WO2013093863A1

WO2013093863A1 - Beverage compositions

Info

Publication number: WO2013093863A1
Application number: PCT/IB2012/057574
Authority: WO
Inventors: David Derek Grant Spratley; Christopher Ian Watkins
Original assignee: David Derek Grant Spratley; Christopher Ian Watkins
Priority date: 2011-12-22
Filing date: 2012-12-21
Publication date: 2013-06-27

Abstract

A beverage or two or more beverages comprising one or more ingredients for treating or preventing dehydration, one or more ingredients for preventing activation and/or aggregation of platelets, and one or more antioxidants. Use of the beverage may result in any one or more of prevention or treatment of dehydration, prevention or reduction in the risk of developing deep vein thrombosis, prevention or treatment of the effects of free radical damage, decreased stress and increased relaxation, increased in energy levels, reduced nausea or vomiting associated with motion sickness, increased gastrointestinal motility and digestion, or prevention or reduction in an inflammatory response in a subject during airline travel, following surgery or following exercise.

Description

BEVERAGE COMPOSITIONS

FIELD OF THE INVENTION

[0001] The present invention relates to a beverage or two or more beverages comprising one or more ingredients for treating or preventing dehydration, one or more ingredients for preventing activation and/or aggregation of platelets, and one or more antioxidants. Use of the beverage may result in any one or more of prevention or treatment of dehydration, prevention or reduction in the risk of developing deep vein thrombosis, prevention or treatment of the effects of free radical damage, decreased stress and increased relaxation, increased in energy levels, reduced nausea or vomiting associated with motion sickness, increased gastrointestinal motility and digestion, or prevention or reduction in an

inflammatory response in a subject during airline travel, following surgery or following exercise.

BACKGROUND OF THE INVENTION

[0002] Airline travel imposes several forms of stress on the body, including hypoxia, low humidity, prolonged inactivity in a typically upright position, oxidative stress, and acute disruption of circadian rhythm. Each of these stressors can lead to an array of adverse effects ranging from mild discomfort to life-threatening illness, and include dehydration, cramping, constipation, restlessness, sleeplessness, nausea and deep vein thrombosis (DVT). Many of these effects are inter-dependent and are driven by more than one stressor.

[0003] Remedial strategies need to target the most upstream, primary and preventable factors. Prolonged inactivity in the upright position and dehydration play an important role in this regard, and are therefore central targets for intervention.

[0004] Dehydration results from an excessive loss of water and electrolytes from body tissues. Symptoms include mild to severe headaches, hypotension, visual impairment and syncope. In severe cases, dehydration can result in delirium, unconsciousness and death.

[0005] Thrombosis within major blood vessels, such as deep veins in the lower limb and arteries, can lead to life-threatening complications, for example, pulmonary embolism, if left untreated. Atherosclerotic plaques can trap embolising thrombi, resulting in partial or complete occlusion of the blood vessel. This in turn can lead to myocardial infarction if the occlusion occurs within the coronary arteries. [0006] A number of factors contribute to an increased risk of thrombosis.

People that are subjected to prolonged periods of inactivity, such as passengers on long-haul flights, the elderly, and patients recovering from surgery, cannot efficiently drain blood from peripheral regions of the body through the venous system. Consequently, blood flow becomes static leading to increased platelet activation and aggregation, and coagulation. Hypercoagulability, due to a genetic predisposition, certain medications (such as the contraceptive pill), smoking or cancer can also increase a person's risk of developing a thrombus.

[0007] Exposure to radiation is an ongoing problem experienced by airline crew and passengers. While the atmosphere does act as a shield against this radiation; frequent travelling at altitude results in higher exposure to radiation. Sub-atomic particles released and rays of energy, such as gamma-rays and X-rays, known as cosmic radiation, along with solar flares, which are bursts of energy from the sun, pose a real danger to cells within the body. Increased or prolonged exposure to this radiation causes damage to cells, which in turn induces the production of reactive oxygen species (ROS) from the irradiated cells and subsequent oxidative stress. Antioxidants are useful for reducing the detrimental effects of ROS and their beneficial health effects are well known.

[0008] It is therefore an object of the present invention to provide an improved or alternative method of preventing or treating dehydration, treating or preventing thrombosis in a subject, and/or protecting a subject from the effects of increased exposure to radiation, or to at least provide the public with a useful choice.

SUMMARY OF THE INVENTION

[0009] Accordingly, in one aspect the invention relates to a beverage composition comprising

a) one or more ingredients for treating or preventing dehydration, b) one or more ingredients for preventing platelet activation and/or

aggregation, and

c) one or more antioxidants,

the beverage composition being in liquid or powder form.

[0010] In a further aspect, the invention relates to a method of treating or preventing dehydration, treating or preventing platelet activation and/or aggregation, and treating or preventing the effects of free radical damage in a subject, the method comprising administering to a subject in need thereof a therapeutically effective amount of a beverage comprising one or more ingredients for treating or preventing dehydration, one or more ingredients for preventing platelet activation and/or aggregation, and

one or more antioxidants.

[0011] In a fu rther aspect, the invention relates to a beverage composition comprising

aggregation, and

c) one or more antioxidants,

for treating or preventing dehydration, treating or preventing platelet activation and/or aggregation, and treating or preventing the effects of free radical damage in a subject, the beverage composition being in liquid or powder form. [0012] In a fu rther aspect, the invention relates to a kit comprising

A) two or more beverage compositions, each beverage composition

comprising

a) one or more ingredients for treating or preventing dehydration, b) one or more ingredients for treating or preventing platelet

activation and/or aggregation, and

c) one or more antioxidants,

each beverage composition being in liquid or powder form, and

B) instructions for administering the two or more beverage compositions to a subject in need thereof over a period of from about 2 hours to about 20 hou rs.

[0013] In a fu rther aspect, the invention relates to a method of treating or preventing dehydration, treating or preventing platelet activation and/or aggregation, and treating or preventing the effects of free radical damage in a su bject, the method comprising

A) providing two or more beverages, each beverage comprising

a) one or more ingredients for treating or preventing dehydration b) one or more ingredients for treating or preventing platelet

activation and/or aggregation, and

c) one or more antioxidants, and B) administering the two or more beverages to a subject in need thereof over a period of from about 2 hours to about 20 hours.

[0014] In a further aspect, the invention relates to a kit comprising

A) two or more beverage compositions, each beverage composition

comprising :

activation and/or aggregation, and

c) one or more antioxidants

each beverage composition being in liquid or powder form, and

B) instructions for administering the two or more beverage compositions to a subject in need thereof over a period of from about 2 hours to about 20 hours,

for treating or preventing dehydration, treating or preventing platelet activation and/or aggregation, and treating or preventing the effects of free radical damage in a subject.

[0015] The following embodiments may relate to any one or more of the above aspects, alone or in any combination of any two or more.

[0016] The beverage may be in a liquid, concentrate or powder form. In one embodiment the beverage is a liquid. In another embodiment the beverage is a concentrate. In another embodiment the beverage is a powder. Powders may be in a bulk format or sachet, for example.

[0017] In one embodiment, administration of the beverage or of the two or more beverages provides hydration, protects from thrombosis, and protects from the effects of radiation exposure.

[0018] In various embodiments, administration of the beverage or of the two or more beverages results in

1) one or more of an increase in extracellular fluid volume or a decrease in haematocrit, and

2) one or more of maintaining an inactivated platelet morphology,

prevention of binding of fibrinogen to platelet GPIIb/IIIa receptors, prevention of binding of von Willibrand factor to platelet GPIIb/IIIa receptors, inhibition of production of thromboxane A2, prevention of formation of a platelet plug, reduction of activation of the extrinsic coagulation cascade, reduction of synthesis of thrombin, or reduction of synthesis of fibrin, and

3) one or more of an increase in the systemic circulation of antioxidant molecules,

to provide hydration, protect from thrombosis, and protect from the effects of radiation exposure.

[0019] In one embodiment, the one or more ingredients for treating or preventing dehydration are selected from the group comprising sodium chloride, sodium citrate, aloe extract, or any combination of any two or more thereof.

[0020] In one embodiment, the one or more ingredients for preventing platelet activation and/or aggregation are selected from the group comprising pomegranate extract, ginger, tomato extract, grape seed extract, or any combination of any two or more thereof. [0021] In one embodiment, the one or more antioxidants are selected from the group comprising vitamin E, ascorbic acid, kiwifruit extract, acai berry extract, blueberry extract, boysenberry extract, grape extract, elderberry extract, green tea extract, or any combination of any two or more thereof.

[0022] In one embodiment the beverage further comprises an agent for stimulating glutathione production.

[0023] In one embodiment the agent for stimulating glutathione production comprises selenium, watermelon extract, or a combination thereof.

[0024] In one embodiment the beverage further comprises a blend of fruit juice concentrates and extracts. [0025] In one embodiment the blend of fruit juice concentrates and extracts has a high oxygen radical absorbance capacity (ORAC).

[0026] In one embodiment the beverage further comprises a flavouring ingredient.

[0027] In one embodiment the flavouring ingredient is selected from the group comprising kiwifruit extract, aloe extract, ginger, apple extract, vanilla, boysenberry extract, grape extract, elderberry extract, pomegranate extract, watermelon extract, or any combination of any two or more thereof.

[0028] In one embodiment the beverage further comprises a colouring agent.

[0029] In one embodiment the colouring agent is selected from the group comprising turmeric solution, green tea extract, kiwifruit extract, boysenberry extract, grape extract, elderberry extract, pomegranate extract, watermelon extract, or any combination of any two or more thereof.

[0030] In one embodiment the beverage further comprises a stabiliser.

[0031] In one embodiment the stabiliser is selected from the group comprising an antifoaming agent, malic acid, citric acid, potassium sorbate, sodium benzoate, or any combination of any two or more thereof.

[0032] In one embodiment the beverage further comprises a stimulant.

[0033] In one embodiment the stimulant comprises green tea extract, a vitamin B6 (for example, pyridoxine hydrochloride), caffeine, or any combination of any two or more thereof.

[0034] In one embodiment the beverage further comprises an anxiolytic agent.

[0035] In one embodiment the anxiolytic agent comprises L-theanine.

[0036] In one embodiment the beverage comprises one or more ingredients to treat or prevent dehydration, and one or more ingredients to prevent platelet activation and/or aggregation.

[0037] In one embodiment the one or more ingredients for treating or preventing dehydration are selected from the group comprising sodium chloride, sodium citrate, or a combination thereof, and the one or more ingredients for preventing platelet activation and/or aggregation are selected from the group comprising pomegranate extract, ginger, or any combination of any two or more thereof.

[0038] In one embodiment the beverage comprises one or more ingredients to treat or prevent dehydration, and one or more antioxidants. [0039] In one embodiment the one or more ingredients for treating or preventing dehydration are selected from the group comprising sodium chloride, sodium citrate, or any combination thereof, and the one or more antioxidants are selected from the group comprising vitamin E, ascorbic acid, kiwifruit extract, acai berry extract, blueberry extract, boysenberry extract, grape extract, elderberry extract, green tea extract, or any combination of any two or more thereof.

[0040] In one embodiment the beverage comprises one or more ingredient to treat or prevent dehydration, and one or more stimulants.

[0041] In one embodiment the one or more ingredients for treating or preventing dehydration are selected from the group comprising sodium chloride, sodium citrate, or any combination thereof, and the one or more stimulants selected from the group comprising green tea extract, caffeine, a vitamin B6 (for example, pyridoxine hydrochloride), or any combination of any two or more thereof. [0042] In one embodiment the beverage comprises from about 0.01% to about 1% w/w of each of one or more ingredients to treat or prevent dehydration, from about 0.01% to about 1% w/w of each of one or more ingredients to prevent platelet activation and/or aggregation, and from about 0.01% to about 1% w/w of each of one or more antioxidants. It should be understood that the beverage may comprise two or more, three or more, four or more, five or more, six or more, seven or more, eight or more, nine or more, or ten or more ingredients within each category, independent of the number of ingredients in other categories.

[0043] In one embodiment the one or more ingredients to treat or prevent dehydration comprise sodium chloride, sodium citrate, or a combination thereof, the one or more ingredients to prevent platelet activation and/or aggregation comprise pomegranate extract, ginger, tomato extract, grape seed extract, or a combination of any two or more thereof, and the one or more antioxidants comprise vitamin E, ascorbic acid, watermelon extract, acai extract, or a combination of any two or more thereof. [0044] In one embodiment the one or more ingredients to treat or prevent dehydration comprise sodium chloride, sodium citrate, or a combination thereof, the one or more ingredients to prevent platelet activation and/or aggregation comprises ginger, and the one or more antioxidants comprise acai extract, blueberry extract, boysenberry extract, grape extract, elderberry extract, or a combination of any two or more thereof.

[0045] In one embodiment the one or more ingredients to treat or prevent dehydration comprise sodium chloride, sodium citrate, or a combination thereof, and the one or more antioxidants comprise vitamin E, ascorbic acid, kiwifruit extract, or a combination of any two or more thereof.

[0046] In one embodiment the beverage comprises from about 0.01% to about 1% w/w of each of one or more ingredients to treat or prevent dehydration, from about 0.01% to about 1% w/w of each of one or more ingredients to prevent platelet activation and/or aggregation, from about 0.01% to about 1% w/w of each of one or more antioxidants, and further comprises one or more of from about 0.01% to about 1% w/w of each of one or more flavouring ingredients, from about 0.01% to about 1% w/w of each of one or more colouring agents, from about 0.01% to about 1% w/w of each of one or more stabilisers, from about 0.01% to about 1% w/w of each of one or more stimulants, or from about 0.01% to about 1% w/w of an anxiolytic agent, or any combination of any two or more thereof. It should be understood that the beverage may comprise two or more, three or more, four or more, five or more, six or more, seven or more, eight or more, nine or more, or ten or more ingredients within each category, independent of the number of ingredients in other categories.

[0047] In one embodiment the one or more ingredients to treat or prevent dehydration comprise sodium chloride, sodium citrate, or a combination thereof, the one or more ingredients to prevent platelet activation and/or aggregation is pomegranate extract, the one or more antioxidants comprise vitamin E, ascorbic acid, acai extract, or a combination of any two or more thereof, and the one or more colouring agents comprise pomegranate extract, watermelon extract, or a combination thereof.

[0048] In one embodiment the one or more ingredients to treat or prevent dehydration is sodium chloride, sodium citrate, or a combination thereof, the one or more ingredients to prevent platelet activation and/or aggregation is ginger, and the one or more antioxidants is acai extract, blueberry extract, boysenberry extract, grape extract, elderberry extract, or a combination of any two or more thereof, and the one or more colouring agents is acai extract, blueberry extract, or a combination thereof.

[0049] In one embodiment the one or more ingredients to treat or prevent dehydration is sodium chloride, sodium citrate, or a combination thereof, and the one or more antioxidants is vitamin E, ascorbic acid, kiwifruit extract, or a combination of any two or more thereof, and the one or more colouring agents is turmeric solution, green tea extract, or a combination thereof.

[0050] In one embodiment the beverage or one or more beverages further provide an anxiolytic effect to decrease stress and promote relaxation in a subject. [0051] In one embodiment the beverage or one or more beverages further provide an increase in energy levels in a subject.

[0052] In one embodiment the beverage or one or more beverages further provide an increase in gastrointestinal motility and digestion in a subject.

[0053] In one embodiment the beverage or one or more beverages further provide prevention or reduction in an inflammatory response in a subject.

[0054] In one embodiment the kit comprises or the method comprises administration of three or more, or four or more beverages.

[0055] In one embodiment the instructions in a kit will include instructions for diluting a concentrate or dissolving or suspending a powder to the appropriate concentration for consumption.

[0056] In one embodiment the kit comprises instructions for administering or the method comprises administering the beverage, or the two or more beverages to a subject over a period of from about 2 hours to about 6 hours, from about 2 hours to about 9 hours, from about 2 hours to about 12 hours, from about 2 hours to about 15 hours or from about 2 hours to about 18 hours.

[0057] In one embodiment the kit comprises instructions for administering or the method comprises administering a first beverage to a subject in a first period of from about 2 hours to about 6 hours, and administering a second beverage to the subject in a second period of from about 2 hours to about 6 hours, the second period being after the first period. [0058] In one embodiment the kit comprises instructions for administering or the method comprises administering a first beverage to a subject in a first period of from about 2 hours to about 6 hours, administering a second beverage to the subject in a second period of from about 2 hours to about 6 hours, and

administering a third beverage to the subject in a third period of from about 2 hours to about 6 hours, the second period being after the first period, and the third period being after the second period.

[0059] In one embodiment the subject is an airline crew member, an airline passenger, an elderly subject, or an athlete. [0060] It is intended that reference to a range of numbers disclosed herein (for example, 1 to 10) also incorporates reference to all rational numbers within that range (for example, 1, 1.1, 2, 3, 3.9, 4, 5, 6, 6.5, 7, 8, 9 and 10) and also any range of rational numbers within that range (for example, 2 to 8, 1.5 to 5.5 and 3.1 to 4.7) and, therefore, all sub-ranges of all ranges expressly disclosed herein are hereby expressly disclosed. These are only examples of what is specifically intended and all possible combinations of numerical values between the lowest value and the highest value enumerated are to be considered to be expressly stated in this application in a similar manner.

[0061] In this specification where reference has been made to patent specifications, other external documents, or other sources of information, this is generally for the purpose of providing a context for discussing the features of the invention. Unless specifically stated otherwise, reference to such external documents is not to be construed as an admission that such documents, or such sources of information, in any jurisdiction, are prior art, or form part of the common general knowledge in the art.

[0062] The invention may also be said broadly to consist in the parts, elements and features referred to or indicated in the specification of the application, individually or collectively, in any or all combinations of two or more of said parts, elements or features, and where specific integers are mentioned herein which have known equivalents in the art to which the invention relates, such known equivalents are deemed to be incorporated herein as if individually set forth. BRIEF DESCRIPTION OF THE DRAWINGS

[0063] Figure 1 is a graph showing the change in plasma volume from baseline volume following consumption of the test electrolyte beverage compared to the placebo control sample. [0064] Figure 2 is a graph showing the total urine output over a 7 hour period following consumption of the test electrolyte beverage compared to the placebo control sample.

[0065] Figure 3 is a graph showing to loss of total body water over a 7 hour period following consumption of the test electrolyte beverage compared to the placebo.

DETAILED DESCRIPTION OF THE INVENTION

[0066] The present inventors have surprisingly determined that a beverage or one or more beverages comprising a)one or more ingredients for treating or preventing dehydration, b) one or more ingredients for preventing platelet activation and/or aggregation, and c) one or more antioxidants has surprisingly beneficial effects for a subject in need thereof. Thus the present invention relates to the use of a beverage for preventing or treating dehydration, preventing platelet activation and/or aggregation, and preventing or treating the effects of free radical damage. In particular the present invention relates to the use of a beverage for preventing or reducing the risk of thrombosis in a subject. Use of the beverage may result in any one or more of prevention or treatment of dehydration, prevention or reduction in the risk of developing deep vein thrombosis, prevention or treatment of the effects of free radical damage, decreased stress and increased relaxation, increased in energy levels, reduced nausea or vomiting associated with motion sickness, increased gastrointestinal motility and digestion, or prevention or reduction in an inflammatory response in a subject during airline travel, following surgery or following exercise.

1. Definitions

[0067] The term "comprising" as used in this specification means "consisting at least in part of". When interpreting statements in this specification which include that term, the features, prefaced by that term in each statement or claim, all need to be present but other features can also be present. Related terms such as "comprise" and "comprised" are to be interpreted in the same manner. [0068] The phrase "treating or preventing dehydration" and its grammatical equivalents and derivatives, refers to achieving or maintaining a state of hydration, or avoiding the onset of clinical signs of dehydration.

[0069] The phrase "preventing platelet activation and/or aggregation" and its grammatical equivalents and derivatives, refers to preventing changes in physiological conditions that may lead to activation and/or aggregation of platelets. Examples of physiological conditions that may be prevented include damage to endothelium, stimulation of platelets to undergo a conformational change by activation factors, release of factors from platelets and adhesion of platelets to endothelium.

[0070] The phrase "treating or preventing the effects free radical damage" and its grammatical equivalents and derivatives, refers to prevention of accumulation of reactive oxygen species that may result in damage to cells or tissues.

[0071] A "subject" is an animal, preferably a mammal, more preferably a mammalian companion animal or human. Preferred companion animals include cats, dogs and horses. In one embodiment the subject is a human. Preferably the human is an adult, a child, or an infant.

[0072] The term "treat" and its derivatives should be interpreted in their broadest possible context. The term should not be taken to imply that a subject is treated until total recovery. Accordingly, "treat" broadly includes amelioration and/or prevention of the onset of the symptoms or severity of a particular condition.

2. Ingredients for treating and preventing dehydration

[0073] Ingredients suitable for use in treating and preventing hydration include sodium chloride and sodium citrate in a hypotonic solution, optionally combined with further suitable electrolytes.

3. Ingredients for preventing platelet activation and/or

aggregation

[0074] Prevention of platelet activation and/or aggregation is achieved using one or more ingredients selected from the group comprising pomegranate extract, ginger, tomato extract or grape seed extract. Any combination of any two or more of the above listed ingredients may also be used in the beverage of the invention. Sodium chloride and sodium citrate are also useful ingredients for assisting circulation by preventing an increase in blood viscosity.

4. Antioxidant ingredients

[0075] Protection from free radical damage is achieved using one or more ingredients selected from the group comprising vitamin E, ascorbic acid, kiwifruit extract, acai berry extract, blueberry extract, boysenberry extract, grape extract, elderberry extract, or green tea extract. Any combination of two or more of the above listed ingredients may also be used in the beverage of the invention.

Selenium and watermelon extract can provide protection from radiation exposure through stimulation of production of glutathione in the body.

5. Beverage compositions

[0076] Provided is a beverage comprising a hydration base component, a component for preventing platelet activation and/or aggregation, and an antioxidant component. The components are combined in proportions to provide an optimal therapeutic outcome as well as ensure palatability of the beverage.

Specifically, the ingredients are combined in a way that reduces any undesirable tastes or textures associated with mixing the ingredients, while maximising the effectiveness of each of the component ingredients. The beverage may be in a liquid, concentrate or powder form. In one embodiment the beverage is a liquid. In another embodiment the beverage is a concentrate. In another embodiment the beverage is a powder. Powders may be in a bulk format or sachet, for example.

[0077] In one embodiment the beverage comprises one or more ingredients for preventing or treating dehydration, one or more ingredients for preventing platelet activation and/or aggregation, and one or more antioxidants. [0078] In one embodiment of a liquid beverage, the concentration of each of any one or more ingredients for preventing or treating dehydration is from about 0.01% to about 1% w/w. It should be understood that the beverage may comprise two or more, or three or more ingredients for treating or preventing dehydration.

[0079] In one embodiment the concentration of each of any one or more ingredients for preventing platelet activation and/or aggregation is from about

0.01% to about 1% w/w. It should be understood that the beverage may comprise two or more, three or more, four or more or five or more ingredients for preventing platelet activation and/or aggregation. [0080] In one embodiment the concentration of the one or more antioxidants is from about 0.01% to about 0.1% w/w. It should be understood that the beverage may comprise two or more, three or more, four or more or five or more

antioxidants. [0081] When the beverage composition is a concentrate or powder, the amount of each component present will be such that, when the concentrate is diluted or the powder is dissolved or suspended for consumption, the concentration of

components will be as recited above.

[0082] In one embodiment, the liquid base of the beverage comprises water. Preferably the water is purified or distilled. Where the beverage composition is a concentrate or powder, the liquid base may be added to the concentrate or powder to dilute the concentrate or dissolve or suspend the powder to the appropriate concentration for consumption. The appropriate concentration for consumption may depend on the preferences of the subject but will otherwise be a concentration that results in the concentration of components as recited above.

[0083] In one embodiment beverage comprises a wide variety of vitamins and minerals. The amounts of vitamins and minerals to be used are preferably those typical of liquid nutritional formulations known to those skilled in the art.

[0084] In one embodiment, a stimulant may be added to the beverage. The stimulant may be caffeine, vitamin B6 (for example, pyridoxine hydrochloride), green tea extract, or any combination thereof.

[0085] In one embodiment of a liquid beverage, the beverage is maintained at a predetermined pH by the addition of an acidifying agent. Examples of acidifying agents include malic acid, citric acid, or a combination thereof. In one embodiment the beverage has a pH of about 3 to about 6, about 3 to about 5, or about 4.

[0086] In one embodiment the beverage comprises a preservative, optionally selected from potassium sorbate, sodium benzoate, or a combination thereof. In one embodiment the beverage further comprises a stabiliser, optionally selected from the group comprising an antifoaming agent, malic acid, citric acid, potassium sorbate, sodium benzoate, or any combination of any two or more thereof. [0087] In one embodiment the beverage comprises a flavouring agent.

Flavouring agents suitable for use in the beverage of the invention include, but are not limited to, kiwifruit extract, aloe extract, ginger, apple extract, vanilla, boysenberry extract, grape extract, elderberry extract, pomegranate extract, watermelon extract, or any combination of any two or more thereof.

[0088] In one embodiment the beverage comprises a colouring agent.

Colouring agents suitable for use in the beverage of the invention include, but are not limited to, turmeric solution, green tea extract, kiwifruit extract, boysenberry extract, grape extract, elderberry extract, pomegranate extract, watermelon extract, or any combination of any two or more thereof.

[0089] In one embodiment the beverage further comprises an anxiolytic agent. In one embodiment the anxiolytic agent is L-theanine.

[0090] The beverages described herein can be prepared by dissolving the one or more ingredients for preventing or treating dehydration, the one or more ingredients for preventing platelet activation and/or aggregation, the one or more antioxidants the one or more flavouring ingredients, the one or more colouring agents, and the one or more stabilisers with a predetermined volume of filtered or distilled water. The solution is mixed and adjusted to the desired pH by addition of suitable acidifying agents, including but not limited to for example malic acid, or citric acid, or a combination thereof.

[0091] In another embodiment the beverage can be prepared by premixing a first solution comprising one or more ingredients for preventing or treating dehydration and water, premixing a second solution comprising one or more ingredients for preventing platelet activation and/or aggregation and water, premixing a third solution comprising one or more antioxidants and water, combining the three separate solutions, adding water and the desired flavouring ingredients, colouring agents, and stabilisers to the desired volume, and adjusting to the desired pH by addition of suitable acidifying agents.

[0092] In yet another embodiment the beverage can be prepared by mixing suitable powders providing each of the desired ingredients to prepare one or more beverage powders. Powders may be prepared by drying liquid compositions, such as through spray drying or lyophilisation. Powder compositions may be suspended in a liquid to prepare a beverage concentrate or a liquid beverage. 6. Therapeutic outcomes and methods of assessing therapeutic outcomes

[0093] Consumption of a beverage of the invention by a subject may result in any one or more of the following : a) prevention or treatment of dehydration,

b) prevention or reduction in the risk of developing deep vein thrombosis, c) prevention of platelet activation and/or aggregation,

d) maintained inactivated platelet morphology,

e) increase in extracellular fluid volume,

f) decrease in haematocrit,

g) prevention of binding of fibrinogen to platelet GPIIb/IIIa receptors, h) prevention of binding of von Willibrand factor to platelet GPIIb/IIIa

receptors,

i) inhibition of production of thromboxane A2,

J) prevention of formation of a platelet plug,

k) reduction of activation of the extrinsic coagulation cascade,

1) reduction of synthesis of thrombin,

m) reduction of synthesis of fibrin,

n) increase in the systemic circulation of antioxidant molecules,

o) prevention or treatment of the effects of free radical damage

P) decreased stress,

q) increased relaxation,

r) increased in energy levels,

s) reduced nausea or vomiting associated with motion sickness, t) increased gastrointestinal motility and digestion, or

u) prevention or reduction in an inflammatory response.

[0094] The method of achieving the above effects comprises the step of administering to a subject in need thereof an effective amount of a beverage of the invention, as described herein, according to methods as described herein. It should be understood that in some embodiments consumption of a beverage of the invention by a subject may result in at least maintenance of one of the above effects. For example, maintaining extracellular fluid volume, or maintaining gastrointestinal motility and digestion. [0095] The efficacy of a beverage useful according to the invention can be evaluated both in vitro and in vivo. Briefly, in one embodiment a candidate beverage can be tested for its ability, to for example, prevent platelet activation and/or aggregation. For in vivo studies, a beverage can be fed to or administered to a subject and its effects on treating or preventing dehydration, preventing platelet activation and/or aggregation, and preventing or treating the effects of free radical damage then assessed. Based on the results, an appropriate dosage range and administration route can be determined.

6.1 Prevention or treatment of dehydration

[0096] Assessment of dehydration status in a subject can be determined by measuring blood plasma volume, haematocrit, urine output and Bioimpedence analysis.

6.2 Prevention of platelet activation and/or aggregation

[0097] Assessment of platelet activation and/or aggregation can be achieved by measuring clotting time.

[0098] Coagulation can be assessed by measuring the activated partial thromboplastin time (APTT) or Prothrombin time (PT), or by conducting a D-dimer assay or a Platelet Function Assessment. Altered APTT and PT indicate an altered risk of haemorrhage or an altered clotting ability. 6.3 Prevention or treatment of the effects of free radical damage

[0099] Oxidative stress as a result of exposure to radiation leading to free radical damage can be assessed by measuring the Advanced Oxidative Protein Products (OAPP) in a plasma sample. Increased levels of OAPP suggest oxidative damage, thus preventing of free radical damage aims to reduce the levels of OAPP in blood.

[00100] Another method for assessing the effectiveness of preventing free radical damage is by measuring the levels of antioxidants in systemic circulation. Increased concentrations of antioxidising agents indicate increased protection from free radical damage and oxidative stress associated with exposure to free radicals. [00101] Various aspects of the invention will now be illustrated in non-limiting ways by reference to the following examples. EXAMPLES

Example 1: Preparation of electrolyte beverages

[00102] Three beverages were prepared as described below, comprising ingredients as summarised in Table 1, with water and optional stabilisers and acidifying agents.

[00103] Beverage 1 was prepared by dissolving carbohydrate with a solution of predetermined volume comprising high ORAC fruit concentrates and extracts. A hydration base was added to the solution, and mixed. Vitamins C and E, L- theanine, anti-platelet agents and preservatives were added. The pH was adjusted with suitable acidifying agents. Additional flavours and colouring agents were adjusted to achieve the desired colour and flavour.

[00104] Beverage 2 was prepared by dissolving carbohydrate with a solution of predetermined volume comprising high ORAC fruit concentrates and extracts. A hydration base was added to the solution, and mixed. Selenium, Vitamins C and E, anti-platelet agents and preservatives were added. The pH was adjusted with suitable acidifying agents. Additional flavours and colouring agents were adjusted to achieve the desired colour and flavour.

[00105] Beverage 3 was prepared by dissolving carbohydrate with a solution of predetermined volume comprising high ORAC fruit concentrates and extracts. A hydration base was added to the solution, and mixed. Selenium, Vitamins B6, C and E, caffeine, anti-platelet agents and preservatives were added. The pH was adjusted with suitable acidifying agents. Additional flavours and colouring agents were adjusted to achieve the desired colour and flavour.

Table 1: Beverage compositions

g per g per g per

Beverage 1 Beverage 2 Beverage 3

lOOmL lOOmL lOOmL

Pomegranate

4.8000 Boysenberry JC 3.4380 Kiwifruit JC 4.0000 JC

Watermelon

1.2000 Grape JC 1.7100 Apple JC 2.0000 JC

Bioactive

tomato 0.9100 Elderberry JC 0.8550 Sodium citrate 0.3040 extract

Sodium

0.3040 Sodium citrate 0.3040 Sodium Chloride 0.1780 citrate Sodium

0.1780 Acai extract 0.2100 Aloe extract 0.1000 Chloride

Ginger Green tea

0.1250 Blueberry 0.2100 0.0500 infusion extract

Grape Seed

0.1000 Sodium Chloride 0.1780 Vitamin C 0.0500 extract

Turmeric Nat

Acai extract 0.0750 Ginger infusion 0.1250 0.0450

Liquid

Vitamin C 0.0500 Vitamin C 0.0500 Vitamin E 0.0200

Grape Seed

Vitamin E 0.0200 0.0250 Caffeine 0.0130

Extract

L-Theanine 0.0150 Vitamin E 0.0200 Vitamin B6 0.0013

L L

0.0001285 0.0001285 selenomethionine selenomethionine

Example 2: Efficacy of an electrolyte beverage for rehydrating and

protecting from thrombosis

[00106] Three 330 mL electrolyte beverages were prepared as described above. A placebo control beverage was prepared comprising water, flavouring ingredients, colouring agents and preservatives similar to those used for the three electrolyte beverages.

[00107] Twelve recreationally active male subjects aged 23-49 years were selected to participate in the trial. Exclusion criteria for the trial included a

requirement to take cardiovascular medication or vitamin supplementation, a history of venous thrombosis or any abnormality of blood clotting, and known overt cardiovascular disease, a cardiac pacemaker, smoking, or an inability to sit for prolonged periods.

[00108] Pre-trial investigations of physical activity and dietary, hydration and stimulant consumption were undertaken. Subjects were also asked to not consume alcohol or perform strenuous exercise in the 24 hour period preceding the trial.

[00109] Subjects were placed in a chamber specifically-designed to mimic an "inflight" environment. The environment conditions within the chamber were 24.2°C with 30% relative humidity. Each subject was provided with two low-sodium snacks during the trial. Throughout the 7 hour duration of the trial, subjects consumed the three electrolyte beverages. The first beverage was consumed 1 hour after entering the chamber. The remaining two beverages were consumed at 3 hourly intervals. Subjects were restricted to two 10-minute periods of movement throughout the 7 hour trial

[OO l lO] Risk of developing a deep vein thrombosis, autonomic and

cardiovascular physiological changes, fluid regulation, cognition and perception of wellness were analysed pre, during and post trial using the following objective measures.

[00111] Blood samples were obtained to measure D-dimer concentration and changes to blood volume using haematocrit and haemoglobin concentrations were measured to assess DVT risk. [00112] Changes in heart rate were used to assess relative and absolute parasympathetic and sympathetic activities.

[00113] Changes in body mass, plasma and urine electrolyte and creatinine concentrations, ingested and urinary volumes and urine specific gravity were measured to assess fluid regulation. [00114] Cognitive assessments using the Stroop test as well as mood and general feeling were also assessed.

[00115] The results of the trial show that consumption of the three electrolyte beverages maintained fluid balance and plasma volume more effectively than the control beverage of the same volume. [00116] The test beverages achieved a 4.1% (±3.5%) increase in plasma volume compared to the placebo beverage which achieved a 1.1% (±2.9%) increase, as shown in Figure 1. Clotting time increased by 10 (±22 seconds) compared to 5 (± 17 seconds) for the placebo beverage.

[00117] Heart rate did not vary between the test beverage and control beverage. Similarly autonomic function, as measured though parasympathetic and

sympathetic activity, were not adversely affected following consumption of either beverage.

[00118] Limb and ankle girth measurements indicated that consumption of the test beverage resulted in a smaller increase in size, suggesting a reduction in oedema in subjects consuming the test beverage compared to those consuming the placebo beverage.

[00119] Total urine output during the trial was significantly lower in subjects consuming the test beverage (1.05 ± 0.48L) compared to those consuming the placebo beverage (1.28 ± 0.34L), as shown in Figure 2. Bioimpedence analysis showed that subjects consuming the test beverage more effectively prevented loss of total body water during the trial compared to those subjects consuming the placebo beverage, as shown in Figure 3.

[00120] Results of the Stroop test showed that cognitive function did not significantly differ between the two beverages. Mean reaction time was slightly better in subjects consuming the test beverage compared to subjects consuming the placebo beverage.

Example 3: Analysis of user acceptability following consumption of an electrolyte beverage [00121] Forty five participants were asked to consume the three test beverages, as described in Example 1, and comment on their flavour, mouthfeel and colour using a numbered scale of between 1 and 9 (1 = dislike extremely, 9 = like extremely).

[00122] Most participants scored each beverage a 7 or above for all three factors, indicating that the test beverages are widely accepted and enjoyable to drink.

Claims

WHAT WE CLAIM IS

1. A beverage composition comprising

(a) one or more ingredients for treating or preventing dehydration,

(b) one or more ingredients for preventing platelet activation and/or aggregation, and

(c) one or more antioxidants the beverage composition being in liquid or powder form.

2. A method of treating or preventing dehydration, treating or preventing platelet activation and/or aggregation, and treating or preventing the effects of free radical damage in a subject, the method comprising administering to a subject in need thereof a therapeutically effective amount of a beverage comprising

(a) one or more ingredients for treating or preventing dehydration,

(c) one or more antioxidants.

3. A beverage composition comprising

(a) one or more ingredients for treating or preventing dehydration,

(c) one or more antioxidants, for treating or preventing dehydration, treating or preventing platelet activation and/or aggregation, and treating or preventing the effects of free radical damage in a subject, the beverage composition being in liquid or powder form.

4. A kit comprising

(a) two or more beverage compositions, each beverage composition comprising

(i) one or more ingredients for treating or preventing dehydration, (ii) one or more ingredients for treating or preventing platelet activation and/or aggregation, and

(iii) one or more antioxidants, each beverage composition being in liquid or powder form, and

(b) instructions for administering the two or more beverage compositions to a subject in need thereof over a period of from about 2 hours to about 20 hours.

5. A method of treating or preventing dehydration, treating or preventing platelet activation and/or aggregation, and treating or preventing the effects of free radical damage in a subject, the method comprising

(a) providing two or more beverages, each beverage comprising

(i) one or more ingredients for treating or preventing dehydration,

(ii) one or more ingredients for treating or preventing platelet

activation and/or aggregation, and

(iii) one or more antioxidants, and

(b) administering the two or more beverages to a subject in need thereof over a period of from about 2 hours to about 20 hours.

6. A kit comprising

(a) two or more beverage compositions, each beverage composition comprising :

(i) one or more ingredients for treating or preventing dehydration,

(ii) one or more ingredients for treating or preventing platelet

activation and/or aggregation, and

(iii) one or more antioxidants, each beverage composition being in liquid or powder form, and (b) instructions for administering the two or more beverage compositions to a subject in need thereof over a period of from about 2 hours to about 20 hours, for treating or preventing dehydration, treating or preventing platelet activation and/or aggregation, and treating or preventing the effects of free radical damage in a subject.

7. A beverage, method or kit of any one of the preceding claims wherein administration of the beverage or of the two or more beverages provides hydration, protects from thrombosis, and protects from the effects of radiation exposure.

8. A beverage, method or kit of any one of the preceding claims wherein administration of the beverage or of the two or more beverages results in

(a) one or more of an increase in extracellular fluid volume or a decrease in haematocrit, and

(b) one or more of maintaining an inactivated platelet morphology,

(c) one or more of an increase in the systemic circulation of antioxidant molecules, to provide hydration, protect from thrombosis, and protect from the effects of radiation exposure.

9. A beverage, method or kit of any one of the preceding claims wherein the one or more ingredients for treating or preventing dehydration are selected from the group comprising sodium chloride, sodium citrate, aloe extract, or any combination of any two or more thereof.

10. A beverage, method or kit of any one of the preceding claims wherein the one or more ingredients for preventing platelet activation and/or aggregation are selected from the group comprising pomegranate extract, ginger, tomato extract, grape seed extract, or any combination of any two or more thereof.

11. A beverage, method or kit of any one of the preceding claims wherein the one or more antioxidants are selected from the group comprising vitamin E, ascorbic acid, kiwifruit extract, acai berry extract, blueberry extract, boysenberry extract, grape extract, elderberry extract, green tea extract, or any combination of any two or more thereof.

12. A beverage, method or kit of any one of the preceding claims wherein the beverage further comprises an agent for stimulating glutathione production.

13. A beverage, method or kit of claim 12 wherein the agent for stimulating glutathione production comprises selenium, watermelon extract, or a combination thereof.

14. A beverage, method or kit of any one of the preceding claims wherein the beverage further comprises a blend of fruit juice concentrates and extracts.

15. A beverage, method or kit of claim 14 wherein the blend of fruit juice concentrates and extracts has a high oxygen radical absorbance capacity (ORAC).

16. A beverage, method or kit of any one of the preceding claims wherein the beverage further comprises a flavouring ingredient.

17. A beverage, method or kit of claim 14 wherein the flavouring ingredient is selected from the group comprising kiwifruit extract, aloe extract, ginger, apple extract, vanilla, boysenberry extract, grape extract, elderberry extract,

pomegranate extract, watermelon extract, or any combination of any two or more thereof.

18. A beverage, method or kit of any one of the preceding claims wherein the beverage further comprises a colouring agent.

19. A beverage, method or kit of claim 18 wherein the colouring agent is selected from the group comprising turmeric solution, green tea extract, kiwifruit extract, boysenberry extract, grape extract, elderberry extract, pomegranate extract, watermelon extract, or any combination of any two or more thereof.

20. A beverage, method or kit of any one of the preceding claims wherein the beverage further comprises a stabiliser.

21. A beverage, method or kit of claim 20 wherein the stabiliser is selected from the group comprising an antifoaming agent, malic acid, citric acid, potassium sorbate, sodium benzoate, or any combination of any two or more thereof.

22. A beverage, method or kit of any one of the preceding claims wherein the beverage further comprises a stimulant.

23. A beverage, method or kit of claim 22 wherein the stimulant comprises green tea extract, a vitamin B6, caffeine, or any combination of any two or more thereof.

24. A beverage, method or kit of any one of the preceding claims wherein the beverage further comprises an anxiolytic agent.

25. A beverage, method or kit of claim 24 wherein the anxiolytic agent comprises L-theanine.

26. A beverage, method or kit of any one of the preceding claims wherein the beverage comprises one or more ingredients to treat or prevent dehydration, and one or more ingredients to prevent platelet activation and/or aggregation.

27. A beverage, method or kit of claim 26 wherein the one or more ingredients for treating or preventing dehydration are selected from the group comprising sodium chloride, sodium citrate, or a combination thereof, and the one or more ingredients for preventing platelet activation and/or aggregation are selected from the group comprising pomegranate extract, ginger, or any combination of any two or more thereof.

28. A beverage, method or kit of any one of the preceding claims wherein the beverage comprises one or more ingredients to treat or prevent dehydration, and one or more antioxidants.

29. A beverage, method or kit of claim 28 wherein the one or more ingredients for treating or preventing dehydration are selected from the group comprising sodium chloride, sodium citrate, or any combination thereof, and the one or more antioxidants are selected from the group comprising vitamin E, ascorbic acid, kiwifruit extract, acai berry extract, blueberry extract, boysenberry extract, grape extract, elderberry extract, green tea extract, or any combination of any two or more thereof.

30. A beverage, method or kit of any one of the preceding claims wherein the beverage comprises one or more ingredient to treat or prevent dehydration, and one or more stimulants.

31. A beverage, method or kit of claim 30 wherein the one or more ingredients for treating or preventing dehydration are selected from the group comprising sodium chloride, sodium citrate, or any combination thereof, and the one or more stimulants selected from the group comprising green tea extract, caffeine, a vitamin B6, or any combination of any two or more thereof.

32. A beverage, method or kit of any one of the preceding claims wherein the beverage comprises from about 0.01% to about 1% w/w of each of one or more ingredients to treat or prevent dehydration, from about 0.01% to about 1% w/w of each of one or more ingredients to prevent platelet activation and/or aggregation, and from about 0.01% to about 1% w/w of each of one or more antioxidants.

33. A beverage, method or kit of claim 32 wherein the one or more ingredients to treat or prevent dehydration comprise sodium chloride, sodium citrate, or a combination thereof, the one or more ingredients to prevent platelet activation and/or aggregation comprise pomegranate extract, ginger, tomato extract, grape seed extract, or a combination of any two or more thereof, and the one or more antioxidants comprise vitamin E, ascorbic acid, watermelon extract, acai extract, or a combination of any two or more thereof.

34. A beverage, method or kit of claim 32 wherein the one or more ingredients to treat or prevent dehydration comprise sodium chloride, sodium citrate, or a combination thereof, the one or more ingredients to prevent platelet activation and/or aggregation comprises ginger, and the one or more antioxidants comprise acai extract, blueberry extract, boysenberry extract, grape extract, elderberry extract, or a combination of any two or more thereof.

35. A beverage, method or kit of claim 32 wherein the one or more ingredients to treat or prevent dehydration comprise sodium chloride, sodium citrate, or a combination thereof, and the one or more antioxidants comprise vitamin E, ascorbic acid, kiwifruit extract, or a combination of any two or more thereof.

36. A beverage, method or kit of any one of the preceding claims wherein the beverage comprises from about 0.01% to about 1% w/w of each of one or more ingredients to treat or prevent dehydration, from about 0.01% to about 1% w/w of each of one or more ingredients to prevent platelet activation and/or aggregation, from about 0.01% to about 1% w/w of each of one or more antioxidants, and further comprises one or more of from about 0.01% to about 1% w/w of each of one or more flavouring ingredients, from about 0.01% to about 1% w/w of each of one or more colouring agents, from about 0.01% to about 1% w/w of each of one or more stabilisers, from about 0.01% to about 1% w/w of each of one or more stimulants, or from about 0.01% to about 1% w/w of an anxiolytic agent, or any combination of any two or more thereof.

37. A beverage, method or kit of claim 36 wherein the one or more ingredients to treat or prevent dehydration comprise sodium chloride, sodium citrate, or a combination thereof, the one or more ingredients to prevent platelet activation and/or aggregation is pomegranate extract, the one or more antioxidants comprise vitamin E, ascorbic acid, acai extract, or a combination of any two or more thereof, and the one or more colouring agents comprise pomegranate extract, watermelon extract, or a combination thereof.

38. A beverage, method or kit of claim 36 wherein the one or more ingredients to treat or prevent dehydration is sodium chloride, sodium citrate, or a combination thereof, the one or more ingredients to prevent platelet activation and/or aggregation is ginger, and the one or more antioxidants is acai extract, blueberry extract, boysenberry extract, grape extract, elderberry extract, or a combination of any two or more thereof, and the one or more colouring agents is acai extract, blueberry extract, or a combination thereof.

39. A beverage, method or kit of claim 36 wherein the one or more ingredients to treat or prevent dehydration is sodium chloride, sodium citrate, or a combination thereof, and the one or more antioxidants is vitamin E, ascorbic acid, kiwifruit extract, or a combination of any two or more thereof, and the one or more colouring agents is turmeric solution, green tea extract, or a combination thereof.

40. A beverage, method or kit of any one of the preceding claims wherein the beverage or one or more beverages further provide an anxiolytic effect to decrease stress and promote relaxation in a subject.

41. A beverage, method or kit of any one of the preceding claims wherein the beverage or one or more beverages further provide an increase in energy levels in a subject.

42. A beverage, method or kit of any one of the preceding claims wherein the beverage or one or more beverages further provide an increase in gastrointestinal motility and digestion in a subject.

43. A beverage, method or kit of any one of the preceding claims wherein the beverage or one or more beverages further provide prevention or reduction in an inflammatory response in a subject.

44. A kit of any one of the preceding claims wherein the kit comprises or the method comprises administration of three or more, or four or more beverages.

45. A kit of any one of the preceding claims wherein the kit comprises instructions for administering or the method comprises administering the beverage, or the two or more beverages to a subject over a period of from about 2 hours to about 6 hours, from about 2 hours to about 9 hours, from about 2 hours to about 12 hours, from about 2 hours to about 15 hours or from about 2 hours to about 18 hours.

46. A kit of any one of the preceding claims wherein the kit comprises instructions for administering or the method comprises administering a first beverage to a subject in a first period of from about 2 hours to about 6 hours, and administering a second beverage to the subject in a second period of from about 2 hours to about 6 hours, the second period being after the first period.

47. A kit of any one of the preceding claims wherein the kit comprises instructions for administering or the method comprises administering a first beverage to a subject in a first period of from about 2 hours to about 6 hours, administering a second beverage to the subject in a second period of from about 2 hours to about 6 hours, and administering a third beverage to the subject in a third period of from about 2 hours to about 6 hours, the second period being after the first period, and the third period being after the second period.

48. A beverage, method or kit of any one of the preceding claims wherein the subject is an airline crew member, an airline passenger, an elderly subject, or an athlete.