Seaweed rehydration and composition and method

Abstract

The rehydration composition comprises water, at least one electrolyte, and a seaweed polysaccharide or specifically fucoidan. The method for rehydrating the subject comprises orally administering the rehydration composition comprising water, at least one electrolyte, and a seaweed polysaccharide or specifically fucoidan.

Description

Technical Field

[0001] This invention claims the priority of U.S. Patent Provisional Application No. 63 / 492,579, filed on March 28, 2023, the entire disclosure of which is incorporated herein by reference.

[0002] The present invention relates to a rehydration composition comprising water, at least one electrolyte and a seaweed polysaccharide, and to a method for effecting rehydration by oral administration of a rehydration composition comprising water, at least one electrolyte and a seaweed polysaccharide or especially fucoidan.

Background Art

[0003] Current oral electrolyte solutions are used to promote rehydration and electrolyte replenishment in both pediatric and adult populations. These solutions provide a balance of sodium, glucose and water to promote fluid and electrolyte absorption and result in rehydration of an individual faster than rehydration with water alone. However, while these electrolyte solutions provide better rehydration than water alone, water loss still often occurs due to the stressed intestinal barrier in the gut.

[0004] In view of the above, there is a need to develop new and available technologies that can advantageously provide improved rehydration using food and beverage products.

Summary of the Invention

Problems to be Solved by the Invention

[0005] (Summary of the Invention) Therefore, an object of the present invention is to provide an improved rehydration composition and method that provide better hydration ability than conventional compositions, and a method due to the surprising effect of a seaweed polysaccharide or especially fucoidan.

Means for Solving the Problems

[0006] In one embodiment, the present invention relates to a rehydrated composition comprising water, at least one electrolyte, and a seaweed polysaccharide.

[0007] In another embodiment, the present invention relates to a method for rehydrating a subject, comprising administering a rehydration composition comprising water, at least one electrolyte, and a seaweed polysaccharide to the subject.

[0008] In another embodiment, the present invention relates to a rehydrated composition comprising water, at least one electrolyte, and fucoidan.

[0009] In another embodiment, the present invention relates to a method for rehydrating a subject, comprising administering a rehydration composition comprising water, at least one electrolyte, and fucoidan to the subject.

[0010] In another embodiment, the present invention relates to a rehydration composition comprising an amount of water, at least one electrolyte, and a seaweed polysaccharide or, in particular, fucoidan, that is effective in imparting an improved hydration effect.

[0011] In another embodiment, the present invention relates to a method for rehydrating a subject, comprising administering a rehydration composition comprising water, at least one electrolyte, and fucoidan to the subject, wherein fucoidan is effective in improving the hydration effect of the composition.

[0012] In another embodiment, the present invention relates to a rehydration composition comprising water, at least one electrolyte, and a seaweed polysaccharide or, in particular, fucoidan, wherein, when consumed orally, the amount of water and electrolyte entering the bloodstream of a subject, the rate at which water and electrolyte enter the bloodstream of a subject, or both, are increased (compared to the consumption of the same amount of the same rehydration composition but without seaweed polysaccharide or, in particular, fucoidan).

[0013] In another embodiment, the present invention relates to a method for rehydrating a subject, comprising administering a rehydration composition comprising water, at least one electrolyte, and a seaweed polysaccharide or, in particular, fucoidan, to the subject, wherein the amount of water and / or electrolytes entering the subject's bloodstream, the rate at which water and / or electrolytes enter the subject's bloodstream, or both, is increased compared to the administration of the same amount of the same rehydration composition but without seaweed polysaccharide or, in particular, fucoidan.

[0014] In another embodiment, the present invention relates to a method for improving the hydration effect of a rehydration composition comprising water and at least one electrolyte by incorporating seaweed polysaccharides or, in particular, fucoidan.

[0015] In another embodiment, the present invention relates to the use of seaweed polysaccharides, or in particular fucoidan, to improve the hydration effect of a rehydration composition comprising water and at least one electrolyte.

[0016] The addition of seaweed polysaccharides, or in particular fucoidan, to the rehydration composition provides a remarkable means of achieving improved rehydration. These and additional objectives and advantages of the present invention will become more fully apparent from the following detailed description.

[0017] The drawings illustrate certain embodiments of the present invention and are essentially illustrative; they are not intended to limit the present invention as defined by the claims. [Brief explanation of the drawing]

[0018] [Figure 1] Figure 1 illustrates the water absorption rate of model intestinal epithelial cells obtained using the rehydration composition according to the present invention, as described in Example 1, in comparison with that obtained using the rehydration composition according to the prior art. [Figure 2] Figure 2 illustrates the water absorption rate of model intestinal epithelial cells obtained using the rehydration composition according to the present invention, as described in Example 2, in comparison with that obtained using the rehydration composition according to the prior art. [Figure 3]Figure 3 illustrates the water uptake in an embodiment of the powdered rehydrated composition containing fucoidan according to the present invention, as described in Example 3, in comparison with that of a prior art powdered rehydrated composition. [Modes for carrying out the invention]

[0019] Specific embodiments of the present invention are described herein. However, the present invention can be embodied in various forms and should not be construed as being limited to the embodiments described herein. Rather, these embodiments are provided to those skilled in the art to illustrate more specific features of certain embodiments of the present invention.

[0020] The terminology used herein is for the sole purpose of describing embodiments and should not be construed as limiting the disclosure as a whole. Every reference in this disclosure to a singular characteristic or limitation includes the corresponding plural characteristic or limitation, unless otherwise specified or the context in which the reference is made clearly suggests the opposite. Unless otherwise specified, “a,” “an,” “the,” and “at least one” are used interchangeably. Furthermore, where used in this description and the appended claims, the singular forms “a,” “an,” and “the” encompass their plural forms unless the context clearly indicates otherwise.

[0021] For the purposes of this specification and the claims, when the terms "includes" or "including" are used in the claims as transitional terms, they are intended to be construed in the same manner as the term "comprising", namely, as encompassing additional elements or steps. Further, where the term "or" (e.g., A or B) is used, it is intended to mean "A or B or both". Where "only A or only B but not both" is intended, the term "only A or only B but not both" is used. Accordingly, the use of the term "or" in this specification is inclusive and not exclusive. When the terms "and" and "or" are used together, as in "A and / or B", this indicates A or B, as well as A and B.

[0022] All ranges and parameters disclosed herein, including but not limited to percentages, parts, and ratios, are to be understood to include any and all sub-ranges and all numbers between the endpoints subsumed therein. For example, the explicitly recited range "1 to 10" is to be considered to include any and all sub-ranges starting with a minimum value of 1 or more and ending with a maximum value of 10 or less within that range (e.g., 1 to 6.1 or 2.3 to 9.4), as well as each integer (1, 2, 3, 4, 5, 6, 7, 8, 9, and 10).

[0023] Any combination of the methods or process steps used herein can be performed in any order, unless otherwise specified or the context in which the recited combination is made clearly suggests the contrary.

[0024] Unless otherwise indicated, all percentages are weight percentages.

[0025] The terms "subject" or "individual," as used herein, refer to a human child or adult individual unless otherwise specified. In certain embodiments, if a subject typically requires rehydration, such a subject may be recovering from exercise.

[0026] As used herein, the term “rehydrated composition” refers, unless otherwise specified, to rehydrate liquid and rehydrate powder, the latter of which may be reconstituted to form a rehydrate liquid or otherwise mixed with a liquid, such as water, and is suitable for oral consumption by humans. The rehydrate liquid may be prepared in ready-to-drink (RTD) form or reconstituted from powder as described.

[0027] As used herein, the term “heat-sterilized” refers, unless otherwise specified, to a liquid rehydrated composition that has been heat-treated at a high temperature for a period sufficient to achieve a sufficient reduction of microorganisms to provide storage stability for the composition. In certain embodiments of the present invention, the liquid rehydrated composition is first heat-sterilized and then packaged into a sterilized bulk container. In other embodiments of the present invention, the liquid rehydrated composition is packaged in a container, and the packaged composition may subsequently be heat-sterilized. Suitable containers include, for example, metal (e.g., aluminum) cans and bottles, glass bottles and plastic containers (e.g., plastic bottles).

[0028] As used herein, the term “electrolyte” refers to an electrically charged ion unless otherwise specified. Charged ions arise from inorganic compounds that are broken down into ions when the corresponding inorganic compound is dissolved in water or body fluids. Examples of electrolytes include, but are not limited to, sodium, potassium, calcium, chlorides, and phosphates.

[0029] As used herein, the term “milliequivalent” (mEq) refers to the number of electrolyte ions in a given volume of solution, unless otherwise specified. One equivalent of an electrolyte (e.g., sodium) is the atomic weight of that electrolyte divided by its valence. The number of milliequivalents of a given electrolyte in a given volume is the weight (milligrams) of the electrolyte multiplied by its valence and divided by its atomic weight. This measure is usually expressed as the number of milliequivalents per liter (mEq / L). Milliequivalents may be converted to milligrams by multiplying mEq by the atomic weight of the electrolyte and then dividing that number by the valence of the electrolyte.

[0030] The term “seaweed” is a common name for countless species of marine plants and algae that grow in the ocean, as well as in rivers, lakes, and other bodies of water. As used herein, “seaweed polysaccharides” refers to complex carbohydrates produced in marine plants and algae, unless otherwise specified. The terms seaweed and algae are used interchangeably herein and include three main categories: green algae, red algae, and brown algae. Green algae include, but are not limited to, varieties such as Monostroma, Ulva, Caulerpa, and Chlorella. Red algae include, but are not limited to, varieties such as Gracilaria, Porphyra, and Eucheuma. Brown algae include, but are not limited to, varieties such as Laminariaceae, Undaria, and Sargassum.

[0031] Fucoidan is an example of a polysaccharide found in seaweed or algal seagrass. It forms a protective film on varieties of seaweed. Fucoidan is a long-chain, partially sulfated polysaccharide that may originate from brown algae and other algal varieties, including Fucus vesiculosus, Undaria pinnatifida, and other marine plants, substances, or commercially cultivated seaweed organisms.

[0032] Certain embodiments of the present invention include fucoidan from seaweed. More specific embodiments of the present invention include fucoidan from brown seaweed. In certain embodiments, the fucoidan is derived from the brown alga Undaria. In another specific embodiment, the fucoidan is derived from the brown alga Fucus.

[0033] Fucoidan may preferably be provided in its unhydrolyzed form, i.e., completely as-is. While not bound by theory, it is believed that in its as-is form, fucoidan acts to bind to water molecules (and water-soluble electrolytes) and deliver them to the absorbent surface of the epithelium, thereby contributing to the improved rehydration effect disclosed herein. If the size of the fucoidan molecule is reduced, for example by hydrolysis, the resulting molecules with lower molecular weight are thought to be less effective, or possibly completely ineffective, in thus binding to and delivering water.

[0034] For example, unadulterated fucoidan is highly hygroscopic due to the potential for interaction between the intrinsic hydroxyl and sulfate groups in its structure with water molecules, which have a weak polar charge. These interactions are weak individually but very strong when present in large numbers. Hydrolyzed, low-molecular-weight fucoidan fragments are expected to have a much lower hygroscopic potential. Furthermore, unadulterated fucoidan has a large molecular weight and charge, which prevents it from passing through the intestinal wall. This allows for sustained interaction between the fucoidan molecule and the absorbent surface of the epithelium, which is thought to contribute to the proposed rehydration. Hydrolyzed fucoidan has a low molecular weight, which limits its potential to interact with the intestinal surface, and instead, its movement across the intestinal wall may increase.

[0035] As shown above, the present invention provides a rehydration composition and method.

[0036] In one embodiment, the present invention relates to a rehydrated composition comprising water, at least one electrolyte, and a seaweed polysaccharide.

[0037] In another embodiment, the present invention relates to a method for rehydrating a subject, comprising orally administering a rehydration composition comprising water, at least one electrolyte, and a seaweed polysaccharide.

[0038] In another embodiment, the present invention relates to a rehydration composition comprising water, at least one electrolyte, and fucoidan. In yet another embodiment, the present invention relates to a method for rehydrating a subject, comprising orally administering a rehydration composition comprising water, at least one electrolyte, and fucoidan.

[0039] The rehydrated composition may be consumed as a ready-to-drink liquid, or it may be formed as a liquid by reconstitution of the powder composition. For example, when the rehydrated composition is reconstituted from powder, a single serving of about 40g to about 60g of powder, for example 45g, 48.6g, or 50g, can be reconstituted into about 1ml to about 500ml of liquid, or in a more specific embodiment, into about 150 to about 450ml of liquid or about 200 to about 400ml of liquid, such as water. Alternatively, a single serving of about 3.5g to about 17g of powder may be reconstituted into about 236ml (8 fluid ounces) to about 474ml (16 fluid ounces) of liquid, such as water. For example, a single serving of about 8.5g of powder may be reconstituted into about 236ml of liquid, such as water.

[0040] A single serving of liquid rehydrated compositions, either reconstituted from powder or manufactured as a ready-to-drink product, ranges from approximately 1 ml to approximately 500 ml, including approximately 100 ml to approximately 500 ml, approximately 110 ml to approximately 417 ml, approximately 120 ml to approximately 500 ml, approximately 120 ml to approximately 417 ml, approximately 177 ml to approximately 417 ml, approximately 207 ml to approximately 296 ml, approximately 230 ml to approximately 275 ml, approximately 200 ml to approximately 300 ml, approximately 110 ml to approximately 237 ml, approximately 120 ml to approximately 245 ml, approximately 110 ml to approximately 150 ml, and approximately 120 ml to approximately 150 ml. In specific embodiments, a single serving is approximately 100 ml, or approximately 225 ml, or approximately 237 ml, or approximately 360 ml, or approximately 500 ml.

[0041] As described above, in certain embodiments of the present invention, the seaweed polysaccharide or, in particular, the brown seaweed polysaccharide comprises fucoidan. The fucoidan is included in the rehydration composition in an amount sufficient to provide the benefits of enhanced rehydration.

[0042] If the rehydration composition is in liquid form, the rehydration composition may contain at least about 0.0001 μg / ml or at least about 0.001 μg / ml or at least about 0.01 μg / ml or at least about 0.1 μg / ml or at least about 1 μg / ml or at least about 5 μg / ml or at least about 10 μg / ml or at least about 50 μg / ml of seaweed polysaccharide or, more specifically, brown seaweed polysaccharide or, more specifically, fucoidan. Similarly, the rehydration composition may contain less than about 500 μg / ml or less than about 400 μg / ml or less than about 300 μg / ml or less than about 200 μg / ml or less than about 150 μg / ml of seaweed polysaccharide or, more specifically, brown seaweed polysaccharide or, more specifically, fucoidan.

[0043] In a particular embodiment of the present invention, the liquid rehydration composition contains about 0.0001 to 15 μg / ml of seaweed polysaccharide, or more specifically, brown seaweed polysaccharide, or more specifically, fucoidan. In another particular embodiment, the liquid rehydration composition contains about 0.001 to 450 μg / ml, or about 0.001 to 400 μg / ml, or about 0.001 to 300 μg / ml, or about 0.001 to 200 μg / ml, or about 0.001 to 150 μg / ml of seaweed polysaccharide, or more specifically, brown seaweed polysaccharide, or more specifically, fucoidan. In another specific embodiment, the liquid rehydration composition contains about 0.1 to 450 μg / ml or about 0.1 to 400 μg / ml or about 0.1 to 300 μg / ml or about 0.1 to 200 μg / ml or about 0.1 to 150 μg / ml of seaweed polysaccharides or more specifically brown seaweed polysaccharides or more specifically fucoidan. In another specific embodiment, the liquid rehydration composition contains about 1 to 450 μg / ml or about 1 to 400 μg / ml or about 1 to 300 μg / ml or about 1 to 200 μg / ml or about 1 to 150 μg / ml of seaweed polysaccharides or more specifically brown seaweed polysaccharides or more specifically fucoidan. In other specific embodiments, the liquid rehydrate composition contains approximately 0.001 to 10 μg / ml or approximately 0.1 to 100 μg / ml or approximately 0.1 to 10 μg / ml or approximately 1 to 100 μg / ml or approximately 1 to 100 μg / ml or approximately 10 to 100 μg / ml or approximately 10 to 150 μg / ml or approximately 0.5 to 150 μg / ml of seaweed polysaccharides or, more specifically, brown seaweed polysaccharides or, more specifically, fucoidan.

[0044] If the rehydrated composition is to be reconstituted from powder, the powdered rehydrated composition may contain at least about 0.00001% by weight or at least about 0.0001% by weight or at least about 0.001% by weight or at least about 0.01% by weight or at least about 0.00001 to 0.5% by weight of seaweed polysaccharides or more specifically brown seaweed polysaccharides or more specifically fucoidan. In certain embodiments of the present invention, the powdered rehydrated composition contains about 0.00001 to 0.5% by weight or about 0.0001 to 0.5% by weight or about 0.001 to 0.5% by weight or about 0.01 to 0.5% by weight of seaweed polysaccharides or more specifically brown seaweed polysaccharides or more specifically fucoidan. In a particular embodiment of the present invention, the powdered rehydrated composition contains about 0.00001 to 0.4% by weight or about 0.0001 to 0.4% by weight or about 0.001 to 0.4% by weight or about 0.01 to 0.4% by weight of seaweed polysaccharides or more specifically brown seaweed polysaccharides or more specifically fucoidan. In a particular embodiment of the present invention, the powdered rehydrated composition contains about 0.00001 to 0.3% by weight or about 0.0001 to 0.3% by weight or about 0.001 to 0.3% by weight or about 0.01 to 0.3% by weight of seaweed polysaccharides or more specifically brown seaweed polysaccharides or more specifically fucoidan. In a particular embodiment of the present invention, the powdered rehydrated composition contains about 0.00001 to 0.2% by weight or about 0.0001 to 0.2% by weight or about 0.001 to 0.2% by weight or about 0.01 to 0.2% by weight of seaweed polysaccharides or more specifically brown seaweed polysaccharides or more specifically fucoidan. In another particular embodiment, the powdered rehydrated composition contains about 0.0001 to 0.1% by weight or about 0.0001 to 0.1% by weight or about 0.001 to 0.1% by weight or about 0.01 to 0.1% by weight of seaweed polysaccharides or more specifically brown seaweed polysaccharides or more specifically fucoidan.

[0045] In certain embodiments of the present invention, a liquid rehydrate composition reconstituted from powder or manufactured as a ready-to-drink product is an acidic liquid rehydrate composition containing at least one acid. In embodiments of the present invention, the at least one acid includes malic acid, phosphoric acid and / or citric acid. In one embodiment, the at least one acid is citric acid. In one embodiment, the composition has a pH of less than about 6, less than about 5, less than about 4, less than about 3, about 3 to 6, or about 3 to 4. The at least one acid is contained in the liquid rehydrate composition in an amount sufficient to give the composition a desired pH and flavor profile. In embodiments of the present invention, the rehydrate composition contains at least about 0.05% by weight, or about 0.05 to 5% by weight, or about 0.05 to 1.5% by weight, or about 0.05 to 2% by weight, or about 0.05 to 4% by weight of at least one acid, specifically citric acid.

[0046] In embodiments of the present invention, at least one electrolyte comprises sodium, potassium, chloride, or a combination of two or more thereof.

[0047] In embodiments of the present invention, liquid rehydration compositions, reconstituted from powder or manufactured as ready-to-drink products, generally contain water and appropriate amounts of electrolytes sodium, potassium, and chloride for rehydration purposes, such as preventing or treating dehydration. The relative amounts of these electrolytes also help maintain (or restore) a proper electrolyte balance in the body. Imbalances of sodium, chloride, and potassium electrolytes, in particular, can lead to life-threatening situations, as these electrolytes may be lost through sweating or as a result of diarrhea, vomiting, or other illnesses or medical conditions.

[0048] In one embodiment, the rehydration composition contains about 35 to about 45 mEq / L of sodium. In other embodiments, the rehydration composition contains about 25 to 75 mEq / L, about 30 to 60 mEq / L, about 35 to 60 mEq / L, or about 40 to 50 mEq / L of sodium.

[0049] Sodium can be supplied by a variety of sources, including one or more of sodium chloride, sodium phosphate, sodium citrate, sodium carbonate, sodium bicarbonate, sodium hydroxide, sodium selenite, and combinations thereof. In some embodiments, sodium ions are obtained by combinations of sodium chloride and sodium citrate, which also provide chloride ions and citrate ions, respectively. Citrates (e.g., as sodium citrate and / or potassium citrate) also act as buffers, helping to maintain the desired pH of the composition.

[0050] In one embodiment, the rehydrated composition contains about 10 to about 20 mEq / L of potassium. In other embodiments, the rehydrated composition is formulated to have about 15 to 40 mEq / L, or about 15 to 25 mEq / L, or about 20 to 40 mEq / L, or about 20 to 30 mEq / L of potassium.

[0051] Potassium can be obtained from a variety of sources, including one or more of potassium chloride, potassium phosphate, potassium citrate, potassium carbonate, potassium bicarbonate, potassium hydroxide, potassium acesulfame, and combinations thereof. In some specific embodiments, potassium ions are obtained by potassium citrate.

[0052] In one embodiment, the rehydrated composition contains about 30 to about 35 mEq / L of chloride. In other embodiments, the rehydrated composition is formulated to have about 20 to 55 mEq / L, about 30 to 50 mEq / L, or about 35 to 45 mEq / L of chloride.

[0053] Chlorides can be obtained from a variety of sources, including one or more of sodium chloride, potassium chloride, calcium chloride, and magnesium chloride, and combinations thereof. In some embodiments, chloride ions are obtained from one or more of the same sources used to obtain all or some of the sodium and potassium. Thus, in some specific embodiments, chloride ions are obtained from sodium chloride (which also provides at least some of the sodium ions in the composition).

[0054] In certain embodiments of the present invention, the rehydrated composition comprises about 35 to about 45 mEq / L of sodium, about 10 to about 20 mEq / L of potassium, and about 30 to about 35 mEq / L of chloride.

[0055] In another specific embodiment, the rehydration composition comprises at least one carbohydrate. In another specific embodiment, the rehydration composition comprises one or more carbohydrates containing fiber, including but not limited to oat fiber, soy fiber and / or corn fiber, human milk oligosaccharides (HMOs), maltodextrin, corn syrup, sucralose, dextrose, fructooligosaccharides, glucose, glucose polymers, sucrose, fructose, fructose polymers, lactose, maltose, amylose glycogen, galactose, galactooligosaccharides, inulin, or two or more combinations thereof.

[0056] In a particular embodiment, the rehydration composition contains dextrose. Embodiments of the present invention may contain enough dextrose to provide rapid hydration, improve sodium absorption, and obtain the necessary calories. However, too much dextrose can slow the absorption of sodium and water, or exacerbate dehydration by drawing water out of the bloodstream. Furthermore, reducing the amount of dextrose or other carbohydrates can provide nutritional benefits and improved patient or consumer acceptance (partly because dextrose increases the calories and sugar content of beverages). In a particular embodiment, the rehydration composition contains enough dextrose to obtain a dextrose-to-sodium molar ratio of about 1:1 to about 3:1, about 2:1 to about 3:1, or about 2:1 to about 2.5:1.

[0057] In one particular embodiment, the rehydrated composition contains up to 225 mmol / L of dextrose. Other embodiments contain dextrose in concentrations of about 25 mmol / L to about 225 mmol / L, or about 30 mmol / L to about 170 mmol / L, or about 35 mmol / L to about 150 mmol / L, or about 70 mmol / L to about 140 mmol / L.

[0058] Some embodiments of the rehydrated composition include one or more sweeteners to improve the flavor profile of the composition. The presence of one or more sweeteners is also beneficial because they allow for a reduction in the amounts of dextrose and other sugars while maintaining an acceptable flavor profile. The sweeteners may be natural and / or artificial. Suitable artificial sweeteners include saccharin, NutraSweet, sucralose, aspartame, and acesulfame K (ace-K). When artificial sweeteners are used, the concentration of the artificial sweetener(s) may be about 0.01 to about 0.5 g / L. In one embodiment, the sweeteners may be added in the form of sucralose, stevia leaf extract, etc.

[0059] Specific embodiments of the rehydration composition include one or more natural sweeteners, particularly high-strength natural sweeteners. Suitable high-strength natural sweeteners include stevia leaf extract (commonly referred to as "stevia") and monk fruit extract (commonly referred to as "monk fruit"). Stevia and monk fruit are non-synthetic high-strength sweeteners that do not contribute measurable amounts of carbohydrates or calories and do not interfere with rehydration. Therefore, the use of stevia and monk fruit allows the composition to have sufficient sweetness for palatability without altering the dextrose-to-sodium ratio for optimal sodium and water absorption.

[0060] In some embodiments, the rehydrated composition contains about 0.003 to about 0.04% by weight of stevia, monk fruit, or a combination of stevia and monk fruit. In certain embodiments containing both stevia and monk fruit, the amount of stevia is equal to or greater than the amount of monk fruit in the formulation. For example, the ratio (by weight) of stevia to monk fruit may be about 1:1 to about 3:1, about 1.5:1 to 2.5:1, or about 2:1. In one embodiment, stevia may be added in the form of an organic stevia leaf extract or the like.

[0061] In certain embodiments, the rehydration composition contains citrate. Citrate is useful in rehydration compositions for the correction of acidosis accompanied by diarrhea and dehydration. The amount of citrate varies widely. In certain exemplary embodiments, the source of citrate is present in an amount sufficient to provide citrate in amounts of about 10 to about 50 mEq / L, about 15 to about 45 mEq / L, or about 20 to about 40 mEq / L. Citrate ions can be obtained by a variety of sources, including citric acid, citrate esters that can be hydrolyzed to citric acid or citrate ions, and one or more citrates such as potassium citrate and sodium citrate. In some embodiments, citrate ions are obtained by one or more of the same sources used to obtain all or some of sodium and / or potassium. Therefore, in some specific embodiments, citrate ions are obtained by sodium citrate (which also provides at least a portion of sodium ions in the composition) and potassium citrate (which also provides at least a portion of potassium ions in the composition).

[0062] Embodiments of the present invention may also include one or more additional components, including those commonly used in electrolyte beverages, that do not adversely affect the rehydration effect of the beverage. Examples of additional components include flavorings, preservatives, excipients, poorly digestible oligosaccharides, such as galactooligosaccharides, amino acids, additional minerals (e.g., calcium), vitamins, nutritional supplements, and combinations thereof.

[0063] Certain embodiments may also contain zinc, as zinc can be particularly important for supporting the immune system (for example, in individuals dehydrated as a result of illness). In one embodiment, zinc may be added in the form of zinc gluconate, zinc sulfate, zinc acetate, etc. Embodiments of the present invention may also contain selenium. In one embodiment, selenium may be added in the form of sodium selenate, etc.

[0064] Any of the various flavorings may be included to add or modify the flavor, or to enhance the palatability of the composition. The flavorings may be natural or artificial. Suitable natural flavorings include citrus oils such as lemon, orange, and lime, and grapefruit oil, as well as fruit extracts including apple, pear, peach, berries, wild berries, jujube, blueberry, kiwi, strawberry, raspberry, cherry, plum, pineapple, and apricot. In one embodiment, the flavorings may be added in the form of organic apple juice concentrate, organic flavor, natural flavor, natural and artificial flavor, or natural flavor including other natural flavors.

[0065] A particular embodiment of the present invention comprises a liquid rehydrated composition containing or essentially consisting of water, seaweed polysaccharide, or more specifically brown seaweed polysaccharide, or more specifically fucoidan, together with dextrose, potassium citrate, salt, sodium citrate, citric acid, and zinc gluconate.

[0066] A particular embodiment of the present invention comprises a liquid rehydrated composition containing or essentially consisting of water, seaweed polysaccharide, or more specifically brown seaweed polysaccharide, or more specifically fucoidan, together with organic apple juice concentrate, organic dextrose, citric acid, organic flavor, potassium citrate, salt, sodium citrate, organic stevia leaf extract, and zinc gluconate.

[0067] A particular embodiment of the present invention comprises a liquid rehydrated composition containing or essentially consisting of water, seaweed polysaccharide, or more specifically brown seaweed polysaccharide, or more specifically fucoidan, together with natural flavors, citric acid, salt, potassium citrate, sodium citrate, sucralose, acesulfame potassium, and zinc gluconate.

[0068] A particular embodiment of the present invention comprises a liquid rehydrated composition containing or essentially consisting of water, seaweed polysaccharides, or more specifically brown seaweed polysaccharides, or more specifically fucoidan, together with dextrose, galactooligosaccharides, citric acid, potassium citrate, salts, natural and artificial flavors, sodium citrate, sucralose, acesulfame potassium, zinc gluconate, and sodium selenate.

[0069] A particular embodiment of the present invention comprises a liquid rehydrated composition containing or essentially consisting of water, seaweed polysaccharides or more specifically brown seaweed polysaccharides or more specifically fucoidan, together with dextrose, galactooligosaccharides, salts, citric acid, potassium citrate, sodium citrate, natural and artificial flavors, sucralose, acesulfame potassium, and zinc gluconate.

[0070] A particular embodiment of the present invention comprises a liquid rehydrated composition containing or essentially consisting of water, seaweed polysaccharides or more specifically brown seaweed polysaccharides or more specifically fucoidan, together with dextrose, galactooligosaccharides, salts, citric acid, potassium citrate, natural and artificial flavors, magnesium chloride, sodium citrate, acesulfame potassium, sucralose, zinc gluconate, and sodium selenate.

[0071] A particular embodiment of the present invention comprises a liquid rehydrated composition containing or essentially consisting of water, seaweed polysaccharides or more specifically brown seaweed polysaccharides or more specifically fucoidan, together with dextrose, galactooligosaccharides, salts, potassium citrate, citric acid, potassium phosphate, natural flavors including other natural flavors, magnesium chloride, sodium citrate, sucralose, and acesulfame potassium.

[0072] The rehydrated composition may be formed using any technique known in the art. Seaweed polysaccharides may be added at any time during the process if desired.

[0073] In embodiments of the present invention, the rehydration composition may be consumed orally by the subject for rehydration. The rehydration composition may be consumed orally in a single dose to rehydrate the subject, or it may be consumed continuously to rehydrate and / or prevent dehydration of the subject. In certain embodiments, the rehydration composition may be consumed orally at least once or multiple times a day for a period of at least about one week, at least about two weeks, at least about three weeks, or at least about four weeks.

[0074] For example, a rehydration composition containing seaweed polysaccharides, or more specifically brown seaweed polysaccharides, or more specifically fucoidan, in an amount of approximately 0.1–100 μg / ml or approximately 10–100 μg / ml is administered to a subject to rehydrate the subject following a period of exercise or other activity that causes or poses a risk of dehydration. In certain embodiments, such a rehydration composition is administered to a subject in a single dose of approximately 100–500 ml, approximately 200–300 ml, approximately 237 ml, or approximately 360 ml. Such a rehydration composition can also be administered in a single dose of approximately 100–500 ml, approximately 200–300 ml, approximately 237 ml, or approximately 360 ml at least once daily for a period of at least approximately one week for the rehydration of the individual.

[0075] In certain embodiments of the present invention, the rehydration of the subject includes strengthening the intestinal barrier of the subject. Strengthening the intestinal barrier includes increasing water absorption through the intestinal barrier, resulting in less water loss from the apical side of the intestinal barrier compared to previous rehydration compositions and methods. Because there is less water loss from the apical side of the intestinal barrier, more water can be delivered to the basal side of the intestinal barrier and into the bloodstream to rehydrate the subject. Since a larger volume or proportion of the orally administered rehydration composition enters the bloodstream, the hydration effect achieved by the compositions of this disclosure is greater than that of conventional rehydration compositions and methods.

[0076] The following embodiments demonstrate various embodiments of the present invention. [Examples]

[0077] [Example 1] Liquid rehydration composition This example describes an exemplary liquid rehydration composition according to the present invention, which has been prepared and tested for the benefits of rehydration.

[0078] Two liquid rehydrate compositions, Sample 1 and Sample 2, were prepared. Both sample compositions initially contained water, dextrose, potassium citrate, sodium chloride, sodium citrate, citrate, and zinc gluconate ("original compositions"). Using a model of intestinal epithelial cells, 500 μL of these original compositions were added to a culture of living human intestinal epithelial cells at time 0, as shown in Figure 1.

[0079] As shown in Figure 1, after 10 minutes, 50 μL of water was added to sample 1, and 50 μL of water containing enough fucoidan (0.55 μg) to bring the total fucoidan concentration in the composition to 1 μg / mL was added to sample 2. The fucoidan was derived from the brown alga Fuchs vesiculosus.

[0080] As shown in Figure 1, current (microangstroms per square centimeter (μA / cm²) 2 The absorption of water was measured over an 80-minute period through the intestinal epithelial barrier of cultured cells in the presence of sample 1 and sample 2, respectively. The measurement was performed by repeating the intestinal culture six times per sample, each time at 3-second intervals, and the mean standard error (SEM) is shown at 5-minute intervals. Negative current indicates net water absorption, with a larger negative current indicating more rapid water absorption. These measurements demonstrate the rehydration advantages of samples 1 and 2 at the molecular level in real time.

[0081] As shown, the data presented in Figure 1 indicate that sample 2 yielded a larger negative current for a longer period compared to sample 1. Therefore, the rehydration composition containing a very small amount of fucoidan, sample 2, unexpectedly yielded enhanced water absorption and thus enhanced rehydration benefits compared to sample 1. This is a surprising result, demonstrating that brown seaweed polysaccharides such as fucoidan enhance water absorption in model intestinal epithelial cells.

[0082] [Example 2] Liquid rehydration composition This example describes additional exemplary liquid rehydration compositions prepared and tested for the advantages of rehydration according to the present invention.

[0083] Two liquid rehydrate compositions, Sample 3 and Sample 4, were prepared. Both sample compositions initially contained water, dextrose, potassium citrate, sodium chloride, sodium citrate, citrate, and zinc gluconate ("original compositions"). Using an intestinal epithelial cell model, 500 μL of these original compositions were added to a culture of living human intestinal epithelial cells at time 0, as shown in Figure 2.

[0084] As shown in Figure 2, after a few minutes, 50 μL of water was added to sample 3, and 50 μL of water containing enough fucoidan (55 μg) to bring the total fucoidan concentration in the composition to 100 μg / mL was added to sample 4. The fucoidan in this example also originated from the brown alga Fuchs vesiculosus. Note that the downward spike in current at time 0 shown in Figure 2 for sample 4 should be ignored as it is due to data normalization at the start.

[0085] As shown in Figure 2 and listed in Table 1 below, current (microamperes per square centimeter (μA / cm)) 2 The values ​​were measured over a 70-minute period through the intestinal epithelial barrier of cultured cells in the presence of samples 3 and 4, respectively. The measurements were performed by repeating the intestinal culture six times per sample, each time at 3-second intervals, and the mean standard error (SEM) is shown at 5-minute intervals. As in Example 1, the negative current indicates net water absorption, and a larger negative current indicates a more rapid water absorption. These measurements demonstrate the rehydration advantages of samples 3 and 4 at the molecular level in real time. These measurements are shown in Table 1 below.

[0086] [Table 1]

[0087] As shown, the data presented in Table 1 and Figure 2 indicate that sample 4 produced a larger negative current for a longer period compared to sample 3. This further demonstrates the surprising result that brown seaweed polysaccharides such as fucoidan enhance water absorption in model intestinal epithelial cells.

[0088] Surprisingly, the small amounts of fucoidan added to sample 2 (1 μg / ml) and sample 4 (100 μg / ml) caused an unexpected increase in the rate and duration of water absorption through model epithelial cells compared to the rehydrated compositions of samples 1 and 3.

[0089] [Example 3] Inhibition of water uptake A major challenge in the production of powdered rehydrated compositions containing one or more electrolytes is caking, i.e., the conversion of free-flowing powder into aggregates or "cakes." Caking is facilitated by moisture uptake. If particles are exposed to high relative humidity, for example, during processing or storage, liquid crosslinks may form between the particles. As humidity decreases, the liquid crosslinks solidify, and the free-flowing powder transforms into a solid cake that does not readily dissolve in water and is aesthetically undesirable.

[0090] Caking, a phenomenon known as blend deliquescence, can become increasingly challenging in powdered rehydrated compositions as the number of components increases, such as electrolytes, carbohydrates, salts, sugars, and vitamins. Caking can be prevented if the humidity of the air to which the powder is exposed can be maintained below the deliquescence point of each individual crystalline component in the powder. However, it is known that when multiple crystalline components are mixed, the deliquescence point of the blend is lower than that of each individual crystalline component alone. This phenomenon is known as blend deliquescence.

[0091] It is common practice to add anti-caking agents to powdered compositions to prevent caking. Commonly used anti-caking agents include silicon dioxide, calcium silicate, magnesium silicate, talc, calcium carbonate, and magnesium stearate.

[0092] This example describes an additional exemplary powdered rehydrated composition tested for water uptake, thereby showing that the addition of a small amount of fucoidan reduces water uptake in the powder over time.

[0093] Several powder compositions containing varying amounts of fucoidan were prepared. The base of each composition was the same and contained dextrose, citric acid, fructooligosaccharides, potassium citrate, sodium chloride, anhydrous sodium citrate, acesulfame potassium, sucralose, calcium silicate, and flavorings. An amount of Undaria pinnatifida (a type of brown seaweed) extract containing approximately 87% fucoidan was added to the base composition. Three test compositions were prepared: the first contained 0.07% by weight of fucoidan, the second contained 0.14% by weight of fucoidan, and the third contained 0.28% by weight of fucoidan. The base composition (without fucoidan) was used as a control.

[0094] Next, the three test compositions and the control were stored for 70 days in an atmosphere with 75% relative humidity. The samples were tested for water absorption at various points throughout the 70-day storage period. The results are shown in Figure 3.

[0095] As shown in Figure 3, surprisingly, all three test samples demonstrated a statistically significant reduction in water uptake compared to the control. For example, over the entire 70-day period, the test sample containing 0.07 wt% fucoidan had approximately 18% less water uptake than the control, the test sample containing 0.14 wt% fucoidan had approximately 21% less water uptake than the control, and the test sample containing 0.28 wt% fucoidan had approximately 24% less water uptake than the control. Additional tests showed that compositions containing significantly higher amounts of fucoidan were ineffective, but it should be noted that these tests were conducted for only 25 days and in a lower humidity atmosphere (68.9% relative humidity) than the tests described above.

[0096] Due to the known relationship between water uptake and caking, as demonstrated by this test, the reduction in water uptake caused by the addition of a small amount of fucoidan is expected to reduce subsequent issues related to caking and dissolution by consumers of the powder rehydrated composition according to this disclosure, thereby resulting in a powder composition with improved shelf life and / or fluidity.

[0097] In summary, the present invention provides improved rehydration compositions and methods. Such compositions and methods enable large-scale commercial production of rehydration compositions having the advantages of improved rehydration.

[0098] The specific embodiments and examples described herein are for illustrative purposes only and are not limited to the present invention as defined in the claims. In addition, the present invention is described by the description of its embodiments, and although the embodiments are described in considerable detail, such descriptions are not intended in any way to limit or restrict the appended claims to such detail. Additional advantages and modifications will be readily apparent to those skilled in the art. Accordingly, in its broader embodiments, the present invention is not limited to specific details, representative compositions and processes or specific examples shown and described. Accordingly, deviations from such details may be made without deviating from the spirit or scope of the general inventive concept.

Claims

1. A rehydrated composition containing water, at least one electrolyte, and seaweed polysaccharide.

2. The rehydrated composition according to claim 1, wherein the seaweed polysaccharide comprises brown seaweed polysaccharide.

3. The rehydrated composition according to claim 1 or 2, comprising approximately 0.1 to approximately 10 μg / ml of seaweed polysaccharide.

4. The rehydrated composition according to claim 1 or 2, comprising approximately 10 to approximately 150 μg / ml, optionally, approximately 10 to 100 μg / ml of seaweed polysaccharides.

5. A rehydrated composition according to any one of claims 1 to 4, wherein the seaweed polysaccharide contains fucoidan.

6. A rehydrated composition comprising water, at least one electrolyte, and fucoidan.

7. The rehydrated composition according to claim 5 or 6, comprising fucoidan in an amount of approximately 0.1 to approximately 300 μg / ml, optionally optionally approximately 0.5 to approximately 300 μg / ml, optionally approximately 0.5 to approximately 150 μg / ml, optionally approximately 1 to approximately 150 μg / ml, and optionally approximately 10 to 100 μg / ml.

8. A rehydration composition according to any one of claims 1 to 7, further comprising at least one acid and having a pH of less than 6.

9. A rehydrated composition according to any one of claims 1 to 8, which has been heat-sterilized.

10. The rehydrated composition according to any one of claims 1 to 9, wherein the electrolyte comprises sodium, potassium, chloride, or a combination of two or more thereof.

11. A rehydrated composition according to any one of claims 1 to 10, comprising approximately 25 to approximately 75 mEq / L of sodium.

12. A rehydrated composition according to any one of claims 1 to 11, comprising approximately 15 to approximately 40 mEq / L of potassium.

13. A rehydrated composition according to any one of claims 1 to 12, comprising approximately 20 to approximately 55 mEq / L of chloride.

14. A rehydrated composition according to any one of claims 1 to 13, further comprising zinc.

15. The rehydrated composition according to any one of claims 1 to 14, further comprising selenium.

16. A rehydrated composition according to any one of claims 1 to 15, further comprising one or more sweeteners.

17. A rehydrated composition according to any one of claims 1 to 16, comprising at least one carbohydrate.

18. A rehydrated composition according to any one of claims 1 to 17, comprising fiber, human milk oligosaccharide (HMO), maltodextrin, corn syrup, sucralose, dextrose, fructooligosaccharide, glucose, glucose polymer, sucrose, fructose, fructose polymer, lactose, maltose, amylose glycogen, galactose, galactooligosaccharide, inulin, or one or more carbohydrates including two or more of these.

19. A powder for forming the rehydrated composition according to any one of claims 1 to 18 by adding water.

20. A powder for forming the rehydrated composition according to claim 19, comprising about 0.00001% to about 0.5% by weight of seaweed polysaccharide, optionally brown seaweed polysaccharide, and optionally fucoidan.

21. A powder for forming the rehydrated composition according to claim 19, comprising about 0.00001% to about 0.2% by weight of seaweed polysaccharide, optionally brown seaweed polysaccharide, and optionally fucoidan.

22. A rehydrated composition or powder for forming a rehydrated composition according to any one of claims 1 to 21, wherein the fucoidan has not been hydrolyzed.

23. A rehydrated composition or a powder for forming a rehydrated composition according to any one of claims 1 to 22, wherein seaweed polysaccharide, optionally brown seaweed polysaccharide, and optionally fucoidan are present in amounts effective for imparting an improved hydration effect to the rehydrated composition.

24. A rehydrated composition or powder for forming a rehydrated composition according to any one of claims 1 to 23, wherein, when the rehydrated composition is consumed orally, seaweed polysaccharide, optionally brown seaweed polysaccharide, or optionally fucoidan is present in an amount effective in increasing the amount of water and electrolytes (multiple) entering the target bloodstream, the rate at which water and electrolytes (multiple) enter the target bloodstream, or both.

25. A rehydration composition or a powder for forming a rehydration composition according to any one of claims 1 to 24, wherein the rehydration composition is identical but configured to provide an improved hydration effect compared to a rehydration composition that does not contain seaweed polysaccharide, optionally brown seaweed polysaccharide, or optionally fucoidan.

26. A rehydration composition or powder for forming a rehydration composition according to any one of claims 1 to 25, wherein, when the rehydration composition is consumed orally, the rehydration composition is configured to increase the amount of water and electrolytes (or more) that enter the target bloodstream, the rate at which water and electrolytes (or more) enter the target bloodstream, or both.

27. A method for rehydrating a subject, comprising orally administering the rehydration composition described in any one of claims 1 to 26 to the subject.

28. The method according to claim 27, wherein the target is a child.

29. The method according to claim 27, wherein the subject is recovering from exercise.

30. The method according to any one of claims 27 to 29, wherein seaweed polysaccharides, optionally brown seaweed polysaccharides, and optionally fucoidan improve the rehydration effect of the composition.

31. The method according to any one of claims 27 to 30, wherein, compared to the administration of the same amount of a rehydrated composition that is identical but does not contain seaweed polysaccharide, optionally brown seaweed polysaccharide, or optionally fucoidan, the amount of water and electrolytes (multiple) entering the target bloodstream, the rate at which water and electrolytes (multiple) enter the target bloodstream, or both, are increased.

32. Use of seaweed polysaccharides, optionally brown seaweed polysaccharides, and optionally fucoidan to improve the hydration effect of a rehydration composition containing water and at least one electrolyte.

33. The use according to claim 32, wherein seaweed polysaccharides, optionally brown seaweed polysaccharides, and optionally fucoidan are present in the rehydrated composition in amounts of approximately 0.1 to approximately 300 μg / ml, optionally approximately 0.1 to approximately 200 μg / ml, optionally approximately 0.1 to approximately 150 μg / ml, and optionally approximately 0.1 to approximately 100 μg / ml.

34. The use according to any one of claims 32 and 33, wherein the seaweed polysaccharide is fucoidan.

35. The use according to claim 34, wherein the fucoidan has not been hydrolyzed.

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