein can be modified, altered, modified, and changed without departing from the true concept, spirit, and scope of this disclosure. More specifically, it will be apparent that the agents, additives, and components described herein can be substituted with certain similar agents, additives, and components according to their physical, chemical, physiological, and / or gustatory properties, while achieving the same or similar results. All such similar substitutions and modifications, which will be apparent to those skilled in the art, are deemed to fall within the spirit, scope, and concept of this disclosure as defined by the claims appended below.

[0177] item 1. An oral composition for rapid hydration, rapid rehydration, long-term hydration, and / or long-term rehydration, comprising at least one active ingredient. 2. An oral composition of item 1, which is a formulation that does not contain amino acids and / or substantially does not contain nutritional sweeteners. 3. An oral composition according to item 1 or 2, further comprising at least two active ingredients. 4. An oral composition of item 2 or 3, wherein at least one active ingredient comprises at least one electrolyte selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate, and combinations thereof, or at least two active ingredients comprise at least two electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate, and combinations thereof. 5. An oral composition according to item 4, wherein at least one active ingredient comprises two or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate, and combinations thereof; or three or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate, and combinations thereof; or four or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate, and combinations thereof; or five or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate, and combinations thereof; or six or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate, and combinations thereof. 6. An oral composition according to item 4, wherein at least two active ingredients comprise two or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate, and combinations thereof; or three or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate, and combinations thereof; or four or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate, and combinations thereof; or five or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate, and combinations thereof; or six or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate, and combinations thereof. 7. An oral composition according to any one of items 2 to 6, wherein at least one active ingredient is a mixture of sodium salts. 8. An oral composition according to any one of items 2 to 6, wherein at least one active ingredient is a mixture of potassium salts. 9. An oral composition according to any one of items 3 to 6, wherein at least two active ingredients are a mixture of sodium salts and potassium salts. 10. An oral composition according to any one of items 3 to 7, wherein at least one active ingredient is a mixture of sodium salts including sodium lactate, sodium chloride, trisodium citrate, and sodium bicarbonate. 11. An oral composition according to any one of items 3 to 6 or 8, wherein at least one active ingredient is a mixture of potassium salts comprising monopotassium phosphate and potassium citrate. 12. An oral composition of item 9, wherein at least two active ingredients are mixtures of sodium and potassium salts, including sodium lactate, sodium chloride, trisodium citrate, sodium bicarbonate, monopotassium phosphate, and potassium citrate. 13. An oral composition according to any one of items 1 to 12, wherein at least one active ingredient is a mixture of sodium salts, having a concentration of about 15 mmol / L to about 35 mmol / L, or about 17 mmol / L to about 30 mmol / L, or about 20 mmol / L to about 30 mmol / L, or about 23 mmol / L to about 28 mmol / L, or about 25 mmol / L to about 26 mmol / L, or about 25.9 mmol / L. 14. An oral composition according to any one of items 1 to 12, wherein at least one active ingredient is a mixture of potassium salts, having a concentration of about 15 mmol / L to about 35 mmol / L, or about 17 mmol / L to about 30 mmol / L, or about 23 mmol / L to about 29 mmol / L, or about 25 mmol / L to about 28 mmol / L, or about 27.8 mmol / L. 15. An oral composition according to any one of items 1 to 12, wherein at least two active ingredients are a first active ingredient, a sodium salt having a concentration of about 10 mmol / L to about 28 mmol / L, or about 13 mmol / L to about 25 mmol / L, or about 16 mmol / L to about 20 mmol / L, or about 17 mmol / L to about 19 mmol / L, or about 18.3 mmol / L, and a second active ingredient, a potassium salt having a concentration of about 10 mmol / L to about 28 mmol / L, or about 13 mmol / L to about 25 mmol / L, or about 16 mmol / L to about 22 mmol / L, or about 18 mmol / L to about 21 mmol / L, or about 20.5 mmol / L. 16. An oral composition according to any one of items 2 to 15, wherein the total electrolyte concentration is at least about 200 mg / L. 17. An oral composition according to any one of items 1 to 16, further comprising at least one sweetener. 18. Sweeteners include stevia and steviol glycoside, monk fruit and related mogroside compounds, monatin and its salts (monatin SS, RR, RS, SR), curculin, glycyrrhizic acid and its salts, thaumatin, monelin, mavinrin, blazein, hernandulcin, phyllodulcin, glycifylin, phlorizin, trilobatin, bayunoside, osrazine, polypodoside A, pterocarioside A, pterocarioside B, muclodioside, flomisoside I An oral composition of item 17, selected from the group comprising periandrin I, abrusoside A, and cyclocarioside I, sugar alcohols such as erythritol, sucralose, acesulfame potassium, acesulfame acid and its salts, aspartame, alitarm, saccharin and its salts, neohesperidin dihydrochalcone, cyclamate, cyclamic acid and its salts, neotame, advantame, glucosylated steviol glycoside (GSG), and combinations thereof. 19. An oral composition according to any one of items 1 to 18, further comprising at least one additive. 20. An oral composition according to any one of items 1 to 18, further comprising at least one functional ingredient. 21. An oral composition according to any one of items 1 to 20, selected from sports drinks and fortified water drinks. 22. An oral composition according to any one of items 1 to 21, selected from a full-calorie beverage, a medium-calorie beverage, a low-calorie beverage, or a zero-calorie beverage. 23. An oral composition according to any one of items 1 to 22, which is a ready-to-drink hydration beverage. 24. An oral composition of any one of items 1 to 22, which is in a dry or semi-dried form. 25. An oral composition of item 24, which is gum, a tablet, a capsule, or a dry powder. 26. A method for providing rapid hydration, rapid rehydration, prolonged hydration, and / or prolonged rehydration in humans, comprising administering an oral composition containing at least one active ingredient. 27. The method of item 26 for obtaining rapid hydration, rapid rehydration, prolonged hydration, and / or prolonged rehydration in humans by administration of an oral composition. 28. The method of item 26 or 27, wherein the oral composition is a ready-to-drink hydration beverage, a sports drink, or a fortified water drink. 29. The method of any one of items 26 to 28, wherein the oral composition is selected from a full-calorie beverage, a medium-calorie beverage, a low-calorie beverage, or a zero-calorie beverage. 30. A method according to any one of items 26 to 29, wherein the oral composition is a formulation that does not contain amino acids and / or substantially does not contain nutritional sweeteners. 31. The method of any one of items 26 to 29, wherein the oral composition further comprises at least two active ingredients. 32. The method of item 30 or 31, wherein at least one active ingredient comprises at least one electrolyte selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate, and combinations thereof, or at least two active ingredients comprise at least two electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate, and combinations thereof. 33. The method of item 32, wherein at least one active ingredient comprises two or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate, and combinations thereof; or three or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate, and combinations thereof; or four or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate, and combinations thereof; or five or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate, and combinations thereof; or six or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate, and combinations thereof. 34. The method of item 32, wherein at least two active ingredients comprise two or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate, and combinations thereof; or three or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate, and combinations thereof; or four or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate, and combinations thereof; or five or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate, and combinations thereof; or six or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate, and combinations thereof. 35. The method of any one of items 27 to 34, wherein at least one active ingredient is a mixture of sodium salts. 36. The method of any one of items 27 to 34, wherein at least one active ingredient is a mixture of potassium salts. 37. The method of any one of items 27 to 34, wherein at least two active ingredients are a mixture of sodium salts and potassium salts. 38. The method of any one of items 27 to 34, wherein at least one active ingredient is a mixture of sodium salts comprising sodium lactate, sodium chloride, trisodium citrate, and sodium bicarbonate. 39. The method of any one of items 27-34 or 36, wherein at least one active ingredient is a mixture of potassium salts comprising monopotassium phosphate and potassium citrate. 40. The method of item 37, wherein at least two active ingredients are a mixture of sodium and potassium salts, including sodium lactate, sodium chloride, trisodium citrate, sodium bicarbonate, monopotassium phosphate, and potassium citrate. 41. The method of any one of items 26 to 40, wherein at least one active ingredient is a mixture of sodium salts having a concentration of about 15 mmol / L to about 35 mmol / L, or about 17 mmol / L to about 30 mmol / L, or about 20 mmol / L to about 30 mmol / L, or about 23 mmol / L to about 28 mmol / L, or about 25 mmol / L, or about 25 mmol / L, or about 25 mmol / L to about 26 mmol / L, or about 25.9 mmol / L. 42. The method of any one of items 26 to 40, wherein at least one active ingredient is a mixture of potassium salts having a concentration of about 15 mmol / L to about 35 mmol / L, or about 17 mmol / L to about 30 mmol / L, or about 20 mmol / L to about 29 mmol / L, or about 25 mmol / L to about 28 mmol / L, or about 27.8 mmol / L. 43. A method according to any one of items 26 to 40, wherein at least two active ingredients are a first active ingredient, a sodium salt having a concentration of about 10 mmol / L to about 28 mmol / L, or about 13 mmol / L to about 25 mmol / L, or about 16 mmol / L to about 20 mmol / L, or about 17 mmol / L to about 19 mmol / L, or about 18.3 mmol / L, and a second active ingredient, a potassium salt having a concentration of about 10 mmol / L to about 28 mmol / L, or about 13 mmol / L to about 25 mmol / L, or about 16 mmol / L to about 22 mmol / L, or about 18 mmol / L to about 21 mmol / L, or about 20.5 mmol / L. 44. A method according to any one of items 27-43, wherein the total electrolyte concentration is at least about 200 mg / L. 45. The method of any one of items 26 to 44, wherein the oral composition further comprises at least one sweetener. 46. ​​Sweeteners include stevia and steviol glycoside, monk fruit and related mogroside compounds, monatin and its salts (monatin SS, RR, RS, SR), curculin, glycyrrhizic acid and its salts, thaumatin, monelin, mavinrin, blazein, hernandulcin, phyllodulcin, glycifylin, phlorizin, trilobatin, bayunoside, osrazine, polypodoside A, pterocarioside A, pterocarioside B, muclodioside, flomisosin Method 45, selected from the group comprising: dihydrochloride I, periandrin I, abrusoside A, and cyclocarioside I; sugar alcohols such as erythritol; sucralose; acesulfame potassium; acesulfame acid and its salts; aspartame; alitarm; saccharin and its salts; neohesperidin dihydrochalcone; cyclamate; cyclamic acid and its salts; neotame; advantame; glucosylated steviol glycoside (GSG); and combinations thereof. 47. The method of any one of items 26 to 46, wherein the oral composition further comprises at least one additive. 48. The method of any one of items 26 to 47, wherein the oral composition further comprises at least one functional ingredient. 49. The method according to any one of items 26 to 48, wherein the oral composition is in a dry or semi-dried form. 50. The method of item 49, wherein the oral composition is gum, tablet, capsule, or dry powder. 51. The method of any one of items 26-50, wherein the percentage of D2O in human plasma increases by at least about 2.5%, at least about 3%, or at least about 4% within 5 minutes after administration of the oral composition. 52. The method of any one of items 26-50, wherein the percentage of D2O in human plasma increases by at least about 4.5%, at least about 5%, at least about 5.5%, or at least about 6% within 15 minutes after administration of the oral composition. 53. The method of any one of items 26-50, wherein the percentage of D2O in human plasma increases by at least about 5%, or at least about 5.5%, or at least about 6%, or at least about 6.5%, or at least about 7% within 30 minutes after administration of the oral composition. 54. The method of any one of items 26 to 50, wherein the percentage of D2O in human plasma, measured 30 minutes after administration of the oral composition, remains substantially unchanged thereafter for at least about 15 minutes, or at least about 30 minutes, or at least about 1 hour. 55. The method of any one of items 26 to 54, wherein the decrease in the percentage of D2O in human plasma measured 30 minutes after administration of the oral composition over at least approximately 30 minutes is less than approximately 1%, or less than approximately 2%, or less than approximately 3%, or less than approximately 4%, or less than approximately 5%, or less than approximately 6%, or less than approximately 7%, or less than approximately 8%, or less than approximately 9%, or less than approximately 10%. 56. The method of any one of items 26 to 54, wherein the human plasma weight osmolality is maintained within the range of approximately 270 mOsm / kg to approximately 330 mOsm / kg, or approximately 280 mOsm / kg to approximately 320 mOsm / kg, or approximately 290 mOsm / kg to approximately 310 mOsm / kg, or approximately 290 mOsm / kg to approximately 300 mOsm / kg for at least 60 minutes after administration of the oral composition. 57. A method according to any one of items 26 to 56, wherein the human plasma gravimetric osmolality before administration of the oral composition changes to 3 mOsm / kg or less at least 60 minutes after administration of the oral composition. 58. A method for improving physical performance or sports performance, comprising administering any oral composition of any one of items 1 to 25. 59. The method of item 34, in which an oral composition is administered before, during, or after endurance exercise. 60. Methods of item 34 or 35 characterized by performance improvement being reduced physical fatigue, reduced muscle soreness, reduced muscle damage, reduced net fluid loss, reduced lactate production, improved time to fatigue, improved time trial performance, improved power output, or any combination thereof.

Claims

1. Oral compositions for rapid hydration, rapid rehydration, long-term hydration, and / or long-term rehydration, The oral composition comprises a first active ingredient and a second active ingredient, The first active ingredient comprises a mixture of sodium salts containing two or more of the following: sodium chloride, sodium lactate, trisodium citrate, and sodium bicarbonate. The second active ingredient comprises a mixture of potassium salts containing at least one of monopotassium phosphate, potassium chloride, and potassium citrate. The concentration of sodium in the oral composition is 23 mmol / L to 28 mmol / L. The concentration of potassium in the oral composition is 16 mmol / L to 22 mmol / L. The oral composition substantially contains no nutritional sweeteners. The oral composition can increase the percentage of D2O in human plasma by at least 4.5%, at least 5%, at least 5.5%, or at least 6% within 15 minutes after administration of a test beverage containing the oral composition, D2O, and water, compared to administration of a control beverage containing D2O and water, after a dehydration period in which a target weight loss is achieved through exercise in a human.

2. The oral composition according to claim 1, wherein the oral composition can increase the percentage of D20 percent in human plasma by at least 5%, at least 5.5%, at least 6%, at least 6.5%, or at least 7% compared to when the control beverage is administered within 30 minutes after administration of the test beverage.

3. The oral composition was measured in the human plasma 30 minutes after administration of the test beverage. ２ The oral composition according to claim 1, wherein the 0 percent reduction can be limited to less than 1%, less than 2%, less than 3%, less than 4%, less than 5%, less than 6%, less than 7%, less than 8%, less than 9%, or less than 10% over at least 30 minutes compared to when the control beverage is administered.

4. The oral composition increases the net fluid balance of humans by at least 8% within 120 minutes after the completion of administration of the test beverage, compared to the case where the control beverage was administered. The oral composition according to claim 1, wherein the net fluid balance is the reduction in the person's body weight compared to the person's body weight before the dehydration period.

5. The oral composition increases the net fluid balance of humans by at least 11% within 180 minutes after the completion of administration of the test beverage, compared to the case where the control beverage was administered. The oral composition according to claim 1, wherein the net fluid balance is the reduction in the person's body weight compared to the person's body weight before the dehydration period.

6. The oral composition according to claim 1, wherein the oral composition does not contain an amino acid.

7. The oral composition according to claim 1, further comprising at least one additive.

8. The oral composition according to claim 1, further comprising one or more functional ingredients selected from saponins, antioxidants, dietary fiber sources, fatty acids, vitamins, glucosamine, minerals, preservatives, hydration agents, probiotics, prebiotics, weight management agents, osteoporosis management agents, phytoestrogens, long-chain aliphatic saturated primary alcohols, phytosterols, and combinations thereof.

9. The oral composition according to claim 1, wherein the oral composition is a zero-calorie beverage.

10. The oral composition according to claim 1, wherein the oral composition is a ready-to-drink hydration beverage.

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