Rapid hydration formulations and methods

Abstract

The present disclosure provides compositions and methods for rapid hydration, rapid rehydration, long-term hydration, and / or long-term rehydration. The compositions for oral ingestion comprise at least one active ingredient, and in some embodiments, the compositions are substantially free of nutritive sweeteners. A method for providing rapid hydration, rapid rehydration, long-term hydration, and / or long-term rehydration in a human, the method comprising administering an effective amount of an oral composition, the oral composition comprising at least one active ingredient, and in some embodiments, the composition is substantially free of nutritive sweeteners.

Description

[Background technology]

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

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

[0003] Humans often experience dehydration or hypohydration under stressful conditions, such as exposure to excessive heat, intense or prolonged exercise, strenuous physical activity with limited water, climbing high mountains, or prolonged water deprivation due to diarrhea, vomiting, or sweating. Negative physiological effects such as electrolyte balance or protein loss often accompany dehydration. It would be beneficial to provide a rapid and effective rehydration or rehydration composition that can quickly restore body water and vital elements to avoid any potential adverse health problems associated with dehydration.

[0004] Previous attempts have been made to prepare rehydration compositions, particularly beverages and sports drinks, that provide a source of energy, electrolytes, and water for rehydration. These beverages may contain mixtures of proteins, sugars such as glucose, fructose, maltose, salts, and other additives such as citric acid, glycerol, triacylglycerol, sodium hydrogen sulfate, and are claimed to be beneficial for rehydration. These beverages and compositions are generally disclosed in, for example, U.S. Patent No. 5,233,633; ...

[0005] However, many of the disclosed compositions could be made more effective. For example, many compositions do not provide rapid restoration of fluid and plasma D2O percentage, and the duration of the rehydration effect is often relatively short. In particular, fluid retention after ingesting these compositions does not last long, and total body water quickly falls to pre-rehydration levels (Non-Patent Document 1). Furthermore, the prior disclosures do not clearly show the active components of the rehydration composition and / or direct evidence of the rehydration effect. Furthermore, many existing compositions contain a high content of carbohydrates and / or other high-calorie ingredients that are less popular with consumers. In addition, when consuming carbohydrate-containing drinks, there is a trade-off between the goal of rapid fluid restoration and the goal of energy replenishment. The higher the carbohydrate concentration of a drink, the higher its energy density and osmolality, which in turn reduces its gastric emptying rate. Thus, the effect of fluid restoration is weakened.

[0006] Therefore, notwithstanding the above disclosure, new rapid rehydration, rapid rehydration, long term rehydration, and / or long term rehydration compositions and beverages that provide a fast acting and effective solution to dehydration and dehydration, long lasting hydration or rehydration, compensation and long term maintenance of total body water, long term restoration of electrolyte balance, and / or improved taste and palatability profile remain highly desirable. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] U.S. Pat. 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. Pat. No. 8,993,032 [Patent Document 8] US Patent Application Publication No. 2005 / 0100637 [Patent Document 9] US Patent Application Publication No. 2005 / 0048136 [Patent Document 10] US Patent Application Publication No. 2009 / 0117224 [Patent Document 11] US Patent Application Publication No. 2012 / 0128815 [Non-patent literature]

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

[0009] The present disclosure provides rapid hydration, rapid rehydration, long-term hydration, and / or long-term rehydration compositions and methods that meet the above needs.

[0010] In one aspect, the present disclosure relates to a composition for oral ingestion comprising at least one or at least two active ingredients. In some embodiments, the composition may be a formulation that does not contain amino acids, and / or the composition may be substantially free of nutritive sweeteners. In some embodiments, the oral composition is a ready-to-drink hydration beverage. A particular example is a sports beverage or sports drink. In some embodiments, the concentration of the active ingredient 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, based on the total volume of the beverage. In some embodiments, the oral composition has a concentration of at least one active ingredient comprising a mixture of sodium salts 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. In some embodiments, the oral composition has a concentration of at least one active ingredient comprising a mixture of potassium salts 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. 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.

[0011] In some embodiments, the oral composition is in dry or semi-dry form. A particular example is a dry powder that is easily soluble in water. In some embodiments, a drinkable solution of the dry powder can be easily prepared by dissolving the dry powder in a drinkable medium, where the solution has a concentration that does not include amino acids. 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-nutritive sweetener, an artificial sweetener, a commercially available sweetener or sweetener composition, or a "natural high potency sweetener" (NHPS). In a particular embodiment, the composition comprises a low-calorie or non-caloric sweetener. In another particular embodiment, the composition is free or substantially free of non-nutritive and / or nutritive sweeteners.

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

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

[0015] In another aspect, the present disclosure relates to a method for hydration or rehydration, in which the compositions described herein are utilized for at least one of the following purposes: to provide a rapid effect on total body water restoration during rehydration, to attenuate or reverse the effects of dehydration or dehydration, to reverse other adverse effects of exercise, high temperature or other activities that cause fluid loss, to provide a positive effect on subsequent physical performance, to extend the duration of fluid retention, to rapidly increase total body water, to maintain increased total body water over an extended period of time, to restore and maintain electrolyte balance, to provide a source of energy, to balance or control caloric intake, and to stimulate thirst and water intake.

[0016] In some embodiments, the present disclosure provides a method for providing rapid hydration, rapid rehydration, long-term hydration, and / or long-term 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 dry or semi-dry form. The oral composition may be in the form of a concentrated beverage, gel, dry powder, tablet, or capsule. In one embodiment, the oral composition is a dry powder that is readily soluble in a drinking medium. In some embodiments, the method includes preparing a drinking solution containing the dry powder by dissolving the dry powder in a drinking medium that includes water, and orally administering the drinking solution.

[0017] In other embodiments, the method includes taking / ingesting an oral composition and a drinking medium comprising water. The oral composition and the drinking medium can 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, based on the total volume of the drinking medium. In some embodiments, the oral composition has a concentration of at least one active ingredient comprising a mixture of sodium salts 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. In some embodiments, the oral composition has a concentration of at least one active ingredient comprising a mixture of potassium salts 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. 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's 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 plasma of a human is increased 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 plasma of a human is increased 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 decline in percent D2O in human plasma measured 30 minutes after administration of the oral composition for 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 osmolality is maintained within the range of about 270 mOsm / kg to about 330 mOsm / kg, or about 280 mOsm / kg to about 320 mOsm / kg, or about 290 mOsm / kg to about 310 mOsm / kg, or about 290 mOsm / kg to about 300 mOsm / kg for at least 60 minutes after administration of the oral composition.

[0026] In some embodiments, the change in plasma osmolality in a human for at least 60 minutes after administration of the oral composition is no greater than 3 mOsm / kg.

[0027] Definitions and Interpretations of Selected Terms As used herein, "weight percent," "wt%," "percent by weight," "wt%" and variations thereof refer to the concentration of a substance as the weight of that substance divided by the total weight of the composition multiplied by 100. As used herein, it is understood that "percent," "%," and the like are intended to be synonymous with "weight percent," "wt%," and the like.

[0028] As used herein, "g" stands for gram, "kg" stands for kilogram or 1000 grams, "L" stands for liter, and "mg" stands for milligram (10 -3 "mL" or "cc" stands for milliliters (10 -3 The units "g / 100g", "g / 100mL", or "g / L" are units of 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, with 1 Da equal to 1 g / mol. The unit of temperature used herein is degrees Celsius (°C).

[0029] The term "about" is used in conjunction with numerical values ​​to include normal variations in measurements expected by one of ordinary skill in the art and is understood to have the same meaning as "approximately" and encompasses typical tolerances, such as ±15%, ±10%, ±5%, ±1%, ±0.5%, or even ±0.1% of the stated value. The term "about" also encompasses amounts that vary due to different equilibrium conditions of the composition resulting from a particular initial composition. The equivalent of an amount, whether modified by the term "about" or not, is included within the scope of the claims.

[0030] It should be noted that, as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly indicates otherwise. Thus, for example, a reference to a composition containing "a compound" includes having two or more compounds that are the same or different from each other. It should also be noted that the term "or" is generally used in a sense that includes "and / or" unless the context clearly indicates otherwise. As used herein, "and / or" refers to and includes any and all possible combinations of one or more of the associated listed items, as well as the absence of combinations when interpreted as alternatives ("or").

[0031] For the sake of brevity and simplicity, any range of values ​​set forth herein contemplates all values ​​within that range, and should be construed as supporting a claim in which any subrange having endpoints that are real values ​​within the subject specified range is recited. As a hypothetical example, the disclosure of a range of 1 to 5 herein shall be deemed to support a claim to any of the following ranges: 1-5; 1-4; 1-3; 1-2; 2-5; 2-4; 2-3; 3-5; 3-4; and 4-5.

[0032] The term "substantially" is used herein to express the inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, or other representation. The term "substantially" is also used herein to express the extent to which a quantitative representation may vary from an explicit reference without causing a change in the basic functionality of the subject matter at issue.

[0033] The term "substantially free" may refer to any component that the composition of the present disclosure lacks or is nearly free of. When referring to "substantially free," it is assumed that the component has not been intentionally added to the composition of the present disclosure. In using the term "substantially free" of a component, it is acceptable for the component to be present in the composition of the present disclosure in trace amounts because they are present in another component. However, when a composition is said to be "substantially free" of a component, it is understood that the component is only acceptable in trace or small amounts. Furthermore, when a composition is said to be "substantially free" of a component when the component is present in a trace or small amount, it is understood that the component does not affect the effect of the composition. If a component is not expressly included herein or the possibility of its inclusion is not expressly stated herein, it is understood that the composition of the present disclosure may also be substantially free of the component. Similarly, the explicit inclusion of a component allows for the component to be explicitly excluded, thereby making the composition substantially free of the explicitly stated component.

[0034] The terms "comprise", "comprises", and "comprising", as used herein, specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0035] As used herein, the transitional phrase "consisting essentially of" means that the claims should be construed to include the explicitly recited materials or steps recited in the claims, as well as materials or steps that do not materially affect the basic and novel characteristic(s) of the claimed disclosure. Thus, the term "consisting essentially of" when used in the claims of this disclosure is not to be construed as the equivalent of "comprising."

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

[0037] As used herein, the terms "reduce," "reduced," "reducing," "reduction," "diminish," and "decrease" (and grammatical variations thereof) describe a decrease, e.g., of at least about 1%, 5%, 10%, 15%, 20%, 25%, 35%, 50%, 75%, 80%, 85%, 90%, 95%, 97%, 98%, 99%, or 100%, as compared to a control. In certain embodiments, the decrease results in no or essentially no detectable activity or amount (i.e., an insignificant amount, e.g., less than about 10% or even 5% or even 1%).

[0038] "Osmolarity" is defined as the number of particles dissolved in a unit volume of an aqueous solution. Osmolarity is defined as the number of particles dissolved in a unit weight of an aqueous solution. As a practical matter, within the scope of this disclosure, the values ​​of osmolarity and osmolarity are very close, and therefore they are used interchangeably. A solution with 1 / 1000 dissolved osmoles per kilogram has a concentration of 1 milliosmole ("mOs") per kilogram. An osmole is the number of particles in one gram of undissociated molecular weight of solute. Tonicity is a measure of the osmotic pressure of a solution compared to that of blood fluids. It should be understood that the osmotic pressure of the body varies somewhat from person to person. A hypotonic solution is a solution that has a lower osmolarity or tonicity than blood. The osmolarity of a hypotonic solution usually falls within the range of about 80 mOs / kg to 250 mOs / kg. An isotonic solution has the same tonicity as blood. Here, the osmolality is usually within the range of about 280 mOs / kg to about 310 mOs / kg. A hypertonic solution is a solution that is more tonic than blood. Normal osmolality is in the range of about 310 mOs / kg to 440 mOs / kg. The osmolality of water is about 10 mOs / kg to 20 mOs / kg.

[0039] The term "beverage" as used herein means any potable 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, the beverage powder can be first mixed with any potable liquid or semi-liquid to obtain a beverage.

[0040] As used herein, dehydration is defined as the condition that occurs when the body loses too much water and other fluids that are normally needed to move. Dehydration is usually caused by severe diarrhea and vomiting, but can also be caused by not drinking enough water or other fluids, excessive sweating, fever, excessive urination, taking certain medicines, or physical exercise. Rehydration is the replacement of water and electrolytes lost through dehydration. Rapid rehydration (or rapid rehydration) is the replacement of water and electrolytes within 30 minutes.

[0041] As used herein, "amino acid" refers to an organic compound or unit that contains an amino (-NH2) functional group and a carboxyl (-COOH) functional group. In the present disclosure, "amino acid" broadly encompasses any compound having at least one amino acid unit. As used herein, "amino acid-free formulation" 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, hydrogen, or coordinate bonds) incorporated therein. Non-limiting examples of amino acids, amino acid compounds, and 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 salt forms thereof, such as sodium or potassium salts or acid salts. Amino acids may also be in D- or L-configuration, and may also be mono-, di-, or tri-forms of the same or different amino acids. Furthermore, amino acids may be α-, β-, and / or γ-isomers, where appropriate. In some embodiments, combinations of the aforementioned amino acids and their corresponding salts (e.g., their sodium, potassium, calcium, magnesium or other alkali or alkaline earth metal salts, or acid salts) are also suitable additives. The amino acids may be natural or synthetic. The amino acids may also be modified. Modified amino acids refer to any amino acid in which at least one atom has been added, removed, substituted, or combinations 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-methyl-glycine, 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 salt forms thereof (e.g., calcium, potassium, sodium, or magnesium salts, e.g., monosodium L-glutamate). Polyamino acid adducts may also be in the D or L configuration. Furthermore, polyamino acids may be in the α, β, γ, δ, and ε isomers, as appropriate. In some embodiments, combinations of the aforementioned polyamino acids and their corresponding salts (e.g., their sodium, potassium, calcium, magnesium or other alkali or alkaline earth metal salts or acid 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, thus having 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 encompass both modified and unmodified polyamino acids. For example, modified polyamino acids include, but are not limited to, polyamino acids of various molecular weights (MW), such as poly-L-α-glycine having a MW of about 100 Daltons (Da), about 200 Da, about 300 Da, about 500 Da, about 1000 Da, about 1500 Da, about 6000 Da, about 25200 Da, about 63000 Da, about 83000 Da, or about 300000 Da. [Brief description of the drawings]

[0042] [Figure 1A] FIG. 1A illustrates the Faster Hydration Benefit of a human study group using three different examples of the present disclosure and water (control) following high temperature and exercise-induced dehydration. [Figure 1B] FIG. 1B illustrates the Faster Hydration Benefit of a human study group using three different examples of the present disclosure and water (control) following high temperature and exercise-induced dehydration. [Figure 2A] FIG. 2A illustrates the Longer Lasting Hydration of a human test group using three different examples of the present disclosure and water (control) after high temperature and exercise induced dehydration. [Figure 2B] FIG. 2B illustrates the Longer Lasting Hydration of a human test group using three different examples of the present disclosure and water (control) after high temperature and exercise induced dehydration. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0043] The present disclosure is based, at least in part, on the discovery that formulations with at least one active ingredient, and in certain embodiments at least two active ingredients, can be used to rapidly improve plasma D2O percentage after exercise and rehydration. Better sustained replenishment of plasma D2O percentage after rehydration provides potential thermoregulatory and performance benefits during subsequent exercise-heat stress.

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

[0045] In some embodiments, the composition is free of amino acids and / or substantially free of nutritive sweeteners. In some embodiments, the composition comprises active ingredients. These active ingredients in the oral composition include beverage compatible ingredients, 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 The composition may include at least one electrolyte. Non-limiting examples of electrolytes include sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate, and combinations thereof. The electrolytes and ionic components of the present disclosure can usually, but not necessarily, be obtained from their corresponding water-soluble and non-toxic salts. Unless otherwise specified, the amount of electrolyte or ionic component in the composition is based on the electrolyte or ionic component present in the final ingestible form. The concentration of electrolyte is the concentration of ions only, 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 a specific embodiment, 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] The potassium ion component can be provided by any salt, including chloride, carbonate, sulfate, acetate, bicarbonate, citrate, phosphate, hydrogen phosphate, tartrate, sorbate, or combinations thereof. Potassium ions are preferably present in the compositions of the present disclosure in an amount of at least 0.0025% to about 0.08%, about 0.0075% to about 0.06%, or about 0.0075% to about 0.015% by weight.

[0049] The composition may contain potassium at 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 oral composition has a concentration of at least one active ingredient composed of a mixture of potassium salts 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.

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

[0051] The present composition contains sodium at a concentration of about 5 mg / L to about 1000 mg / L, more preferably about 300 mg / L to about 800 mg / L, for example, about 300 mg / L to about 700 mg / L, about 300 mg / L to about 600 mg / L, about 300 mg / L to about 500 mg / L, about 300 mg / L to about 400 mg / L, about 400 mg / L to about 800 mg / L, or about 400 mg In certain embodiments, the composition may contain from about 600 mg / L to about 700 mg / L, from about 400 mg / L to about 600 mg / L, from about 400 mg / L to about 500 mg / L, from about 500 mg / L to about 800 mg / L, from about 500 mg / L to about 700 mg / L, from about 500 mg / L to about 600 mg / L, from about 600 mg / L to about 800 mg / L, from about 600 mg / L to about 700 mg / L, and from about 700 mg / L to about 800 mg / L. In certain embodiments, the composition contains from about 600 mg / L to about 700 mg / L of sodium. In some embodiments, the oral composition has a concentration of at least one active ingredient comprised of a mixture of sodium salts of from about 15 mmol / L to about 35 mmol / L, or from about 17 mmol / L to about 30 mmol / L, or from about 20 mmol / L to about 30 mmol / L, or from about 23 mmol / L to about 28 mmol / L, or from about 25 mmol / L to about 26 mmol / L, or about 25.9 mmol / L.

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

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

[0054] The present composition may contain magnesium from about 5 mg / L to about 1000 mg / L, more preferably from about 1 mg / L to about 50 mg / L, for example, from about 5 mg / L to about 20 mg / L.

[0055] The composition may contain about 0.005% to about 0.20%, about 0.01% to about 0.15%, or about 0.02% to about 0.075% chloride ion by weight. The chloride ion component can be provided from a salt such as sodium chloride, potassium chloride, or a combination thereof.

[0056] In certain embodiments, the beverages of the present disclosure contain at least one electrolyte selected from the group consisting of sodium, potassium, magnesium, calcium, and combinations thereof. In another particular embodiment, the beverages of the present disclosure contain at least one electrolyte selected from the group consisting of sodium, potassium, magnesium, calcium, and combinations thereof, where the amount of each electrolyte is as described above. 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.

[0057] sweetener The composition may optionally include 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 that is naturally found in nature and is characterized by a higher sweetness than sucrose, fructose, or glucose, yet is low in calories. The natural high-intensity sweetener may be provided as a pure compound, or alternatively, may be provided as part of an extract. As used herein, the phrase "synthetic sweetener" refers to any composition that is not naturally found in nature and is characterized by a higher sweetness than sucrose, fructose, or glucose, yet is low in calories. In certain embodiments, the oral composition does not have a sweetener. In certain embodiments, the oral composition does not contain any and / or is substantially free of nutritive and / or non-nutritive sweeteners.

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

[0059] In certain embodiments, the steviol glycoside blend comprises at least about 5% by weight steviol glycosides, e.g., 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%. In exemplary embodiments, the steviol glycoside blend comprises at least about 50% by weight steviol glycosides, e.g., from about 50% to about 90%, from about 50% to about 80%, from about 50% to about 70%, from about 50% to about 60%, from about 60% to about 90%, from about 60% to about 80%, from about 60% to about 70%, from about 70% to about 90%, from about 70% to about 80%, and from about 80% to about 90%.

[0060] Another exemplary NHPS is Momordica oleracea and related mogroside compounds, such as, for example, grosmogroside 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-oxomogroside IV, 11-oxomogroside IVA, mogroside V, isomogroside V, 11-deoxymogroside V, 7-oxomogroside V, 11-oxomogroside V, isomogroside V, mogroside VI, mogrol, 11-oxomogrol, siamenoside I, isomers of siamenoside I (see, e.g., U.S. Pat. No. 6,313,363, which is incorporated by reference in its entirety). (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-norlanost-5-en-24-yl-[2-O-β-D-glucopyranosyl-6-O-β-D-glucopyranosyl]-β-D-glucopyranosyl 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-norlanost-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-norlanost-5-en-24-yl-[2-O-β-D-glucopyranosyl-6-O-β-D-glucopyranosyl]-β-D-glucopyranoside).

[0061] In certain embodiments, the mogroside blend comprises at least about 5% by weight mogroside, e.g., 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, glycyrrhizic acid and its salts, thaumatin, monellin, mabinlin, brazzein, hernandulcin, phyllodulcin, glycyphyllin, phloridzin, trilobatin, bayounoside, osladin, polypodoside A, pterocaryoside A, pterocaryoside B, mukurozioside, phlomisoside I, periandrin I, abrusoside A, and cyclocaryoside I.

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

[0064] In certain embodiments, the compositions are free 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, monellin, mabinlin, brazzein, hernandulcin, phyllodulcin, glycyphyllin, phloridzin, trilobatin, bayunoside, osladin, polypodoside A, pterocaryoside A, pterocaryoside B, mukurozioside, phlomisoside I, periand. Examples of suitable steviol glycosides include glycerin I, abrusoside A, steviolbioside and cyclocaryoside I, sugar alcohols such as erythritol, sucralose, acesulfame potassium, acesulfame acid and its salts, aspartame, alitame, saccharin and its salts, neohesperidin dihydrochalcone, cyclamate, cyclamic acid and its salts, neotame, advantame, glucosylated steviol glycosides (GSG), and combinations thereof.

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

[0067] In certain embodiments, the compositions are free or substantially free of caloric sweeteners.

[0068] In another embodiment, the sweetener is a rare sugar selected from allulose, gulose, kojibiose, 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 the composition depends on the identity of the sweetener and the level of sweetness desired, in a preferred embodiment, the sweetener is present in a sweetening amount, i.e., at a level at which sweetness is detectable.

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

[0071] In one embodiment, the sweetener(s) provide the composition with a sucrose equivalent sweetness of about 1% (w / v), e.g., 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 from about 2% to about 14%, e.g., from about 2% to about 10%, from about 2% to about 5%, from about 5% to about 15%, from about 5% to about 10%, or from about 10% to about 15% SE.

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

[0074] Functional components / ingredients The composition may optionally include functional ingredients. Exemplary functional ingredients include, but are not limited to, 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.

[0075] In certain embodiments, the functional ingredient is at least one saponin. As used herein, at least one saponin may include a single saponin or multiple saponins as functional ingredients for the compositions presented herein. Saponins are natural plant-produced glycosides that contain an aglycone ring structure and one or more sugar moieties. Non-limiting examples of specific saponins for use in certain embodiments of the present disclosure include Group A acetylsaponin, Group B acetylsaponin, and Group E acetylsaponin. Some common sources of saponins include soybeans, which have a saponin content of approximately 5% by dry weight, the soap plant (Saponaria), whose roots have been used historically as soap, as well as alfalfa, aloe, asparagus, grape, chickpea, yucca, and various other beans and grasses. 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 US Patent Application Publication No. 2005 / 0123662.

[0076] In certain embodiments, the functional ingredient is at least one antioxidant. As used herein, "antioxidant" refers to any substance that inhibits, prevents, 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, esters of phenols, esters of polyphenols, non-flavonoid phenols, isothiocyanates, and combinations thereof. In some embodiments, the antioxidant is vitamin A, vitamin C, vitamin E, ubiquinone, the minerals selenium, manganese, melatonin, oc-carotene, beta-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, tocotrienols, tocopherol, coenzyme Q10, zeaxanthin, astaxanthin, canthaxanthin, saponin, limonoids, kaempferol, myricetin, isorhamune. Chin, proanthocyanidins, quercetin, rutin, luteolin, apigenin, tangeretin, hesperetin, naringenin, eriodictyol, flavan-3-ols (e.g., anthocyanidins), gallocatechin, epicatechin and its gallate forms, epigallocatechin and its gallate forms (ECGC), theaflavin and its 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, gallotannins, ellagitannins, anthoxanthins, betacyanins and other plant pigments, silymarin, citric acid, lignans, antinutritional factors, bilirubin, uric acid, R-oc-lipoic acid,N-acetylcysteine, emblicanin, apple extract, apple skin extract (applephenon), red rooibos extract, green rooibos extract, hawthorn extract, red raspberry extract, green coffee antioxidant (GCA), aronia extract 20%, grape seed extract (VinOseed), cocoa extract, hops extract, mangosteen extract, mangosteen hull extract, cranberry extract, pomegranate extract, pomegranate hull extract, pomegranate seed extract, hawthorn extract, pomella extract, cinnamon bark extract, grape skin 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, black currant, ginger, acai powder, green coffee bean extract, green tea extract, and phytic acid, or combinations thereof. In alternative embodiments, the antioxidant is a synthetic antioxidant, such as, for example, butylated hydroxytoluene or butylated hydroxyanisole. Other sources of suitable antioxidants for embodiments of the present disclosure include, but are not limited to, fruits, vegetables, tea, cocoa, chocolate, spices, herbs, rice, animal offal, yeast, whole grains, or grains.

[0078] Certain antioxidants belong to a class of phytonutrients called polyphenols (also known as "polyphenols"), a group of chemicals found in plants and characterized by the presence of two or more phenolic groups per molecule. Suitable polyphenols for embodiments of the present disclosure include catechin, proanthocyanidin, procyanidin, anthocyanin, quercetin, rutin, resveratrol, isoflavones, curcumin, punicalagin, ellagitannin, 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 combinations thereof. In a particular embodiment, the antioxidant is an anthocyanin. In yet another embodiment, the antioxidant is selected from quercetin, rutin, or combinations thereof. In one embodiment, the antioxidant is resveratrol. In another embodiment, the antioxidant is an isoflavone. In yet another embodiment, the antioxidant is curcumin. In yet another embodiment, the antioxidant is selected from punicalagins, ellagitannins, or combinations thereof. In yet another embodiment, the antioxidant is chlorogenic acid.

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

[0081] In certain embodiments, the functional ingredient is at least one fatty acid. As used herein, "fatty acid" refers to any straight-chain monocarboxylic acid, including 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 with a long aliphatic tail. As used herein, "omega-3 fatty acid" refers to any polyunsaturated fatty acid that has its first double bond as the third carbon-carbon bond from the terminal methyl of its carbon chain. In certain embodiments, omega-3 fatty acid may include long-chain omega-3 fatty acid. As used herein, "omega-6 fatty acid" refers to any polyunsaturated fatty acid that has its first double bond as the sixth carbon-carbon bond from the terminal methyl of its carbon chain.

[0082] Suitable omega-3 fatty acids for use in the embodiments of the present disclosure can be derived from, for example, algae, fish, animals, plants, or combinations thereof.Examples of suitable omega-3 fatty acids include, but are not limited to, linoleic acid, alpha-linolenic acid, eicosapentaenoic acid, docosahexaenoic acid, stearidonic acid, eicosatetraenoic acid, and combinations thereof.In some embodiments, suitable omega-3 fatty acids can be provided in fish oil (e.g., herring oil, tuna oil, salmon oil, bonito oil, and cod oil), microalgae omega-3 oil, 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). Suitable omega-6 fatty acids include, but are not limited to, linoleic acid, gamma-linolenic acid, dihomo-gamma-linolenic acid, arachidonic acid, eicosadienoic acid, docosadienoic acid, adrenic acid, docosapentaenoic acid, and combinations thereof.

[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, or triacylglycerols containing omega-3 and / or omega-6 fatty acids, and combinations thereof.

[0084] In certain embodiments, the functional ingredient 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 have been classified as vitamins by some authorities. These compounds may be referred to as pseudovitamins and include, but are not limited to, compounds such as 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 ingredient is glucosamine, optionally further comprising chondroitin sulfate.

[0087] In certain embodiments, the functional ingredient is at least one mineral. Minerals, according to the teachings of the present disclosure, contain inorganic chemical elements that are required by living organisms. Minerals are made up of a wide range of compositions (e.g., elements, simple salts, and complex silicates) and also vary widely in crystal structure. Minerals may be naturally occurring in foods and beverages, may be added as dietary supplements, or may be ingested or administered separately from foods or beverages.

[0088] Minerals can be classified as either bulk minerals, which are required in relatively large amounts, or trace minerals, which are required in relatively small amounts. Macro minerals are generally required in amounts of about 100 mg or more per day, and trace minerals are those that are required in amounts less than about 100 mg per day. In one embodiment, the minerals are selected from macro minerals, trace minerals, or combinations thereof. Non-limiting examples of macro 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. Iodine is generally classified as a trace mineral, but is required in larger amounts than other trace minerals and is often classified as a macro mineral.

[0089] In certain embodiments, the minerals are trace minerals believed to be necessary for human nutrition, non-limiting examples of which 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 ingredient is at least one preservative. In certain embodiments, the preservative is selected from an antimicrobial agent, an antioxidant, an antienzyme agent, or a combination thereof. Non-limiting examples of antimicrobial agents include sulfites, propionates, benzoates, sorbates, nitrates, nitrites, bacteriocins, salts, sugars, acetate, dimethyl dicarbonate (DMDC), ethanol, and ozone. In one embodiment, the preservative is a sulfite. Sulfites include, but are not limited to, sulfur dioxide, sodium bisulfite, and potassium bisulfite. In another embodiment, the preservative is a propionate. Propionates include, but are not limited to, propionic acid, calcium propionate, and sodium propionate. In yet another embodiment, the preservative is a benzoate. Benzoates include, but are not limited to, sodium benzoate and benzoic acid. In yet another embodiment, the preservative is a sorbate. Sorbates include, but are not limited to, potassium sorbate, sodium sorbate, calcium sorbate, and sorbic acid. In yet another embodiment, the preservative is a nitrate and / or nitrite. Nitrates and nitrites include, but are not limited to, sodium nitrate and sodium nitrite. In another embodiment, 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 antienzyme agents for use as preservatives in certain embodiments of the present disclosure include ascorbic acid, citric acid, and metal chelators such as ethylenediaminetetraacetic acid (EDTA).

[0092] In certain embodiments, the functional ingredient is an additional hydrating agent to the formulation without amino acids. The additional hydrating agent may be a synergist that further enhances the hydration or rehydration effect of the composition when combined with the formulation without amino acids. In one particular embodiment, the additional hydrating agent is a carbohydrate to replenish the energy stores burned by muscles. Suitable carbohydrates for use in certain embodiments of the present disclosure are described in U.S. Pat. No. 4,312,856, U.S. Pat. No. 5,681,569, and U.S. Pat. No. 6,989,171. Non-limiting examples of suitable carbohydrates include monosaccharides, disaccharides, oligosaccharides, complex polysaccharides, or combinations thereof. Non-limiting examples of suitable types of monosaccharides for use in certain embodiments include triose, tetrose, pentose, hexose, heptose, octose, and nonose. Non-limiting examples of specific types of suitable monosaccharides include glyceraldehyde, dihydroxyacetone, erythrose, threose, erythrulose, arabinose, lyxose, ribose, xylose, ribulose, xylulose, allose, altrose, galactose, glucose, gulose, idose, mannose, talose, fructose, psicose, sorbose, tagatose, mannoheptulose, sedoheptulose, octolose, and sialos. 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, the carbohydrate is provided by corn syrup, sugar beet, sucrose, juice, or tea.

[0093] In another particular embodiment, the additional hydrating agent is a flavanol that provides cell rehydration. Flavanols are a class of natural substances found in plants, and generally contain a 2-phenylbenzopyrone molecular skeleton bound to one or more chemical moieties. Non-limiting examples of suitable flavanols for use in particular embodiments of the present 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 flavanols are extracted from green tea.

[0094] In certain embodiments, the additional hydration agent is a glycerol solution to improve exercise endurance. Ingestion of glycerol-containing solutions has been shown to result 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, and combinations thereof. Probiotics are beneficial microorganisms that affect the naturally occurring gastrointestinal microflora of the human body. Examples of probiotics include, but are not limited to, bacteria of the genus Lactobacilli, Bifidobacteria, Streptococci, or combinations thereof that confer beneficial effects on humans. In certain embodiments of the present disclosure, at least one probiotic is selected from the genus Lactobacilli. According to other certain embodiments of the present 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 the present disclosure are known to those of skill in the art. Non-limiting examples of foodstuffs that contain probiotics include yogurt, sauerkraut, kefir, kimchi, fermented vegetables, and other foodstuffs that contain microbial elements that beneficially affect 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, the prebiotics are selected from dietary fibers, including, but not limited to, polysaccharides and oligosaccharides. Non-limiting examples of oligosaccharides classified as prebiotics according to certain embodiments of the present disclosure include fructooligosaccharides, inulin, isomaltooligosaccharides, lactitol, lactofructose, lactulose, pyrodextrin, soybean oligosaccharides, transgalactooligosaccharides, and xylooligosaccharides.

[0098] Prebiotics are found naturally in a variety of foods, including, but not limited to, bananas, berries, asparagus, garlic, wheat, oats, barley (and other whole grains), flaxseed, tomatoes, Jerusalem artichokes, onions and chicory, leafy vegetables (e.g., dandelion greens, spinach, collard greens, Swiss 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 agents" includes appetite suppressants and / or thermogenic agents. As used herein, the phrases "appetite suppressants", "appetite satiation compositions", "satiety agents" and "satiety ingredients" are synonymous. The phrase "appetite suppressants" refers to macronutrients, herbal extracts, exogenous hormones, appetite suppressants, appetite reducers, pharmaceuticals, and combinations thereof that, when delivered in an effective amount, suppress, inhibit, reduce, or otherwise deprive a person of appetite. The phrase "thermogenic agents" refers to macronutrients, herbal extracts, exogenous hormones, appetite suppressants, appetite reducers, pharmaceuticals, and combinations thereof that, when delivered in an effective amount, activate or otherwise enhance a person's thermogenesis or metabolism.

[0100] Suitable weight management agents include macronutrients selected from the group consisting of protein, carbohydrate, dietary fat, and combinations thereof.Ingestion of protein, carbohydrate, and dietary fat stimulates the release of peptides that have appetite suppressing effects.For example, ingestion of protein and dietary fat stimulates the release of gastrointestinal hormone cholecystokinin (CCK), while ingestion of carbohydrate and dietary fat stimulates the release of glucagon-like peptide 1 (GLP-1).

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

[0102] In another particular embodiment, the weight management agent is a 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. Thus, the dietary fat embodied herein desirably comprises polyunsaturated fatty acids, non-limiting examples of which include triacylglycerols. In another particular embodiment, the weight management agent is an herbal extract. Extracts from numerous types of plants have been identified to have appetite suppressing properties. Non-limiting examples of plants whose extracts have appetite suppressing properties include plants of the genus Hoodia, Trichocaulon, Caralluma, Stapelia, Orbea, Asclepias, and Camellia. Other embodiments include extracts derived from Gymnema Sylvestre, Kola Nut, Citrus Aurantium, Yerba Mate, Griffonia Simplicifolia, Guarana, Myrrh, Guggul Lipids, and Black Currant Seed Oil.

[0103] Herbal extracts can be prepared from any type of plant material or plant biomass. Non-limiting examples of plant material and biomass include stems, roots, leaves, dried powders obtained from plant material, and 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 may be desirable to further fractionate the initial extract (e.g., by column chromatography) to obtain herbal extracts with enhanced activity. Such techniques are known to those skilled in the art.

[0104] In one embodiment, the herbal extract is derived from a plant of the genus Hoodia. The sterol glycoside of Hoodia is known as P57 and is believed to be responsible for the appetite suppressant effect of Hoodia species. In another embodiment, the herbal extract is derived from a plant of the genus Caralluma, including, but not limited to, caratuberside A, caratuberside B, bouceroside I, bouceroside II, bouceroside III, bouceroside IV, bouceroside V, bouceroside VI, bouceroside VII, bouceroside VIII, bouceroside IX, and bouceroside X. In another embodiment, at least one herbal extract is derived from a plant of the genus Trichocaulon. Trichocaulon plants are generally succulent plants native to South Africa, similar to Hoodia, and include species T. piliferum and T. officinale. In another embodiment, the herbal extract is derived from a plant of the genus Stapelia or Orbea. Without wishing to be bound by any theory, it is believed that the compounds exhibiting appetite suppressant activity are saponins, e.g., pregnane glycosides, including stavaloside A, B, C, D, E, F, G, H, I, J, and K. In another embodiment, the herbal extract is derived from a plant of the genus Asclepias. Without wishing to be bound by any theory, it is believed that the extract contains steroidal compounds, e.g., pregnane glycosides and pregnane aglycones, that have appetite suppressant effects. In another particular embodiment, the weight management agent is an exogenous hormone that has 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 control agent is a pharmaceutical drug, non-limiting examples of which include phentenime, diethylpropion, phendimetrazine, sibutramine, rimonabant, oxyntomodulin, fluoxetine hydrochloride, ephedrine, phenethylamines, or other stimulants.

[0106] In certain embodiments, the functional ingredient is at least one osteoporosis treatment agent.In certain embodiments, the osteoporosis treatment 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 treatment 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, solubilized species thereof, and mixtures thereof.

[0108] In another embodiment, 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 being effective in preventing and treating osteoporosis. Non-limiting examples of plants and plant extracts suitable as osteoporosis management agents include species of the genera Taraxacum and Amelanchier, which are disclosed in U.S. Patent Application Publication No. 2005 / 0106215, and species of the genera Lindera, Artemisia, Acorus, Carthamus, Carum, Cnidium, Curcuma, Cyperus, Juniperus, Cherry, and others, which are disclosed in U.S. Patent Application Publication No. 2005 / 0079232. runus, Iris, Cichorium, Dodonaea, Epimedium, Erigonoum, Rioya, Mentha, Ocimum, Thymus, Tanacetum, Plantago, Spearmint, Bixa, Vitis, Rosemarinus, Rhus, and Anethum species.

[0110] In certain embodiments, the functional ingredient is at least one phytoestrogen.Phytoestrogens are compounds found in plants and can generally be delivered to the human body by ingesting plants or plant parts that contain phytoestrogen.As used herein, "phytoestrogen" refers to any substance that, when introduced into the body, causes estrogen-like effects to any degree.For example, phytoestrogens can bind to estrogen receptors in the body and have small estrogen-like effects.

[0111] Examples of suitable phytoestrogens for embodiments of the present disclosure include, but are not limited to, isoflavones, stilbenes, lignans, resorcylic acid lactones, coumestans, coumestrol, equol, and combinations thereof. Sources of suitable phytoestrogens include, but are not limited to, whole grains, cereals, fiber, fruits, vegetables, black cohosh, agave root, black currant, black hawthorn, chasteberry, crump skin, angelica root, American yarrow root, false unicorn root, ginseng root, ground geranium herb, licorice, life root herb, buzz cut herb, peony root, raspberry leaf, rose family, sage leaf, sarsaparilla root, saw palmetto fruit, wild yam root, yarrow flower, legumes, soybeans, soy products (e.g., miso, da, In some embodiments, the active ingredients may include wheat flour, soy milk, roasted soybeans, soy protein isolate, tempeh, or tofu, chickpeas, nuts, lentils, seeds, clover, red clover, dandelion leaves, dandelion root, fenugreek seed, green tea, hops, red wine, flaxseed, garlic, onion, flaxseed, borage, willow milkweed, caraway, chaste tree, vitex, dates, dill, fennel seed, gotu kola, milk thistle, pennyroyal mint, pomegranate, southernwood, soy flour, tansy, and kudzu root (pueraria root), and the like, and combinations thereof.

[0112] Isoflavones belong to a group of phytonutrients called polyphenols. In general, polyphenols (also known as "polyphenols") are a group of chemicals found in plants and characterized by the presence of two or more phenolic groups per molecule.

[0113] Suitable phytoestrogen isoflavones according to embodiments of the present disclosure include genistein, daidzein, glycitein, biochanin A, formononetin, their respective naturally occurring glycosides and glycoside conjugates, matairesinol, secoisolariciresinol, enterolactone, enterodiol, textured vegetable protein, 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 ingredient 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 feature a hydroxyl group (-OH) attached to a carbon atom. Non-limiting examples of specific long chain aliphatic saturated primary alcohols for use in certain embodiments of the present disclosure include 1-octanol having 8 carbon atoms, 1-nonanol having 9 carbon atoms, 1-decanol having 10 carbon atoms, 1-dodecanol having 12 carbon atoms, 1-tetradecanol having 14 carbon atoms, 1-hexadecanol having 16 carbon atoms, 1-octadecanol having 18 carbon atoms, 1-eicosanol having 20 carbon atoms, 1-docosanol having 22 carbon atoms, 1-tetracosanol having 24 carbon atoms, 1-hexacosanol having 26 carbon atoms, 1-heptacosanol having 27 carbon atoms, 1-octacosanol having 28 carbon atoms, 1-nonacosanol having 29 carbon atoms, 1-triacontanol having 30 carbon atoms, 1-dotriacontanol having 32 carbon atoms, and 1-tetracontanol having 34 carbon atoms.

[0115] In one embodiment, the long chain aliphatic saturated primary alcohol is polycosanol, a term for a mixture of long chain aliphatic saturated primary alcohols composed primarily of 1-octacosanol (C28) and 1-triacontanol (C30), as well as lower concentrations of other alcohols such as 1-docosanol (C22), 1-tetracosanol (C24), 1-hexacosanol (C26), 1-heptacosanol (C27), 1-nonacosanol (C29), 1-dotriacontanol (C32), and 1-tetracontanol (C34).

[0116] In certain embodiments, the functional ingredient is at least one phytosterol, phytostanol, or a combination thereof. As used herein, the phrases "stanol", "plant stanol" and "phytostanol" are synonymous. Plant sterols and stanols occur naturally in small amounts in many fruits, vegetables, nuts, seeds, grains, legumes, vegetable oils, tree bark, and other plant sources. Sterols are a subgroup of steroids that have a hydroxyl group at C3. In general, phytosterols have a double bond in the steroid nucleus, similar to cholesterol. However, phytosterols may also contain a substitute side chain (R) at C24, such as an ethyl or methyl group, or an additional double bond. The structure of phytosterols is known to those skilled in the art.

[0117] At least 44 naturally occurring phytosterols have been found, which are generally derived from plants such as corn, soybean, wheat, and wood oil. However, these phytosterols can also be synthetically produced to form identical compositions or to have similar properties to those of naturally occurring phytosterols. Non-limiting suitable phytosterols include, but are not limited to, 4-desmethylsterols (e.g., β-sitosterol, campesterol, stigmasterol, brassicasterol, 22-dehydrobrassicasterol, and A5-avenasterol), 4-monomethylsterols, and 4,4-dimethylsterols (triterpene alcohols) (e.g., cycloartenol, 24-methylenecycloartanol, and cyclobranol).

[0118] As used herein, the phrases "stanol," "plant stanol," and "phytostanol" are synonymous. Phytostanols are saturated sterol alcohols that occur naturally in only trace amounts and can also be produced synthetically, 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, include various isomers, such as α-isomers and β-isomers. The phytosterols and phytostanols of the present disclosure may also be in their ester form. Suitable methods for deriving esters of phytosterols and phytostanols are known to those skilled in the art and are also disclosed in U.S. Patent No. 6,589,588, U.S. Patent No. 6,635,774, U.S. Patent No. 6,800,317, and U.S. Patent Application Publication No. 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 the present disclosure may also include their derivatives.

[0120] Exemplary additives include, but are not limited to, carbohydrates, polyols, sugar acids and their corresponding salts, nucleotides, organic acids, inorganic acids, organic salts including organic acid salts and organic base salts, inorganic salts, bitter compounds, caffeine, flavors and flavor ingredients, astringent compounds, proteins or protein hydrolysates, surfactants, emulsifiers, botanical extracts, flavonoids, alcohols, polymers, and combinations thereof.

[0121] In one embodiment, the composition further comprises one or more polyols. The term "polyol" as used herein refers to a molecule containing two or more hydroxyl groups. The polyol may be a diol, triol, or tetrahydric polyol, containing two, three, and four hydroxyl groups, respectively.

[0122] The polyol may be one that contains five or more hydroxyl groups, such as a pentahydric polyol, hexaol, heptaol, etc., each containing five, six, or seven hydroxyl groups. Additionally, the polyol may be a sugar alcohol, polyhydric alcohol, or polyalcohol, which is a reduced form of a carbohydrate, in which the carbonyl group (aldehyde or ketone, reduced sugar) has been 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), threitol, galactitol, palatinose, reduced isomaltooligosaccharides, reduced xylooligosaccharides, reduced gentiooligosaccharides, reduced maltose syrup, reduced glucose syrup, and sugar alcohols, or any other carbohydrate that can be reduced without adversely affecting the taste.

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

[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, alkali metal or alkaline earth metal salts thereof, 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 that contains an α-COOH moiety, such as C2-C30 carboxylic acids, substituted hydroxyl C2-C30 carboxylic acids, butyric acid (ethyl esters), substituted butyric acid (ethyl esters), benzoic acid, substituted benzoic acids (e.g., 2,4-dihydroxybenzoic acid), substituted cinnamic acids, hydroxy acids, substituted hydroxybenzoic acids, anisic acid, substituted cyclohexyl carboxylic acids, tannic acid, aconitic acid, lactic acid, tartaric acid, citric acid, isocitric acid, gluconic acid, glucoheptonic acid, adipic acid, hydroxycitric acid, malic acid, fruit acids, and the like. Examples of organic acid additives include: malic acid (a mixture of malic acid, fumaric acid, and tartaric acid), fumaric acid, maleic acid, succinic acid, chlorogenic acid, salicylic acid, caffeic acid, bile acid, acetic acid, ascorbic acid, alginic acid, erythorbic acid, polyglutamic acid, glucono delta lactone, and their alkali metal or alkaline earth metal salt derivatives. Additionally, the organic acid additives may be in either the D or L configuration. Suitable organic acid additive salts include, but are not limited to, sodium, calcium, potassium, and magnesium salts of all organic acids, such as 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. The 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, amido, carboxyl derivatives, alkylamino, dialkylamino, arylamino, alkoxy, aryloxy, nitro, cyano, sulfo, thiol, imine, sulfonyl, sulfenyl, sulfmyl, sulfamyl, carboxyalkoxy, carboxamide, phosphonyl, phosphinyl, phosphoryl, phosphino, thioester, thioether, anhydride, oximino, hydrazino, carbamyl, phosphoro, or phosphonato.In certain embodiments, the organic acid additive is present in the sweetener composition in an amount effective to provide a concentration of from about 10 ppm to about 5000 ppm when present in an ingestible product, such as a beverage.

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

[0127] Suitable bitter compound additives include, but are not limited to, caffeine, quinine, urea, bitter orange oil, naringin, bitter orange, and salts thereof.

[0128] Suitable flavoring and flavor ingredient additives include, but are not limited to, vanillin, vanilla extract, mango extract, cinnamon, citrus, palm, ginger, viridiflorol, almond, menthol (including non-mint menthol), grape skin extract, and grape seed extract. "Flavoring agent" and "flavoring ingredient" are synonymous and may include natural or synthetic substances or combinations thereof. Flavoring agents also include any other substance that imparts flavor and may include natural or non-natural (synthetic) substances that are safe for humans or animals when used within generally accepted limits. Non-limiting examples of proprietary flavorants 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, pectinic acid, pectinic acid, polyuronic acid, polygalacturonic acid, starch, food hydrocolloids or crude extracts thereof (e.g., gum arabic of Senegal species (FIBERGUM™), gum arabic of Seyal species, 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 example embodiments, oral compositions for hydration or rehydration may include a hydrolyzed protein additive, hi related embodiments, the compositions may include a hydrolyzed protein additive as an alternative to ingredients 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, lauric acid arginate, 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-limiting examples of flavonoid additives include, but are not limited to, catechins (e.g., green tea extracts, such as 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, neohesperidin dihydrochalcone, etc. 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), alum, tannic acid, and polyphenols (e.g., tea polyphenols).

[0133] Compositions and methods The composition may generally be in any edible form, for example, 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 beverages and non-carbonated beverages. Carbonated beverages include, but are not limited to, frozen carbonated beverages, high-effervescent beverages, cola, fruit-flavored effervescent 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 flavors), 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, cafe au lait, milk tea, fruit milk beverages), beverages containing cereal extracts, and smoothies.

[0134] In certain embodiments, the present disclosure relates to sports drinks or enhanced water drinks.

[0135] The beverage may be a full-calorie beverage having up to about 120 calories per 8 oz serving. The beverage may be a medium-calorie beverage having up to about 60 calories per 8 oz serving. The beverage may be a low-calorie beverage having up to about 40 calories per 8 oz serving. The beverage may be a zero-calorie beverage having less than about 5 calories per 8 oz serving.

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

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

[0138] The present disclosure also provides a method of preparing a ready-to-drink beverage, the method comprising: (i) providing a beverage base; and (ii) adding beverage ingredients as described herein above to the beverage base, thereby resulting in a ready-to-drink beverage. The method optionally comprises a further mixing step, in which the beverage ingredients and the base are mixed to promote dissolution. The method also optionally comprises a heating step, in which the beverage ingredients and the base are heated to promote dissolution.

[0139] The beverage ingredients are dissolved in the beverage base. Exemplary beverage bases include drinking quality water, such as tap water, deionized water, distilled water, reverse osmosis water, carbon-treated water, purified water, demineralized water, and combinations thereof. Additional suitable bases include, but are not limited to, phosphoric acid, phosphate buffers, citric acid, citrate buffers, and carbon-treated water.

[0140] The method can be carried out at any temperature necessary to formulate a ready-to-drink beverage. For example, for temperature sensitive ingredients, the method is carried out at less than 70° C. Similarly, the beverage ingredients 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, gum, etc. A dry composition can be easily ingested or easily and quickly dissolved in a potable medium such as water.

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

[0143] In one embodiment, a method of preparing a ready-to-drink solution comprises mixing an oral composition described herein with a drinking vehicle in a weight ratio such that the concentration of the active ingredient in the formulation is from about 1 g / L to about 50 g / L, or from about 2 g / L to about 30 g / L, or from about 3 g / L to about 30 g / L, or from about 4 g / L to about 20 g / L, or from about 5 g / L to about 10 g / L, or from about 0.05 g / L to about 1 g / L, based on the total volume of the ready-to-drink solution. In certain embodiments, the oral composition has a concentration of at least one active ingredient comprising a mixture of sodium salts 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. In some embodiments, the oral composition has a concentration of at least one active ingredient comprising a mixture of potassium salts 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. 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. Exemplary drinking media include drinking quality water, such as tap water, deionized water, distilled water, reverse osmosis water, carbon treated water, purified water, demineralized water, and combinations thereof. The drinking medium may also be a conventional beverage such as sparkling water, juice, tea, milk, or coffee.

[0144] In some embodiments, the composition can be prepared as a dry powder mix. The dry powder mix is ​​combined with a support for dispersion in water / liquid, e.g., maltodextrin with a non-glucose sweetening base such as 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 concentrations are merely indicative, and more concentrated drinks may be prepared based on the same formula.

[0145] The above powder mixture may be added to a suitable support for tableting, such as sorbitol and magnesium stearate, with good organoleptic properties. The mass may be optionally sweetened with known natural sweeteners, such as neohesperidin dihydrochalcone, and the total energy content should not exceed an average daily intake of 120 kcal. The product may be flavored with any selected fruit or other flavor, such as orange, lemon, menthol, eucalyptol, etc. The compressed tablets (or equivalent solid forms with the same composition) are intended for an average daily intake of between 5 and 10 tablets.

[0146] In some embodiments, the present disclosure relates to methods of rapid hydration, rapid rehydration, long-term hydration, and / or long-term rehydration, generally comprising administering any of the oral compositions described herein.

[0147] In the methods, the compositions described herein are generally utilized for at least one of the following purposes: to provide a rapid effect on the restoration of plasma D2O percentage during the rehydration phase, to attenuate or reverse the effects of dehydration or dehydration, to reverse other adverse effects of exercise, high temperature or other activities that cause fluid loss, to provide a positive effect on subsequent physical performance, to extend the duration of fluid retention, to rapidly increase plasma D2O percentage, to maintain increased plasma D2O percentage over an extended period of time, to restore electrolyte balance, to provide a source of energy, to improve physical performance, and to limit or reduce caloric intake.

[0148] In some embodiments, the present disclosure provides a method of providing rapid hydration, rapid rehydration, long-term hydration, and / or long-term rehydration to a human, comprising administering an effective amount of an oral composition described herein, wherein the oral composition does not include a nutritive sweetener. Administration of the oral composition may be before, during, or after dehydration or fluid loss.

[0149] In some embodiments, the method includes administering a sports drink to a human as described herein, wherein the sports drink is further configured to improve the human's sports performance, reduce lactate production, reduce fatigue, reduce muscle soreness (actual muscle damage and perceived pain), improve time to fatigue, improve time trial performance, improve power output, reduce lactate production, and reduce net fluid loss observed with exercise. As used herein, "improved sports performance" refers to improved sports performance associated with ingestion of a sports drink of the embodiments presented herein compared to sports performance without ingestion of the sports drink or water. Ingestion of the sports drink may occur 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 an extended period of time (e.g., greater than about 30 minutes), while non-endurance exercise includes aerobic activity over a shorter period of time (e.g., less than about 30 minutes).

[0150] In one particular embodiment, the present disclosure relates to a method of improving athletic performance comprising administering / consuming a sports drink before, during, or after endurance exercise, wherein the sports drink comprises an aqueous solution as described herein, and wherein the formulation comprises the 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, based on the total volume of the sports drink. In some embodiments, the oral composition has a concentration of at least one active ingredient comprising a mixture of sodium salts 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. In some embodiments, the oral composition has a concentration of at least one active ingredient comprising a mixture of potassium salts 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. 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.

[0151] In some embodiments, the method includes preparing a drinking solution by dissolving a dry powder composition containing the formulation in a drinking medium containing water, and orally administering the drinking solution. In some embodiments, the concentration of the active ingredient in the formulation not containing amino acids 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, based on the total volume of the drinking solution.

[0152] In other embodiments, the method includes ingesting / administering an oral composition and a drinking medium comprising water. The administration of the oral composition and the drinking medium can be performed 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, based on the total volume of the drinking medium. In some embodiments, the oral composition has a concentration of at least one active ingredient comprising a mixture of sodium salts 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. In some embodiments, the oral composition has a concentration of at least one active ingredient comprising a mixture of potassium salts 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. 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.

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

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

[0155] In some embodiments, the percent D2O in plasma of a human is increased 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 percent D2O in human plasma is increased 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% at about 45 minutes after administration of the oral composition.

[0157] In some embodiments, the percent D2O in human plasma is increased 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% at about 60 minutes after administration of the oral composition.

[0158] 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.

[0159] In some embodiments, the decline in percent D2O in human plasma measured 30 minutes after administration of the oral composition for 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 the method, the human plasma osmolality is maintained within the range of about 270 mOsm / kg to about 330 mOsm / kg, or about 280 mOsm / kg to about 320 mOsm / kg, or about 290 mOsm / kg to about 310 mOsm / kg, or about 290 mOsm / kg to about 300 mOsm / kg for at least 60 minutes after administration of the oral composition.

[0161] In some embodiments, the change in plasma osmolality in a human for at least 60 minutes after administration of the oral composition is no greater than 3 mOsm / kg. EXAMPLES

[0162] Example 1 Human studies using example beverages of the present disclosure have been conducted to assess the benefits of more rapid hydration (assessing the speed of absorption into the bloodstream by measuring plasma heavy water (D2O) accumulation) and longer-term hydration (assessing the amount of beverage volume ingested by measuring net fluid balance (body weight minus urine volume over time)) (Maughan et al, 2016). In this study, the effectiveness of three test beverages for more rapid and longer-term hydration during a 3-hour rehydration period following exercise-induced dehydration in a high temperature was evaluated compared to water intake (water as control). Healthy men (n=12) completed four dehydration / rehydration studies that differed in the beverage consumed during the rehydration period.

[0163] method The study group consisted of 12 apparently healthy men aged 18-40 years who were randomly assigned to one of four interventions (water and three test beverages) in a crossover, double-blind fashion. To maintain the double-blind study design, the test beverages were assigned an alphanumeric code. All beverages were free of any nutrients, flavor, or color, and only the electrolyte content of the test beverages differed.

[0164] Each study participant was subjected to a dehydration period in an environmental room capable of maintaining temperature and humidity levels within the range of approximately 95°F / 35°C and 40% RH (relative humidity) ±2°C and ±3% RH. Prior to the dehydration period, a butterfly needle was inserted and a blood sample was taken without hemostasis after the participant remained seated for 15 minutes (Pre-D: Pre-Dehydration Period). After fasting blood collection, participants were provided with a light meal (Clif Bar, 250 kcal-260 kcal; sodium 130 mg-230 mg) and consumed in the presence of the study personnel. Just prior to starting the dehydration period, participants were weighed naked (after Clif Bar and blood collection).

[0165] During the dehydration phase, participants participated in an intermittent cycling protocol (sequential repeats of 20 min exercise, 5 min rest) at approximately 95°F and 40% RH to induce weight loss (dehydration phase). Cycling exercise workload was set at a pre-determined intensity from the baseline assessment (approximately 50% HRR). During each 5 min rest period, participants were weighed to obtain net fluid loss from baseline.

[0166] After the dehydration phase, participants participated in the rehydration phase. Once the desired weight loss had been achieved, participants were transported back to the laboratory, placed in a mild environment (approximately 20°C-22°C), and rested in a seated position for 15 minutes. After the 15 minutes of rest, an intravenous catheter was inserted and participants continued to rest in a seated position for an additional 15 minutes before a pre-rehydration (Pre-R) blood sample was collected without hemostasis. Once the Pre-R blood sample was collected, a total urine sample was collected and participants were weighed naked to calculate total weight loss relative to Pre-D levels (% Dehydration = % Fluid Loss). After this transitional rest period (approximately 40 minutes), participants began the rehydration / recovery phase of the protocol.

[0167] During the rehydration phase, participants consumed equal portions of their assigned beverage (water or test beverage) every 15 minutes for 60 minutes (a total of five bolus drinks) to restore 150% of the weight lost during the dehydration phase. During the rehydration phase of the protocol, participants were asked to maintain a seated position to limit fluid shifts. During the recovery phase of the protocol, participants remained seated quietly in a mild environment (approximately 20°C to 22°C) for 3 hours.

[0168] More rapid hydration (plasma D2O accumulation) The appearance of the beverages in the blood was compared across beverages using a deuterium oxide dilution method following the technique of Davis et al. (1987). Venous blood samples for D2O analysis were collected without hemostasis from an indwelling Teflon catheter placed before the rehydration phase. After maintaining a sitting position for at least 20 minutes, a baseline blood sample was obtained (3 ml EDTA) immediately prior to the last drink bolus to control for any background D2O. Participants then consumed a final bolus of the test beverage containing D2O within 5 minutes (timed to be similar across trials). 50 ml of the final drink was then used as a rinse to ensure all D2O was taken. Additional venous blood (3 ml) was obtained 5 min (5min-R), 10 min (10min-R), 15 min (15min-R), 20 min (20min-R), 25 min (25min-R), 30 min (30min-R), and 45 min (45min-R) after the start of rehydration, after rehydration (Post-R), 20 min after the last fluid bolus (20Post-R), 40 min after the last fluid bolus (40Post-R), and 60 min after the last fluid bolus (60Post-R). Blood samples were centrifuged at 3000 rpm and plasma was stored at -80°C. Plasma DO enrichment was measured in an independent laboratory. DO enrichment in blood does not provide a quantitative measure of the amount of fluid that leaves the stomach and is absorbed in the intestine, but it does estimate the relative differences in volume and delivery rate (Hill et al. 2008).

[0169] 1A discloses the beverage intake (D2O in PPM) for each group and time for three examples of the present disclosure and water, before rehydration (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), after rehydration (Post-R), 20 minutes (20Post-R), 40 minutes (40Post-R), and 60 minutes (60Post-R) after the last fluid bolus. Example 228 is a 25.9 mmol / L sodium blend, containing sodium lactate, sodium chloride, trisodium citrate, and sodium bicarbonate. Example 460 is a 27.8 mmol / L potassium mixture, containing monopotassium phosphate and potassium citrate. Example 351 is a 18.3 mmol / L sodium and 20.5 mmol / L potassium mixture, 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 rehydration / after dehydration (Post-D), immediately after taking the last fluid bolus (Post-R), and every 60 min after the last fluid bolus (60Post-R, 120Post-R, and 180Post-R). Body weight was measured in duplicate, naked, after urination and towel drying on an electronic scale with a precision of 10 grams. Fluid losses caused by the dehydration protocol were calculated from the acute change in body weight from Pre-D to Pre-R (corrected for fecal loss, if necessary) and expressed as a percentage of baseline body weight (Cheuvront et.al. 2004, 2010). For all calculations, sweat and urinary fluid and weight losses were considered equivalent (1 L = 1 kg).

[0171] FIG. 2A shows net fluid balance (in kg) by group and time for each of the three examples of the present disclosure and water, post-dehydration (Post-D), post-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).

[0172] result More rapid hydration FIG 1B discloses a graph of the data from FIG 1A. Both the sodium blend (228) and the sodium + potassium blend (351) provided a more rapid rehydration benefit compared to water (741) beginning 45 minutes after rehydration began (45min-R). The sodium blend (228) provided a more rapid rehydration benefit compared to the potassium blend (460) beginning 20 minutes after the last fluid bolus (20Post-R), while the sodium + potassium blend (351) provided a more rapid rehydration benefit compared to the potassium blend (460) beginning 20 minutes after rehydration began (20Min-R).

[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. The sodium blend (228) showed a longer hydration benefit compared to water at 120 and 180 minutes, while the sodium + potassium blend (351) showed a longer hydration benefit compared to water at 180 minutes. The sodium blend (228) and the sodium + potassium blend (351) demonstrated a longer hydration benefit compared to the potassium blend (460) at 120 and 180 minutes. The sodium blend (228) also showed a longer hydration benefit compared to the sodium + potassium blend (351) at 180 minutes.

[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 mentioned in this specification are indicative of the level of those skilled in the art to which this disclosure pertains.

[0176] All compositions and methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure. Although the compositions and methods of the present disclosure have been described with reference to the above exemplary embodiments, it will be apparent to those skilled in the art that variations, changes, modifications, and alterations can be applied to the compositions, methods, and steps or sequence of steps of the methods described herein without departing from the true concept, spirit, and scope of the present disclosure. More specifically, it will be apparent that certain agents, additives, and components similar according to their physical, chemical, physiological, and / or taste characteristics can be substituted for the agents, additives, and components described herein, while the same or similar results are achieved. All such similar substitutions and modifications apparent to those skilled in the art are deemed to be within the spirit, scope, and concept of the present disclosure as defined by the following appended claims.

[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. The oral composition of item 1, which is a formulation that is free of amino acids and / or that is substantially free of nutritive sweeteners. 3. The oral composition of item 1 or 2, further comprising at least two active ingredients. 4. The oral composition of item 2 or 3, wherein the 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 the 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. The oral composition of item 4, wherein the 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. The oral composition of item 4, wherein the 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. The oral composition of any one of items 2 to 6, wherein at least one active ingredient is a mixture of sodium salts. 8. The oral composition of any one of items 2 to 6, wherein at least one active ingredient is a mixture of potassium salts. 9. The oral composition of any one of items 3 to 6, wherein the at least two active ingredients are a mixture of sodium and potassium salts. 10. The oral composition of any one of items 3 to 7, wherein the at least one active ingredient is a mixture of sodium salts including sodium lactate, sodium chloride, trisodium citrate, and sodium bicarbonate. 11. The oral composition of any one of items 3 to 6 or 8, wherein at least one active ingredient is a mixture of potassium salts including monopotassium phosphate and potassium citrate. 12. The oral composition of item 9, wherein the 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. 13. The oral composition of any one of items 1 to 12, wherein the at least one active ingredient is a mixture of sodium salts and has 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. The oral composition of any one of items 1 to 12, wherein the at least one active ingredient is a mixture of potassium salts and has 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. The oral composition according to any one of items 1 to 12, wherein the at least two active ingredients are a first active ingredient which is 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 which is 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. The oral composition of any one of items 2 to 15, wherein the concentration of total electrolytes is at least about 200 mg / L. 17. The oral composition of any one of items 1 to 16, further comprising at least one sweetener. 18. Sweeteners include stevia and steviol glycosides, swingle and related mogroside compounds, monatin and its salts (monatin SS, RR, RS, SR), curculin, glycyrrhizic acid and its salts, thaumatin, monellin, mabinlin, brazzein, hernandulcin, phyllodulcin, glycyphyllin, phloridzin, trilobatin, baioside, osladin, polypodoside A, pterocaryoside A, pterocaryoside B, mukurozioside, and phlomisoside I. 18. The oral composition of item 17, wherein the active ingredient is selected from the group consisting of periandrin I, abrusoside A, and cyclocaryoside I, sugar alcohols such as erythritol, sucralose, acesulfame potassium, acesulfamic acid and its salts, aspartame, alitame, saccharin and its salts, neohesperidin dihydrochalcone, cyclamate, cyclamic acid and its salts, neotame, advantame, glucosylated steviol glycosides (GSG), and combinations thereof. 19. The oral composition of any one of items 1 to 18, further comprising at least one additive. 20. The oral composition of any one of items 1 to 18, further comprising at least one functional ingredient. 21. The oral composition of any one of items 1 to 20, which is selected from sports drinks and enhanced water drinks. 22. The oral composition of 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. The oral composition of any one of items 1 to 22, which is a ready-to-drink hydration beverage. 24. The oral composition of any one of items 1 to 22, which is in a dry or semi-dry form. 25. The oral composition of item 24, which is a gum, tablet, capsule, or dry powder. 26. A method for providing rapid hydration, rapid rehydration, long-term hydration, and / or long-term rehydration in a human, comprising administering an oral composition comprising at least one active ingredient. 27. The method of item 26, wherein a human obtains rapid hydration, rapid rehydration, long-term hydration, and / or long-term rehydration by administration of the oral composition. 28. The method of items 26 or 27, wherein the oral composition is a ready-to-drink hydration drink, or a sports drink, or an enhanced 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. The method of any one of items 26 to 29, wherein the oral composition is a formulation that is free of amino acids and / or is substantially free of nutritive 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 items 30 or 31, wherein the 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 the 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 the 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 the 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 the at least two active ingredients are a mixture of sodium and potassium salts. 38. The method of any one of items 27 to 34, wherein the at least one active ingredient is a mixture of sodium salts including sodium lactate, sodium chloride, trisodium citrate, and sodium bicarbonate. 39. The method of any one of items 27-34 or 36, wherein the at least one active ingredient is a mixture of potassium salts including monopotassium phosphate and potassium citrate. 40. The method of item 37, wherein the 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 the at least one active ingredient is a mixture of sodium salts and has 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, 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 the at least one active ingredient is a mixture of potassium salts and has 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. The method according to any one of items 26 to 40, wherein 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. 44. The method of any one of items 27 to 43, wherein the concentration of total electrolytes 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 glycosides, swingle and related mogroside compounds, monatin and its salts (monatin SS, RR, RS, SR), curculin, glycyrrhizic acid and its salts, thaumatin, monellin, mabinlin, brazzein, hernandulcin, phyllodulcin, glycyphyllin, phloridzin, trilobatin, bayunoside, osladin, polypodoside A, pterocaryoside A, pterocaryoside B, mukurozioside, phlomisozin, and phlomisozin. 46. ​​The method of claim 45, wherein the antioxidant is selected from the group consisting of glycerol, glycerol, glycerol-containing esters such as glycerol-containing esters, ... 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 of any one of items 26 to 48, wherein the oral composition is in a dry or semi-dry form. 50. The method of item 49, wherein the oral composition is a gum, tablet, capsule, or dry powder. 51. The method of any one of items 26 to 50, wherein the percent D2O in human plasma is increased by at least about 2.5%, or 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 to 50, wherein the percent D2O in human plasma is increased 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. 53. The method of any one of items 26 to 50, wherein the percent D2O in human plasma is increased 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 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. 55. The method of any one of items 26-54, wherein the decrease in percent D2O in human plasma measured 30 minutes after administration of the oral composition 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% for at least about 30 minutes. 56. The method of any one of items 26 to 54, wherein the human plasma osmolality is maintained within the range of about 270 mOsm / kg to about 330 mOsm / kg, or about 280 mOsm / kg to about 320 mOsm / kg, or about 290 mOsm / kg to about 310 mOsm / kg, or about 290 mOsm / kg to about 300 mOsm / kg for at least 60 minutes after administration of the oral composition. 57. The method of any one of items 26 to 56, wherein the human plasma osmolality prior to administration of the oral composition is changed by no more than 3 mOsm / kg at least 60 minutes after administration of the oral composition. 58. A method for improving physical or sports performance, comprising administering any oral composition according to any one of items 1 to 25. 59. The method of item 34, wherein the oral composition is administered before, during, or after endurance exercise. 60. The method of items 34 or 35, wherein the improved performance is characterized by reduced physical fatigue, reduced muscle soreness, reduced muscle damage, reduced net fluid loss, reduced lactic acid production, improved time to fatigue, improved time trial performance, improved power output, or any combination thereof.

Claims

1. 1. An oral composition for rapid hydration, rapid rehydration, long-term hydration, and / or long-term rehydration, said oral composition comprising at least one active ingredient.

2. 10. The oral composition of claim 1, which is a formulation that is free of amino acids and / or that is substantially free of nutritive sweeteners.

3. The oral composition of claim 1 further comprising at least two active ingredients.

4. 4. The oral composition of claim 3, wherein the 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. 10. The oral composition of claim 1, wherein the at least one active ingredient is a mixture of sodium salts.

6. 10. The oral composition of claim 1, wherein the at least one active ingredient is a mixture of potassium salts.

7. 4. The oral composition of claim 3, wherein the at least two active ingredients are a mixture of sodium and potassium salts.

8. 6. The oral composition of claim 5, wherein the at least one active ingredient is a mixture of sodium salts including sodium lactate, sodium chloride, trisodium citrate, and sodium bicarbonate.

9. 7. The oral composition of claim 6, wherein the at least one active ingredient is a mixture of potassium salts including monopotassium phosphate and potassium citrate.

10. 8. The oral composition of claim 7, wherein the 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.

11. 9. The oral composition of claim 8, wherein the at least one active ingredient is a mixture of sodium salts and has a concentration of from about 15 mmol / L to about 35 mmol / L, or from about 17 mmol / L to about 30 mmol / L, or from about 20 mmol / L to about 30 mmol / L, or from about 23 mmol / L to about 28 mmol / L, or from about 25 mmol / L to about 26 mmol / L, or about 25.9 mmol / L.

12. 10. The oral composition of claim 9, wherein the at least one active ingredient is a mixture of potassium salts and has a concentration of from about 15 mmol / L to about 35 mmol / L, or from about 17 mmol / L to about 30 mmol / L, or from about 23 mmol / L to about 29 mmol / L, or from about 25 mmol / L to about 28 mmol / L, or about 27.8 mmol / L.

13. 11. The oral composition of claim 10, wherein 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.

14. 14. The oral composition of claim 13, wherein the concentration of total electrolytes is at least about 200 mg / L.

15. 14. The oral composition of claim 13, further comprising at least one sweetener.

16. The sweetener may be selected from the group consisting of stevia and steviol glycosides, swingle and related mogroside compounds, monatin and its salts (monatin SS, RR, RS, SR), curculin, glycyrrhizic acid and its salts, thaumatin, monellin, mabinlin, brazzein, hernandulcin, phyllodulcin, glycyphyllin, phloridzin, trilobatin, bayounoside, osladin, polypodoside A, pterocaryoside A, pterocaryoside B, mukurozioside, phlomisoside I, penicillin, phenoxyethanol ...

16. The oral composition of claim 15, wherein the oleic acid salt is selected from the group consisting of liandrin I, abrusoside A, and cyclocaryoside I, sugar alcohols such as erythritol, sucralose, acesulfame potassium, acesulfamic acid and its salts, aspartame, alitame, saccharin and its salts, neohesperidin dihydrochalcone, cyclamate, cyclamic acid and its salts, neotame, advantame, glucosylated steviol glycosides (GSG), and combinations thereof.

17. 16. The oral composition of claim 15, further comprising at least one additive.

18. 20. The oral composition of claim 17, further comprising at least one functional ingredient.

19. 20. The oral composition of claim 18 selected from sports drinks and enhanced water drinks.

20. 20. The oral composition of claim 17, selected from a full-calorie beverage, a medium-calorie beverage, a low-calorie beverage, or a zero-calorie beverage.

21. 20. The oral composition of claim 19, which is a ready-to-drink hydration beverage.

22. 20. The oral composition of claim 19 in a dry or semi-dry form.

23. 23. The oral composition of claim 22, which is a gum, tablet, capsule, or dry powder.

24. 1. A method for rapid hydration, rapid rehydration, long-term hydration, and / or long-term rehydration in a human comprising administering an oral composition comprising at least one active ingredient.

25. 25. The method of claim 24, wherein the human obtains rapid hydration, rapid rehydration, long-term hydration, and / or long-term rehydration by administration of the oral composition.

26. 26. The method of claim 25, wherein the oral composition is a ready-to-drink hydration beverage, or a sports drink, or an enhanced water drink.

27. 26. The method of claim 25, wherein the oral composition is selected from a full-calorie beverage, a medium-calorie beverage, a low-calorie beverage, or a zero-calorie beverage.

28. 27. The method of claim 26, wherein the oral composition is a formulation that is free of amino acids and / or that is substantially free of nutritive sweeteners.

29. 27. The method of claim 26, wherein the oral composition further comprises at least two active ingredients.

30. 30. The method of claim 29, wherein the at least two active ingredients comprise at least one, two electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate, and combinations thereof.

31. 27. The method of claim 26, wherein the at least one active ingredient is a mixture of sodium salts.

32. 27. The method of claim 26, wherein the at least one active ingredient is a mixture of potassium salts.

33. 30. The method of claim 29, wherein the at least two active ingredients are a mixture of sodium and potassium salts.

34. 32. The method of claim 31 , wherein the at least one active ingredient is a mixture of sodium salts including sodium lactate, sodium chloride, trisodium citrate, and sodium bicarbonate.

35. 33. The method of claim 32, wherein the at least one active ingredient is a mixture of potassium salts including monopotassium phosphate and potassium citrate.

36. 34. The method of claim 33, wherein the 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.

37. 35. The method of claim 34, wherein the at least one active ingredient is a mixture of sodium salts and has 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.

38. 36. The method of claim 35, wherein the at least one active ingredient is a mixture of potassium salts and has 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.

39. 37. The method of claim 36, wherein 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.

40. 40. The method of claim 39, wherein the concentration of total electrolytes is at least about 200 mg / L.

41. 40. The method of claim 39, wherein the oral composition further comprises at least one sweetener.

42. The sweetener may be selected from the group consisting of stevia and steviol glycosides, swingle and related mogroside compounds, monatin and its salts (monatin SS, RR, RS, SR), curculin, glycyrrhizic acid and its salts, thaumatin, monellin, mabinlin, brazzein, hernandulcin, phyllodulcin, glycyphyllin, phloridzin, trilobatin, bayounoside, osladin, polypodoside A, pterocaryoside A, pterocaryoside B, mukuroziosides, phlomisoside I, 42. The method of claim 41, wherein the active ingredient is selected from the group consisting of periandrin I, abrusoside A, and cyclocaryoside I, sugar alcohols such as erythritol, sucralose, acesulfame potassium, acesulfamic acid and its salts, aspartame, alitame, saccharin and its salts, neohesperidin dihydrochalcone, cyclamate, cyclamic acid and its salts, neotame, advantame, glucosylated steviol glycosides (GSG), and combinations thereof.

43. 42. The method of claim 41, wherein the oral composition further comprises at least one additive.

44. 44. The method of claim 43, wherein the oral composition further comprises at least one functional ingredient.

45. 45. The method of claim 44, wherein the oral composition is in a dry or semi-dry form.

46. 46. ​​The method of claim 45, wherein the oral composition is a gum, tablet, capsule, or dry powder.

47. The human plasma D ２ 47. The method of claim 46, wherein the percent O increases by at least about 2.5%, or at least about 3%, or at least about 4% within 5 minutes after administration of the oral composition.

48. The human plasma D ２ 47. The method of claim 46, wherein the percent O is increased 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.

49. The human plasma D ２ 47. The method of claim 46, wherein the percent O is increased 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.

50. The plasma D of the human measured 30 minutes after administration of the oral composition ２ 47. The method of claim 46, wherein the O percent remains substantially unchanged for at least about 15 minutes, or at least about 30 minutes, or at least about 1 hour thereafter.

51. The plasma D of the human measured 30 minutes after administration of the oral composition ２ 47. The method of claim 46, wherein the decrease in O percent 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%.

52. 47. The method of claim 46, wherein the human plasma osmolality is maintained within the range of about 270 mOsm / kg to about 330 mOsm / kg, or about 280 mOsm / kg to about 320 mOsm / kg, or about 290 mOsm / kg to about 310 mOsm / kg, or about 290 mOsm / kg to about 300 mOsm / kg for at least 60 minutes after administration of the oral composition.

53. 47. The method of claim 46, wherein the human's plasma osmolality prior to administration of the oral composition changes by no more than 3 mOsm / kg at least 60 minutes after administration of the oral composition.

54. 14. A method of improving physical or sports performance comprising administering any of the oral compositions of claim 13.

55. 55. The method of claim 54, wherein the oral composition is administered before, during, or after endurance exercise.

56. 56. The method of claim 55, wherein the improved performance is characterized by 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.

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