Rapid hydration formulations and methods

Abstract

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

Description

[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 Serial No. 63 / 346,470 filed on May 27, 2022, the entire disclosure of which is incorporated herein by reference in its entirety.

[0002] introduction

[0003] The present disclosure generally relates to compositions and methods for rapid hydration, rapid rehydration, sustained hydration, and / or sustained rehydration.

[0004] People often suffer from dehydration or lack of water under stressful conditions, such as exposure to high heat, high intensity or prolonged exercise, strenuous physical activity with limited water, mountain climbing, or prolonged water loss due to diarrhea, vomiting or sweating. Dehydration is often accompanied by negative physiological effects such as electrolyte imbalance or protein loss. It would be beneficial to provide a fast and effective hydration or rehydration composition that can quickly restore body water and key elements to avoid any potential adverse health problems caused by dehydration.

[0005] Previously, attempts have been made to prepare rehydration compositions, particularly beverages and sports drinks, which provide energy sources, electrolytes and water for rehydration. These beverages may contain a mixture of protein, carbohydrates (e.g., glucose, fructose, maltose), salts and other additives (e.g., citric acid, glycerol, triglycerides, sodium bisulfate), which are claimed to be useful for rehydration. These beverages and compositions are generally disclosed in, for example, U.S. Patents No. 4,853,237, No. 5,447,730, No. 6,221,910, No. 6,485,764, No. 7,001,612, No. 7,160,565, No. 8,993,032 and U.S. Patent Applications No. 2005 / 0100637, No. 2005 / 0048136, No. 2009 / 0117224, No. 2012 / 0128815.

[0006] However, many disclosed compositions may be more effective. For example, many compositions cannot provide rapid recovery of body fluid and plasma D20 percentage, and the duration of rehydration effect is often relatively short. In particular, after ingesting these compositions, the retention of body fluid may not be lasting, and the total body water will quickly decrease to the level before rehydration (Jeukendrup, Nutr. Metab. (Nutrition and Metabolism) 2009). In addition, direct evidence of the active ingredients and / or rehydration effects of rehydration compositions is not clearly pointed out in the existing disclosures. In addition, many existing compositions contain a large amount of carbohydrates and / or other high-calorie ingredients, which may not be favored by consumers. When people drink carbohydrate-containing beverages, there is also a trade-off between the purpose of rapid recovery of body fluids and the purpose of replenishing energy. As the carbohydrate concentration in the beverage increases, its energy density and osmotic pressure also increase, thereby reducing its gastric emptying rate. Therefore, the effectiveness of body fluid recovery is weakened.

[0007] Therefore, despite the above disclosure, there remains a great need for new rapid hydration, rapid rehydration, sustained hydration and / or sustained rehydration compositions and beverages that provide rapid and effective solutions to dehydration and dehydration, prolonged hydration or rehydration, total body water replacement and extended retention time, extended restoration of electrolyte balance and / or improved taste and palatability. Summary of the invention

[0008] The present disclosure provides compositions and methods for rapid hydration, rapid rehydration, sustained hydration and / or sustained rehydration that meet the above needs.

[0009] In one aspect, the present disclosure relates to a composition for oral consumption, comprising at least one or at least two active ingredients. In some embodiments, the composition can be a preparation without amino acids and / or a composition substantially free of nutritious sweeteners. In some embodiments, the oral composition is a ready-to-drink hydrating beverage. A specific example is a sports drink or sports drink. In some embodiments, based on the total volume of the beverage, the beverage has a concentration of about 1g / L to about 50g / L, or about 2g / L to about 30g / L, or about 3g / L to about 30g / L, or about 4g / L to about 20g / L, or about 5g / L to about 10g / L, or about 0.05g / L to about 1g / L of active ingredients. In some embodiments, the concentration of at least one active ingredient comprising a sodium salt mixture 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 comprising a potassium salt mixture in the oral composition is about 15 mmol / L to about 35 mmol / L, or about 17 mmol / L to about 30 mmol / L, or about 23 mmol / L to about 29 mmol / L, or about 25 mmol / L to about 28 mmol / L, or about 27.8 mmol / L. In certain embodiments, the at least two active ingredients are a first active ingredient, a sodium salt, having a concentration of about 10 mmol / L to about 28 mmol / L, or about 13 mmol / L to about 25 mmol / L, or about 16 mmol / L to about 20 mmol / L, or about 17 mmol / L to about 19 mmol / L, or about 18.3 mmol / L; and a second active ingredient, a potassium salt, having a concentration of about 10 mmol / L to about 28 mmol / L, or about 13 mmol / L to about 25 mmol / L, or about 16 mmol / L to about 22 mmol / L, or about 18 mmol / L to about 21 mmol / L, or about 20.5 mmol / L.

[0010] In some embodiments, the oral composition is in dry or semi-dry form. A specific example is a dry powder that is easily soluble in water. In some embodiments, a drinkable solution of the dry powder can be easily prepared by dissolving the dry powder in a drinkable medium, wherein the solution has a concentration that does not contain amino acids. In some embodiments, the composition of the present invention also includes at least one electrolyte. Examples of electrolytes include sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate, and combinations thereof.

[0011] In some embodiments, the composition of the present invention also includes at least one sweetener. Sweetener can be carbohydrate, peptide-based sweetener, non-nutritive sweetener, artificial sweetener, commercial sweetener or sweetener composition or "natural high potency sweetener" (natural high potency sweetener, NHPS). In a specific embodiment, the composition of the present invention includes low-calorie sweetener or non-calorie sweetener. In another specific embodiment, the composition of the present invention does not contain or is substantially free of non-nutritive sweetener and / or nutritious sweetener.

[0012] In some embodiments, the compositions of the present invention further comprise at least one additive, at least one functional ingredient, or both.

[0013] In some embodiments, the compositions of the invention have an osmotic pressure of about 250 to about 350 mOsm / kg (milliosmole / kilogram), or about 260 to about 340 mOsm / kg, or about 270 to about 330 mOsm / kg, or about 280 to about 320 mOsm / kg, or about 290 to about 310 mOsm / kg, or about 290 to about 300 mOsm / kg.

[0014] In another aspect, the present disclosure relates to methods for hydration or rehydration. The methods of the present invention utilize the compositions described herein to achieve at least one of the following objectives: provide a rapid effect on total body water restoration during rehydration, reduce or reverse the effects of dehydration or water deprivation, ameliorate other adverse effects of exercise, heat or other activities that result in fluid loss, provide a positive effect on subsequent body function, increase the duration of fluid retention, rapidly increase total body water, maintain increased total body water for a long period of time, restore and maintain electrolyte balance, provide a source of energy, balance or control calorie intake, and stimulate thirst and drinking.

[0015] In some embodiments, the present disclosure provides a method for rapid hydration, rapid rehydration, providing lasting hydration and / or providing lasting rehydration to the human body, the method comprising administering an effective amount of an oral composition as described herein. In some embodiments of the method of the present invention, the oral composition is in a dry form or a semi-dry form. The oral composition can be in the form of a beverage concentrate, a gel, a dry powder, a tablet or a capsule. In one embodiment, the oral composition is a dry powder that is easily soluble in a drinkable medium. In some embodiments, the method comprises preparing a drinkable solution containing the dry powder by dissolving the dry powder in a drinkable medium comprising water, and then orally administering the drinkable solution.

[0016] In other embodiments, the method includes taking / consuming an oral composition and a drinkable medium comprising water. The intake of the oral composition and the drinkable medium can be performed simultaneously, concurrently, separately or continuously. In some embodiments, the ratio of the oral composition to the drinkable medium is such that the content of the active ingredient in the preparation is from about 1 g / L to about 50 g / L, or from about 2 g / L to 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 relative to the total volume of the drinkable medium. In some embodiments, the concentration of at least one active ingredient comprising a sodium salt mixture in the oral composition 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 comprising the potassium salt mixture in the oral composition 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 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 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.

[0017] In some embodiments of the methods of the invention, within 10 minutes after administration of the oral composition, the D20 percentage of plasma volume in the human increases by at least about 2.5%, or at least about 3%, or at least about 4%.

[0018] In some embodiments, within 15 minutes after administration of the oral composition, the human's plasma D20 percentage increases by at least about 4.5%, or at least about 5%, or at least about 5.5%, or at least about 6%.

[0019] In some embodiments, within 30 minutes after administration of the oral composition, the human's plasma D20 percentage 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%.

[0020] In some embodiments, within 45 minutes after administration of the oral composition, the human's plasma D20 percentage 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%.

[0021] In some embodiments, within 60 minutes after administration of the oral composition, the human's plasma D20 percentage 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%.

[0022] In some embodiments, the human's plasma D20 percentage 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.

[0023] In some embodiments, the percentage of plasma D20 in a human measured 30 minutes after administration of the oral composition is reduced by less than about 1%, or less than about 2%, or less than about 3%, or less than about 4%, or less than about 5%, or less than about 6%, or less than about 7%, or less than about 8%, or less than about 9%, or less than about 10% for at least about 30 minutes.

[0024] In some embodiments of the methods of the invention, the plasma osmolality of the human is maintained in the range of about 270 to about 330 mOsm / kg, or about 280 to about 320 mOsm / kg, or about 290 to about 310 mOsm / kg, or about 290 to about 300 mOsm / kg for at least 60 minutes after administration of the oral composition.

[0025] In some embodiments, the plasma osmolality of the human does not change by more than 3 mOsm / kg for at least 60 minutes following administration of the oral composition.

[0026] Definitions and explanations of selected terms

[0027] As used herein, "weight percent," "wt %," "percent by weight," "% by weight," and variations thereof refer to the concentration of a substance by dividing the weight of the substance by the total weight of the composition and multiplying by 100. It should be understood that, as used herein, "percent," "%," and the like are intended to be synonymous with "weight percent," "wt %," and the like.

[0028] As used herein, "g" means gram; "kg" means kilogram or 1000 grams; "L" means liter; "mg" means "milligram (10-3 gram)"; "mL" or "cc" means milliliter (10-3 liter). The unit "g / 100g", "g / 100mL", or "g / L" is the unit of concentration or content of a component in a composition. 1 "mg / L" is equal to 1 ppm (parts per million). "Da" refers to Dalton, which is the unit of molecular weight; 1 Da is equal to 1 g / mol. The unit of temperature used herein is degree Celsius (°C).

[0029] The term "about" is used in conjunction with a numerical value to include normal variations in measurements as would be expected by one skilled in the art, and should be understood to have the same meaning as "approximately" and encompass typical margins of error, such as ±15%, ±10%, ±5%, ±1%, ±0.5%, or even ±0.1% of the stated value. The term "about" also encompasses different amounts due to different equilibrium conditions of compositions resulting from a particular initial composition. Whether or not modified by the term "about," the claims include equivalents of the quantities.

[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 content clearly dictates otherwise. Thus, for example, reference to a composition containing "a compound" includes compounds having two or more that are the same as each other or that are different from each other. It should also be noted that the term "or" is generally used in its sense including "and / or" unless the content clearly dictates otherwise. As used herein, "and / or" refers to and encompasses any and all possible combinations of one or more of the associated listed items, as well as combinations that are lacking when interpreted with the alternative word ("or").

[0031] For the sake of brevity and conciseness, any range of values ​​stated in this specification contemplates all values ​​within that range and should be interpreted as supporting claims reciting any sub-ranges having endpoints with actual numerical values ​​within the specified range in question. By way of hypothetical illustrative example, a range disclosed in this specification of 1 to 5 should be considered supporting 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 utilized herein to represent the inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, or other representation. The term "substantially" is also utilized herein to represent the degree by which a quantitative representation may vary from a stated reference without resulting in a change in the basic function of the subject matter at issue.

[0033] The term "substantially free of" may refer to any component that is lacking or mainly lacking in the composition of the present disclosure. When referring to "substantially free of", it is intended that the component is not intentionally added to the composition of the present disclosure. The use of the term "substantially free of" a certain component allows trace amounts of the component to be included in the composition of the present disclosure because they are present in another component. However, it should be recognized that when a composition is referred to as "substantially free of" a certain component, only trace amounts or trace amounts of the component will be allowed. In addition, if a composition is referred to as "substantially free of" a certain component, if the component is present in trace amounts or trace amounts, it should be understood that it will not affect the effectiveness of the composition. It should be understood that if an ingredient is not explicitly included in this article or it is not stated in this article that it may be included, the composition of the present disclosure may be substantially free of the ingredient. Similarly, the explicit inclusion of an ingredient allows its explicit exclusion, thereby allowing the composition to be substantially free of explicitly stated ingredients.

[0034] As used herein, the terms “comprise,” “comprises,” and “comprising” indicate the presence of stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0035] As used herein, the transitional phrase "consisting essentially of" means that the scope of a claim is interpreted to include the specified materials or steps recited in the claim and those materials or steps that do not materially affect one or more basic and novel features of the claimed disclosure. Therefore, the term "consisting essentially of" when used in the claims of the present disclosure is not intended to be interpreted as equivalent to "comprising".

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

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

[0038] "Osmotic pressure" is defined as the amount of dissolved particles in a unit volume of an aqueous solution. Osmotic concentration is defined as the amount of dissolved particles in a unit weight of an aqueous solution. In practice, osmotic pressure and osmotic concentration have very close values ​​within the scope of the present disclosure and are therefore used interchangeably. A solution having 1 / 1000 osmoles dissolved per kilogram has a concentration of 1 milliosmole ("mOs") per kilogram. An osmotic pressure mole is the number of particles in 1 gram of undissociated solute. Tension is a measure of the osmotic pressure of a solution relative to the osmotic pressure of blood. It should be understood that the osmotic pressure of the human body varies slightly from one another. A hypotonic solution is a solution having a lower osmotic pressure or tension than blood. The osmotic pressure of a hypotonic solution is typically about 80-250 mOs / kg. An isotonic solution has the same tension as blood. Here, the osmotic pressure is typically about 280 to about 310 mOs / kg. A hypertonic solution is a solution having a greater tension than blood. Its osmotic pressure is typically about 310-440 mOs / kg. The osmotic pressure of water is about 10-20 mOs / kg.

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

[0040] As used herein, dehydration is defined as a condition that occurs when the body loses too much water and other fluids it needs to function properly. Dehydration is usually caused by severe diarrhea and vomiting, but it can also be caused by not drinking enough water or other fluids, excessive sweating, fever, frequent urination, taking certain medications, or physical exertion. Rehydration is the replacement of water and electrolytes lost due to dehydration. Rapid rehydration (or rapid hydration) is the replacement of water and electrolytes within 30 minutes.

[0041] As used herein, "amino acid" refers to an organic compound or unit containing amino (-NH2) and carboxyl (-COOH) functional groups. "Amino acid" of the present disclosure broadly covers any compound having at least one amino acid unit. "Amino acid-free preparation" as used herein refers to a preparation that does not contain molecules, compounds, complexes, oligomers, polymers, mixtures or compositions having at least one amino acid unit physically (via non-covalent bonds) or chemically (via covalent bonds, hydrogen bonds or coordination bonds) bound in the preparation. Non-limiting examples of amino acids, amino acid compounds, and amino acids used herein include aspartic acid, alanine, glycine, glutamic acid, proline (praline), threonine, theanine, cysteine, cystine, alanine, valine, tyrosine, leucine, arabinose, trans-4-hydroxyproline, isoleucine, asparagine, serine, lysine, histidine, ornithine, methionine, carnitine, aminobutyric acid (α-isomer, β-isomer and / or γ-isomer), glutamine, hydroxyproline, taurine, norvaline, sarcosine, and salt forms thereof, such as sodium or potassium salts or acid salts. Amino acids can also be in the D-configuration or the L-configuration, as well as single-form, two-form, or three-form of the same or different amino acids. In addition, if appropriate, amino acids can be α-isomers, β-isomers, and / or γ-isomers. The combination of the aforementioned amino acids and their corresponding salts (e.g., sodium salts, potassium salts, calcium salts, magnesium salts or other alkali metal salts or alkaline earth metal salts or acid salts) is also a suitable additive in some embodiments.Amino acids can be natural or synthetic.Amino acids can also be modified.The modified amino acid refers to any amino acid (e.g., N-alkyl amino acids, N-acyl amino acids or N-methyl amino acids) in which at least one atom is added, removed, substituted or a combination thereof.Non-limiting examples of modified amino acids include amino acid derivatives, such as trimethylglycine, N-methylglycine and N-methylalanine.As used herein, modified amino acids include modified and unmodified amino acids.As used herein, amino acids also 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). The polyamino acid additive can also be in the D configuration or the L configuration. In addition, if appropriate, the polyamino acid can be an α-isomer, a β-isomer, a γ-isomer, a δ-isomer, and an ε-isomer. Combinations of the foregoing polyamino acids and their corresponding salts (e.g., sodium salts, potassium salts, calcium salts, magnesium salts or other alkali metal salts or alkaline earth metal salts or acid salts) are also suitable additives in some embodiments.Polyamino acids as described herein can also include copolymers of different amino acids. Polyamino acids as described herein can also include copolymers of different amino acids. Polyamino acids can be natural or synthetic. Polyamino acids can also be modified so that at least one atom is added, removed, substituted, or a combination thereof (e.g., N-alkyl polyamino acids or N-acyl polyamino acids). As used herein, polyamino acids include modified and unmodified polyamino acids. For example, modified polyamino acids include but are not limited to polyamino acids of various molecular weights (MW), such as poly-L-α-glycine having a MW of about 100 Daltons (Da), about 200 Daltons, about 300 Daltons, about 500 Daltons, about 1000 Daltons, about 1500 Daltons, about 6000 Daltons, about 25200 Daltons, about 63000 Daltons, about 83000 Daltons, or about 300000 Daltons. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] Figure 1A-1B The benefits of faster hydration of a human study group following heat-induced dehydration and exercise-induced dehydration using 3 different embodiments of the present disclosure and water (control) are demonstrated.

[0043] Figure 2A-2B Longer lasting hydration of a human study group following heat-induced dehydration and exercise-induced dehydration using 3 different embodiments of the present disclosure and water (control) was demonstrated. DETAILED DESCRIPTION

[0044] The present disclosure is based at least in part on the discovery that formulations having at least one active ingredient, and in certain embodiments at least two active ingredients, can be used to rapidly improve plasma D20 percentages after exercise and rehydration. A more sustained and replenished plasma D20 percentage after rehydration will provide possible thermoregulatory and performance advantages in subsequent exercise heat stress.

[0045] The present disclosure advantageously provides compositions that are effective for improving rapid rehydration and maintaining hydration, including sustained hydration and / or sustained rehydration.

[0046] In some embodiments, the composition is free of amino acids and / or substantially free of nutritious sweeteners. In some embodiments, the composition comprises active ingredients. These active ingredients in the oral composition of the present invention include beverage compatible ingredients, such as at least one electrolyte and / or at least one sweetener and / or at least one functional ingredient and / or at least one additive.

[0047] Electrolytes

[0048] The composition of the present invention may contain at least one electrolyte. Non-limiting examples of electrolytes include sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate and combinations thereof. The electrolyte and ion components of the present disclosure are generally (but not necessarily) available from their corresponding water-soluble and non-toxic salts. Unless otherwise defined, the amount of the electrolyte or ion component in the composition is based on the amount present in the final ingestible form. The electrolyte concentration is only the concentration of the ion, not the concentration of the salt.

[0049] The compositions of the present invention preferably contain a total electrolyte concentration of 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 specific embodiments, the compositions of the present invention contain electrolyte concentrations of about 400 mg / L to about 1000 mg / L, about 400 mg / L to about 900 mg / L, about 400 mg / L to about 800 mg / L, about 400 mg / L to about 700 mg / L, about 400 mg / L to about 600 mg / L, about 400 mg / L to about 500 mg / L, about 500 mg / L to about 1000 mg / L.

[0050] The potassium ion component can be provided by any salt, including chloride, carbonate, sulfate, acetate, bicarbonate, citrate, phosphate, hydrogen phosphate, tartrate, sorbate, or a combination thereof. Potassium ions are preferably present in the composition of the present disclosure in an amount of at least 0.0025% to about 0.08% by weight, about 0.0075% to about 0.06% by weight, or about 0.0075% to about 0.015% by weight.

[0051] The composition of the present invention 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 comprising a potassium salt mixture 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.

[0052] The sodium ion component can be provided by any salt, such as chloride, carbonate, sulfate, acetate, bicarbonate, citrate, phosphate, hydrogen phosphate, tartrate, sorbate or a combination thereof. Sodium ions are preferably present in the composition of the present invention in an amount of at least about 0.005% to about 0.1% by weight, about 0.0075% to about 0.075% by weight, or about 0.015% to about 0.05% by weight.

[0053] The composition of the present invention may contain about 5 mg / L to about 1000 mg / L of sodium, more preferably about 300 mg / L to about 800 mg / L of sodium, 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 500 mg / L, about 300 mg / L to about 400 mg / L, about 400 mg / L to about 500 mg / L, about 400 mg / L to about 600 mg / L, about 400 mg / L to about 700 mg / L, about 400 mg / L to about 800 mg / L, about 400 mg / L to about 5 ... In some embodiments, the composition of the present invention contains about 600 mg / L to about 700 mg / L of sodium. In some embodiments, the concentration of at least one active ingredient comprising the sodium salt mixture in the oral composition 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.

[0054] The calcium ion component can be provided by any salt, such as chloride, carbonate, sulfate, acetate, bicarbonate, citrate, phosphate, hydrogen phosphate, tartrate, sorbate or a combination thereof. Calcium ions are preferably present in the composition of the present invention in an amount of at least about 0.0005% to about 0.010% by weight.

[0055] The composition of the present invention may contain from about 5 mg / L to about 1000 mg / L of calcium, more preferably from about 1 mg / L to about 50 mg / L, for example from about 5 mg / L to about 10 mg / L. The magnesium ion component may be provided by any salt, such as chloride, carbonate, sulfate, acetate, bicarbonate, citrate, phosphate, hydrogen phosphate, tartrate, sorbate, or a combination thereof. Magnesium ions are preferably present in the composition of the present invention in an amount of at least about 0.0005% to about 0.010% by weight.

[0056] The composition of the present invention may contain from about 5 mg / L to about 1000 mg / L of magnesium, more preferably from about 1 mg / L to about 50 mg / L, such as from about 5 mg / L to about 20 mg / L.

[0057] The compositions of the present invention may contain from about 0.005% to about 0.20%, from about 0.01% to about 0.15%, or from about 0.02% to about 0.075% chloride ion by weight. The chloride ion component may be provided by a salt such as sodium chloride, potassium chloride, or a combination thereof.

[0058] In a specific embodiment, the beverage of the present disclosure contains at least one electrolyte selected from sodium, potassium, magnesium, calcium and combinations thereof. In another specific embodiment, the beverage of the present disclosure contains at least one electrolyte selected from sodium, potassium, magnesium, calcium and combinations thereof, wherein the amount of each electrolyte is as provided above. In certain embodiments, at least two active ingredients are a first active ingredient 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 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.

[0059] Sweeteners

[0060] Compositions of the present invention may optionally include sweeteners. Sweeteners may be artificial or synthetic sweeteners, natural sweeteners, natural high-efficiency sweeteners. As used herein, phrase "natural high-efficiency sweeteners" (NHPS) refers to any sweeteners that exist naturally in nature and have a sweetness effect characteristically greater than sucrose, fructose or glucose and have lower calories. Natural high-efficiency sweeteners may be provided as pure compounds or alternatively as a part of an extract. As used herein, phrase "synthetic sweeteners" refers to any composition that exists non-naturally in nature and has a sweetness effect characteristically greater than sucrose, fructose or glucose and has lower calories. In certain embodiments, oral compositions do not have sweeteners. In certain embodiments, oral compositions are completely free of and / or substantially free of nutritional sweeteners and / or non-nutritional sweeteners.

[0061] Non-limiting examples of NHPS include stevia and steviol glycosides, such as rebaudioside M, rebaudioside D, rebaudioside A, rebaudioside N, rebaudioside O, rebaudioside E, stevioside, 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 glycosylated steviol glycosides, and combinations thereof. Examples of high-purity steviol glycosides and methods for making them are provided in U.S. Patent Application No. 2021 / 0107933, which is incorporated herein in its entirety.

[0062] In certain embodiments, the steviol glycoside blend comprises at least about 5% steviol glycosides by weight, 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. In an exemplary embodiment, the steviol glycoside blend comprises at least about 50% steviol glycosides by weight, 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.

[0063] Another exemplary NHPS is Luo Han Guo and related mogroside compounds, such as grosmogroside I, mogroside IA, mogroside IE, 11-oxomogroside IA, mogroside II, mogroside II A, mogroside II B, mogroside II E, 7-oxomogroside II E, mogroside III, mogroside HIE, 11-oxomogroside HIE, 11-deoxymogroside III, mogroside IV, mogroside IVA, 11-oxomogroside IV, 11-oxomogroside IVA, mogroside V, isomogroside V, 11-deoxymogroside V, 7-oxomogroside V, 11-oxomogroside V, isomogroside V, mogroside VI, mogroside alcohol, 11-oxomogroside Glucose alcohol, simenoside I, isomers of simenoside I (e.g., those disclosed in U.S. Patent Application No. 20170119032; which is incorporated by reference in its entirety), (3β,9β,10α,11α,24R)-3-[(4-O-β-D-glucopyranosyl-6-O-β-D-glucopyranosyl]-25-hydroxy-9-methyl-19-norlanost-5-en-24-yl-[2-O-β-D-glucopyranosyl] pyranosyl]-β-D-glucopyranosyl); (3β,9β,10α,11α,24R)-[(2-O-β-D-pyranosyl-6-O-β-D-pyranosyl-β-D-pyranosyl)oxy]-25-hydroxy-9-methyl-19-norlanost-5-en-24-yl-[2-O-β-D-pyranosyl-6-O-β-D-pyranosyl]-β-D-pyranosyl) pyranosyl]-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).

[0064] In certain embodiments, the mogroside blend comprises at least about 5% mogroside by weight, e.g., at least about 10%, at least about 20%, at least about 30%, at least about 40%, at least about 50%, at least about 60%, at least about 70%, at least about 80%, at least about 90%, at least about 95%, or at least about 97%.

[0065] Other exemplary NHPSs include monatin and its salts (monatin SS, RR, RS, SR), curculin, glycyrrhizic acid, acid and its salts, thaumatin, monellin, mabinlin, brazzein, hernandulcin, phyllodulcin, glycyphyllin, phloridzin, trilobatin, baiyunoside, osladin, polypodoside A, pterocaryoside A, pterocaryoside B, mukurozioside, phlomisoside I, periandrin I, abrusoside A, and cyclocarioside I.

[0066] In one embodiment, the sweetener is a carbohydrate sweetener. Suitable carbohydrate sweeteners include, but are not limited to, 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, octulose, fucose, rhamnose, arabinose, turanose, sialoses and combinations thereof.

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

[0068] Other suitable sweeteners include simmondtin, monatin and its salts (monatin SS, RR, RS, SR), curculin, glycyrrhizic acid and its salts, thaumatin, monellin, mabinlin, brazzein, hernandulcin, phyllotoxin, glycyphyllin, phloridzin, trilobatin, baiyunoside, eugenol, phenoxyethanol ... Osladin, polypodoside A, pterocaryoside A, pterocaryoside B, mukurozioside, phlomisoside I, periandrin I, abrusoside A, and cyclocarioside I, sugar alcohols such as erythritol, sucralose, potassium acesulfame, acesulfame acid and its salts, aspartame, alitame, saccharin and its salts, neohesperidin dihydrochalcone, cyclohexylaminosulfonate, cyclohexylaminosulfonic acid and its salts, neotame, advantame, glycosylated steviol glycosides (GSG), and combinations thereof.

[0069] 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.

[0070] In certain embodiments, the compositions of the present invention are free or substantially free of caloric sweeteners.

[0071] In another embodiment, the sweetener is a rare sugar selected from the group consisting of psicose, gulose, kojibiose, sorbose, lyxose, ribulose, xylose, xylulose, D-allose, L-ribose, D-tagatose, L-glucose, L-fucose, L-arabinose, turanose, and combinations thereof.

[0072] The amount of sweetener in the composition of the present invention depends on the identity of the sweetener and the desired sweetness level. In a preferred embodiment, the sweetener is present in a sweetening amount, i.e., a concentration at which sweetness is detectable.

[0073] As will be appreciated by those skilled in the art, high potency sweeteners are more effective and therefore require lower concentrations to reach a specific sucrose equivalence (SE). The sweetness of non-sucrose sweeteners can be measured relative to a sucrose reference by determining the sucrose equivalence (SE) of the non-sucrose sweetener. Typically, taste panelists are trained to detect the sweetness of a reference sucrose solution containing 1% to 15% sucrose (w / v). Other non-sucrose sweeteners are then tasted at a series of dilutions to determine the concentration of the non-sucrose sweetener that is as sweet as a given percentage of sucrose reference. For example, if a 1% solution of a non-sucrose sweetener is as sweet as a 10% sucrose solution, the sweetener is said to be 10 times as potent as sucrose and has a sucrose equivalence of 10%.

[0074] In one embodiment, one or more sweeteners provide the composition of the present invention with a sucrose equivalence 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 of sucrose equivalence therebetween.

[0075] In another embodiment, the compositions of the present invention have from about 2% to about 14% SE, e.g., from about 2% to about 10%, from about 2% to about 5%, from about 5% to about 15%, from about 5% to about 10%, or from about 10% to about 15% SE.

[0076] The amount of sucrose in a reference solution can be described with Brix (°Bx), and therefore another measure of sweetness. One Brix (Brix) is 1 gram of sucrose in 100 grams of solution, and represents the intensity of the solution as a weight percentage (%w / w) (strictly speaking, by mass). In embodiments where the composition of the present invention is sweetened with sucrose, the beverage can have about 1 Brix, about 2 Brix, about 3 Brix, about 4 Brix, about 5 Brix, about 6 Brix, about 7 Brix, about 8 Brix, about 9 Brix, about 10 Brix, about 11 Brix, about 12 Brix, about 13 Brix, about 14 Brix, or any range between these values.

[0077] Functional ingredients / raw materials

[0078] The composition of the present invention may optionally include functional ingredients. Exemplary functional ingredients include, but are not limited to, saponins, antioxidants, dietary fiber sources, fatty acids, vitamins, glucosamine, minerals, preservatives, hydrating agents, probiotics, prebiotics, weight management agents, osteoporosis management agents, phytoestrogens, long-chain aliphatic saturated primary alcohols, phytosterols, and combinations thereof.

[0079] In certain embodiments, the functional ingredient is at least one saponin. As used herein, at least one saponin can include a single saponin or multiple saponins as the functional ingredient of the composition provided herein. Saponin is a glycoside natural plant product comprising an aglycon ring structure and one or more sugar moieties. Non-limiting examples of specific saponins used in the specific embodiments of the present disclosure include A group acetylated saponins, B group acetylated saponins, and E group acetylated saponins. Several common sources of saponin include soybeans, soapwort plants (Saponaria, whose roots are used as soap in history) and alfalfa, aloe, asparagus, grapes, chickpeas, yucca and various other beans and weeds with saponin content of about 5% by dry weight. Saponin can be obtained from these sources by using extraction techniques well known to those of ordinary skill in the art. The description of conventional extraction techniques can be found in U.S. Patent Application No. 2005 / 0123662.

[0080] In certain embodiments, the functional ingredient is at least one antioxidant.As used herein, "antioxidant" refers to any substance that inhibits, suppresses, or reduces oxidative damage to cells and biomolecules.

[0081] Examples of suitable antioxidants for use with embodiments of the present disclosure include, but are not limited to, vitamins, vitamin cofactors, minerals, hormones, carotenoids, carotenoid terpenes, non-carotenoid terpenes, flavonoids, flavonoid polyphenols (e.g., bioflavonoids), flavonols, flavones, phenols, polyphenols, phenolic esters, polyphenolic esters, non-flavonoid phenols, isothiocyanates, and combinations thereof. In some embodiments, the antioxidant is vitamin A, vitamin C, vitamin E, ubiquinone, the mineral selenium, manganese, melatonin, oc-carotene, beta-carotene, lycopene, lutein, zeanthin, crypoxanthin, reservatol, eugenol, quercetin, catechins, gossypol, hesperidin, curcumin, ferulic acid, thymol, hydroxytyrosol, turmeric, thyme, olive oil, lipoic acid, glutathione, gutamine, oxalic acid, tocopherol derivative compounds, butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), ethylenediaminetetraacetic acid (EDTA), tert-butylhydroquinone, acetic acid, pectin, tocotrienols, tocopherols, coenzyme Q10, zeaxanthin, astaxanthin, canthaxanthin, saponins, limonin, kaempfedrol, myricetin, isorhamnetin, proanthocyanidins, quercetin, rutin, luteolin, apigenin, tangeritin, hesperidin, naringenin, erodictyol, flavan-3-ols (e.g., anthocyanidins), gallocatechin, epicatechin and its gallate forms, epigallocatechin and its gallate forms (ECGC), theaflavins and its gallate forms, thearubigins, isoflavones, phytoestrogens, genistein, daidzein, glycitein, anythocyanin, cyaniding, delphinidin, malvaceae, malvidin, methylcyanidin, petunidin, ellagic acid, gallic acid, salicylic acid, rosmarinic acid, cinnamic acid and its derivatives (e.g., ferulic acid), chlorogenic acid, chicoric acid acid), gallotannins, ellagitannins, anthocyanins, beta-cyanins and other plant pigments, silymarin, citric acid, lignans, antinutrients, bilirubin, uric acid, R-oc-lipoic acid, N-acetylcysteine, emblicanin, apple extract, apple peel extract (apple polyphenols), rooibos extract red, rooibos extract greengreen), hawthorn fruit extract, raspberry extract, green coffee antioxidant (GCA), wild aronia extract 20%, grape seed extract (i.e., VinOseed), cocoa bean extract, hops extract, mangosteen extract, mangosteen shell extract, cranberry extract, pomegranate extract, pomegranate peel extract, pomegranate seed extract, hawthorn berry extract, pomegranate extract, cinnamon bark extract, grape skin extract, bilberry extract, pine bark extract, pycnogenol, elderberry extract, mulberry root extract, gogi extract, blackberry extract, blueberry extract, blueberry leaf extract, raspberry extract, turmeric extract, citrus bioflavonoids, black currant, ginger, acai powder, green coffee bean extract, green tea extract, and phytic acid, or a combination thereof. In alternative embodiments, the antioxidant is a synthetic antioxidant, such as 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 beans, chocolate, spices, herbs, rice, organ meats from livestock, yeast, whole grains, or cereal grains.

[0082] Specific antioxidants belong to the class of phytonutrients known as polyphenols (also known as "polyphenols"), which are a class of chemicals found in plants characterized by the presence of more than one phenolic group per molecule. Polyphenols suitable for use with embodiments of the present disclosure include catechins, proanthocyanidins, proanthocyanidins, anthocyanidins, quercerin, rutin, reservatrol, isoflavones, curcumin, punicalagins, ellagitannins, hesperidin, naringin, citrus flavonoids, chlorogenic acid, other similar materials, and combinations thereof.

[0083] In one embodiment, the antioxidant is a catechin, such as epigallocatechin gallate (EGCG). In another embodiment, the antioxidant is selected from proanthocyanidins, proanthocyanidins, or a combination thereof. In a specific embodiment, the antioxidant is anthocyanidin. In other embodiments, the antioxidant is selected from quercetin, rutin, or a combination thereof. In one embodiment, the antioxidant is resveratrol. In another embodiment, the antioxidant is isoflavone. In yet another embodiment, the antioxidant is curcumin. In yet another embodiment, the antioxidant is selected from punicalagin, ellagitannins, or a combination thereof. In yet another embodiment, the antioxidant is chlorogenic acid.

[0084] In certain embodiments, functional ingredient is at least one dietary fiber.Multiple polymer carbohydrates with significant different structures in composition and key fall within the definition of dietary fiber.Such compounds are well known to those skilled in the art, and its limiting examples include non-starch polysaccharides, lignin, cellulose, methylcellulose, hemicellulose, b-glucan, pectin, gum, mucilage, wax, inulin, oligosaccharides, fructooligosaccharides, cyclodextrin, chitin and combinations thereof.Although dietary fiber is usually derived from plant sources, indigestible animal products such as chitin are also classified as dietary fiber.Chitin is a polysaccharide consisting of acetylglucosamine units connected by b (1-4) keys similar to the keys of cellulose.

[0085] In certain embodiments, the functional ingredient is at least one fatty acid. As used herein, "fatty acid" refers to any straight-chain monocarboxylic acid and includes saturated fatty acids, unsaturated fatty acids, long-chain fatty acids, medium-chain fatty acids, short-chain fatty acids, fatty acid precursors (including ω-9 fatty acid precursors) and esterified fatty acids. As used herein, "long-chain polyunsaturated fatty acids" refers to any polyunsaturated carboxylic acid or organic acid with a long aliphatic tail. As used herein, "ω-3 fatty acids" refers to any polyunsaturated fatty acid, which has the first double bond as the third carbon-carbon bond from the terminal methyl end of its carbon chain. In a specific embodiment, ω-3 fatty acids can include long-chain ω-3 fatty acids. As used herein, "ω-6 fatty acids" are any polyunsaturated fatty acids, which have the first double bond as the sixth carbon-carbon bond from the terminal methyl end of its carbon chain.

[0086] Suitable ω-3 fatty acids for embodiments of the present disclosure can be derived from, for example, algae, fish, animals, plants or a combination thereof. The example of suitable ω-3 fatty acids includes, but is not limited to, linolenic acid, α-linolenic acid, eicosapentaenoic acid, docosahexaenoic acid, octadecatetraenoic acid, eicosatetraenoic acid and a combination thereof. In some embodiments, suitable ω-3 fatty acids can be provided in fish oil (for example, herring oil, tuna oil, salmon oil, bonito oil and cod oil), microalgae ω-3 oil or a combination thereof. In particular embodiments, suitable ω-3 fatty acids can be derived from commercially available ω-3 fatty acid oils, such as microalgae DHA oil (from Martek, Columbia, MD), OmegaPure (from Omega Protein, Houston, TX), Marinol C-38 (from Lipid Nutrition, Channahon, IL), bonito oil and MEG-3 (from Ocean Nutrition, Dartmouth, NS), Evogel (from Symrise, Holzminden, Germany), marine oils from tuna or salmon (from Arista Wilton, CT), OmegaSource 2000, marine oil from herring and marine oil from cod (from OmegaSource, RTP, NC). Suitable omega-6 fatty acids include, but are not limited to, linoleic acid, gamma-linolenic acid, dihomo-gamma-linolenic acid, arachidonic acid, eicosadienoic acid, docosadienoic acid, adrenic acid, docosapentaenoic acid, and combinations thereof.

[0087] Suitable esterified fatty acids for use in embodiments of the present disclosure include, but are not limited to, monoacylglycerols containing ω-3 and / or ω-6 fatty acids, diacylglycerols containing ω-3 and / or ω-6 fatty acids, or triacylglycerols containing ω-3 and / or ω-6 fatty acids, and combinations thereof.

[0088] In certain embodiments, the functional ingredient is at least one vitamin. Suitable vitamins include vitamin A, vitamin D, vitamin E, vitamin K, vitamin Bl, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B7, vitamin B9, vitamin B12 and vitamin C.

[0089] Various other compounds have been classified as vitamins by some authorities. These compounds can be called pseudovitamins, and include but are not limited to compounds such as ubiquinone (coenzyme Q10), pancreatic acid, dimethylglycine, taestrile, amygdalin, flavonoids, p-aminobenzoic acid, adenine, adenylic acid and s-methylmethionine. As used herein, the term vitamin includes pseudovitamins. In some embodiments, vitamins are fat-soluble vitamins selected from vitamin A, vitamin D, vitamin E, vitamin K and combinations thereof. In other embodiments, vitamins are water-soluble vitamins selected from the following: vitamin B1, vitamin B2, vitamin B3, vitamin B6, vitamin B12, folic acid, biotin, pantothenic acid, vitamin C and combinations thereof.

[0090] In certain embodiments, the functional ingredient is glucosamine, optionally further comprising chondroitin sulfate.

[0091] In certain embodiments, the functional ingredient is at least one mineral. According to the teaching of the present disclosure, mineral includes the inorganic chemical elements needed by living organisms. Mineral is composed of a wide range of compositions (e.g., elements, simple salts and complex silicates) and crystalline structures are also widely different. They can be naturally present in food and beverages, can be added as supplements, or can be consumed or applied separately from food or beverages.

[0092] Mineral can be classified as the main mineral (bulk mineral) that is needed in a relatively large amount or the trace mineral that is needed in a relatively small amount. The usual requirement of the main mineral is greater than or equal to about 100mg / day, and the trace mineral is the one whose requirement is less than about 100mg / day. In one embodiment, the mineral is selected from the main mineral, the trace mineral or its combination. The non-limiting examples of the main mineral include calcium, chlorine, magnesium, phosphorus, potassium, sodium and sulfur. The non-limiting examples of the trace mineral include chromium, cobalt, copper, fluorine, iron, manganese, molybdenum, selenium, zinc and iodine. Although iodine is usually classified as a trace mineral, its requirement is larger than other trace minerals and is often classified as a main mineral.

[0093] In specific embodiments, the mineral is a trace mineral considered essential for human nutrition, non-limiting examples of which include bismuth, boron, lithium, nickel, rubidium, silicon, strontium, tellurium, tin, titanium, tungsten, and vanadium.

[0094] The minerals presented herein can be in any form known to those of ordinary skill in the art. For example, in one embodiment, the mineral can be in its ionic form with a positive or negative charge. In another embodiment, the mineral can be in its molecular form. For example, sulfur and phosphorus are usually naturally present as sulfates, sulfides, and phosphates.

[0095] In certain embodiments, the functional ingredient is at least one preservative. In a specific embodiment, the preservative is selected from an antimicrobial, an antioxidant, an antienzyme, or a combination thereof. Non-limiting examples of antimicrobials 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. Sorbic acid includes, but is not limited to, potassium sorbate, sodium sorbate, calcium sorbate, and sorbic acid. In yet another embodiment, the preservative is a nitrate and / or a nitrite. Nitrates and nitrites include, but are not limited to, sodium nitrate and sodium nitrite. In yet another embodiment, at least one preservative is a bacteriocin, such as nisin. In yet another embodiment, the preservative is ethanol. In yet another embodiment, the preservative is ozone. Non-limiting examples of antienzyme agents suitable for use as preservatives in specific embodiments of the present disclosure include ascorbic acid, citric acid, and metal chelators, such as ethylenediaminetetraacetic acid (EDTA).

[0096] In certain embodiments, the functional ingredient is an additional hydrating agent without an amino acid formulation. When combined with a formulation that does not contain amino acids, the additional hydrating agent can be a synergist to further enhance the hydration or rehydration effect of the composition. In a specific embodiment, the additional hydrating agent is a carbohydrate to supplement the energy reserves burned by muscle. The carbohydrate applicable to the specific embodiments of the present disclosure is described in U.S. Patent No. 4312856, No. 4853237, No. 5681569 and No. 6989171. The non-limiting examples of suitable carbohydrates include monosaccharides, disaccharides, oligosaccharides, complex polysaccharides or a combination thereof. The non-limiting examples of the suitable types of monosaccharides applicable to the specific embodiments include trisaccharides, tetrasaccharides, pentoses, hexoses, heptoses, octose and nonoses. The limiting examples of the 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 sialosaccharide (sialose). The limiting examples of suitable disaccharides include sucrose, lactose and maltose. The limiting examples of suitable oligosaccharides include sucrose, maltotriose and maltodextrin. In other specific embodiments, carbohydrate is provided by corn syrup, beet sugar, sucrose, fruit juice or tea.

[0097] In another specific embodiment, the additional hydrating agent is a flavanol that provides cell rehydration. Flavanols are a class of natural substances found in plants and typically comprise a 2-phenylbenzopyrone molecular backbone connected to one or more chemical moieties. Non-limiting examples of flavanols suitable for use in specific embodiments of the present disclosure include catechins, epicatechin, gallocatechin, epigallocatechin, epigallocatechin gallate, epigallocatechin 3-gallate, theaflavins, theaflavins 3-gallate, theaflavins 3'-gallate, theaflavins 3,3' gallate, thearubigins, or a combination thereof. Several common sources of flavanols include tea trees, fruits, vegetables, and flowers. In a preferred embodiment, flavanols are extracted from green tea.

[0098] In a specific embodiment, the additional hydration agent is a glycerol solution to enhance exercise endurance. Ingestion of solutions containing glycerol has been shown to provide beneficial physiological effects, such as expansion of blood volume, reduction of heart rate, and reduction of rectal temperature.

[0099] In certain embodiments, the functional ingredient is selected from at least one probiotic, prebiotic and combination thereof. Probiotics are beneficial microorganisms that affect the gastrointestinal microflora naturally present in the human body. Examples of probiotics include, but are not limited to, bacteria of the genus Lactobacilli, the genus Bifidobacteria, the genus Streptococci, or a combination thereof that impart beneficial effects to humans. In a specific embodiment of the present disclosure, at least one probiotic is selected from the genus Lactobacilli. According to other specific embodiments of the present disclosure, probiotics are selected from the genus Bifidobacterium. In a specific embodiment, probiotics are selected from the genus Streptococcus.

[0100] Probiotics that can be used according to the present disclosure are well known to those skilled in the art. Non-limiting examples of foods containing probiotics include yogurt, sauerkraut, kefir, kimchi, fermented vegetables, and other foods containing microbial elements that favorably affect the host animal by improving the intestinal microbalance.

[0101] In an embodiment according to the present disclosure, prebiotics include but are not limited to mucopolysaccharides, oligosaccharides, polysaccharides, vitamins, nutrient precursors, proteins and combinations thereof. According to a specific embodiment of the present disclosure, prebiotics are selected from dietary fibers, including but not limited to polysaccharides and oligosaccharides. Non-limiting examples of oligosaccharides classified as prebiotics according to a specific embodiment of the present disclosure include fructooligosaccharides, inulin, isomalt oligosaccharides, lactitol, lactulose, lactulose, pyrodextrin, soybean oligosaccharides, trans-galacto-oligosaccharides and xylo-oligosaccharides.

[0102] Prebiotics occur naturally in a variety of foods including, but not limited to, bananas, berries, asparagus, garlic, wheat, oats, barley (and other whole grains), flaxseed, tomatoes, Jerusalem artichokes, onions and chicory, greens (e.g., dandelion leaves, spinach, collard greens, beets, kale, mustard greens, turnip greens), and legumes (e.g., lentils, kidney beans, chickpeas, navy beans, white beans, black beans).

[0103] In certain embodiments, the functional ingredient is at least one weight management agent. As used herein, "weight management agents" include appetite suppressants and / or thermogenic agents. As used herein, the phrases "appetite suppressants," "appetite satiety compositions," "satiants," and "satiating ingredients" are synonymous. The phrase "appetite suppressants" describes macronutrients, herbal extracts, exogenous hormones, anorectics, anorexigenics, drugs, and combinations thereof that inhibit, constrain, reduce, or otherwise reduce a person's appetite when delivered in an effective amount. The phrase "thermogenic agents" describes macronutrients, herbal extracts, exogenous hormones, anorectics, anorexigenics, drugs, and combinations thereof that activate or otherwise enhance a person's thermogenesis or metabolism when delivered in an effective amount.

[0104] Suitable weight management agents include macronutrients selected from protein, carbohydrates, dietary fats, and combinations thereof. The consumption of protein, carbohydrates, and dietary fats stimulates the release of peptides that have an appetite suppressant effect. For example, the consumption of protein and dietary fats stimulates the release of the gastrointestinal hormone cholecystokinin (CCK), while the consumption of carbohydrates and dietary fats stimulates the release of glucagon-like peptide 1 (GLP-1).

[0105] Suitable macronutrient weight management agents also include carbohydrates. Carbohydrates generally include sugars, starches, cellulose and gums that are converted into glucose for energy by the body. Carbohydrates are generally divided into two categories: digestible carbohydrates (e.g., monosaccharides, disaccharides and starch) and indigestible carbohydrates (e.g., dietary fiber). Studies have shown that indigestible carbohydrates and complex polymer carbohydrates with reduced absorption and digestibility in the small intestine stimulate the physiological response of inhibiting food intake. Therefore, the carbohydrates presented herein ideally include indigestible carbohydrates or carbohydrates with reduced digestibility. Non-limiting examples of such carbohydrates include polydextrose; inulin; monosaccharide-derived polyols such as erythritol, mannitol, xylitol and sorbitol; disaccharide-derived alcohols such as isomalt, lactitol and maltitol; and hydrogenated starch hydrolysate. Carbohydrates are described in more detail below.

[0106] In another specific embodiment, the weight management agent is dietary fat.Dietary fat is a lipid comprising a combination of saturated fatty acids and unsaturated fatty acids.Polyunsaturated fatty acids have been shown to have a greater satiety capacity than monounsaturated fatty acids.Therefore, the dietary fat presented herein desirably includes polyunsaturated fatty acids, and its non-limiting examples include triacylglycerols.In another specific embodiment, the weight management agent is an herbal extract.Extracts from various types of plants have been determined to have appetite suppressing properties.Non-limiting examples of plants whose extracts have appetite suppressing properties include plants belonging to the genus Hoodia, the genus Trichocaulon, the genus Caralluma, the genus Stapelia, the genus Orbea, the genus Asclepias and the genus Camelia. Other examples include extracts derived from Gymnema Sylvestre, Kola Nut, Citrus Aurantium, Yerba Mate, Griffonia Simplicifolia, Guarana, Myrrh, Guggul Lipid, and black currant seed oil.

[0107] Herbal extracts can be prepared from any type of plant material or plant biomass. Non-limiting examples of plant material and biomass include stems, roots, leaves, dry powders obtained from plant material, and sap or dried sap. Herbal extracts are usually prepared by extracting sap from plants and then spray drying the sap. Alternatively, a solvent extraction procedure can be used. After the initial extraction, it may be desirable to further fractionate the initial extract (e.g., by column chromatography) to obtain an herbal extract with enhanced activity. Such techniques are well known to those of ordinary skill in the art.

[0108] In one embodiment, the herbal extract is derived from a plant of the genus Hoodia. Sterol glycosides of the genus Hoodia, called P57, are believed to be responsible for the appetite suppressant effects of Hoodia species. In another embodiment, the herbal extract is derived from a plant of the genus Buffalo, non-limiting examples of which include caratuberside A, caratuberside B, bouceroside I, bouceroside II, bouceroside III, bouceroside IV, bouceroside V, bouceroside VI, bouceroside VII, bouceroside VIII, bouceroside IX, and bouceroside X. In another embodiment, at least one herbal extract is derived from a plant of the genus Alocasia. Plants of the genus Alocasia are succulent plants that are generally native to South Africa, similar to the genus Hoodia, and include species T piliferum and Tofficinale. In another embodiment, the herbal extract is derived from a plant of the genus Stapelia or Orbea. Without wishing to be bound by any theory, it is believed that the compounds exhibiting appetite suppressant activity are saponins, such as pregnane glycosides, which include stavaroside A, B, C, D, E, F, G, H, I, J, and K. In another embodiment, the herbal extract is derived from a plant of the genus Asclepiadaceae. Without wishing to be bound by any theory, it is believed that these extracts contain steroidal compounds with appetite suppressant effects, such as pregnane glycosides and pregnane aglycones. In another specific embodiment, the weight management agent is an exogenous hormone with 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, somastatin, and leptin.

[0109] In another embodiment, the weight management agent is a drug. Non-limiting examples include phentenime, diethylpropion, phendimetrazine, sibutramine, rimonabant, oxyntomodulin, fluoxetine hydrochloride, ephedrine, phenylethylamine or other stimulants.

[0110] 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 a specific embodiment, the calcium source is any compound containing calcium, including salt complexes, dissolved substances and other forms of calcium. 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, dissolved substances thereof and combinations thereof.

[0111] According to a specific embodiment, the osteoporosis management agent is a magnesium source. A magnesium source is any compound containing magnesium, including salt complexes, dissolved substances and other forms of magnesium. Non-limiting examples of magnesium sources include magnesium chloride, magnesium citrate, magnesium glucoheptonate, magnesium gluconate, magnesium lactate, magnesium hydroxide, magnesium picolate, magnesium sulfate, dissolved substances thereof and mixtures thereof.

[0112] In other embodiments, the osteoporosis agent is selected from vitamin D, vitamin C, vitamin K, precursors thereof, and / or beta-carotene, and combinations thereof.

[0113] Various plants and plant extracts have also been identified as being effective for preventing and treating osteoporosis. Non-limiting examples of suitable plants and plant extracts as osteoporosis management agents include species of the genera Taraxacum and Amelanchier as disclosed in U.S. Patent Publication No. 2005 / 0106215, and species of the genera Lindera, Artemisia, Acorus, Carthamus, Carum, Cnidium, Curcuma, Cyperus, Juniperus as disclosed in U.S. Patent Application No. 2005 / 0079232. rus, Prunus, Iris, Cichorium, Dodonaea, Epimedium, Erigonoum, Rioya, Mentha, Ocimum, Thymus, Tanacetum, Plantago, Spearmint, Bixa, Vitis, Rosemarinus, Rhus, and Anethum.

[0114] In certain embodiments, the functional ingredient is at least one phytoestrogen. Phytoestrogens are compounds present in plants that can typically be delivered to the human body by ingesting plants or plant parts having phytoestrogens. As used herein, "phytoestrogen" refers to any substance that causes any degree of estrogen-like effects when introduced into the body. For example, phytoestrogens can bind to estrogen receptors in the body and have a small estrogen-like effect.

[0115] Examples of suitable phytoestrogens for use in embodiments of the present disclosure include, but are not limited to, isoflavones, stilbenes, lignans, resorcyclic acid lactones, coumestan, coumestrol, equol, and combinations thereof. Sources of suitable phytoestrogens include, but are not limited to, whole grains, cereals, fiber, fruits, vegetables, black cohosh, agave root, black currant, black haw, chasteberries, cramp bark, dongquai root, devil's club root, false unicorn root, ginseng root, groundsel herb, licorice, liferoot herb, motherwort, peony root, raspberry leaf, rose family, sage leaf, sarsaparilla root, saw palmetto berried, wild yam root, root), yarrow blossoms, legumes, soybeans, soy products (e.g., miso, soy flour, soy milk, soy nuts, soy protein isolate, tempen, or tofu), chickpeas, nuts, lentils, seeds, clover, red clover, dandelion leaves, dandelion roots, fenugreek seeds, green tea, hops, red wine, flaxseed, garlic, onions, flax seeds, borage, butterfly weed, caraway, chaste tree, vitex, dates, dill, fennel seeds, gotu kola, milk thistle, pennyroyal, pomegranate, southernwood, soy flour, tansy, kudzu vine (pueraria root), etc., and combinations thereof.

[0116] Isoflavones belong to a group of phytonutrients called polyphenols. In general, polyphenols (also called "polyphenols") are a class of chemicals found in plants that are characterized by the presence of more than one phenolic group per molecule.

[0117] 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, matai resinol, secoisolariciresinol, enterodiol, enterodiol, plant tissue protein, and combinations thereof. Suitable sources of isoflavones for embodiments of the present disclosure include, but are not limited to, soybeans, soybean products, beans, alfalfa sprouts, chickpeas, peanuts, and red clover.

[0118] In certain embodiments, the functional ingredient is at least one long-chain aliphatic saturated primary alcohol.Long-chain aliphatic saturated primary alcohols are organic compounds of different groups.The term alcohol refers to the following fact: the feature of these compounds is the hydroxyl (-OH) that is bonded to the carbon atom.The non-limiting examples of the specific long-chain aliphatic saturated primary alcohols for the specific embodiments of the present disclosure include 8 carbon atoms 1-octanol, 9 carbon 1-nonanol, 10 carbon atoms 1-decanol, 12 carbon atoms 1-dodecanol, 14 carbon atoms 1-tetradecanol, 16 carbon atoms 1-hexadecanol, 18 carbon atoms 1-octadecanol, 20 carbon atoms 1-eicosanol, 22 carbon 1-docosanol, 24 carbon 1-tetracosanol, 26 carbon 1-hexacosanol, 27 carbon 1-heptacosanol, 28 carbon 1-octacosanol (octanosol), 29 carbon 1-nonacosanol, 30 carbon 1-triacontanol, 32 carbon 1-dotriacontanol and 34 carbon 1-tetratriacontanol.

[0119] 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 consisting primarily of 28 carbon 1-octacosanol and 30 carbon 1-triacontanol and lower concentrations of other alcohols such as 22 carbon 1-docosanol, 24 carbon 1-tetracosanol, 26 carbon 1-hexacosanol, 27 carbon 1-heptacosanol, 29 carbon 1-nonacosanol, 32 carbon 1-dotriacontanol, and 34 carbon 1-tetracontanol.

[0120] In certain embodiments, the functional ingredient is at least one plant sterol, plant stanol, or a combination thereof. As used herein, the phrases "stanol," "plant stanol," and "phytostanol" are synonymous. Plant sterols and stanols are naturally present in small amounts in many fruits, vegetables, nuts, seeds, grains, legumes, vegetable oils, bark, and other plant sources. Sterols are a subgroup of steroidal compounds with a hydroxyl group at C-3. Typically, plant sterols have a double bond within the steroid nucleus, such as cholesterol; however, plant sterols may also include a substituted side chain (R) at C-24, such as an ethyl or methyl group, or an additional double bond. The structure of plant sterols is well known to those skilled in the art.

[0121] At least 44 naturally occurring phytosterols have been found, and they are generally derived from plants, such as corn, soybean, wheat and tung oil; however, they can also be produced synthetically to form compositions identical to those of natural ones or compositions having properties similar to those of naturally occurring phytosterols. Non-limiting suitable phytosterols include, but are not limited to, 4-demethyl sterols (e.g., b-sitosterol, campesterol, stigmasterol, rapeseed sterol, 22-dehydrorapeseed sterol and A5-avenasterol), 4-monomethyl sterols and 4,4-dimethyl sterols (triterpene alcohols) (e.g., cycloartenol, 24-methylenecycloartanol and cyclostanol (cyclobranol)).

[0122] As used herein, the phrases "stanol," "phytostanol," and "plant stanols" are synonymous. Phytostanols are saturated sterols found only in trace amounts in nature and may also be produced synthetically, such as by hydrogenating phytosterols. Suitable phytostanols include, but are not limited to, b-sitostanol, campestanol, cycloartanol, and saturated forms of other triterpene alcohols.

[0123] As used herein, both phytosterols and phytostanols include multiple isomers, such as a and b isomers. Phytosterols and phytostanols disclosed herein can also be in the form of their esters. Suitable methods for deriving the esters of phytosterols and phytostanols are well known to those of ordinary skill in the art and are disclosed in U.S. Patent Nos. 6589588, 6635774, 6800317 and U.S. Patent Application No. 2003 / 0045473. Non-limiting examples of the esters of suitable phytosterols and phytostanols include acetic acid sitosterol ester, oleic acid sitosterol ester, oleic acid stigmasterol ester and corresponding phytostanol esters thereof. Phytosterols and phytostanols disclosed herein can also include their derivatives.

[0124] 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, flavoring agents and flavoring ingredients, astringent compounds, proteins or protein hydrolysates, surfactants, emulsifiers, plant extracts, flavonoids, alcohols, polymers, and combinations thereof.

[0125] In one embodiment, the composition further comprises one or more polyols. As used herein, the term "polyol" refers to a molecule containing more than one hydroxyl group. The polyol can be a diol, triol or tetraol containing 2, 3 and 4 hydroxyl groups, respectively.

[0126] Polyol can also contain more than 4 hydroxyls, for example, pentahydric alcohol, hexahydric alcohol, heptahydric alcohol etc. containing 5, 6 or 7 hydroxyls respectively.In addition, polyol can also be sugar alcohol, polyhydroxy alcohol or polyol as the reduced form of carbohydrate, wherein carbonyl (aldehyde or ketone, reducing sugar) has been reduced to primary hydroxyl or secondary hydroxyl.In some embodiments, the limiting examples of polyol include maltitol, mannitol, sorbitol, lactitol, xylitol, isomalt, propylene glycol, glycerine (glycerine), threitol, galactitol, palatinose, reducing oligomeric isomaltose, reducing oligomeric xylo-oligosaccharide, reducing oligomeric gentioose, reducing maltose syrup, reducing glucose syrup and sugar alcohol or any other carbohydrate that can be reduced and can not adversely affect taste.

[0127] Suitable sugar acid additives include, but are not limited to, aldonic acid, uronic acid, aldaric acid, alginic acid, gluconic acid, glucuronic acid, glucaric acid, galactaric acid, galacturonic acid, and salts thereof (e.g., sodium, potassium, calcium, magnesium or other physiologically acceptable salts), and combinations thereof.

[0128] Suitable nucleotide additives include, but are not limited to, inosine monophosphate (IMP), guanosine monophosphate (GMP), adenosine monophosphate (AMP), cytosine monophosphate (CMP), uracil monophosphate (UMP), inosine diphosphate, guanosine diphosphate, adenosine diphosphate, cytosine diphosphate, uracil diphosphate, inosine triphosphate, guanosine triphosphate, adenosine triphosphate, cytosine triphosphate, uracil triphosphate, alkali metal salts or alkaline earth metal salts thereof, and combinations thereof. The nucleotides described herein may also include nucleotide-related additives such as nucleosides or nucleic acid bases (e.g., guanine, cytosine, adenine, thymine, uracil).

[0129] Suitable organic acid additives include any compound containing a -COOH moiety, such as C2-C30 carboxylic acids, substituted hydroxy C2-C30 carboxylic acids, butyric acid (ethyl ester), substituted butyric acid (ethyl ester), benzoic acid, substituted benzoic acid (e.g., 2,4-dihydroxybenzoic acid), substituted cinnamic acid, hydroxy acids, substituted hydroxybenzoic acids, anisic acid substituted cyclohexyl carboxylic acids, tannic acid, aconitic acid, lactic acid, tartaric acid, citric acid, isocitric acid, gluconic acid, glucoheptonic acid, adipic acid, hydroxycitric acid, malic acid, fruitaric acid (a blend of malic acid, fumaric acid, and tartaric acid), fumaric acid, maleic acid, succinic acid, chlorogenic acid, salicylic acid, caffeic acid, bile acid, acetic acid, ascorbic acid, alginic acid, isoascorbic acid, polyglutamic acid, glucono delta lactone, and alkali metal salts or alkaline earth metal salt derivatives thereof. In addition, the organic acid additive may also be in the D-configuration or the L-configuration. Suitable organic acid additive salts include, but are not limited to, sodium, calcium, potassium, and magnesium salts of all organic acids, such as citrates, malates, tartrates, fumarates, lactates (e.g., sodium lactate), alginates (e.g., sodium alginate), ascorbates (e.g., sodium ascorbate), benzoates (e.g., sodium or potassium benzoate), sorbates, and adipates. The example of described organic acid additive can optionally be substituted by at least one group selected from following: hydrogen, alkyl, alkenyl, alkynyl, halogen, haloalkyl, carboxyl, acyl, acyloxy, amino, amido, carboxyl derivative, alkylamino, dialkylamino, arylamino, alkoxy, aryloxy, nitro, cyano, sulfo, thiol, imines, sulfonyl, sulfenyl, sulfinyl, sulfamoyl, carboxyalkoxy, carboxamido, phosphono, phosphinyl, phosphoryl, phosphino, thioester, thioether, anhydride, oxime, hydrazine, carbamyl, phosphorus or phosphonate.In a particular embodiment, when being present in consumer's goods (such as beverage), organic acid additive is present in the sweetener composition with the amount effectively providing the concentration of about 10ppm to about 5000ppm.

[0130] 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 (eg, phytate Mg / Ca).

[0131] Suitable bitter compound additives include, but are not limited to, caffeine, quinine, urea, bitter orange oil, naringin, quassia, and salts thereof.

[0132] Suitable flavoring agents and flavoring ingredient additives include, but are not limited to, vanillin, vanilla extract, mango extract, cinnamon, citrus, coconut, ginger, viridiflorol, almonds, menthol (including mint-free menthol), grape skin extract, and grape seed extract. "Flavoring agent" and "flavoring ingredient" are synonymous and may include natural or synthetic substances or combinations thereof. Flavoring agents also include any other substances that impart flavor and may include natural or non-natural (synthetic) substances that are safe for humans or animals when used within generally accepted ranges. Non-limiting examples of proprietary flavoring agents include DOHLER TM Natural flavoring sweetness enhancer K14323 (DOHLER TM , Darmstadt, Germany), Symrise TM Sweetness Natural Flavor Masking Agents 161453 and 164126 (Symrise TM , Holzminden, Germany), Natural Advantage TM Bitterness Blockers 1, 2, 9 and 10 (Natural Advantage TM , Freehold, New Jersey, USA), and SUCRAMASK TM (Creative Research Management, Stockton, California, USA). Suitable polymer additives include, but are not limited to, chitosan, pectin, pectic acid, pectinic acid, polyuronic acid, polygalacturonic acid, starch, food hydrocolloids or crude extracts thereof (e.g., FIBERGUM Senegal gum arabic). TM ), gum arabic, carrageenan), poly-L-lysine (e.g., poly-L-α-lysine or poly-L-ε-lysine), poly-L-ornithine (e.g., poly-L-α-ornithine or poly-L-ε-ornithine), polypropylene glycol, polyethylene glycol, poly(ethylene glycol methyl ether), polyarginine, polyaspartic acid, polyglutamic acid, polyethyleneimine, alginic acid, sodium alginate, propylene glycol alginate, and sodium polyethylene glycol alginate, sodium hexametaphosphate and its salts, and other cationic polymers and anionic polymers.

[0133] In some exemplary embodiments, an oral composition for hydration or rehydration may include a protein hydrolysate additive. In a related embodiment, the composition may include a protein hydrolysate additive as a replacement for ingredients such as amino acids.

[0134] Suitable surfactant additives include, but are not limited to, polysorbates (e.g., polyoxyethylene sorbitan monooleate (polysorbate 80), polysorbate 20, polysorbate 60), sodium dodecylbenzene sulfonate, dioctyl sulfosuccinate or sodium dioctyl sulfosuccinate, sodium lauryl sulfate, cetylpyridinium chloride (cetylpyridinium chloride), cetyltrimethylammonium bromide, sodium cholate, carbamoyl, choline chloride, sodium glycocholate, sodium taurodeoxycholate, lauric arginate, sodium stearoyl lactylate, sodium taurocholate, lecithin, sucrose oleate, sucrose stearate, sucrose palmitate, sucrose laurate and other emulsifiers, and the like.

[0135] 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 TM 60. Polyphenon TM 30 and Polyphenon TM 25 (Mitsui Norin Co., Ltd., Japan), polyphenols, rutin (e.g., enzyme-modified rutin Sanmelin TM AO (San-fi Gen FFI, Inc., Osaka, Japan), neohesperidin, naringin, neohesperidin dihydrochalcone, etc. Suitable alcohol additives include, but are not limited to, ethanol.

[0136] Suitable astringent compound additives include, but are not limited to, tannic acid, europium chloride (EuCl3), gadolinium chloride (GdCl3), terbium chloride (TbCl3), alum, tannic acid, and polyphenols (eg, tea polyphenols).

[0137] Compositions and methods

[0138] The composition of the present invention can generally be in any edible form, such as liquid, semi-liquid, solid or semi-solid. In some embodiments, the composition of the present invention is a beverage or a beverage product. An example of a beverage is a ready-to-drink beverage. Ready-to-drink beverages include carbonated beverages and non-carbonated beverages. Carbonated beverages include but are not limited to frozen carbonated beverages, enhanced bubble beverages, cola, fruit-flavored bubble beverages (e.g., lemon flavor, orange flavor, grape flavor, strawberry flavor and pineapple flavor), ginger ale, soft drinks and root beer. Non-carbonated beverages include but are not limited to fruit juice, fruit-flavored fruit juice, fruit juice drinks, pulp drinks, vegetable juice, vegetable-flavored fruit juice, sports drinks, energy drinks, enhanced water drinks (enhanced water drink), enhanced water drinks containing vitamins, near water drinks (near water drinks) (e.g., water containing natural or synthetic flavoring agents), coconut water, tea drinks (e.g., black tea, green tea, black tea, oolong tea), coffee, cocoa drinks, beverages containing milk ingredients (e.g., milk drinks, coffee containing milk ingredients, milk coffee, milk tea, fruit milk drinks), beverages containing cereal extracts and smoothies.

[0139] In specific embodiments, the present disclosure relates to sports drinks or fortified water beverages.

[0140] The beverage can be a high-calorie beverage, having up to about 120 calories per 8 oz serving. The beverage can be a medium-calorie beverage, having up to about 60 calories per 8 oz serving. The beverage can be a low-calorie beverage, having up to about 40 calories per 8 oz serving. The beverage can be zero-calorie, having less than about 5 calories per 8 oz serving.

[0141] In another embodiment, the beverage is free of milk and / or dairy ingredients.

[0142] In some embodiments, the beverages of the present invention have a plasma osmolality of about 250 to about 350 mOsm / kg, or about 270 to about 330 mOsm / kg, or about 290 to about 310 mOsm / kg, or about 290 to about 300 mOsm / kg.

[0143] The present disclosure also provides a method for preparing a ready-to-drink beverage, comprising (i) providing a beverage matrix, and (ii) adding the beverage ingredients described herein to the beverage matrix, thereby providing a ready-to-drink beverage. The method optionally includes a further mixing step, wherein the beverage ingredients and the matrix are mixed to promote dissolution. The method may also optionally include a heating step, wherein the beverage ingredients and the matrix are heated to promote dissolution.

[0144] The beverage ingredients are dissolved in a beverage matrix. Exemplary beverage matrices include beverage-quality water, such as tap water, deionized water, distilled water, reverse osmosis water, carbon-treated water, purified water, desalted water, and combinations thereof. Other suitable matrices include, but are not limited to, phosphoric acid, phosphate buffer, citric acid, citrate buffer, and carbon-treated water.

[0145] The process may be carried out at any temperature required to prepare a ready-to-drink beverage. For example, for temperature sensitive ingredients, the process is carried out at less than 70°C. Similarly, the beverage ingredients may be added to the beverage base in any order.

[0146] In some embodiments, the composition of the present invention is in dry or semi-dry form, such as dry powder, beverage concentrate, tablet, capsule, gel, chewing gum. Dry composition can be easily eaten or easily and quickly dissolved in a drinkable medium (such as water).

[0147] In a specific embodiment, the composition of the present invention can be prepared in the form of a concentrate or powder to be reconstituted for use by a subject by adding water or any other suitable liquid. Such reconstitution is performed using the necessary amount of water / liquid to ensure that the beverage to be consumed contains the active ingredients in the proportions previously described. In another embodiment, the composition can be dissolved in water / liquid and then in a frozen state to provide, for example, a flavored ice in the form of a stick, such as those sold under the trade name or trademark "Popsicle".

[0148] In one embodiment, the method of preparing a ready-to-drink solution comprises mixing an oral composition as described herein with a drinkable medium in a weight ratio such that the concentration of the active ingredient in the preparation is about 1 g / L to about 50 g / L, or about 2 g / L to 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 ready-to-drink solution. In certain embodiments, the concentration of at least one active ingredient comprising a sodium salt mixture 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 comprising the potassium salt mixture in the oral composition 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 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 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 potable media include beverage-quality water, such as tap water, deionized water, distilled water, reverse osmosis water, carbon-treated water, purified water, desalinated water, and combinations thereof. The potable medium can also be an existing beverage, such as sparkling water, juice, tea, milk, or coffee.

[0149] In some embodiments, the composition of the present invention 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 and a non-glucose sweet base, such as neohesperidin dihydrochalcone, whose level does not exceed 120kcal / L when reconstituted, and may be flavored with fruit extracts or spices, such as orange, lemon, strawberry, etc. A dose is intended to be dissolved in 591ml of drinking water / liquid (a standard sports bottle). The concentration is only for reference, and a more concentrated beverage can be prepared based on the same formula.

[0150] The above powder mixture can be added to a carrier suitable for tableting with good organoleptic properties, such as sorbitol and magnesium stearate. The material may be made more palatable with known natural sweeteners, such as neohesperidin dihydrochalcone, and the total energy content should not exceed 120 kcal in the average daily intake. The product can be flavored with any fruit or other flavors, such as orange, lemon, menthol, eucalyptus oil (eucaplytol), etc. The average daily intake of compressed tablets (or equivalent solid forms with the same composition) is intended to be 5 to 10 tablets.

[0151] In some embodiments, the disclosure relates to methods for rapid hydration, rapid rehydration, sustained hydration, and / or sustained rehydration.The methods generally comprise administering any of the oral compositions described herein.

[0152] The methods of the present invention generally utilize the compositions described herein to achieve at least one of the following objectives: provide a rapid effect on the restoration of plasma D20 percentage during rehydration, reduce or reverse the effects of dehydration or water deprivation, ameliorate other adverse effects of exercise, heat or other activities that result in fluid loss, provide a positive effect on subsequent physical function, increase the duration of fluid retention, rapidly increase plasma D20 percentage, maintain increased D20 percentage for a long time, restore electrolyte balance, provide a source of energy, improve physical function, limit or reduce calorie intake.

[0153] In some embodiments, the present disclosure provides a method of rapid hydration, rapid rehydration, providing sustained hydration and / or providing sustained rehydration in a human body, the method comprising administering an effective amount of an oral composition as described herein, wherein the oral composition does not contain a nutritive sweetener. The oral composition can be administered before, during or after dehydration or fluid loss.

[0154] In some embodiments, the method includes applying a sports drink as described herein to a person, wherein the sports drink is further configured to enhance the person's athletic performance, reduce lactic acid production, reduce perceived physical fatigue, reduce muscle soreness (actual muscle damage and perceived soreness), improve the time to exhaustion, improve time trial performance, improve power output, reduce lactic acid production, and reduce the net fluid loss observed during exercise. As used herein, "enhanced athletic performance" refers to the improvement of athletic performance associated with the embodiment of drinking sports drinks provided herein compared to the athletic performance of not drinking sports drinks or water. Sports drinks can be taken before, during, or after athletic performance. As used herein, "athletic performance" refers to both endurance sports and non-endurance sports. Endurance sports include aerobic activities for a long time (e.g., greater than about 30 minutes), while non-endurance sports include aerobic activities for a shorter time (e.g., less than about 30 minutes).

[0155] In a specific embodiment, the present disclosure relates to a method for enhancing athletic performance, comprising administering / drinking a sports drink before, during, or after endurance exercise, wherein the sports drink comprises an aqueous solution as described herein, wherein the formulation comprises an active ingredient in an amount of about 1 g / L to about 50 g / L, or about 2 g / L to about 30 g / L, or about 3 g / L to about 30 g / L, or about 4 g / L to about 20 g / L, or about 5 g / L to about 10 g / L, or about 0.05 g / L to about 1 g / L based on the total volume of the sports drink. In some embodiments, the concentration of at least one active ingredient comprising a sodium salt mixture 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 comprising the potassium salt mixture in the oral composition 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 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 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.

[0156] In some embodiments, the method comprises preparing a drinkable solution by dissolving a dry powder composition comprising the formulation in a drinkable medium comprising water, and then orally administering the drinkable solution. In some embodiments, the concentration of the active ingredient in the formulation without amino acids is from about 1 g / L to about 50 g / L, or from about 2 g / L to 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 drinkable solution.

[0157] In other embodiments, the method comprises taking / ingesting an oral composition and a drinkable medium comprising water. The ingestion of the oral composition and the drinkable medium may be performed simultaneously, concurrently, separately or continuously. In some embodiments, the ratio of the oral composition to the drinkable medium is such that the content of the active ingredient in the preparation is from about 1 g / L to about 50 g / L, or from about 2 g / L to 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 relative to the total volume of the drinkable medium. In some embodiments, the concentration of at least one active ingredient comprising a sodium salt mixture in the oral composition 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 comprising the potassium salt mixture in the oral composition 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 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 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.

[0158] Methods according to the present disclosure provide rapid and effective hydration and retention of human body fluids. In some embodiments, within about 10 minutes after administration of the oral composition, the plasma D20 percentage of the human increases by at least about 2.5%, or at least about 3%, or at least about 4%.

[0159] In some embodiments, within about 15 minutes after administration of the oral composition, the human's plasma D20 percentage increases by at least about 4.5%, or at least about 5%, or at least about 5.5%, or at least about 6%.

[0160] In some embodiments, within about 30 minutes after administration of the oral composition, the human's plasma D20 percentage 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%.

[0161] In some embodiments, within about 45 minutes after administration of the oral composition, the human's plasma D20 percentage 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%.

[0162] In some embodiments, within about 60 minutes after administration of the oral composition, the human's plasma D20 percentage 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%.

[0163] In some embodiments, the human's plasma D20 percentage 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.

[0164] In some embodiments, the percentage of plasma D20 in a human measured 30 minutes after administration of the oral composition is reduced by less than about 1%, or less than about 2%, or less than about 3%, or less than about 4%, or less than about 5%, or less than about 6%, or less than about 7%, or less than about 8%, or less than about 9%, or less than about 10% for at least about 30 minutes.

[0165] In some embodiments of the methods of the invention, the plasma osmolality of the human is maintained in the range of about 270 to about 330 mOsm / kg, or about 280 to about 320 mOsm / kg, or about 290 to about 310 mOsm / kg, or about 290 to about 300 mOsm / kg for at least 60 minutes after administration of the oral composition.

[0166] In some embodiments, the plasma osmolality of the human does not change by more than 3 mOsm / kg for at least 60 minutes following administration of the oral composition.

[0167] Example

[0168] Example 1

[0169] Human trials were conducted using exemplary beverages of the present disclosure to measure the benefits of more rapid hydration (assessed by measuring the rate of absorption into the blood by measuring the accumulation of plasma deuterium oxide (D2O)) and the benefits of more sustained hydration (assessed by measuring the volume of beverage consumed by measuring net fluid balance (urine output subtracted from body weight, over time)) (Maughan et al., 2016). The study evaluated the effects of 3 test beverages on more rapid hydration and more sustained hydration compared to drinking water (water as a control) during a 3-hour rehydration period following exercise-induced dehydration in the heat. Healthy men (n=12) completed 4 dehydration / rehydration trials, varying in the beverages consumed during the rehydration period.

[0170] method

[0171] The study group consisted of 12 apparently healthy males aged 18 to 40 years, and the study participants were randomly assigned to one of the four intervention trials (water and three test beverages) in a crossover double-blind manner. In order to maintain the double-blind study design, the test beverages were given alphanumeric codes. All beverages did not have any nutrients, flavors, or colors, and the only difference was the electrolyte content of the test beverages.

[0172] Each study participant underwent a dehydration phase in an environmental chamber capable of maintaining temperature and humidity at approximately 95°F / 35°C and 40% RH (relative humidity) within a range of ±2°C and ±3% RH. Prior to the dehydration phase, a butterfly needle was inserted and the participant sat for 15 minutes before a blood sample without stasis was drawn (Pre-D: pre-dehydration phase). After the fasting blood draw, the researcher provided the participant with a small snack (Clif bar, 250-260 kcal; 130-230 mg sodium) to eat in front of the researcher. Prior to starting the dehydration phase, the participant was weighed naked immediately (after consuming the Clif bar and drawing blood).

[0173] During the dehydration phase, participants participated in an intermittent cycling regimen (20 minutes of exercise, 5 minutes of rest repeated cycles) at approximately 95°F, 40% RH to induce weight loss (dehydration phase). The workload of the cycling exercise was set to a predetermined intensity (approximately 50% HRR) based on the baseline assessment. During each 5-minute rest period, participants were weighed to obtain net fluid loss relative to baseline.

[0174] After the dehydration phase, participants participated in the rehydration phase. After achieving target weight loss, participants were returned to the laboratory and placed in a mild environment (approximately 20 to 22°C) to rest in a seated position for 15 minutes. After resting for 15 minutes, an intravenous catheter was inserted and participants continued to rest in a seated position for 15 minutes, after which a pre-rehydration (Pre-R) blood sample was drawn without pooling. After the Pre-R blood sample was drawn, a total urine sample was collected and participants were weighed naked to calculate total weight loss compared to Pre-D levels (% dehydration = % body fluid loss). After this transitional rest period (approximately 40 minutes), participants began the rehydration / recovery phase of the protocol.

[0175] During the rehydration phase, participants consumed an equal amount of a designated beverage (water or test beverage) every 15 minutes for 60 minutes (a total of 5 beverages) to replace 150% of the body weight lost during the dehydration phase. During the rehydration phase of the protocol, participants were asked to remain seated to limit fluid shifts. During the recovery phase of the protocol, participants sat in a temperate environment (approximately 20 to 22°C) for 3 hours.

[0176] Faster hydration (plasma D2O accumulation)

[0177] The performance of the different beverages in the blood was compared using the deuterium oxide dilution method according to the technique of Davis et al. (1987). Venous blood samples for D2O analysis were drawn without stagnation from an indwelling Teflon catheter placed before the rehydration phase. After remaining seated for at least 20 minutes, a baseline blood sample was obtained immediately before the final rehydration to control for any background D2O (3 ml EDTA). Participants then drank the final rehydration solution containing D2O in <5 minutes (but the time was similar for each trial). The final 50 ml drink was then used as a wash to ensure that all the D2O was ingested. Additional venous blood (3 ml) was obtained at 5 minutes (5min-R) after the start of rehydration, 10 minutes (10min-R) after the start of rehydration, 15 minutes (15min-R) after the start of rehydration, 20 minutes (20min-R) after the start of rehydration, 25 minutes (25min-R) after the start of rehydration, 30 minutes (30min-R) after the start of rehydration, and 45 minutes (45min-R) after the start of rehydration, after rehydration (Post-R), 20 minutes (20Post-R) after the final rehydration, 40 minutes (40Post-R) after the final rehydration, and 60 minutes (60Post-R) after the final rehydration. The blood samples were centrifuged at 3000rpm, and the plasma was stored at -80°C. Plasma D2O enrichment was measured by an independent laboratory. D2O enrichment in the blood does not provide a quantitative measure of the amount of fluid emptied from the stomach and absorbed in the intestine, but it can estimate relative differences in the amount and rate of delivery (Jeukendrup et al., 2009; Hill et al., 2008).

[0178] Figure 1ADisclosed are beverage intake (D2O in PPM) by group and time for each of the 3 Examples of the present disclosure and water before rehydration (Pre-R), 5 minutes after start of rehydration (5min-R), 10 minutes after start of rehydration (10min-R), 15 minutes after start of rehydration (15min-R), 20 minutes after start of rehydration (20min-R), 25 minutes after start of rehydration (25min-R), 30 minutes after start of rehydration (30min-R), and 45 minutes after start of rehydration (45min-R), after rehydration (Post-R), 20 minutes after final rehydration (20Post-R), 40 minutes after final rehydration (40Post-R), and 60 minutes after final rehydration (60Post-R). Example 228 is a 25.9 mmol / L sodium blend comprising sodium lactate, sodium chloride, trisodium citrate, and sodium bicarbonate. Example 460 is a 27.8 mmol / L potassium blend comprising monopotassium phosphate and potassium citrate. Example 351 is a 18.3 mmol / L sodium and 20.5 mmol / L potassium blend comprising sodium lactate, sodium chloride, trisodium citrate, sodium bicarbonate, monopotassium phosphate and potassium citrate. Example 741 is water. Example 228, Example 460, Example 351 and Example 741 are identical throughout the experiment.

[0179] Longer-lasting hydration (net fluid balance)

[0180] Body weight was measured before dehydration (Pre-D), before rehydration / after dehydration (Post-D), immediately after the final rehydration (Post-R), and every 60 minutes after the final rehydration (60Post-R, 120Post-R, and 180Post-R). After urination and towel drying, naked body weight was measured in duplicate on an electronic scale accurate to 10 grams. The fluid loss resulting from the dehydration regimen was calculated from the acute change in body weight from Pre-D to Pre-R (correcting for fecal losses if necessary) and expressed as a percentage of baseline body weight (Cheuvront et al., 2004, 2010). For all calculations, water and body weight losses due to sweat and urine were considered equal (1 L = 1 kg).

[0181] Figure 2A Disclosed are net fluid balance (in kg) by group and time after dehydration (Post-D), after rehydration (Post-R), 60 minutes after the final rehydration (60Post-R), 120 minutes after the final rehydration (120Post-R), and 180 minutes after the final rehydration (180Post-R) for each of the 3 Examples of the present disclosure and water.

[0182] result

[0183] Faster hydration

[0184] Figure 1B Public Figure 1A Data graph in . At 45 minutes after the start of rehydration (45min-R), sodium blend (228) and sodium + potassium blend (351) began to have a faster hydration benefit compared to water (741). At 20 minutes after the final rehydration (20Post-R), sodium blend (228) showed a faster hydration benefit compared to potassium blend (460), while starting from 20 minutes after the start of rehydration (20Min-R), sodium + potassium blend (351) showed a faster hydration benefit compared to potassium blend (460).

[0185] Longer lasting hydration

[0186] Figure 2B yes Figure 2A , and also includes pre-dehydration (Pre-D) as the zero measurement. At 120 and 180 minutes post-R, the sodium blend (228) showed a longer lasting hydration benefit compared to water, while at 180 minutes post-R, the sodium + potassium blend (351) showed a longer lasting hydration benefit compared to water. At 120 and 180 minutes post-R, the sodium blend (228) and the sodium + potassium blend (351) showed a longer lasting hydration benefit compared to the potassium blend (460). At 180 minutes post-R, the sodium blend (228) also showed a longer lasting hydration benefit compared to the sodium + potassium blend (351).

[0187] Non-patent references

[0188] 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.

[0189] 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.

[0190] 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.

[0191] 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.

[0192] 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 Parent Enteral Nutr, 2018, 42(7), 1185-1193.

[0193] SMShirreffs, AJTaylor, JB Leiper, RJ 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.

[0194] SNCheuvront, R.Carter 3rd, SJMontain, MN Sawka, Daily body mass variability and stability in active men undergoing exercise-heat stress. Int J Sport Nutr Exerc Metab. 2004, 14(5): 532-40.

[0195] SN Cheuvront, BRE Ly, RW Kenefick, MN Sawka, Biological variation and diagnostic accuracy of dehydration assessment markers. Am J Clin Nutr. 2010, 92(3): 565-73.

[0196] LB Baker, Sweating Rate and Sweat Sodium Concentration in Athletes: A Review of Methodology and Intra / Interindividual Variability. Sports Med. 2017, 47(Suppl 1): 111-128.

[0197] All publications, patents, and patent applications mentioned in the specification are indicative of the levels of those skilled in the art to which the present disclosure pertains.

[0198] All compositions and methods disclosed and claimed herein can be carried out and implemented without excessive experimentation according to the present disclosure. Although the compositions and methods of the present disclosure have been described according to the aforementioned illustrative embodiments, it will be apparent to those skilled in the art that changes, variations, modifications and alterations can be applied to compositions, methods, and to the steps or step sequences of the methods described herein without departing from the true concept, spirit and scope of the present disclosure. More specifically, it will be apparent that certain reagents, additives and ingredients similar to their physical, chemical, physiological and / or taste properties can replace the reagents, additives and ingredients described herein, while obtaining the same or similar results. All such similar substitutes and modifications apparent to those skilled in the art are considered to be within the spirit, scope and concept of the present disclosure as defined by the claims hereinafter appended.

[0199] Terms

[0200] 1. An oral composition for rapid hydration, rapid rehydration, sustained hydration and / or sustained rehydration, the oral composition comprising at least one active ingredient.

[0201] 2. The oral composition according to clause 1, wherein the oral composition is an amino acid-free formulation and / or is substantially free of nutritive sweeteners.

[0202] 3. The oral composition according to any one of clauses 1 to 2, further comprising at least two active ingredients.

[0203] 4. An oral composition according to any one of clauses 2 to 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.

[0204] 5. An oral composition according to claim 4, wherein the at least one active ingredient comprises two or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate and combinations thereof, or three or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate and combinations thereof, or four or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate and combinations thereof, or five or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate and combinations thereof, or six or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate and combinations thereof.

[0205] 6. An oral composition according to claim 4, wherein the at least two active ingredients comprise two or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate and combinations thereof, or three or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate and combinations thereof, or four or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate and combinations thereof, or five or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate and combinations thereof, or six or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate and combinations thereof.

[0206] 7. An oral composition according to any one of clauses 2 to 6, wherein the at least one active ingredient is a mixture of sodium salts.

[0207] 8. An oral composition according to any one of clauses 2 to 6, wherein the at least one active ingredient is a mixture of potassium salts.

[0208] 9. An oral composition according to any one of clauses 3 to 6, wherein the at least two active ingredients are a mixture of sodium and potassium salts.

[0209] 10. An oral composition according to any one of clauses 3 to 7, wherein the at least one active ingredient is a mixture of sodium salts comprising sodium lactate, sodium chloride, trisodium citrate and sodium bicarbonate.

[0210] 11. An oral composition according to any one of clauses 3 to 6 or 8, wherein the at least one active ingredient is a mixture of potassium salts comprising potassium dihydrogen phosphate and potassium citrate.

[0211] 12. The oral composition according to clause 9, wherein the at least two active ingredients are a mixture of sodium and potassium salts comprising sodium lactate, sodium chloride, trisodium citrate, sodium bicarbonate, potassium dihydrogen phosphate and potassium citrate.

[0212] 13. An oral composition according to any one of clauses 1 to 12, wherein the at least one active ingredient is a mixture of sodium salts and has a concentration of about 15 mmol / L to about 35 mmol / L, or about 17 mmol / L to about 30 mmol / L, or about 20 mmol / L to about 30 mmol / L, or about 23 mmol / L to about 28 mmol / L, or about 25 mmol / L to about 26 mmol / L, or about 25.9 mmol / L.

[0213] 14. An oral composition according to any one of clauses 1 to 12, wherein the at least one active ingredient is a mixture of potassium salts and has a concentration of about 15 mmol / L to about 35 mmol / L, or about 17 mmol / L to about 30 mmol / L, or about 23 mmol / L to about 29 mmol / L, or about 25 mmol / L to about 28 mmol / L, or about 27.8 mmol / L.

[0214] 15. An oral composition according to any one of clauses 1 to 12, 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.

[0215] 16. An oral composition according to any one of clauses 2 to 15, wherein the total electrolyte concentration is at least about 200 mg / L.

[0216] 17. An oral composition according to any one of clauses 1 to 16, further comprising at least one sweetener.

[0217] 18. An oral composition according to clause 17, wherein the sweetener is selected from the group consisting of stevia and steviol glycosides, monk fruit and related mogroside compounds, monatin and its salts (monatin SS, RR, RS, SR), curculin, glycyrrhizic acid and its salts, thaumatin, monellin, mabinin, brazzein, hemandulcin, phyllotoxin, glycyphyllin, phloridzin, trilobatin, baiyunoside, osladin, pterocaryoside A, pterocaryoside A, pterocaryoside B, pterocaryoside C, pterocaryoside D, pterocaryoside E, pterocaryoside F ... The invention relates to a group consisting of erythritol, sucralose, potassium acesulfame, acesulfame acid and its salts, aspartame, alitame, saccharin and its salts, neohesperidin dihydrochalcone, cyclohexylaminosulfonate, cyclohexylaminosulfonic acid and its salts, neotame, advantame, glycosylated steviol glycosides (GSG), and combinations thereof.

[0218] 19. The oral composition according to any one of clauses 1 to 18, further comprising at least one additive.

[0219] 20. An oral composition according to any one of clauses 1 to 18, further comprising at least one functional ingredient.

[0220] 21. An oral composition according to any one of clauses 1 to 20, wherein the oral composition is selected from a sports drink and a fortified water drink.

[0221] 22. An oral composition according to any one of clauses 1 to 21, wherein the oral composition is selected from a high-calorie beverage, a medium-calorie beverage, a low-calorie beverage or a zero-calorie beverage.

[0222] 23. An oral composition according to any one of clauses 1 to 22, wherein the oral composition is a ready-to-drink hydration beverage.

[0223] 24. An oral composition according to any one of clauses 1 to 22, wherein the oral composition is in dry form or semi-dry form.

[0224] 25. The oral composition according to clause 24, wherein the oral composition is a chewing gum, a tablet, a capsule or a dry powder.

[0225] 26. A method of rapidly hydrating, rapidly rehydrating, providing sustained hydration and / or providing sustained rehydration in a human, the method comprising administering an oral composition comprising at least one active ingredient.

[0226] 27. The method according to clause 26, wherein administration of the oral composition enables the human to achieve rapid hydration, rapid rehydration, sustained hydration, and / or sustained rehydration.

[0227] 28. The method according to any one of clauses 26 to 27, wherein the oral composition is a ready-to-drink hydration beverage, or a sports drink, or a fortified water beverage.

[0228] 29. The method according to any one of clauses 26 to 28, wherein the oral composition is selected from a high-calorie beverage, a medium-calorie beverage, a low-calorie beverage or a zero-calorie beverage.

[0229] 30. The method according to any one of clauses 26 to 29, wherein the oral composition is an amino acid-free formulation and / or is substantially free of nutritive sweeteners.

[0230] 31. The method according to any one of clauses 26 to 29, wherein the oral composition further comprises at least two active ingredients.

[0231] 32. A method according to any one of clauses 30 to 31, wherein at least one of the active ingredients 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 of the active ingredients comprise at least two electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate and combinations thereof.

[0232] 33. A method according to claim 32, wherein the at least one active ingredient comprises two or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate and combinations thereof, or three or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate and combinations thereof, or four or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate and combinations thereof, or five or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate and combinations thereof, or six or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate and combinations thereof.

[0233] 34. A method according to claim 32, wherein the at least two active ingredients comprise two or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate and combinations thereof, or three or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate and combinations thereof, or four or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate and combinations thereof, or five or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate and combinations thereof, or six or more electrolytes selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, phosphate, bicarbonate and combinations thereof.

[0234] 35. The method according to any one of clauses 27 to 34, wherein the at least one active ingredient is a mixture of sodium salts.

[0235] 36. The method according to any one of clauses 27 to 34, wherein the at least one active ingredient is a mixture of potassium salts.

[0236] 37. The method according to any one of clauses 27 to 34, wherein the at least two active ingredients are a mixture of sodium and potassium salts.

[0237] 38. The method according to any one of clauses 27 to 34, wherein the at least one active ingredient is a mixture of sodium salts comprising sodium lactate, sodium chloride, trisodium citrate and sodium bicarbonate.

[0238] 39. The method according to any one of clauses 27 to 34 or 36, wherein the at least one active ingredient is a mixture of potassium salts comprising potassium dihydrogen phosphate and potassium citrate.

[0239] 40. The method according to clause 37, wherein the at least two active ingredients are a mixture of sodium and potassium salts comprising sodium lactate, sodium chloride, trisodium citrate, sodium bicarbonate, potassium dihydrogen phosphate and potassium citrate.

[0240] 41. A method according to any one of clauses 26 to 40, wherein the at least one active ingredient is a mixture of sodium salts and has a concentration of about 15mmol / L to about 35mmol / L, or about 17mmol / L to about 30mmol / L, or about 20mmol / L to about 30mmol / L, or about 23mmol / L to about 28mmol / L, or about 25mmol / L, or about 25mmol / L to about 26mmol / L, or about 25.9mmol / L.

[0241] 42. A method according to any one of clauses 26 to 40, wherein the at least one active ingredient is a mixture of potassium salts and has a concentration of about 15 mmol / L to about 35 mmol / L, or about 17 mmol / L to about 30 mmol / L, or about 20 mmol / L to about 29 mmol / L, or about 25 mmol / L to about 28 mmol / L, or about 27.8 mmol / L.

[0242] 43. A method according to any one of clauses 26 to 40, wherein the at least two active ingredients are a first active ingredient, a sodium salt, having a concentration of about 10 mmol / L to about 28 mmol / L, or about 13 mmol / L to about 25 mmol / L, or about 16 mmol / L to about 20 mmol / L, or about 17 mmol / L to about 19 mmol / L, or about 18.3 mmol / L; and a second active ingredient, a potassium salt, having a concentration of about 10 mmol / L to about 28 mmol / L, or about 13 mmol / L to about 25 mmol / L, or about 16 mmol / L to about 22 mmol / L, or about 18 mmol / L to about 21 mmol / L, or about 20.5 mmol / L.

[0243] 44. A method according to any one of clauses 27 to 43, wherein the total electrolyte concentration is at least about 200 mg / L.

[0244] 45. The method according to any one of clauses 26 to 44, wherein the oral composition further comprises at least one sweetener.

[0245] 46. ​​The method according to clause 45, wherein the sweetener is selected from stevia and steviol glycosides, monk fruit and related mogroside compounds, monatin and its salts (monatin SS, RR, RS, SR), curculin, glycyrrhizic acid and its salts, thaumatin, monellin, mabinin, brazzein, hemandulcin, phyllotoxin, glycyphyllin, phloridzin, trilobatin, baiyunosidin, scutellariae ... e), osladin, pterocaryoside A, pterocaryoside A, pterocaryoside B, mukurozioside, phlomisoside I, periandrin I, abrusoside A, and cyclocarioside I, sugar alcohols such as erythritol, sucralose, potassium acesulfame, acesulfame acid and its salts, aspartame, alitame, saccharin and its salts, neohesperidin dihydrochalcone, cyclamates, cyclamic acid and its salts, neotame, advantame, glycosylated steviol glycosides (GSG), and combinations thereof.

[0246] 47. The method according to any one of clauses 26 to 46, wherein the oral composition further comprises at least one additive.

[0247] 48. The method according to any one of clauses 26 to 47, wherein the oral composition further comprises at least one functional ingredient.

[0248] 49. The method according to any one of clauses 26 to 48, wherein the oral composition is in dry or semi-dry form.

[0249] 50. The method according to clause 49, wherein the oral composition is a chewing gum, a tablet, a capsule or a dry powder.

[0250] 51. The method of any one of clauses 26 to 50, wherein within 5 minutes after administration of the oral composition, the human's plasma D20 percentage increases by at least about 2.5%, or at least about 3%, or at least about 4%.

[0251] 52. The method of any one of clauses 26 to 50, wherein within 15 minutes after administration of the oral composition, the human's plasma D20 percentage increases by at least about 4.5%, or at least about 5%, or at least about 5.5%, or at least about 6%.

[0252] 53. The method of any one of clauses 26 to 50, wherein within 30 minutes after administration of the oral composition, the human's plasma D20 percentage 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%.

[0253] 54. The method of any one of clauses 26 to 50, wherein the human's plasma D20 percentage 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.

[0254] 55. A method according to any one of clauses 26 to 54, wherein the human's plasma D20 percentage measured 30 minutes after administration of the oral composition is reduced by less than about 1%, or less than about 2%, or less than about 3%, or less than about 4%, or less than about 5%, or less than about 6%, or less than about 7%, or less than about 8%, or less than about 9%, or less than about 10% for at least about 30 minutes.

[0255] 56. The method of any one of clauses 26 to 54, wherein the plasma osmolality of the human is maintained in the range of about 270 to about 330 mOsm / kg, or about 280 to about 320 mOsm / kg, or about 290 to about 310 mOsm / kg, or about 290 to about 300 mOsm / kg for at least 60 minutes after administration of the oral composition.

[0256] 57. The method according to any one of clauses 26 to 56, wherein the plasma osmolality of the human at least 60 minutes after administration of the oral composition does not change by more than 3 mOsm / kg compared to the plasma osmolality of the human before administration of the oral composition.

[0257] 58. A method of improving physical or athletic performance, the method comprising administering any oral composition according to clauses 1 to 25.

[0258] 59. The method of clause 34, wherein the oral composition is administered before, during or after endurance exercise.

[0259] 60. A method according to any of clauses 34 to 35, wherein the performance enhancement is characterized by reduced perceived physical exhaustion, reduced muscle soreness, reduced muscle damage, reduced net fluid loss, reduced lactic acid production, improved time to exhaustion, improved time trial performance, improved power output, or any combination thereof.

Claims

1. An oral composition for rapid hydration, rapid rehydration, sustained hydration and / or sustained rehydration, the oral composition comprising at least one active ingredient.

2. The oral composition according to claim 1, wherein the oral composition is an amino acid-free formulation and / or is substantially free of nutritive sweeteners.

3. The oral composition according to claim 1, further comprising at least two active ingredients.

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

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

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

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

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

10. The oral composition according to claim 7, wherein the at least two active ingredients are a mixture of sodium and potassium salts comprising sodium lactate, sodium chloride, trisodium citrate, sodium bicarbonate, potassium dihydrogen phosphate and potassium citrate.

11. The oral composition of claim 8, 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.

12. The oral composition of claim 9, 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.

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

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

16. The oral composition of claim 15, wherein the sweetener is selected from the group consisting of stevia and steviol glycosides, monk fruit and related mogroside compounds, monatin and its salts (monatin SS, RR, RS, SR), curculin, glycyrrhizic acid and its salts, thaumatin, monellin, mabinin, brazzein, hemandulcin, phyllotoxin, glycyphyllin, phloridzin, trilobatin, baiyunoside, osladin, pterocaryoside A, pterocaryoside A, pterocaryoside B, pterocaryoside C, pterocaryoside D, pterocaryoside E, pterocaryoside F ... The invention relates to a group consisting of: terocaryoside B, mukurozioside, phlomisoside I, periandrin I, abrusoside A, and cyclocarioside I, sugar alcohols such as erythritol, sucralose, potassium acesulfame, acesulfame acid and its salts, aspartame, alitame, saccharin and its salts, neohesperidin dihydrochalcone, cyclohexylaminosulfonate, cyclohexylaminosulfonic acid and its salts, neotame, advantame, glycosylated steviol glycosides (GSG), and combinations thereof.

17. The oral composition according to claim 15, further comprising at least one additive.

18. The oral composition according to claim 17, further comprising at least one functional ingredient.

19. The oral composition according to claim 18, wherein the oral composition is selected from the group consisting of sports drinks and fortified water beverages.

20. The oral composition according to claim 17, wherein the oral composition is selected from a high-calorie beverage, a medium-calorie beverage, a low-calorie beverage or a zero-calorie beverage.

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

22. The oral composition according to claim 19, wherein the oral composition is in a dry form or a semi-dry form.

23. The oral composition according to claim 22, wherein the oral composition is chewing gum, tablet, capsule or dry powder.

24. A method of rapidly hydrating, rapidly rehydrating, providing sustained hydration and / or providing sustained rehydration in a human, the method comprising administering an oral composition comprising at least one active ingredient.

25. The method of claim 24, wherein administration of the oral composition provides rapid hydration, rapid rehydration, sustained hydration, and / or sustained rehydration to the human.

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

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

28. The method of claim 26, wherein the oral composition is an amino acid-free formulation and / or is substantially free of nutritive sweeteners.

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

30. The method of claim 29, 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.

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

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

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

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

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

36. The method of claim 33, wherein the at least two active ingredients are a mixture of sodium and potassium salts comprising sodium lactate, sodium chloride, trisodium citrate, sodium bicarbonate, potassium dihydrogen phosphate, and potassium citrate.

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

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

42. The method of claim 41, wherein the sweetener is selected from the group consisting of stevia and steviol glycosides, monk fruit and related mogroside compounds, monatin and its salts (monatin SS, RR, RS, SR), curculin, glycyrrhizic acid and its salts, thaumatin, monellin, mabinin, brazzein, hemandulcin, phyllotoxin, glycyphyllin, phloridzin, trilobatin, baiyunosin, safflower oil ... de), osladin, pterocaryoside A, pterocaryoside A, pterocaryoside B, mukurozioside, phlomisoside I, periandrin I, abrusoside A, and cyclocarioside I, sugar alcohols such as erythritol, sucralose, potassium acesulfame, acesulfame acid and its salts, aspartame, alitame, saccharin and its salts, neohesperidin dihydrochalcone, cyclohexylaminosulfonate, cyclohexylaminosulfonic acid and its salts, neotame, advantame, glycosylated steviol glycosides (GSG), and combinations thereof.

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

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

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

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

47. The method of claim 46, wherein within 5 minutes after administration of the oral composition, the human's plasma D20 percentage increases by at least about 2.5%, or increases by at least about 3%, or increases by at least about 4%.

48. The method of claim 46, wherein within 15 minutes after administration of the oral composition, the human's plasma D20 percentage increases by at least about 4.5%, or increases by at least about 5%, or increases by at least about 5.5%, or increases by at least about 6%.

49. The method of claim 46, wherein within 30 minutes after administration of the oral composition, the human's plasma D20 percentage increases by at least about 5%, or increases by at least about 5.5%, or increases by at least about 6%, or increases by at least about 6.5%, or increases by at least about 7%.

50. The method of claim 46, wherein the human's plasma D20 percentage 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.

51. The method of claim 46, wherein the human's plasma D20 percentage measured 30 minutes after administration of the oral composition is decreased by less than about 1%, or by less than about 2%, or by less than about 3%, or by less than about 4%, or by less than about 5%, or by less than about 6%, or by less than about 7%, or by less than about 8%, or by less than about 9%, or by less than about 10% for at least about 30 minutes.

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

53. The method of claim 46, wherein the plasma osmolality of the human at least 60 minutes after administration of the oral composition does not change by more than 3 mOsm / kg compared to the plasma osmolality of the human before administration of the oral composition.

54. A method of enhancing physical or athletic performance comprising administering any oral composition according to claim 13.

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

56. The method of claim 55, wherein the performance enhancement is characterized by reduced perceived physical exhaustion, reduced muscle soreness, reduced muscle damage, reduced net fluid loss, reduced lactic acid production, improved time to exhaustion, improved time trial performance, improved power output, or any combination thereof.

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