Fast hydration formulation and methods

Abstract

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

Description

Background Art

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

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

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

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

[0005] However, many of the disclosed compositions can be made more effective. For example, in many compositions, a rapid recovery of the D2O percentage in body fluids and plasma is not achieved, and often the duration of the rehydration effect is relatively short. In particular, the retention of body fluids after ingesting these compositions does not last long, and the total body water content quickly drops to pre-rehydration levels (Non-Patent Document 1). Furthermore, the prior disclosure does not clearly show the effective components of the rehydration composition and / or direct evidence of the rehydration effect. Moreover, many existing compositions contain a large amount of carbohydrates and / or other high-calorie components that are not very preferred by consumers. Also, when consuming carbohydrate-containing drinks, there is a trade-off between the goal of rapid body fluid recovery and the goal of energy replenishment. The higher the carbohydrate concentration of the drink, the higher its energy density and weight osmolarity, thereby reducing the gastric emptying rate. Therefore, the effect of body fluid recovery is weakened.

[0006] Therefore, despite the above disclosure, new rapid hydration, rapid rehydration, long-term hydration, and / or long-term rehydration compositions and beverages that provide a quick and effective solution for dehydration and dehydration sickness, long-lasting water replenishment or rehydration, compensation and long-term retention of total body water content, long-term restoration of electrolyte balance, and / or improvement of taste and palatability profiles are still highly desirable.

Prior Art Documents

Patent Documents

[0007]

Patent Document 1

Patent Document 2

Patent Document 3

Patent Document 4

Patent Document 5

Patent Document 6

Patent Document 7

Patent Document 8

Patent Document 9

Patent Document 10

Patent Document 11

Non-Patent Document

[0008]

Non-Patent Document 1

Summary of the Invention

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

[0010] In one aspect, the present disclosure relates to an oral intake composition 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 rehydration beverage. A specific example is a sports beverage or a 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 concentration of at least one active ingredient composed of a mixture of sodium salts in the oral composition is about 15 mmol / L to about 35 mmol / L, or about 17 mmol / L to about 30 mmol / L, or about 20 mmol / L to about 30 mmol / L, or about 23 mmol / L to about 28 mmol / L, or about 25 mmol / L to about 26 mmol / L, or about 25.9 mmol / L. In some embodiments, the concentration of at least one active ingredient composed of a mixture of potassium salts in the oral composition is about 15 mmol / L to about 35 mmol / L, or about 17 mmol / L to about 30 mmol / L, or about 23 mmol / L to about 29 mmol / L, or about 25 mmol / L to about 28 mmol / L, or about 27.8 mmol / L. In certain specific embodiments, 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.

[0011] In some embodiments, the oral composition is in a dry or semi-dry form. A specific example is a dry powder that is highly soluble in water. In some embodiments, a drinking solution of the dry powder can be easily prepared by dissolving the dry powder in a drinking medium, where the solution has a concentration that does not contain 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 sweetening composition, or a "natural high potency sweetener" (NHPS). In one specific embodiment, the composition comprises a low-calorie or non-calorie sweetener. In another specific embodiment, the composition does not contain or substantially does not contain non-nutritive sweeteners 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 weight 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 of rehydration or water replenishment. In this method, the compositions described herein are utilized for at least one of the following purposes: to have a rapid effect on the restoration of total body water volume during rehydration, to attenuate or reverse the effects of dehydration or dehydration sickness, to ameliorate other adverse effects of exercise, heat, or other activities that cause fluid loss, to have a positive effect on subsequent physical performance, to extend the duration of fluid retention, to rapidly increase total body water volume, to maintain the increased total body water volume over a long period of time, to restore and maintain electrolyte balance, to provide an energy source, to balance or control calorie intake, and to stimulate thirst and water intake.

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

[0017] In other embodiments, the method comprises taking / ingesting a drinking medium comprising an oral composition and water. The taking of the oral composition and the drinking medium can be 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 with respect to the total volume of the drinking medium. In some embodiments, the concentration of at least one active ingredient composed of a mixture of sodium salts in the oral composition is about 15 mmol / L to about 35 mmol / L, or about 17 mmol / L to about 30 mmol / L, or about 20 mmol / L to about 30 mmol / L, or about 23 mmol / L to about 28 mmol / L, or about 25 mmol / L to about 26 mmol / L, or about 25.9 mmol / L. In some embodiments, the concentration of at least one active ingredient composed of a mixture of potassium salts in the oral composition is about 15 mmol / L to about 35 mmol / L, or about 17 mmol / L to about 30 mmol / L, or about 23 mmol / L to about 29 mmol / L, or about 25 mmol / L to about 28 mmol / L, or about 27.8 mmol / L. In certain embodiments, the at least two active ingredients are a first active ingredient 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.

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

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

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

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

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

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

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

[0025] In some embodiments, the human plasma weight osmolarity 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 human plasma weight osmolarity at least 60 minutes after administration of the oral composition is 3 mOsm / kg or less.

[0027] Definitions and Interpretations of Selected Terms As used herein, "weight percent", "wt%", "percent by weight", "weight %" and variations thereof refer to the concentration of a substance obtained by dividing the weight of the substance by the total weight of the composition and multiplying by 100. It is understood that when used herein, "percent", "%", etc. are intended to be synonymous with "weight percent", "wt%", etc.

[0028] As used herein, "g" represents grams, "kg" represents kilograms or 1000 grams, "L" represents liters, "mg" represents milligrams (10 -3 grams), "mL" or "cc" represents milliliters (10 -3 liters). The units "g / 100g", "g / 100mL", or "g / L" are units of the concentration or content of the components in the composition. 1 "mg / L" is equal to 1 ppm (parts per million). "Da" refers to Daltons, which is a unit of molecular weight and 1 Da is equal to 1 g / mol. The unit of temperature used herein is degrees Celsius (°C).

[0029] The term "about" is used in conjunction with a numerical value to include the normal variations in the measured value as would be predicted by a person of ordinary skill in the art and is understood to have the same meaning as "approximately" and to include typical tolerances, for example, ±15%, ±10%, ±5%, ±1%, ±0.5%, or even ±0.1% of the stated value. The term "about" also includes amounts that differ due to different equilibrium conditions of the compositions resulting from a particular initial composition. Whether or not modified by the term "about", equivalents of that amount are included in the claims.

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

[0031] For brevity and conciseness, all ranges of values described herein are intended to include all values within that range, and any sub-ranges having endpoints that are real numbers within the specified range of interest should be construed as supporting claims that recite such sub-ranges. By way of hypothetical example, the disclosure of a range from 1 to 5 herein is considered to support claims 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 represent the degree of inherent uncertainty that can be attributed to any quantitative comparison, value, measurement, or other indication. The term "substantially" is also used herein to represent the degree to which a quantitative indication can vary from an explicitly stated reference without causing a change in the basic function of the subject matter in question.

[0033] The term "substantially free of" can refer to any component that is absent or nearly absent from the compositions of the present disclosure. When referring to "substantially free of", it is assumed that the component is not intentionally added to the compositions of the present disclosure. In the use of the term "substantially free of" a component, it is acceptable for that component to be present in trace amounts in the compositions of the present disclosure because they are present in another component. However, it is understood that when a composition is said to be "substantially free of" a component, that component is only permitted in trace or negligible amounts. Further, when a composition is said to be "substantially free of" a component when that component is present in trace or negligible amounts, it is understood that the component does not affect the effect of the composition. It is understood that the compositions of the present disclosure may also be substantially free of a component if that component is not explicitly included herein or if its inclusion is not explicitly stated herein as a possibility. Similarly, the explicit inclusion of a component allows for that component to be explicitly excluded, thereby enabling the composition to be substantially free of the explicitly recited components.

[0034] The terms "comprise", "comprises", and "comprising" as used herein specify the presence of the stated feature, integer, step, operation, element, and / or component, but do not preclude 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 in a claim, materials or steps not expressly recited in the claim, as well as materials or steps that do not substantially affect the basic and novel characteristics (which may be plural) of the claimed disclosure, are to be construed as being included within the claim. Thus, the term "consisting essentially of" is not to be construed as equivalent to "comprising" when used in the claims of this disclosure.

[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 greater as compared to a control.

[0037] As used herein, the terms "reduce", "reduced", "reducing", "reduction", "diminish" and "decrease" (and grammatical variations thereof) describe, for example, a decrease 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, as a result of the reduction, a detectable activity or amount is eliminated or substantially eliminated (i.e., a minor amount, e.g., less than about 10% or even further 5% or even further 1%).

[0038] "Volume osmolarity" is defined as the number of particles dissolved in a unit volume of an aqueous solution. Molality is defined as the number of particles dissolved in a unit weight of an aqueous solution. For practical purposes, in the scope involved in the present disclosure, the numerical values of volume osmolarity and molality are very close, and thus, they are used interchangeably. The concentration of a solution with 1 / 1000 osmoles dissolved per kilogram is 1 milliosmole ("mOs") per kilogram. An osmole is the number of particles in 1 gram of the molecular weight of an undissociated solute. Tonicity is a measure of the osmotic pressure of a solution compared to the osmotic pressure of blood fluids. It should be understood that the osmotic pressure of the body varies somewhat from person to person. A hypotonic solution is a solution with an osmotic pressure or tonicity lower than that of blood. The molality 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 molality usually falls within the range of about 280 mOs / kg to about 310 mOs / kg. A hypertonic solution is a solution with a higher tonicity than that of blood. The normal molality is in the range of about 310 mOs / kg to 440 mOs / kg. The molality of water is about 10 mOs / kg to 20 mOs / kg.

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

[0040] As used herein, dehydration is defined as a condition that occurs when the body loses an excessive amount of the water and other fluids normally needed for movement. 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 medications, or physical exertion. Rehydration is the replenishment of the water and electrolytes lost due to dehydration. Rapid rehydration (or rapid fluid replacement) is the replenishment of water and electrolytes within 30 minutes.

[0041] As used herein, "amino acid" refers to an organic compound or unit containing an amino (-NH2) functional group and a carboxyl (-COOH) functional group. The "amino acids" of the present disclosure broadly encompass any compound having at least one amino acid unit. As used herein, "amino acid-free formulation" refers to a formulation in which molecules, compounds, complexes, oligomers, polymers, mixtures, or compositions having at least one amino acid unit are not physically (by non-covalent bonds) or chemically (by covalent bonds, hydrogen bonds, or coordination bonds) incorporated. 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 their salt forms, such as sodium or potassium salts or acidic salts. Amino acids may also be in the D-configuration or L-configuration, and may also be in mono-, di-, or tri-forms of the same or different amino acids. Further, amino acids may, where appropriate, be α-isomers, β-isomers, and / or γ-isomers. In some embodiments, combinations of the aforementioned amino acids and their corresponding salts (e.g., their sodium, potassium, calcium, magnesium, or other alkali metal or alkaline earth metal salts, or acidic salts) are also suitable additives. Amino acids may be natural or synthetic. Amino acids may also be modified. A modified amino acid refers to any amino acid (e.g., N-alkyl amino acid, N-acyl amino acid, or N-methyl amino acid) to which at least one atom has been added, removed, substituted, or any combination thereof. 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 their salt forms (e.g., calcium salts, potassium salts, sodium salts, or magnesium salts, such as monosodium L-glutamate). Polyamino acid adducts may also be in the D-configuration or the L-configuration. Further, polyamino acids may, where appropriate, be α-isomers, β-isomers, γ-isomers, δ-isomers, and ε-isomers. In some embodiments, combinations of the foregoing polyamino acids and their corresponding salts (e.g., their sodium salts, potassium salts, calcium salts, magnesium salts or other alkali metal salts or alkaline earth metal salts or acidic salts) are also suitable adducts. The polyamino acids described herein may include copolymers of different amino acids. The polyamino acids described herein may include copolymers of different amino acids. Polyamino acids may be natural or synthetic. Polyamino acids may also be modified and thus may have at least one atom added, removed, substituted, or a combination thereof (e.g., N-alkyl polyamino acids or N-acyl polyamino acids). As used herein, polyamino acids include both modified and unmodified polyamino acids. For example, modified polyamino acids include, but are not limited to, polyamino acids of various molecular weights (MW), such as poly-L-α-glycine having an 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, or about 300000 Da.

Brief Description of the Drawings

[0042]

Figure 1A

Figure 1B

Figure 2A

Figure 2B

Modes for Carrying Out the Invention

[0043] The present disclosure is based, at least in part, on the discovery that a formulation with at least one active ingredient and, in certain embodiments, at least two active ingredients can rapidly improve the percent D2O in plasma after exercise and rehydration. By better and more sustainably replenishing the percent D2O in plasma after rehydration, advantages regarding possible temperature regulation and performance during subsequent exercise-heat stress are provided.

[0044] The present disclosure advantageously provides compositions effective for improving rapid rehydration and maintenance of rehydration, including long-term rehydration and / or long-term water replenishment.

[0045] In some embodiments, the composition is free of amino acids and / or substantially free of nutritive sweeteners. In some embodiments, the composition contains an active ingredient. These active ingredients in the present oral composition include ingredients compatible with beverages, 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 present composition may contain at least one electrolyte. Non-limiting examples of electrolytes include sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate, and combinations thereof. The electrolytes and ionic constituents of the present disclosure can usually, but not necessarily, be obtained from their corresponding water-soluble and non-toxic salts. Unless otherwise specifically defined, the amount of electrolyte or ionic constituent in the composition is based on the electrolyte or ionic constituent present in the final ingestible form. The concentration of the electrolyte is the concentration of the ions only, not the concentration of the salt.

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

[0048] The potassium ion constituent can be provided from any salt including chloride, carbonate, sulfate, acetate, bicarbonate, citrate, phosphate, hydrogen phosphate, tartrate, sorbate or a combination thereof. The potassium ions are preferably present in the composition of the present disclosure in an amount of at least 0.0025 wt% to about 0.08 wt%, about 0.0075 wt% to about 0.06 wt%, or about 0.0075 wt% to about 0.015 wt%.

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

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

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

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

[0053] The composition may contain calcium in an amount of about 5 mg / L to about 1000 mg / L, more preferably about 1 mg / L to about 50 mg / L, for example, about 5 mg / L to about 10 mg / L. The magnesium ion component can be provided from any salts such as chlorides, carbonates, sulfates, acetates, bicarbonates, citrates, phosphates, hydrogen phosphates, tartrates, sorbates, or combinations thereof. The magnesium ions are preferably present in the composition in an amount of at least about 0.0005 wt% to about 0.010 wt%.

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

[0055] The composition may contain chloride ions in an amount of about 0.005 wt% to about 0.20 wt%, about 0.01 wt% to about 0.15 wt%, or about 0.02% to about 0.075%. The chloride ion component can be provided from salts such as sodium chloride, potassium chloride, or combinations thereof.

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

[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-potency sweetener. As used herein, the term "natural high-potency sweetener" (NHPS) refers to any sweetener that is found naturally in nature and is characterized by having a lower calorie content despite having a higher sweetness than sucrose, fructose, or glucose. The natural high-potency sweetener may be provided as a pure compound or, alternatively, as part of an extract. As used herein, the term "synthetic sweetener" refers to any composition that is not found naturally in nature and is characterized by having a lower calorie content despite having a higher sweetness than sucrose, fructose, or glucose. In certain embodiments, the oral composition does not have a sweetener. In certain embodiments, the oral composition does not contain 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 monoside, steviolbioside, rubusoside, dulcoside B, dulcoside A, rebaudioside B, rebaudioside G, stevioside, rebaudioside C, rebaudioside F, rebaudioside I, rebaudioside H, rebaudioside L, rebaudioside K, rebaudioside J, rebaudioside M2, rebaudioside D2, rebaudioside S, rebaudioside T, rebaudioside U, rebaudioside V, rebaudioside W, rebaudioside Z1, rebaudioside Z2, rebaudioside IX, enzymatically glucosylated steviol glycosides, and combinations thereof. Examples of high-purity steviol glycosides and methods for making the same are presented in U.S. Patent Application Publication No. 2021 / 0107933, which is hereby incorporated by reference in its entirety.

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

[0060] Another exemplary NHPS is lakanka and related mogroside compounds, such as gros mogroside 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, cyanomenoside I, an isomer of cyanomenoside I (e.g., as disclosed in U.S. Patent Application Publication No. 20170119032, which is hereby incorporated by reference in its entirety), (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-glucopyranoside); (3β,9β,10α,11α,24R)-[(2-O-β-D-glucopyranosyl-6-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]-25-hydroxy-9-methyl-19-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 mixture comprises at least about 5%, such as 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% mogroside by weight.

[0062] Other exemplary NHPSs include monatin and its salts (monatin SS, RR, RS, SR), curculin, glycyrrhizinate and its salts, thaumatin, monellin, mabinlin, brazzein, hernandulcin, phyllodulcin, glyciphilin, phlorizin, trilobatin, baiyunoside, osladin, polypodoside A, pterocarioside A, pterocarioside B, mukurojidoside, phlomidoside I, perandrin I, abrusoside A, and cyclocarioside I.

[0063] In one embodiment, the sweetener is a carbohydrate sweetener. Suitable carbohydrate sweeteners include, but are not limited to, 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 composition is free or substantially free of carbohydrate sweeteners.

[0065] Other suitable sweeteners include phloridzin, monatin and its salts (monatin SS, RR, RS, SR), curcumin, mogroside, glycyrrhizic acid and its salts, thaumatin, monellin, mabinlin, brazzein, hernandezine, phyllodulcin, glycyphyllin, phlorizin, trilobatin, baiyunoside, osladin, polypodoside A, pterocarioside A, pterocarioside B, mukurozioside, phlorimoside I, perandrin I, abrusoside A, steviolbioside and cyclocarioside 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 glycoside (GSG), and combinations thereof.

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

[0067] In certain embodiments, the composition is 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-allulose, 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 desired level of sweetness. In a preferred embodiment, the sweetener is present in an amount that imparts sweetness, i.e., at a concentration at which sweetness is detectable.

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

[0071] In one embodiment, the sweetener(s) provide the composition with a sucrose equivalence sweetness intensity 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 an SE of about 2% to about 14%, e.g., about 2% to about 10%, about 2% to about 5%, about 5% to about 15%, about 5% to about 10%, or about 10% to about 15%.

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

[0074] Functional component / ingredient The composition may optionally contain a functional ingredient. Exemplary functional ingredients include, but are not limited to, saponins, antioxidants, dietary fiber sources, fatty acids, vitamins, glucosamine, minerals, preservatives, rehydrating agents, probiotics, prebiotics, weight management agents, osteoporosis management agents, phytoestrogens, long-chain aliphatic saturated primary alcohols, phytosterols and combinations thereof.

[0075] In certain embodiments, the functional component is at least one saponin. As used herein, at least one saponin may include a single saponin or multiple saponins as a functional component 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 acetyl saponins, Group B acetyl saponins, and Group E acetyl saponins. Some common sources of saponins include soybeans, which have an approximate saponin content of about 5% by dry weight, the soapwort plant (Saponaria), whose roots have historically been used as soap, as well as alfalfa, aloe, asparagus, grapes, chickpeas, 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 U.S. Patent Application Publication No. 2005 / 0123662.

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

[0077] Examples of suitable antioxidants for embodiments of the present disclosure include, but are not limited to, vitamins, vitamin cofactors, minerals, hormones, carotenoids, carotenoid terpenoids, non-carotenoid terpenoids, flavonoids, flavonoid polyphenols (e.g., bioflavonoids), flavonols, flavones, phenols, polyphenols, 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 mineral selenium, manganese, melatonin, oc-carotene, β-carotene, lycopene, lutein, zeaxanthin, cryptoxanthin, resveratrol, eugenol, quercetin, catechin, gossypol, hesperetin, curcumin, ferulic acid, thymol, hydroxytyrosol, turmeric, thyme, olive oil, lipoic acid, glutathione, glutamine, oxalic acid, tocopherol-derived compounds, butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), ethylenediaminetetraacetic acid (EDTA), tert-butylhydroquinone, acetic acid, pectin, tocotrienol, tocopherol, coenzyme Q10, zeaxanthin, astaxanthin, canthaxanthin, saponin, limonoid, kaempferol, myricetin, isorhamnetin, proanthocyanidin, quercetin, rutin, luteolin, apigenin, tangeretin, hesperetin, naringenin, eriodyctiol, flavan-3-ol (e.g., anthocyanidin), gallocatechin, epicatechin and its gallate forms, epigallocatechin and its gallate forms (ECGC), theaflavin and its gallate forms, thearubigin, isoflavone, phytoestrogen, genistein, daidzein, glycitein, anthocyanin, cyanidin, delphinidin, malvidin, pelargonidin, peonidin, petunidin, ellagic acid, gallic acid, salicylic acid, rosmarinic acid, cinnamic acid and its derivatives (e.g., ferulic acid), chlorogenic acid, chicoric acid, gallotannin, ellagitannin, anthoxanthin, betacyanin and other plant pigments, silymarin, citric acid, lignan, antinutritional factor, bilirubin, uric acid, R-oc-lipoic acid,N-acetylcysteine, emblicanin, apple extract, apple peel extract (apple phenone), red rooibos extract, green rooibos extract, blackthorn extract, red raspberry extract, green coffee antioxidant (GCA), aronia extract 20%, grape seed extract (VinOseed), cocoa extract, hop extract, mangosteen extract, mangosteen pericarp extract, cranberry extract, pomegranate extract, pomegranate pericarp extract, pomegranate seed extract, blackthorn extract, pomella pomegranate extract, cinnamon extract, grape skin extract, bilberry extract, pine bark extract, picnogenol, elderberry extract, mulberry root extract, goji (wolfberry) extract, blackcurrant extract, blueberry extract, blueberry leaf extract, raspberry extract, turmeric extract, citrus bioflavonoids, crocus sativus, 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 viscera, yeast, whole grains, or grains.,

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

[0079] In one embodiment, the antioxidant is a catechin such as epigallocatechin gallate (EGCG). In another embodiment, the antioxidant is selected from proanthocyanidins, procyanidins, or combinations thereof. In certain embodiments, the antioxidant is an anthocyanin. In still other embodiments, 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 still another embodiment, the antioxidant is selected from punicalagin, ellagitannins, or combinations thereof. In still another embodiment, the antioxidant is chlorogenic acid.

[0080] In certain embodiments, the functional ingredient is at least one dietary fiber. A number of polymeric carbohydrates having structures that are significantly different in both composition and linkage fall within the definition of dietary fiber. Such compounds are known to those of skill in the art, and non-limiting examples thereof include non-starch polysaccharides, lignin, cellulose, methylcellulose, hemicellulose, β-glucan, pectin, gums, mucilage, waxes, inulin, oligosaccharides, fructooligosaccharides, cyclodextrin, chitin, and combinations thereof. Dietary fiber generally derives from plant sources, but indigestible animal products such as chitin are also classified as dietary fiber. Chitin is a polysaccharide composed of units of N-acetylglucosamine joined by β(1-4) linkages similar to those of cellulose.

[0081] In certain embodiments, the functional component is at least one fatty acid. As used herein, "fatty acid" refers to any straight-chain monocarboxylic acid and includes saturated fatty acids, unsaturated fatty acids, long-chain fatty acids, medium-chain fatty acids, short-chain fatty acids, fatty acid precursors (including omega-9 fatty acid precursors), and esterified fatty acids. As used herein, "long-chain polyunsaturated fatty acid" refers to any polyunsaturated carboxylic or organic acid having a long aliphatic tail. As used herein, "omega-3 fatty acid" refers to any polyunsaturated fatty acid having the first double bond as the third carbon-carbon bond from the terminal methyl of its carbon chain. In certain embodiments, the omega-3 fatty acid may include long-chain omega-3 fatty acids. As used herein, "omega-6 fatty acid" refers to any polyunsaturated fatty acid having the 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 embodiments of the present disclosure can be derived from, for example, algae, fish, animals, plants, or combinations thereof. Examples of suitable omega-3 fatty acids include, but are not limited to, linolenic acid, alpha-linolenic acid, eicosapentaenoic acid, docosahexaenoic acid, stearidonic acid, eicosatetraenoic acid, and combinations thereof. In some embodiments, suitable omega-3 fatty acids can be provided in fish oil (e.g., 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 can be derived from commercially available omega-3 fatty acid oils such as, for example, 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). Examples of 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 component is at least one vitamin. Suitable vitamins include vitamin A, vitamin D, vitamin E, vitamin K, vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B7, vitamin B9, vitamin B12, and vitamin C.

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

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

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

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

[0089] In certain embodiments, the minerals are trace minerals that are considered 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 forms, which have either a positive or negative charge. In another embodiment, the minerals may be in their molecular forms. For example, sulfur and phosphorus are often found naturally 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 antibacterial agents, antioxidants, anti - enzyme agents, or combinations thereof. Non - limiting examples of antibacterial agents include sulfites, propionates, benzoates, sorbates, nitrates, nitrites, bacteriocins, salts, sugars, acetic acid, dimethyl dicarbonate (DMDC), ethanol, and ozone. In one embodiment, the preservative is a sulfite. Sulfites include, but are not limited to, sulfur dioxide, sodium bisulfite, and potassium bisulfite. In another embodiment, the preservative is a propionate. Propionates include, but are not limited to, propionic acid, calcium propionate, and sodium propionate. In yet another embodiment, the preservative is a benzoate. Benzoates include, but are not limited to, sodium benzoate and benzoic acid. In 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, for example. In yet another embodiment, the preservative is ethanol. In yet another embodiment, the preservative is ozone. Non - limiting examples of suitable anti - enzyme agents for use as preservatives in certain embodiments of the present disclosure include metal chelating agents such as ascorbic acid, citric acid, and ethylenediaminetetraacetic acid (EDTA).

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

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

[0094] In a specific embodiment, the additional hydrating agent is a glycerol solution for improving exercise endurance. It has been shown that taking a glycerol-containing solution brings about beneficial physiological effects such as an increase in blood volume, a decrease in heart rate, and a decrease in rectal temperature.

[0095] In a certain specific embodiment, the functional component is selected from at least one probiotic, prebiotic, and combinations thereof. Probiotics are beneficial microorganisms that affect the natural gastrointestinal microflora present in 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 the specific embodiments of the present disclosure, at least one probiotic is selected from the genus Lactobacilli. According to other specific embodiments of the present disclosure, the probiotic is selected from the genus Bifidobacteria. In a specific embodiment, the probiotic is selected from the genus Streptococci.

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

[0097] Prebiotics according to embodiments of the present disclosure include, without limitation, 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, without limitation, polysaccharides and oligosaccharides. Non-limiting examples of oligosaccharides classified as prebiotics according to certain embodiments of the present disclosure include fructooligosaccharides, inulin, isomaltooligosaccharides, lactitol, lactulose oligosaccharides, lactulose, pyrodextrin, soybean oligosaccharides, transgalactooligosaccharides, and xylooligosaccharides.

[0098] Prebiotics are found naturally in a variety of foods including, without limitation, bananas, fruits, asparagus, garlic, wheat, oats, barley (and other whole grains), flax, tomatoes, Jerusalem artichokes, onions and chicory, leafy vegetables (e.g., young dandelion leaves, spinach, collard greens, mustard greens, kale, turnip greens, cabbage leaves), and legumes (e.g., lentils, green beans, chickpeas, white beans, white kidney beans, black beans).

[0099] In certain embodiments, the functional component is at least one weight management agent. As used herein, "weight management agent" includes appetite suppressants and / or thermogenic agents. As used herein, the terms "appetite suppressant," "appetite satiation compositions," "satiety agents," and "satiety ingredients" are synonymous. The term "appetite suppressant" refers to macronutrients, herbal extracts, exogenous hormones, anorectic agents, anorexigenic agents, formulations, and combinations thereof that, when delivered in an effective amount, suppress, inhibit, reduce, or otherwise deprive a human's appetite. The term "thermogenic agent" refers to macronutrients, herbal extracts, exogenous hormones, anorectic agents, anorexigenic agents, formulations, and combinations thereof that, when delivered in an effective amount, activate or otherwise enhance a human's thermogenesis or metabolism.

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

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

[0102] In another specific embodiment, the weight management agent is dietary fat. Dietary fat is a lipid composed of a combination of saturated and unsaturated fatty acids. Polyunsaturated fatty acids have been shown to have a stronger satiety effect than monounsaturated fatty acids. Therefore, the dietary fat embodied herein preferably contains polyunsaturated fatty acids, and non-limiting examples thereof include triacylglycerol. In another specific embodiment, the weight management agent is a herb extract. Extracts from a number of types of plants have been identified as having appetite-suppressing properties. Non-limiting examples of plants whose extracts have appetite-suppressing properties include plants of the genera Hoodia, Trichocaulon, Caralluma, Stapelia, Orbea, Asclepias, and Camellia. Other embodiments include extracts derived from Gymnema Sylvestre, kola nuts, Citrus Aurantium, Yerba Mate, Griffonia Simplicifolia, guarana, myrrh, googel lipids, and crotonus seed oil.

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

[0104] In one embodiment, the herb extract is derived from a Hoodia plant. The sterol glycoside of Hoodia is known as P57 and is thought to be involved in the appetite-suppressing effect of Hoodia species. In another embodiment, the herb extract is derived from a plant of the genus Kalanchoe, and non-limiting examples thereof include karatuberoside A, karatuberoside 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 herb 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 the species T. piliferum and T. officinale. In another embodiment, the herb extract is derived from a plant of the genus Stapelia or Orbea. Without wishing to be bound by any theory, it is thought that the compounds exhibiting appetite-suppressing activity are saponins, such as pregnane glycosides including stevaroside A, B, C, D, E, F, G, H, I, J, and K. In another embodiment, the herb extract is derived from a plant of the genus Saccharum. Without wishing to be bound by any theory, this extract is thought to contain steroid compounds having an appetite-suppressing effect, such as pregnane glycosides and pregnane aglycones. In another specific embodiment, the weight management agent is an exogenous hormone having a weight management effect. Non-limiting examples of such hormones include CCK, peptide YY, ghrelin, bombesin, and gastrin-releasing peptide (GRP), enterostatin, apolipoprotein A-IV, GLP-1, amylin, somatostatin, and leptin.

[0105] In another embodiment, the weight management agent is a formulated drug. Non-limiting examples include phentenime, diethylpropion, phentermine, sibutramine, rimonabant, oxyntomodulin, hydrochloric acid fluoxetine, ephedrine, phenethylamine, or other stimulants.

[0106] In certain embodiments, the functional ingredient is at least one osteoporosis management agent. In certain embodiments, the osteoporosis management agent is at least one calcium source. According to 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, their solubilized species, and combinations thereof.

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

[0108] In other embodiments, the osteoporosis management agent is selected from vitamin 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 the prevention and treatment of osteoporosis. Non-limiting examples of plants and plant extracts suitable as osteoporosis management agents include species of the genera Taraxacum and Amelanchier disclosed in U.S. Patent Application Publication No. 2005 / 0106215, and the genera Lindera, Artemisia, Acorus, Carthamus, Carum, Cnidium, Curcuma, Cyperus, Juniperus, Prunus, Iris, Cichorium, Dodonaea, Epimedium, Erigonoum, rioya, Mentha, Ocimum, thymus, Tanacetum, Plantago, Spearmint, Bixa, Vitis, Rosmarinus, Rhus, and Anethum disclosed in U.S. Patent Application No. 2005 / 0079232.

[0110] In certain embodiments, the functional ingredient is at least one phytoestrogen. Phytoestrogens are compounds found in plants and can generally be delivered into the human body by taking plants or parts of plants that contain phytoestrogens. As used herein, "phytoestrogen" refers to any substance that, when introduced into the body, causes estrogen-like effects regardless of degree. For example, phytoestrogens can bind to estrogen receptors in the body and have minor 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 grain flour, cereals, fiber, fruits, vegetables, black cohosh, rhubarb root, kudzu, black horehound, bilberry, cramp bark, kava root, American ginseng root, false unicorn root, Japanese carrot root, fleabane herb, licorice, life root herb, motherwort herb, peony root, raspberry leaf, rose plants, sage leaf, sarsaparilla root, saw palmetto fruit, wild yam root, sawtooth oyster flower, legumes, soybeans, soybean products (e.g., miso, soybean powder, soy milk, roasted soybeans, soy protein isolate, tempeh, or tofu), chickpeas, nuts, lentils, seeds, clover, purple gromwell, dandelion leaf, dandelion root, sesame seeds, green tea, hops, red wine, flaxseed, garlic, onion, hemp, lythrum, cottonwood, caraway, chestnut tree, bitex, dates, dill, fennel seeds, gotu kola, milk thistle, pennyroyal mint, pomegranate, southernwood, soybean powder, tansy, and kudzu root (pueraria root), etc., and combinations thereof.

[0112] Isoflavones belong to a group of plant nutrients called polyphenols. In general, polyphenols (also known as "polyphenolics") 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 purple gromwell.

[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) bonded 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-tetratriacontanol having 34 carbon atoms.

[0115] In one embodiment, the long-chain aliphatic saturated primary alcohol is policosanol. Policosanol is a term for a mixture of long-chain aliphatic saturated primary alcohols mainly composed of 1-octacosanol having 28 carbon atoms and 1-triacontanol having 30 carbon atoms, and other alcohols in lower concentrations, such as 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-nonacosanol having 29 carbon atoms, 1-dotriacontanol having 32 carbon atoms, and 1-tetratriacontanol having 34 carbon atoms.

[0116] In certain embodiments, the functional ingredient is at least one phytosterol, phytostanol, or a combination thereof. As used herein, the terms "stanol", "phytostanol", and "plant stanol" are synonymous. Phytosterols and stanols are present in small amounts naturally in many fruits, vegetables, nuts, seeds, grains, legumes, vegetable oils, tree bark, and other plant sources. Sterols are a subgroup of steroids having a hydroxyl group at C3. Generally, phytosterols, like cholesterol, have a double bond in the steroid nucleus. However, phytosterols may contain a substituted 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 discovered, and these are generally derived from plants such as corn, soybeans, wheat, and wood oil. However, these phytosterols can also be produced synthetically so that they form the same composition as the natural ones or have properties similar to those of naturally occurring phytosterols. Suitable phytosterols, without limitation, 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 (triterpenoid alcohols) (e.g., cycloartenol, 24-methylenecycloartanol, and cyclobranol).

[0118] As used herein, the terms "stanol", "phytostanol", and "plant stanol" are synonymous. Phytostanol is a saturated sterol alcohol that occurs in only trace amounts in nature and can also be produced synthetically, for example, by hydrogenation of phytosterols. Suitable phytostanols, without limitation, include the saturated forms of β-sitostanol, campestanol, cycloartanol, and other triterpenoid 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 containing five or more hydroxyl groups, for example, a pentavalent polyol, hexavalent polyol, heptavalent polyol, etc. each containing five, six, or seven hydroxyl groups. Further, the polyol may be a sugar alcohol, polyhydric alcohol, or polyalcohol which is a reduced form of a carbohydrate in which a carbonyl group (aldehyde or ketone, reducing sugar) is reduced to a primary or secondary hydroxyl group. In some embodiments, non-limiting examples of the polyol include maltitol, mannitol, sorbitol, lactitol, xylitol, isomalt, propylene glycol, glycerol (glycerin), trehalose, galactitol, palatinose, reduced isomaltooligosaccharide, reduced xylooligosaccharide, reduced gentiooligosaccharide, reduced maltose syrup, reduced glucose syrup, and sugar alcohol, 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 salt, potassium salt, calcium salt, magnesium salt 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), cytidine monophosphate (CMP), uridine monophosphate (UMP), inosine diphosphate, guanosine diphosphate, adenosine diphosphate, cytidine diphosphate, uridine diphosphate, inosine triphosphate, guanosine triphosphate, adenosine triphosphate, cytidine triphosphate, uridine triphosphate, their alkali metal salts or alkaline earth metal salts, and combinations thereof. The nucleotides described herein may also include nucleotide-related additives such as nucleosides or nucleobases (e.g., guanine, cytosine, adenine, thymine, uracil).

[0125] Suitable organic acid additives include any compound containing an α-COOH moiety, such as C2-C30 carboxylic acids, substituted hydroxyl C2-C30 carboxylic acids, butyric acid (ethyl ester), substituted butyric acid (ethyl ester), benzoic acid, substituted benzoic acids (e.g., 2,4-dihydroxybenzoic acid), substituted cinnamic acid, hydroxy acids, substituted hydroxybenzoic acids, anisic acid, substituted cyclohexylcarboxylic acids, tannic acid, aconitic acid, lactic acid, tartaric acid, citric acid, isocitric acid, gluconic acid, glucoheptonic acid, adipic acid, hydroxycitric acid, malic acid, fruitaric acid (a mixture of malic acid, fumaric acid, and tartaric acid), fumaric acid, maleic acid, succinic acid, chlorogenic acid, salicylic acid, caffeic acid, bile acids, acetic acid, ascorbic acid, alginic acid, erythorbic acid, polyglutamic acid, glucono-delta-lactone, and derivatives of their alkali metal or alkaline earth metal salts. Further, the organic acid additive may be in either the D-configuration or the L-configuration. Suitable organic acid additive salts include, but are not limited to, sodium salts, calcium salts, potassium salts, and magnesium salts of all organic acids, such as salts of citric acid, malic acid, tartaric acid, fumaric acid, lactic acid (e.g., sodium lactate), alginic acid (e.g., sodium alginate), ascorbic acid (e.g., sodium ascorbate), benzoic acid (e.g., sodium benzoate or potassium benzoate), sorbic acid salts, and adipic acid salts. The examples of the described organic acid additives may optionally be substituted with at least one group selected from hydrogen, alkyl, alkenyl, alkynyl, halo, haloalkyl, carboxyl, acyl, acyloxy, amino, amide, carboxyl derivatives, alkylamino, dialkylamino, arylamino, alkoxy, aryloxy, nitro, cyano, sulfo, thiol, imine, sulfonyl, sulfenyl, sulfmyl, sulfamyl, carboxyalkoxy, carboxyamide, phosphonyl, phosphinyl, phosphoryl, phosphino, thioester, thioether, anhydride, oxyimino, hydrazino, carbamyl, phosphor, or phosphonato.In certain embodiments, the organic acid additive is present in an effective amount to provide a concentration of about 10 ppm to about 5000 ppm in the sweetener composition, such as in an ingestible, e.g., 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., inositol hexaphosphate Mg / Ca).

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

[0128] Suitable flavorings and flavor component additives include, but are not limited to, vanilla, vanilla extract, mango extract, cinnamon, citrus fruits, coconut, ginger, viridiflorol, almond, menthol (including menthol without mint), grape skin extract, and grape seed extract. "Flavoring" and "flavor component" are synonymous and may include natural substances, synthetic substances, or combinations thereof. Flavorings also include any other substances that impart flavor and may include natural or non-natural (synthetic) substances that are safe for humans or animals when used within generally recognized limits. Non-limiting examples of branded flavorings include DOHLER (trademark) Natural Flavoring Sweetness Enhancer K14323 (DOHLER (trademark), Darmstadt, Germany), Symrise (trademark) Natural Flavor Mask for Sweeteners 161453 and 164126 (SYMRISE (trademark), Holzminden, Germany), Natural Advantage (trademark) Bitterness Blockers 1, 2, 9 and 10 (Natural Advantage (trademark), Freehold, New Jersey, U.S.A.), and SUCRAMASK (trademark) (Creative Research Management, Stockton, California, U.S.A.).Suitable polymer additives include, but are not limited to, chitosan, pectin, pectinic acid, pectinic acid, polyuronic acid, polygalacturonic acid, starch, food hydrocolloids or their crude extracts (e.g., Senegal gum (FIBERGUM (trademark)), Seyal gum, 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 alginate polyethylene glycol, sodium hexametaphosphate and its salts, and other cationic polymers and anionic polymers.

[0129] In some embodiments, the oral composition for rehydration or water supplementation may contain a protein hydrolysate additive. In related embodiments, the composition may contain a protein hydrolysate additive as an alternative to components such as amino acids.

[0130] Suitable surfactant additives include, but are not limited to, polysorbates (e.g., polyoxyethylene sorbitan monooleate (polysorbate 80), polysorbate 20, polysorbate 60), sodium dodecylbenzenesulfonate, dioctyl sulfosuccinate or sodium dioctyl sulfosuccinate, sodium dodecyl sulfate, cetylpyridinium chloride (hexadecylpyridinium chloride), hexadecyltrimethylammonium bromide, sodium cholate, carbamoyl, choline chloride, sodium glycolate, sodium taurodeoxycholate, sodium lauryl alginate, sodium stearoyl lactate, sodium taurocholate, lecithin, sucrose oleate, sucrose stearate, sucrose palmitate, sucrose laurate, and other emulsifiers, etc.

[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., enzymatically treated rutin Sanmelin™ AO (San-Ei Gen F.F.I., Inc., Osaka, Japan)), neohesperidin, naringin, neohesperidin dihydrochalcone, and the like. Suitable alcohol additives include, but are not limited to, ethanol.

[0132] Suitable astringency 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, such as a liquid, semi-liquid, solid, or semi-solid. In some embodiments, the composition is a beverage or a beverage product. One example of a beverage is a ready-to-drink beverage. Ready-to-drink beverages include carbonated and non-carbonated beverages. Examples of carbonated beverages include, but are not limited to, frozen carbonated beverages, highly effervescent beverages, cola, fruit-flavored effervescent beverages (e.g., lemon-lime, orange, grape, strawberry, and pineapple), ginger ale, soft drinks, and root beer. Examples of non-carbonated beverages include, but are not limited to, fruit juices, fruit-flavored juices, juice drinks, nectars, vegetable juices, vegetable-flavored juices, sports drinks, energy drinks, fortified water drinks, fortified water with vitamins, water-like drinks (e.g., water with natural or synthetic flavorings), coconut water, tea-based drinks (e.g., black tea, green tea, rooibos tea, oolong tea), coffee, cocoa drinks, beverages containing milk components (e.g., milk drinks, coffee containing milk components, caffeol, milk tea, fruit milk drinks), beverages containing cereal extracts, and smoothies.

[0134] In certain embodiments, the present disclosure relates to a sports drink or a fortified water drink.

[0135] The beverage may be a full-calorie beverage having up to about 120 calories per 226.8 g (8 oz) serving. The beverage may be a medium-calorie beverage having up to about 60 calories per 226.8 g (8 oz) serving. The beverage may be a low-calorie beverage having up to about 40 calories per 226.8 g (8 oz) serving. The beverage may be a zero-calorie beverage having less than about 5 calories per 226.8 g (8 oz) serving.

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

[0137] In some embodiments, the plasma weight osmolarity of the present 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 for preparing a ready-to-drink beverage, comprising: (i) preparing a beverage base material; and (ii) adding the beverage components described herein to the beverage base material, thereby resulting in a ready-to-drink beverage. The method optionally includes a further mixing step of mixing the beverage components and the base material to facilitate dissolution. The method also optionally includes a heating step of heating the beverage components and the base material to facilitate dissolution.

[0139] Dissolve the beverage components in the beverage base material. Exemplary beverage base materials include potable-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 base materials include, but are not limited to, phosphoric acid, phosphate buffer, citric acid, citrate buffer, and carbon-treated water.

[0140] The method can be carried out at any temperature necessary for formulating the ready-to-drink beverage. For example, for temperature-sensitive components, the method is carried out at less than 70°C. Similarly, the beverage components can be added to the beverage base material 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. The dry composition can be easily ingested or easily and rapidly dissolved in a drinking medium such as water.

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

[0143] In one embodiment, a method for preparing a ready-to-drink solution comprises mixing the oral composition described herein with a drinking medium in a weight ratio such that the concentration of the active ingredient in the formulation is 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 concentration of at least one active ingredient in the oral composition, which is composed of a mixture of sodium salts, is 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. In some embodiments, the concentration of at least one active ingredient in the oral composition, which is composed of a mixture of potassium salts, is 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. In certain embodiments, at least two active ingredients are a first active ingredient, which is a sodium salt having a concentration of from about 10 mmol / L to about 28 mmol / L, or from about 13 mmol / L to about 25 mmol / L, or from about 16 mmol / L to about 20 mmol / L, or from 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 from about 10 mmol / L to about 28 mmol / L, or from about 13 mmol / L to about 25 mmol / L, or from about 16 mmol / L to about 22 mmol / L, or from about 18 mmol / L to about 21 mmol / L, or about 20.5 mmol / L. Exemplary drinking media include beverage-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 an existing beverage such as sparkling water, juice, tea, milk, or coffee.

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

[0145] The above powder mixture may be added to a carrier suitable for tableting, such as sorbitol and magnesium stearate, having good sensory stimulation properties. The mass may optionally be sweetened with a known natural sweetener such as neohesperidin dihydrochalcone, and the total energy content should be such that the daily intake does not exceed 120 kcal on average. 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 having the same composition) are intended to have a daily intake of between 5 and 10 tablets on average.

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

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

[0148] In some embodiments, the disclosure provides a method of providing rapid rehydration, rapid hydration, long-term rehydration, and / or long-term hydration to a human, comprising administering an effective amount of an oral composition described herein, wherein the oral composition is free of nutritive sweeteners. 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, where the sports drink is configured such that the human's sports performance is improved, lactate production is reduced, fatigue is reduced, muscle soreness (actual muscle damage and felt pain) is reduced, time to fatigue is improved, time trial performance is improved, output is improved, lactate production is reduced, and net fluid loss observed with exercise is reduced. As used herein, "improvement in sports performance" refers to the improvement in sports performance associated with the ingestion of the sports drink of the embodiments presented herein, compared to sports performance when no sports drink or water is ingested. Ingestion of the sports drink may be before, during, or after sports performance. As used herein, "sports performance" refers to both endurance and non-endurance exercise. Endurance exercise includes aerobic activity over a long period of time (e.g., over about 30 minutes), while non-endurance exercise includes aerobic activity over a short period of time (e.g., less than about 30 minutes).

[0150] In one particular embodiment, the present disclosure is a method of improving athletic performance, comprising administering / ingesting a sports drink before, during, or after endurance exercise, wherein the sports drink comprises the aqueous solution described herein, and 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 concentration of at least one active ingredient composed of a mixture of sodium salts in the oral composition is about 15 mmol / L to about 35 mmol / L, or about 17 mmol / L to about 30 mmol / L, or about 20 mmol / L to about 30 mmol / L, or about 23 mmol / L to about 28 mmol / L, or about 25 mmol / L to about 26 mmol / L, or about 25.9 mmol / L. In some embodiments, the concentration of at least one active ingredient composed of a mixture of potassium salts in the oral composition is about 15 mmol / L to about 35 mmol / L, or about 17 mmol / L to about 30 mmol / L, or about 23 mmol / L to about 29 mmol / L, or about 25 mmol / L to about 28 mmol / L, or about 27.8 mmol / L. In a certain particular embodiment, 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.

[0151] In some embodiments, the method comprises preparing a drinking solution by dissolving a dry powder composition comprising the formulation in a drinking medium comprising water, and orally administering the drinking solution. In some embodiments, the concentration of the active ingredient in the formulation that does not contain 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 comprises ingesting a drinking medium comprising an oral composition and water. The ingestion of the oral composition and the drinking medium can be carried out in parallel, simultaneously, separately, or sequentially. In some embodiments, the ratio of the oral composition to the drinking medium is such that the content of the active ingredient in the formulation is about 1 g / L to about 50 g / L, or about 2 g / L to about 30 g / L, or about 3 g / L to about 30 g / L, or about 4 g / L to about 20 g / L, or about 5 g / L to about 10 g / L, or about 0.05 g / L to about 1 g / L with respect to the total volume of the drinking medium. In some embodiments, the concentration of at least one active ingredient composed of a mixture of sodium salts in the oral composition is about 15 mmol / L to about 35 mmol / L, or about 17 mmol / L to about 30 mmol / L, or about 20 mmol / L to about 30 mmol / L, or about 23 mmol / L to about 28 mmol / L, or about 25 mmol / L to about 26 mmol / L, or about 25.9 mmol / L. In some embodiments, the concentration of at least one active ingredient composed of a mixture of potassium salts in the oral composition is about 15 mmol / L to about 35 mmol / L, or about 17 mmol / L to about 30 mmol / L, or about 23 mmol / L to about 29 mmol / L, or about 25 mmol / L to about 28 mmol / L, or about 27.8 mmol / L. In certain embodiments, the at least two active ingredients are a first active ingredient 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.

[0153] The method according to the present disclosure provides rapid and effective hydration and fluid retention for humans. In some embodiments, the percent D2O in human plasma increases by at least about 2.5%, or at least about 3%, or at least about 4% at about 10 minutes after administration of the oral composition.

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

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

[0156] 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% at about 45 minutes after administration of the oral composition.

[0157] 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% 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 decrease in the 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 weight 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 human plasma weight osmolality at least 60 minutes after administration of the oral composition is 3 mOsm / kg or less.

Example

[0162] Example 1 A human study was conducted using examples of the beverages of the present disclosure to evaluate the benefits of more rapid hydration (assessing the speed of absorption into the bloodstream by measuring the accumulation of deuterium oxide (D2O) in plasma) and the benefits of longer-term hydration (evaluating the amount of beverage volume ingested by measuring the net fluid balance (subtracting urine volume from body weight over time)) (Maughan et al, 2016). In this study, the effectiveness of three test beverages for more rapid hydration and longer-term hydration during a 3-hour rehydration period after exercise-induced dehydration in the heat was evaluated in comparison to water intake (using water as a control). Healthy men (n = 12) completed four dehydration / rehydration tests with different beverages taken during the rehydration period.

[0163] Method The test group consisted of 12 apparently healthy men aged 18 to 40 years. A crossover, double-blind design was used, and the study participants were randomly assigned to one of four intervention trials (water and three test beverages). To maintain the double-blind study design, the test beverages were assigned alphanumeric codes. All beverages had no nutrients, flavors, or colors, and only the electrolyte content of the test beverages differed.

[0164] Each study participant was subjected to a dehydration period in an environmental chamber capable of maintaining temperature and humidity levels within the range of approximately 95°F / 35°C and 40% relative humidity (RH) ± 2°C and ± 3% RH. Prior to the dehydration period, a winged needle was inserted, and after the participant had sat for 15 minutes, a blood sample was collected without arresting blood flow (Pre-D: pre-dehydration). After fasting blood sampling, the participant was provided with a light meal (Clif Bar, 250 kcal - 260 kcal; sodium 130 mg - 230 mg) and ate in front of the study staff. Immediately before starting the dehydration period, the participant's weight was measured naked (after the Clif Bar and blood sampling).

[0165] During the dehydration period, the participant participated in an intermittent cycling protocol (repeated cycles of 20 minutes of exercise and 5 minutes of rest) at approximately 95°F and 40% RH to induce weight loss (dehydration period). The workload of the cycling exercise was set at a predetermined intensity from the baseline assessment (approximately 50% HRR). During each 5-minute rest period, the participant's weight was measured to obtain the net fluid loss from the baseline.

[0166] After the dehydration period, the participant participated in a rehydration period. Once the target weight loss was achieved, the participant was transported back to the laboratory, entered a mild environment (approximately 20°C - 22°C), and rested seated for 15 minutes. After the 15-minute rest, an intravenous catheter was inserted, and after the participant continued to rest seated for an additional 15 minutes, a pre-rehydration (Pre-R) blood sample was collected without arresting blood flow. After collecting the Pre-R blood sample, a total urine sample was collected, and the participant's weight was measured naked to calculate the total weight loss compared to the Pre-D level (% dehydration = % fluid loss). After this transition rest period (approximately 40 minutes), the participant started the rehydration / recovery period of the protocol.

[0167] During the rehydration period, participants took equal volumes of the assigned beverage (water or test beverage) every 15 minutes over 60 minutes (a total of 5 bolus drinks) such that 150% of the weight loss during dehydration was restored. To limit fluid shifts during the protocol rehydration period, participants were asked to remain seated. During the protocol recovery period, participants remained quietly seated for 3 hours in a mild environment (about 20°C to 22°C).

[0168] More rapid rehydration (D2O accumulation in plasma) The appearance of the beverage in blood was compared across beverages using the deuterium dilution method according to the technique of Davis et al. (1987). Venous blood samples for D2O analysis were taken without arresting blood flow from a Teflon indwelling catheter placed prior to the rehydration period. After maintaining a seated position for at least 20 minutes, a baseline blood sample (3 ml of EDTA) was obtained immediately prior to the last drink bolus to control for any background D2O. The participants then ingested the last bolus of the test beverage containing D2O within 5 minutes (time adjusted similarly throughout the study). Then 50 ml of the last drink was used as a rinse to ensure all D2O was ingested. Additional venous blood (3 ml) was obtained at 5 minutes (5 min-R), 10 minutes (10 min-R), 15 minutes (15 min-R), 20 minutes (20 min-R), 25 minutes (25 min-R), 30 minutes (30 min-R), and 45 minutes (45 min-R) after the start of rehydration, after rehydration (Post-R), 20 minutes after the last fluid bolus (20 Post-R), 40 minutes after the last fluid bolus (40 Post-R), and 60 minutes after the last fluid bolus (60 Post-R). Blood samples were centrifuged at 3000 rpm and plasma was stored at -80°C. D2O enrichment in plasma was measured in an independent laboratory. Although quantitative measurements of the amount of fluid leaving the stomach and absorbed in the intestine cannot be obtained from D2O enrichment in blood, relative differences in volume and delivery rate can be estimated (Non-Patent Document 1, Hill et al. 2008).

[0169] Figure 1A shows the beverage intake (D2O, in PPM units) for each of the three examples of the present disclosure and water for each group and time point before rehydration (Pre-R), 5 minutes after the start of rehydration (5 min-R), 10 minutes (10 min-R), 15 minutes (15 min-R), 20 minutes (20 min-R), 25 minutes (25 min-R), 30 minutes (30 min-R), and 45 minutes (45 min-R), after rehydration (Post-R), 20 minutes after the last fluid bolus (20 Post-R), 40 minutes after the last fluid bolus (40 Post-R), and 60 minutes after the last fluid bolus (60 Post-R). Example 228 is a sodium mixture of 25.9 mmol / L and contains sodium lactate, sodium chloride, trisodium citrate, and sodium bicarbonate. Example 460 is a potassium mixture of 27.8 mmol / L and contains monopotassium phosphate and potassium citrate. Example 351 is a mixture of 18.3 mmol / L of sodium and 20.5 mmol / L of potassium and contains 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 rehydration (net body fluid balance) Body weight was measured before dehydration (Pre-D), before / after rehydration (Post-D), immediately after administration of the last fluid bolus (Post-R), and every 60 minutes after the last fluid bolus (60 Post-R, 120 Post-R, and 180 Post-R). Body weight was measured twice, naked, using an electronic scale with an accuracy of 10 grams after urination and wiping with a towel. The body fluid loss caused by the dehydration protocol was calculated from the rapid change in body weight from Pre-D to Pre-R (corrected for fecal loss if necessary) and expressed as a percentage of the baseline body weight (Cheuvront et al. 2004, 2010). For all calculations, water and weight loss due to sweat and urine were considered equivalent (1 L = 1 kg).

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

[0172] Results More rapid rehydration Figure 1B discloses a graph of the data of Figure 1A. A more rapid rehydration benefit compared to water (741) began to be seen 45 minutes after the start of rehydration (45min-R) with both the sodium mixture (228) and the sodium + potassium mixture (351). In the sodium mixture (228), a more rapid rehydration benefit compared to the potassium mixture (460) was shown 20 minutes after the last fluid bolus (20Post-R), while in the sodium + potassium mixture (351), a more rapid rehydration benefit compared to the potassium mixture (460) began to be shown 20 minutes after the start of rehydration (20Min-R).

[0173] Longer-term rehydration Figure 2B is a graph of the data of Figure 2A and further includes pre-dehydration (Pre-D) as a zero measurement. In the sodium mixture (228), a longer-term rehydration benefit compared to water was shown at 120 and 180 minutes after rehydration, while in the sodium + potassium mixture (351), a longer-term rehydration benefit compared to water was shown at 180 minutes after rehydration. In the sodium mixture (228) and the sodium + potassium mixture (351), a longer-term rehydration benefit compared to the potassium mixture (460) was demonstrated at 120 and 180 minutes after rehydration. Also in the sodium mixture (228), a longer-term rehydration benefit was shown at 180 minutes after rehydration compared to the sodium + potassium mixture (351).

[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. S. N. Cheuvront, R. Carter 3rd, S. J. Montain, M. N. 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. S. N. Cheuvront, B. R. Ely, R. W. Kenefick, M. N. Sawka, Biological variation and diagnostic accuracy of dehydration assessment markers. Am J Clin Nutr. 2010, 92(3):565-73. L. B. 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 of the 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 are described with reference to the foregoing 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 series of steps of the methods described herein without departing from the true concept, spirit, and scope of the present disclosure. More specifically, while the agents, additives, and components described herein can be substituted with certain similar agents, additives, and components according to their physical, chemical, physiological, and / or gustatory properties, it will be apparent that the same or similar results will be achieved. All such similar substitutions and modifications that are apparent to those skilled in the art are considered to fall within the scope of the spirit, scope, and concept of the present disclosure as defined by the claims appended hereto.

[0177] Item 1. An oral composition for rapid hydration, rapid water replenishment, long-term hydration, and / or long-term water replenishment, the oral composition comprising at least one active ingredient. 2. The oral composition of item 1, which is a formulation that does not contain amino acids and / or substantially does not contain 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 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 wherein 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 at least one active ingredient is 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 at least two active ingredients are 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 according to any one of items 2 - 6, wherein at least one active ingredient is a mixture of sodium salts. 8. The oral composition according to any one of items 2 - 6, wherein at least one active ingredient is a mixture of potassium salts. 9. The oral composition according to any one of items 3 - 6, wherein at least two active ingredients are a mixture of sodium salts and potassium salts. 10. An oral composition according to any one of items 3 to 7, wherein at least one active ingredient is a mixture of sodium salts including sodium lactate, sodium chloride, trisodium citrate, and sodium bicarbonate. 11. An oral composition according to any one of items 3 to 6 or 8, wherein at least one active ingredient is a mixture of potassium salts including monopotassium phosphate and potassium citrate. 12. An oral composition according to item 9, wherein at least two active ingredients are a mixture of sodium salts and potassium salts including sodium lactate, sodium chloride, trisodium citrate, sodium bicarbonate, monopotassium phosphate, and potassium citrate. 13. An oral composition according to any one of items 1 to 12, wherein at least one active ingredient is a mixture of sodium salts 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. An oral composition according to any one of items 1 to 12, wherein 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. An oral composition according to any one of items 1 to 12, wherein 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. An oral composition according to any one of items 2 to 15, wherein the total electrolyte concentration is at least about 200 mg / L. 17. An oral composition according to any one of items 1 to 16, further comprising at least one sweetener. 18. The oral composition of item 17, wherein the sweetener is selected from the group consisting of stevia and steviol glycosides, luo han guo and related mogroside compounds, monatin and its salts (monatin SS, RR, RS, SR), curcumin, glycyrrhizic acid and its salts, thaumatin, monellin, mabinlin, brazzein, hernandulcin, phyllodulcin, glyciphilin, phloridzin, trilobatin, baiyunoside, osthenin, polypodoside A, pterocaryoside A, pterocaryoside B, mukurozioside, phlorimoside I, perandrin I, abrusoside A, and cyclocarioside 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 glycoside (GSG), and combinations thereof. 19. An oral composition according to any one of items 1 to 18, further comprising at least one additive. 20. An oral composition according to any one of items 1 to 18, further comprising at least one functional ingredient. 21. An oral composition according to any one of items 1 to 20, selected from sports drinks and fortified water drinks. 22. An oral composition according to any one of items 1 to 21, selected from full-calorie beverages, medium-calorie beverages, low-calorie beverages, or zero-calorie beverages. 23. An oral composition according to any one of items 1 to 22, which is a ready-to-drink hydration beverage. 24. An oral composition according to 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 water replenishment, long-term hydration, and / or long-term water replenishment in humans, the method comprising administering an oral composition comprising at least one active ingredient. 27. The method of item 26, wherein a human obtains rapid hydration, rapid water replenishment, long-term hydration, and / or long-term water replenishment by administration of the oral composition. 28. The method of item 26 or 27, wherein the oral composition is a ready-to-drink hydration beverage, a sports drink, or a fortified water drink. 29. The method of any one of items 26 to 28, wherein the oral composition is selected from a full-calorie beverage, a medium-calorie beverage, a low-calorie beverage, or a zero-calorie beverage. 30. The method of any one of items 26 to 29, wherein the oral composition is a formulation that does not contain amino acids and / or substantially does not contain 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 item 30 or 31, wherein at least one active ingredient comprises at least one electrolyte selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate, and combinations thereof, or wherein at least two active ingredients comprise at least two electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate, and combinations thereof. 33. The method of item 32, wherein at least one active ingredient is two or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate, and combinations thereof, or three or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate, and combinations thereof, or four or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate, and combinations thereof, or five or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate, and combinations thereof, or six or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate, and combinations thereof. 34. The method of item 32, wherein at least two active ingredients are two or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate, and combinations thereof, or three or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate, and combinations thereof, or four or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate, and combinations thereof, or five or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate, and combinations thereof, or six or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate, and combinations thereof. 35. The method of any one of items 27 to 34, wherein at least one active ingredient is a mixture of sodium salts. 36. The method of any one of items 27 to 34, wherein at least one active ingredient is a mixture of potassium salts. 37. The method of any one of items 27 to 34, wherein at least two active ingredients are a mixture of sodium salts and potassium salts. 38. The method according to any one of items 27 to 34, wherein at least one active ingredient is a mixture of sodium salts including sodium lactate, sodium chloride, trisodium citrate, and sodium bicarbonate. 39. The method according to any one of items 27 to 34 or 36, wherein at least one active ingredient is a mixture of potassium salts including monopotassium phosphate and potassium citrate. 40. The method according to item 37, wherein at least two active ingredients are a mixture of sodium salts and potassium salts including sodium lactate, sodium chloride, trisodium citrate, sodium bicarbonate, monopotassium phosphate, and potassium citrate. 41. The method according to any one of items 26 to 40, wherein 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 according to any one of items 26 to 40, wherein 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 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. 44. The method according to any one of items 27 to 43, wherein the total electrolyte concentration is at least about 200 mg / L. 45. The method according to any one of items 26 to 44, wherein the oral composition further comprises at least one sweetener. 46. The method according to item 45, wherein the sweetener is selected from the group consisting of stevia and steviol glycosides, lo han guo and related mogroside compounds, monatin and its salts (monatin SS, RR, RS, SR), curcumin, glycyrrhizinate and its salts, thaumatin, monellin, mabinlin, brazzein, hernandezine, phyllodulcin, glycyphyllin, phloridzin, trilobatin, baiyunoside, osthenoside, polypodoside A, pterocaryoside A, pterocaryoside B, mukurozioside, phlorimoside I, perandrin I, abrusoside A, and cyclocarioside 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 glycoside (GSG), and combinations thereof. 47. The method according to any one of items 26 to 46, wherein the oral composition further comprises at least one additive. 48. The method according to any one of items 26 to 47, wherein the oral composition further comprises at least one functional ingredient. 49. The method according to any one of items 26 to 48, wherein the oral composition is in a dry or semi-dry form. 50. The method according to item 49, wherein the oral composition is a gum, tablet, capsule, or dry powder. 51. The method according to any one of items 26 to 50, wherein the percentage of D2O in human plasma 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. 52. The method according to any one of items 26 to 50, wherein the percentage of D2O in human plasma increases by at least about 4.5%, or at least about 5%, or at least about 5.5%, or at least about 6% within 15 minutes after administration of the oral composition. 53. The method of any one of items 26 - 50, wherein the percentage of D2O in human plasma increases by at least about 5%, or at least about 5.5%, or at least about 6%, or at least about 6.5%, or at least about 7% within 30 minutes after administration of the oral composition. 54. The method of any one of items 26 - 50, wherein the percentage of 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 the percentage of 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%. 56. The method of any one of items 26 - 54, wherein the plasma weight osmolarity in humans 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 - 56, wherein the plasma weight osmolarity in humans before administration of the oral composition changes by 3 mOsm / kg or less at least 60 minutes after administration of the oral composition. 58. The method as described above, which is a method for improving physical performance or sports performance, and includes administering any oral composition of any one of items 1 - 25. 59. The method of item 34, wherein the oral composition is administered before, during, or after endurance exercise. 60. The method of item 34 or 35, wherein the improvement in performance is characterized by a reduction in physical fatigue, a reduction in muscle pain, a reduction in muscle damage, a reduction in net body fluid loss, a reduction in lactic acid production, an improvement in the time to fatigue, an improvement in time trial performance, an improvement in 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 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.

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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