AU2008229631A1

AU2008229631A1 - Body fluid supplement compositions and their use in subjects undergoing medical treatment

Info

Publication number: AU2008229631A1
Application number: AU2008229631A
Authority: AU
Inventors: Sai Ying Ko
Original assignee: Felton Grimwade & Bosistos Pty Ltd
Current assignee: Felton Grimwade & Bosisto's Pty Ltd
Priority date: 2007-03-16
Filing date: 2008-03-14
Publication date: 2008-09-25
Also published as: AU2008229632A1; WO2008113114A1; WO2008113115A1

Description

WO 2008/113114 PCT/AU2008/000371 Body Fluid Supplement Compositions and Their Use in Subjects Undergoing Medical Treatment Technical Field 5 The present invention relates to a body fluid supplement composition and uses thereof. Background of the Invention In order to maintain its physical capabilities, the human body requires optimal amounts of water, electrolytes, carbohydrate and a range of other minerals/nutrients. io Where these optimal amounts are disturbed, physical and mental capabilities may be compromised. The present inventor has developed a body fluid supplement composition which, surprisingly, finds utility in treating a number of ailments and conditions. Summary of the Invention is In a first aspect, the present invention provides an aqueous beverage composition comprising the following components: (i) sodium ions; (ii) potassium ions; (iii) magnesium ions; 20 (iv) phosphate ions; (v) citrate ions; (vi) vitamin B6; and (vii) carbohydrate. The composition may consist essentially of the above components. 25 The sodium ions may be present in an amount between about 10 meq. and about 35 meq. per litre of the beverage composition. The potassium ions may be present in an amount between about 5 meq. and about 30 meq. per litre of the beverage composition. The magnesium ions may be present in an amount between about 5 meq. and about 30 25 meq. per litre of the beverage composition.

WO 2008/113114 PCT/AU2008/000371 -2 The phosphate ions may be present in an amount between about 1 meq. and about 55 meq. per litre of the beverage composition. The citrate ions may be present in an amount between about 0.1 meq. and about 45 meq. per litre of the beverage composition. 5 The vitamin B6 may be present in an amount between about 0.1 mg and about 200 mg per litre of the beverage composition. The carbohydrate may be present in an amount between about 2% and about 20% by weight of the total beverage composition (w/w). The carbohydrate may be a monosaccharide or a disaccharide, or a mixture thereof. 10 In one embodiment, the carbohydrate is a monosaccharide, for example glucose, fructose, mannose or galactose, or a mixture thereof. The sodium ions may be present by inclusion of sodium phosphate, sodium chloride, sodium citrate, sodium sulfate or any combination thereof in the beverage composition. The potassium ions may be present by inclusion of potassium chloride, potassium 15 citrate, potassium phosphate, potassium sulfate or any combination thereof in the beverage composition. The magnesium ions may be present by inclusion of magnesium sulfate, magnesium phosphate, magnesium citrate, magnesium- chloride or any combination thereof in the beverage composition. 20 The phosphate ions may be present by inclusion of sodium phosphate, potassium phosphate, magnesium phosphate or any combination thereof in the beverage composition. The citrate ions may be present by inclusion of sodium citrate, potassium citrate, magnesium citrate or any combination thereof in the beverage composition. The composition may further comprise vitamin C. 25 The vitamin C may be present in an amount between about 30 mg and about 2000 mg per litre of the beverage composition. In one embodiment, the beverage composition may be isotonic. In another embodiment, the beverage composition may have a pH in the range of about 3.0 to about 5.0, or from about 3.0 to about 4.5, or from about 3.0 to about 4.0, or 30 from about 3.2 to about 4.0, or from about 3.2 to about 3.8, or from about 3.4 to about 3.8. The composition may be dried to form, for example, a powder, granules or tablets.

WO 2008/113114 PCT/AU2008/000371 -3 In a second aspect, the present invention provides a concentrate for use in preparing an aqueous beverage composition, the concentrate comprising a mixture of components in amounts such that when constituted with water or an appropriate liquid to form the aqueous beverage composition, the following proportions of the components are obtained: 5 (i) sodium ions in an amount between about 10 meq. and about 35 meq. per litre of the beverage composition. (ii) potassium ions in an amount between about 5 meq and about 30 meq. per litre of the beverage composition. (iii) magnesium ions in an amount between about 5 meq. and about 25 meq. per io litre of the beverage composition. (iv) phosphate ions in an amount between about 1 meq. and about 55 meq. per litre of the beverage composition. (v) citrate ions in an amount between about 0.1 meq. and about 45 meq. per litre of the beverage composition. 15 (vi) vitamin B6 in an amount between about 0.1 rmg and 200 mg per litre of the beverage composition; and (viii) carbohydrate in an amount between about 2% and about 20% by weight of the total beverage composition. The concentrate may be in the form of a powder, granules or tablets. 20 In a third aspect, the present invention provides a process for the manufacture of an aqueous beverage composition, wherein the concentrate of the second aspect is mixed with a quantity of water, or an appropriate liquid, sufficient to provide a solution suitable for consumption by drinking. In a fourth aspect, the present invention provides an aqueous beverage composition 25 whenever prepared by the process of the third'aspect. In a fifth aspect, the beverage composition of the invention comprises between about 12 meq. and about 32 meq. per litre of sodium ions, between about 10 meq. and about 25 meq. per litre of potassium ions, between about 7 meq. and about 20 meq. per litre of magnesium ions, between about 5 meq. and 25 meq. per litre of phosphate ions, between 1 30 and 15 meq. per litre of citrate ions; between 20 mg and 40 mg per litre of vitamin B6 and between 10% and 20% glucose (w/w). This composition may additionally comprise WO 2008/113114 PCT/AU2008/000371 -4 vitamin C in an amount between' about 250 mg and about 1200 mg per litre. The composition may have a pH of about 3.4 to 3.8. In a sixth aspect, the beverage composition of the invention comprises about 22 meq. per litre of sodium ions, about 17 meq. per litre of potassium ions, about 13 meq. per litre 5 of magnesium ions, about 10 meq. per litre of phosphate ions, about 5 meq. per litre of citrate ions, about 20 rug per litre. of vitaiiin B6 and about 16% glucose (w/w). The composition may have a pH of about 3.4 to 3.8. In a seventh aspect, the beverage composition of the invention comprises about 22 meq. per litre of sodium ions, about 17 meq. per litre of potassium ions, about 13 meq. per 10 litre of magnesium ions, about 10 meq. per litre of phosphate ions, about 5 meq. per litre of citrate ions, 20 rug per litre of vitamin B6,.16% glucose (w/w), and 480 mg per litre of vitamin C. The composition may have a pH of about 3.4 to 3.8. In an eighth aspect, the beverage composition of the invention comprises about 22 meq. per litre of sodium ions, about 17 meq. per litre of potassium ions, about 13 meq. per 15 litre of magnesium ions, about 10 meq. per litre of phosphate ions, about 5 meq. per litre of citrate ions, about 40 mug per litre of vitamin B6, about 16% glucose (w/w), and 1000 mg per litre of vitamin C. The composition may have a pH of about 3.4 to 3.8. In a ninth aspect, the beverage composition of the invention comprises about 22 meq. per litre of sodium ions, about 17 meq. per litre of potassium ions, about 13 meq. per litre 20 of magnesium ions, about 10 meq. per litre of phosphate ions, about 5 meq. per litre of citrate ions, about 40 rug per litre of vitamin B6, about 16% glucose (w/w), and about 480 mg per litre of vitamin C. The composition may have a pH of about 3.4 to 3.8. In a tenth aspect, the beverage composition of the invention comprises between about 12 meq. and about 32 meq. per litre of sodium ions, between about 10 meq. and about 25 25 meq. per litre of potassium ions, between about 12 meq. and about 22 meq. per litre of magnesium ions, between about 10 meq. and about 20 meq. per litre of phosphate ions, between 0.1 meq. and about 8 meq. per litre of citrate ions, between about 50 rug and about 200 mg per litre of vitamin C, between about 10 and 80 rug per litre of vitamin B6, and between about 10% and about 20% glucose (w/w). The pH of this composition may be 30 about 3.4 to about 3.8. In an eleventh aspect, the beverage composition of the invention comprises between WO 2008/113114 PCT/AU2008/000371 -5 about 17 meq. and about 27 meq. per litre of sodium ions, between about 13 meq. and about 21 meq. per litre of potassium ions, between about 13 meq. and about 21 meq. per litre of magnesium ions, between about 11 meq. and about 17 meq. per litre of phosphate ions, between about 0.25 meq. and about 5 meq. per litre of citrate ions, between about 100 5 mg and about 200 mg per litre of vitamin C, between about 20 and 60 mg per litre of vitamin B6, and between about 14% and about 18% glucose (w/w). The pH of this composition may be about 3.4 to about 3.8. In a twelfth aspect, the beverage composition of the invention comprises about 22 meq. per litre of sodium ions, about 17 meq. per litre of potassium ions, about 17 meq. per io litre of magnesium ions, about 15 meq. per litre of phosphate ions, about 1 meq. per litre of citrate ions, about 160 mg per litre of vitamin C, about 40 mg per litre of vitamin B6, and about 16% glucose (w/w). The pH of this composition may be about 3.4 to about 3.8. In a thirteenth aspect, the beverage composition of the invention is prepared by adding: sodium phosphate monobasic (400 to 550 mg), sodium chloride (60 to 80 mg), 15 sodium citrate dihydrate (100 to 140 mg), potassium chloride (270 to 350 mg), magnesium sulfate (230 to 290 mg), vitamin C (30 to 50 mg), vitamin B6 (5 to 15 mg) and glucose (about 35 to 45 grams), to 250 mL of water, or other suitable liquid. The pH of this composition may be about 3.4 to about 3.8. In a fourteenth aspect, the beverage composition of the invention is prepared by 20 adding: sodium phosphate monobasic (470.0 mg), sodium chloride (69.0 mg), sodium citrate dihydrate (120.0 mg), potassium chloride (318.0 mg), magnesium sulfate (260.0 mg), vitamin C (40.0 mg), vitamin B6 (10.0 mg) and glucose (about 40 grams), to 250 mL of water, or other suitable liquid. The pH of this composition may be about 3.4 to about 3.8. 25 In a fifteenth aspect, the present invention provides a method of reducing or preventing one or more symptoms of altitude sickness in a subject, said method comprising administration to said subject of an effective amount of the composition of the first, second, fourth or fifth to fourteenth aspects. The amount of vitamin B6 present in- the composition used in the fifteenth aspect 30 may be between about 10 mg and about 50 mg per litre of the beverage composition. In a sixteenth aspect, the present invention provides a method of reducing or WO 2008/113114 PCT/AU2008/000371 -6 preventing one or more symptoms of dehydration in a subject, said method comprising administration to said subject of an effective amount of the composition of the first, second, fourth or fifth to fourteenth aspects. The amount of vitamin B6 present in the composition used in the sixteenth aspect s may be between about 2 mg and about 10 mg per litre of the beverage composition. In one embodiment, the amount of vitamin B6 present in the composition used in the sixteenth aspect may be about 5 mg per litre of the beverage composition. In a seventeenth aspect, the present invention provides a method of reducing the blood alcohol concentration in a subject, said method comprising administration to said io subject of an effective amount of the composition of the first, second, fourth or fifth to fourteenth aspects. The method may comprise the step of administering the composition to the subject before the subject drinks a first alcoholic drink. The method may further comprise the step of administering the composition to the 15 subject after the subject drinks a first alcoholic drink, and prior to the subject drinking a second alcoholic drink. The method may further comprise the step of administering the composition to the subject after each subsequent alcoholic drink consumed after the first alcoholic drink. The amount of vitamin B6 present in thie composition used in the seventeenth aspect 20 may be between about 10 mg and about 25 mg per litre of the beverage composition. In an eighteenth aspect, the present invention provides a method for supplementing the meals or replacing the meals of a subject undergoing medical treatment, said method comprising administration to said subject of an effective amount of the composition of the first, second, fourth or fifth to fourteenth aspects. 25 The medical treatment may be any type of medical treatment or intervention that causes a reduction in the appetite of the subject. The medical treatment may be a surgical procedure such as an appendix operation, or a treatment in which anaesthetic or pain killers are used, or alternatively a treatment that results in diarrhea in the subject, or a treatment that involves drugs that suppress appetite 30 and/or cause nausea. The medical treatment may be cancer therapy.

WO 2008/113114 PCT/AU2008/000371 -7 The cancer therapy may be surgery, chemotherapy, radiotherapy, hormone therapy or immunotherapy. The subject may be a human. In a nineteenth aspect, the present invention provides a method for enhancing the 5 response of a subject to cancer therapy, said method comprising administration to said subject of an effective amount of the composition of the first, second, fourth or fifth to fourteenth aspects. In a twentieth aspect, the present invention provides a method for the treatment of cancer in a subject in need of said treatment, said method comprising administering to said io subject an effective amount of the composition of the first, second, fourth or fifth to fourteenth aspects, together with chemotherapy and/or radiotherapy and/or biological therapy. In a twenty-first aspect, the present invention provides the use of the composition of the first, second, fourth or fifth to fourteenth aspects as an adjunct to cancer therapy. 15 In a twenty-second aspect, the present invention provides a method for reducing or preventing cramps, said method comprising administration of an effective amount of the composition of the first, second, fourth or fifth to fourteenth aspects. In the methods of the invention, the composition may be given in the form of a beverage composition, or alternatively in the form of a concentrate as defined in the second 20 aspect. The compositions of the first or fifth to fourteenth aspects may be in the form of a concentrate that is used for preparing an aqueous beverage composition, the concentrate comprising a mixture of components in amounts such that when constituted with water or an appropriate liquid to form the aqueous beverage composition, the proportions of the 25 components are those given in the first or fifth to fourteenth aspects. Definitions As used herein, the term "carbohydrate" refers to monosaccharides, oligosaccharides, complex polysaccharides, or mixtures thereof. As used herein, the term "comprising" means "including principally, but not 30 necessarily solely". Furthermore, variations of the word "comprising", such as "comprise" and "comprises", have correspondingly varied meanings.

WO 2008/113114 PCT/AU2008/000371 -8 As used herein, the term "effective amount", includes within its meaning an amount of the composition that provides the desired effect. The exact amount required will vary from subject to subject depending on factors such as the subject's general health, age and the condition for which they are receiving treatment. 5 As used herein, the term "standard drink(s)" refers to a drink that contains about 10 grams of alcohol. As used herein, the terms "reduction" and "reducing" in the context of "one or more symptoms" encompass the elimination or substantial elimination of a symptom, the arresting of a symptom such that the symptom does not worsen, and the amelioration, i including partial amelioration, of a, symptom. By these tens, it will also be understood that where a condition to which the present invention relates may display more than one symptom, the elimination, substantial elimination, arresting or amelioration need not be of all symptoms of the condition, but may be of one or more symptoms thereof. Brief Description of the Drawings 15 Figure 1 shows the blood alcohol concentrations (mg/L) after a given time in individuals consuming a combination of (i) alcohol and a composition in accordance with the invention (composition X, -+-), and (ii) alcohol and water (- ). Figure 2 shows a heart rate measurement performed every 10 minutes in individuals consuming a combination of (i) alcohol and a composition in accordance with the 20 invention (composition X, -+- ), and (ii) alcohol and water (--). Detailed Description of the Invention In one aspect, the present invention relates to an aqueous beverage composition comprising sodium ions, potassium ions, magnesium ions, phosphate ions, citrate ions, 25 vitamin B6 and carbohydrate. The present invention also relates to a concentrate for use in preparing an aqueous beverage composition, the concentrate comprising a mixture of components in amounts such that when constituted with water, or an appropriate liquid, to form the aqueous beverage composition, specific proportions of the components are obtained. The present invention also relates to a process for the manufacture of an aqueous 30 beverage composition, wherein a concentrate is mixed with a quantity of water, or an WO 2008/113114 PCT/AU2008/000371 -9 appropriate liquid, sufficient to provide a solution suitable for consumption by drinking, and a beverage composition obtained by sucl a process. The amount of sodium ions present in the aqueous beverage composition may be between about 10 meq. and about 35 meq. per litre of the beverage composition, or 5 between about 12 meq. and about 35 meq., or between about 14 meq. and about 35 meq., or between about 16 meq. and about 35 meq., or between about 18 meq. and about 35 meq., or between about 20 meq. and about 35 meq., or between about 22 meq. and about 35 meq., or between about 24 meq. and about 35 meq., or between about 26 meq. and about 35 meq., or between about 28 meq. and about 35 meq., or between about 10 meq. 10 and about 32 meq., or between about 10 meq. and about 30 meq., or between about 10 meq., and about 28 meq., or between about 10 meq. and about 26 meq., or between about 10 meq. and about 24 meq., or between about 10 meq. and about 22 meq., or between about 10 meq. and about 20 meq., or betiveen about 10 meq. and about 18 meq., or between about 10 meq. and about 16 meq., or between about 12 meq. and about 35 meq., 15 or between about 14 meq. and about 32 meq., or between about 16 meq. and about 30 meq., or between about 17 meq. and about 28 meq., or between about 18 meq. and about 26 meq., or between about 20 meq. and about 24 meq. per litre of the beverage composition. In one embodiment, the amount of sodium ions present in the beverage composition 20 may be 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34 or 35 meq. per litre of the beverage composition. The amount of potassium ions present in the aqueous beverage composition may be between about 5 meq. and about 30 meq. per litre of the beverage composition, or between about 7 meq. and about 30 meq., or between about 9 meq. and about 30 meq., or between 25 about 11 meq. and about 30 meq., or between about 13 meq. and about 30 meq., or between about 15 meq. and about 30 meq., or between about 17 meq. and about 30 meq., or between about 19 meq. and about 30 meq., or between about 21 meq. and about 30 meq., or between about 23 meq. and about 30 meq., or between about 25 meq. and about 30 meq., or between about 5 meq. and about 28 meq., or between about 5 meq. and about 30 26 meq., or between about 5 meq. and about 24 meq., or between about 5 meq. and about 22 meq., or between about 5 meq. and about 20 meq., or between about 5 meq. and about WO 2008/113114 PCT/AU2008/000371 -10 18 meq., or between about 5 meq. and about 16 meq., or between about 5 meq. and about 14 meq., or between about 5 meq. and about 12 meq., or between about 5 meq. and about 10 meq., or between 10 meq. and about 25 meq., or between about 12 meq. and about 23 meq., or between about 14 meq. and about 21 meq., or between about 15 meq. and about 5 19 meq. per litre of the beverage composition. In one embodiment, the amount of potassium ions present in the beverage composition may be 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29 or 30 meq. per litre of the beverage composition. The amount of magnesium ions present in the composition may be between about 5 10 meq. and about 25 meq. per litre of the beverage composition, or between about 5 meq. and about 23 meq., or between about 5 meq. and about 21 meq., or between about 5 meq. and about 21 meq., or between about 5 meq. and about 19 meq., or between about 5 meq. and about 17 meq., or between about 5 meq. and about 16 meq., or between about 5 meq. and about 15 meq., or between about 5 meq: and about 14 meq., or between about 6 meq. 15 and about 25 meq, or between about 7 meq. and about 25 meq, or between about 9 meq. and about 25 meq., or between about 11 meq. and about 25 meq., or between about 12 meq. and about 25 meq., or between about 14 meq. and about 25 meq., or between about 16 meq. and about 25 meq., or between about 18 meq. and about 25 meq., or between about 20 meq. and 25 meq., or between about 22 meq. and about 25 meq., or between 20 about 6 meq. and about 22 meq., or between about 7 meq. and about 20 meq., or between about 8 meq. and about 20 meq., or between about 10 meq. and about 18 meq., or between about 11 meq. and 16 meq., or between about 11 meq. and about 15 meq., or between about 11 meq. and about 14 meq., or between about 12 meq. and about 23 meq., or between about 13 meq. and about 20 meq., or between about 13 meq. and about 17 meq. 25 per litre of the beverage composition. In one embodiment, the amount of magnesium ions present in the beverage composition may be 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 or 25 meq. per litre of the beverage composition. The phosphate ions in the beverage composition are present as mixtures of P04, 30 H 2

PO

4 and HPO4, the relative concentrati6ns of which are pH dependent. As such, the term "phosphate" is understood to encompass P04 , H 2

PO

4 and HP0 4 , unless otherwise WO 2008/113114 PCT/AU2008/000371 - 11 specifically stated. At a pH of about 3.4 to 3.8, H 2 P0 4 is by far the most abundant species in solution, whereas at pH 7.4, HP02 is the most abundant species. The amount of phosphate ions present in the composition may be between about 1 meq. and about 55 meq., or between about 2 meq. and about 55 meq., or between about 4 5 meq. and about 55 meq., or between about 6 meq. and about 55 meq., or between about 8 meq. and about 55 meq., or between about 10 meq. and about 55 meq., or between about 12 meq. and about 55 meq., or between about 14 meq. and about 55 meq., or between about 16 meq. and about 55 meq, or between about 18 meq. and about 55 meq., or between about 20 meq. and about 55 meq., or between about 22 meq. and about 55 meq., io or between about 24 meq. and about 55 meq., or between about 26 meq. and about 55 meq., or between about 28 meq. and about 55 meq., or between about 30 meq. and about 55 meq., or between about 32 meq. and about 55 meq., or between about 34 meq. and about 55 meq., or between about 36 meq. and about 55 meq., or between about 38 meq. and about 55 meq., or between about 40 meq. and about 55 meq., or between about 42 15 meq. and about 53 meq., or between about 8 meq. and about 50 meq., or between about 8 meq. and about 47 meq., or between about 8 meq. and about 43 meq., or between about 8 meq. and about 41 meq., or between about 8 meq. and about 39 meq., or between about 8 meq. and about 37 meq., or between about 8 meq. and about 35 meq., or between about 8 meq. and about 33 meq., or between about 8 meq. and about 31 meq., or between about 8 20 meq. and about 29 meq., or between about 8 meq. and about 27 meq., or between about 8 meq. and about 25 meq., or between about 8 meq. and about 23 meq., or between about 8 meq. and about 21 meq., or between about 8 meq. and about 19 meq., or between about 8 meq. and about 17 meq., or between about 8 meq. and about 15 meq., or between 15 meq. and about 45 meq., or between about 18 meq. and about 42 meq., or between about 20 25 meq. and about 40 meq., or between about 22 meq. and about 38 meq., or between about 24 meq. and about 36 meq., or between about 26 meq. and about 34 meq., or between about 28 meq. and about 32 meq:, or between about 35 meq. and about 50 meq., or between about 40 meq. and about 50 meq., or between about 25 meq. and 55 meq, or between about 28 meq. and about 50 meq., or between about 1 meq. and about 30 meq., or 30 between about 3 meq. and about 28 meq., or between about 5 meq. and about 25 meq., or between about 6 meq. and about 22 meq., or between about or between about 8 meq. and WO 2008/113114 PCT/AU2008/000371 - 12 about 21 meq., or between about 9 meq. and about 20 meq., or between about 10 meq. and about 20 meq, or between about 12 meq., and about 18 meq., or about 10 meq., or about 15 meq. per litre of the beverage composition. In one embodiment, the amount of phosphate ions present in the beverage 5 composition may be 1, 2, 3, 4, 5, 6; 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37-, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54 or 55 meq. per litre of the beverage composition. When adjusted to a pH of about 3.6, the amount of phosphate ions in the beverage composition (as H 2 P0 4 ~) may be between about I meq. and about 30 meq., or between io about 3 meq. and about 28 meq., or between about 5 meq. and about 25 meq., or between about 6 meq. and about 22 meq., or between about or between about 8 meq. and about 21 meq., or between about 9 meq. and about 20'meq., or between about 10 meq. and about 20 meq, or between about 12 meq., and about 18 meq., or about 10 meq., or about 15 meq. per litre of the beverage composition. 15 The amount of phosphate ions present in the beverage composition (as either P0 -,

H

2 PO4~, HPO -) may be between about 0.25 and about 3.5, or between about 0.5 and about 3.25, or between about 0.5 and about 3, or between about 0.5 and about 2.5, or between about 0.5 and about 2.25, or between about 0.5 and about 2, or between about 0.75 and about 1.75, or about 1.5, or about 1, grams per litre of the beverage composition. 20 The citrate ions in the beverage composition are present as mixtures of C 6

H

7 07-,

C

6

H

6 0 7 2 and C 6

H

5 0 7 , the relative concentrations of which are pH dependent. As such, the tenn "citrate" is understood to encompass C 6

H

7 07, C 6

H

6 0 7 2 and C 6

H

5 0 7 3 , unless otherwise specifically stated. At a pH of about 3.4 to 3.8, C 6

H

7 07~ is the most abundant species. 25 The amount of citrate ions present in the composition may be between about 0.1 meq. and about 45 meq., or between about 0.5 meq. and about 45 meq., or between about 1 meq. and about 45 meq., or between about 2 meq. and about 45 meq., or between about 4 meq. and about 45 meq., or between about 6 meq. and about 45 meq., or between about 8 meq. and about 45 meq., or between about 10 meq. and about 45 meq., or between about 30 12 meq. and about 45 meq., or between about 14 meq. and about 45 meq., or between about 16 meq. and about 45 meq., or between about 18 meq. and about 45 meq., or WO 2008/113114 PCT/AU2008/000371 - 13 between about 20 meq. and about 45 meq., or between about 22 meq. and about 45 meq., or between about 24 meq. and about 45 meq., or between about 26 meq. and about 45 meq., or between about 28 meq. and about 45 meq., or between about 30 meq. and about 45 meq., or between about 32 meq. and about 45 meq., or between about 34 meq. and 5 about 45 meq., or between about 36 meq. and about 45 meq., or between about 38 meq. and about 45 meq., or between about 40 meq. and about 45 meq., or between about 10 meq. and about 43 meq., or between about 10 meq. and about 41 meq., or between about 10 meq. and about 39 meq., or between about 10 meq. and about 37 meq., or between about 10 meq. and about 35 meq., or between about 10 meq. and about 33 meq., or 1o between about 10 meq. and about 31 meq., or between about 10 meq. and about 29 meq., or between about 10 meq. and about 27 meq., or between about 10 meq. and about 25 meq., or between about 10 meq. and about 23 meq., or between about 10 meq. and about 21 meq., or between about 10 meq. and about 19 meq., or between about 10 meq. and about 17 meq., or between about 10 meq. and about 15 meq., or between 15 meq. and 15 about 45 meq., or between about 18 meq. and about 42 meq., or between about 20 meq. and about 40 meq., or between about 22 meq. and about 38 meq., or between about 22 meq. and about 36 meq., or between about 24 meq. and about 34 meq., or between about 26 meq. and about 32 meq., or between about 26 meq. and about 30 meq., or between about 1 meq. and about 30 meq., or. between about 1 meq. and about 25 meq., or between 20 about 1 meq. and about 20 meq., or between about 1 meq. and about 15 meq., or between about 1 meq. and about 12 meq., or between about 1 meq. and about 10 meq., or between about 0.25 meq. and about 15 meq., or between about 0.5 meq. and about 15 meq., or between about 1 meq. and about 13 meq., or between about 1 meq. and about 12 meq., or between about 1 meq. and about 10 meq., or'between about 1 meq. and about 8 meq., or 25 between about 1 meq. and about 7 meq., or between about 0.25 meq. and about 12 meq., or between about 0.25 meq. and about 10 meq., or between about 0.25 meq, and about 8 meq., or about 5 meq., or about 1 meq. per litre of the beverage composition. In one embodiment, the amount of citrate ions present in the beverage composition may be 0.1, 0.5, 1, 2, 3, 4, 5, 6, 7, 8; 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 30 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, or 45 meq. per litre of the beverage composition.

WO 2008/113114 PCT/AU2008/000371 -14 When adjusted to a pH of about 3.6, the amount of citrate ions in the beverage composition (as C 6

H

7 07~) may be between about 0.25 meq. and about 15 meq., or between about 0.5 meq. and about 15 meq., or between about 1 meq. and about 13 meq., or between about 1 meq. and about 12 meq., or between about 1 meq. and about 10 meq., or between 5 about 1 meq. and about 8 meq., or between about 1 meq. and about 7 meq., or between about 0.25 meq. and about 12 meq., or between about 0.25 meq. and about 10 meq., or between about 0.25 meq. and about 8 meq., or about 5 meq., or about 1 meq. per litre of the beverage composition. The amount of citrate ions present in the beverage composition (as either C 6

H

7 07~, 10 C 6

H

6 0 7 2 and C 6

H

5 0 7 3 ) may be between about 0.1 and about 3.5, or between about 0.1 and about 3.25, or between about 0.1 and about 3, or between about 0.1 and about 2.5, or between about 0.1 and about 2.25, or between about 0.1 and about 2, or between about 1 and about 2.5, or between about 1 and about 2.25, or between about 1.25 and about 2.25, or between about 1.5 and about 2, or between about 0.1 and about 1, or between about 0.1 15 and about 0.75, or between about. 0.1 and about 0.5, grams per litre of the beverage composition. The amount of vitamin B6 present in the composition may be between about 0.1 mg and 200 mg per litre of the beverage composition, or between about 0.1 mg and 180 mg, or between about 0.1 mg and about 170 mg, or between about 0.1 mg and about 160 mg, or 20 between about 0.1 mg and about 150 mg, or between about 0.1 mg and about 140 mg, or between about 0.1 mg and about 130 mg, or between about 0.1 mg and about 120 mg, or between about 0.1 mg and about 110 mg, or between about 0.1 mg and about 100 mg, or between about 0.1 mg and about 90 mg, or between about 0.1 mg and about 80 mg, or between about 0.1 mg and about 70 mg, or between about 0.1 mg and about 60 mg, or 25 between about 0.1 mg and about 50mg, orbetween about 0.1 and about 45 mg, or between about 1 and about 200 mg, or between about 5 mg and about 200 mg, or between about 10 mg and about 200 mg, or between about 20 mg and about 200 mg, or between about 30 mg and about 200 mg, or between about 40 mg and about 200 mg, or between about 50 mg and about 200 mg, or between about 60 mg and about 200 mg, or between about 70 mg 30 and about 200 mg, or between about 80 mg and about 200 mg, or between about 90 mg and about 200 mg, or between about 100 mg and about 200 mg, or between about 110 mg WO 2008/113114 PCT/AU2008/000371 - 15 and about 200 mg, or between about 5 mg and about 110 mg, or between about 5 mg and about 100 mg, or between about 10 mg and about 100 mg, or between about 10 mg and about 90 mg, or between about 10 ig and about 80 mg, or between about 10 mg and about 70 mg, or between about 10 mg and about 60 mg, or between about 10 mg and about 50 5 mg, or between about 15 mg and about 45 mg, or between about 20 mg and about 40 mg of vitamin B6 per litre of the beverage composition. In one embodiment, the amount of vitamin B6 per litre of the beverage composition may be 0.1, 0.5, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190 or 200 mg. 10 The carbohydrate included in the beverage compositions may be present in an amount between about 2% and about 20% by weight of the beverage composition, or between about 2% and about 19%, or between about 2% and about 18%, or between about 2% and about 17%, or between about 2% and about 16%, or between about 2% and about 13%, or between about 2% and about 12%, or between about 2% and about 11%, or is between about 2% and about 10%, or between about 7% and about 20%, or between about 9 % and about 20%, or between about 10% and about 20%, or between about 11% and about 20%, or between about 12% and about 20%, or between about 13% and about 20%, or between about 14% and about 20%, or between about 14% and about 18%, or between about 15% and about 18% or between about 15% and about 17%. In one embodiment, the 20 carbohydrate is present in 16% by weight of the total beverage composition. The meq. per litre ratio of sodium ions to potassium ions may be between about 1.0 and about 1.8, or between about 1.1 and about 1.75, or between about 1.1 and about 1.7, or between about 1.15 and about 1.6, or between about 1.2 and about 1.55, or between about 1.2 and about 1.5, or between about 1.2 and about 1.45, or between about 1.2 and about 25 1.4, or between about 1.25 and about 1.35, or about 1.3. The beverage composition of the first aspect may be prepared by simply adding the relevant components to an aqueous medium with or without agitation. The resultant solution may then be consumed by drinking. The beverage composition of the first aspect may be dehydrated to provide a dry mixture of the composition. This dry mixture, either 30 as powder, granules or tablets, can be later re-dissolved in an appropriate amount of water, or other appropriate liquid, to re-establish the drinkable beverage composition.

WO 2008/113114 PCT/AU2008/000371 -16 The concentrate of the second aspect may be prepared by simply mixing the relevant components together in the necessary amounts. The concentrate may be prepared in the form of a powder, granules or tablets, which may be reconstituted for use by the addition of water, or any other appropriate liquid. The reconstitution is made with appropriate 5 amounts of water/liquid to ensure that the beverage obtained comprises the components in the proportions given in the second aspect. In another embodiment, the composition may be solubilised in water/liquid and then frozen to provide "ice blocks". The beverage composition of the invention provides an advantage over many other currently available body fluid supplement beverages in that it has improved palatability. io The beverage composition has a taste that is similar to apple juice. In one embodiment, the beverage composition of the invention comprises between about 10 meq. and about 32 meq. per litre-of sodium ions, between about 10 meq. and about 25 meq. per litre of potassium ions, between about 8 meq. and about 25 meq. per litre of magnesium ions, between about 10 meq. and about 50 meq. per litre of phosphate 15 ions, between about 0.5 meq. and about 30 meq. per litre of citrate ions, between about 10 mg and about 60 mg per litre of vitamin B6 and between about 10% and 20% glucose (w/w). This composition may additionally comprise vitamin C in an amount between about 100 mg and about 1500 mg'per litre. The composition may be in the form of a powder or granules, or may be in the form of an aqueous solution. 20 In another embodiment, the beverage composition of the invention comprises between about 12 meq. and about 32 meq. per litre of sodium ions, between about 10 meq. and about 25 meq. per litre of potassium ions, between about 7 meq. and about 20 meq. per litre of magnesium ions, between about 5 meq. and about 25 meq. per litre of phosphate ions, between about 1 meq. and about 15 meq. per litre of citrate ions, between about 20 25 mg and about 40 mg per litre of vitamin B6 and between about 10% and 20% glucose (w/w). This composition may additionally comprise vitamin C in an amount between about 250 mg and about 1200 mg per litre. The composition in solution may have a pH of about 3.4 to 3.8. The composition may be in the form of a powder or granules, or may be in the form of an aqueous solution. 30 In another embodiment, the beverage composition of the invention comprises about 22 meq. per litre of sodium ions, about 17 meq. per litre of potassium ions, about 13 meq.

WO 2008/113114 PCT/AU2008/000371 -17 per litre of magnesium ions, about 10 meq. per litre of phosphate ions, about 5 meq. per litre of citrate ions, about 20 mg per litre of vitamin B6 and about 16% glucose (w/w). The composition in solution may have a pH of about 3.4 to 3.8. The composition may be in the form of a powder or granules, or may be in the form of an aqueous solution. 5 In another embodiment, the beverage composition of the invention comprises about 22 meq. per litre of sodium ions, about 17 meq. per litre of potassium ions, about 13 meq. per litre of magnesium ions, about 10 meq. per litre of phosphate ions, about 5 meq. per litre of citrate ions, 20 mg per litre of vitamin B6, 16% glucose (w/w), and 480 mg per litre of vitamin C. The composition in solution may have a pH of about 3.4 to 3.8. The io composition may be in the form of a powder or granules, or may be in the form of an aqueous solution. In another embodiment, the beverage composition of the invention comprises about 22 meq. per litre of sodium ions, about 17 meq. per litre of potassium ions, about 13 meq. per litre of magnesium ions, about 10 meq. per litre of phosphate ions, about 5 meq. per is litre of citrate ions, about 40 mg per litre of vitamin B6, about 16% glucose (w/w), and 1000 mg per litre of vitamin C. The composition in solution may have apH of about 3.4 to 3.8. The composition may be in the form of a powder or granules, or may be in the form of an aqueous solution. In another embodiment, the beverage composition of the invention comprises about 20 22 meq. per litre of sodium ions, about 17 meq. per litre of potassium ions, about 13 meq. per litre of magnesium ions, about 10 meq. per litre of phosphate ions, about 5 meq. per litre of citrate ions, about 40 mg per litre of vitamin B6, about 16% glucose (w/w), and about 480 mg per litre of vitamin C. The composition in solution may have a pH of about 3.4 to 3.8. The composition may be in the form of a powder or granules, or may be in the 25 form of an aqueous solution. In a further embodiment, the beverage composition of the invention comprises between about 12 meq. and about 32 meq. per litre of sodium ions, between about 10 meq. and about 25 meq. per litre of potassium ions, between about 12 meq. and about 22 meq. per litre of magnesium ions, between about 10 meq. and about 20 meq. per litre of 30 phosphate ions, between 0.1 meq. and about 8 meq. per litre of citrate ions, between about 50 mg and about 200 mg per litre of vitamin C, between about 10 and 80 mg per litre of WO 2008/113114 PCT/AU2008/000371 - 18 vitamin B6, and between about 10% and about 20% glucose (w/w). The pH of the composition in solution may be about 3.4 to about 3.8. The composition may be in the form of a powder or granules, or may be in the form of an aqueous solution. In a further embodiment, the beverage composition of the invention comprises 5 between about 17 meq. and about 27 meq. per litre of sodium ions, between about 13 meq. and about 21 meq. per litre of potassium ions, between about 13 meq. and about 21 meq. per litre of magnesium ions, between about 11 meq. and about 17 meq. per litre of phosphate ions, between about 0.25 meq. and about 5 meq. per litre of citrate ions between about 100 mg and about 200 mg per litre of vitamin C, between about 20 and 60 mg per 10 litre of vitamin B6, and between about 14%'and about 18% glucose (w/w). The pH of the composition in solution may be about 3.4 to about 3.8. The composition may be in the form of a powder or granules, or may be in the form of an aqueous solution. In a further embodiment, the beverage composition of the invention comprises about 22 meq. per litre of sodium ions, about 17 meq. per litre of potassium ions, about 17 meq. 15 per litre of magnesium ions, about 15 meq..per litre of phosphate ions, about 1 meq. per litre of citrate ions, about 160 mg per litre of vitamin C, about 40 mg per litre of vitamin B6, and about 16% glucose (w/w). The pH of the composition in solution may be about 3.4 to about 3.8. The composition may be in the form of a powder or granules, or may be in the form of an aqueous solution. 20 In yet another embodiment, the beverage composition of the invention is prepared by adding: sodium phosphate monobasic (400 to 550 mg), sodium chloride (60 to 80 mg), sodium citrate dihydrate (100 to 140 mg), potassium chloride (270 to 350 mg), magnesium sulfate (230 to 290 mg), vitamin C (30 to 50 mg), vitamin B6 (5 to 15 mg) and glucose (about 35 to 45 grams), to 250 mL of water, or other suitable liquid. The pH of the 25 composition in solution may be about 3.4 to about 3.8. The composition may be in the form of a powder or granules, or may be in the form of an aqueous solution. In yet another embodiment, the beverage composition of the invention is prepared by adding: sodium phosphate monobasic (470.0 mg), sodium chloride (69.0 mg), sodium citrate dihydrate (120.0 mg), potassium chloride (318.0 mg), magnesium sulfate (260.0 30 mg), vitamin C (40.0 mg), vitamin B6 (10.0 mg) and glucose (about 40 grams), to 250 mL of water, or other suitable liquid. The pH of the composition in solution may be about 3.4 WO 2008/113114 PCT/AU2008/000371 - 19 to about 3.8. The composition may be in the form of a powder or granules, or may be in the form of an aqueous solution. In a further embodiment, the present invention provides an aqueous beverage composition comprising: glucose (30 to 50 grams), sodium ions (100 mg to 150 mg), 5 potassium ions (120 mg to 180 mg), magnesium ions (20 mg to 55 mg), phosphate ions (200 mg to 800 mg), vitamin C (80 mg to 1000 mg), vitamin B6 (1 mg to 20 mg) and citrate ions (200 mg to 900 mg), per 250 mL of composition. The beverage composition may also comprise additional components commonly used in beverages intended for use- as body fluid supplements, such as but not limited to 10 colouring agents, flavouring agents and preservatives. Additional vitamins and minerals may also be added to the beverage composition, if desired. Suitable vitamins include, but are not limited to, vitamin B 1, vitamin B2, vitamin B3, vitamin B5, vitamin B12, folic acid, vitamin C, vitamin D and vitamin E. Suitable minerals include, but are not limited to selenium, chromium, calcium, iron, zinc, is manganese and copper. In another embodiment, the beverage composition may include protein. The beverage composition of the present invention may be used in the following situations: (i) To reduce one or more symptoms of altitude sickness; 20 (ii) To reduce one or more symptoms of dehydration; (iii) To reduce the blood alcohol concentration of a subject; (iv) To supplement or replace the meals of a subject undergoing medical treatment; (v) To enhance the response of a subject to cancer therapy; 25 (vi) To reduce or prevent cramps; and (vii) To increase the stamina of a sportsman In the above uses, those skilled in the art will realise that the amount of the beverage composition consumed, and the number of discreet consumptions per unit time will vary 30 depending on the actual use to which the beverage is put, the condition of the subject who will consume the beverage, the subject's age, sex, weight and general health.

WO 2008/113114 PCT/AU2008/000371 - 20 In another aspect, the present, invention relates to a method of reducing one or more symptoms of altitude sickness in a subject comprising administration to said subject of an effective amount of the composition of the first, second, fourth or fifth to fourteenth aspects. 5 Altitude sickness is a pathological condition resulting from exposure to high altitudes. Altitude sickness typically occurs at heights above 2000 metres above sea level. Symptoms of altitude sickness include, but aie not limited to: appetite loss, persistent rapid pulse, headache, nausea, fatigue, dizziness, weakness, insomnia, shortness of breath on exertion, peripheral edema, swollen hands and/or feet and/or face, and general malaise. 10 Consumption of the composition of the first or fourth aspects effectively reduces one or more of the above symptoms of altitude sickness, even at altitudes above 6500 metres. In one embodiment, the composition of the first; second, fourth or fifth to fourteenth aspects may be consumed in an amount of about 1 litre per day in order to reduce one or more symptoms of altitude sickness. It is to be noted however, that the amount of the is composition required may vary depending on the altitude and location, the subject's age, sex, weight and prevailing health and fitness at the particular time. In another aspect, the present invention relates to a method of reducing or preventing one or more symptoms of dehydration in a subject, comprising administration of an effective amount of the composition of the first, second, fourth or fifth to fourteenth 20 aspects. Typical symptoms associated with dehydration include, but are not limited to: headache, decreased blood pressure, thirst, appetite loss, constipation, darkened urine, dizziness and dry mouth. Consumption of the composition of the first, second, fourth or fifth to fourteenth 25 aspects effectively reduces one or more symptoms of dehydration by replacing lost fluid and re-establishing electrolyte balance. In order to prevent symptoms of dehydration, the composition of the first or fourth aspects may be consumed before and during exercise, exertion or any other activity which leads 'to a depletion in the amount of fluid and electrolytes in the body. The composition may also be consumed by a subject already 30 suffering from one or more symptoms of dehydration, thereby leading to a reduction in one or more of the symptoms thereof. When undertaking moderately strenuous exercise (for WO 2008/113114 PCT/AU2008/000371 -21 example running at a speed of about 7 to 10 km/h for 1 hour), the composition of the first, second, fourth or fifth to fourteenth aspects may be consumed: (i) 250 mL to 350 mL prior to exercise; (ii) 50 mL to 100 mL every 30 minutes during exercise; 5 (iii) 250 mL to 300 mL post exercise. The above amounts will vary where more or less strenuous exercise is performed over a given period of time. In such a case, those skilled in the art will realise that greater or reduced amounts of the composition may be consumed at different time intervals depending on the subject's age, sex, weight and general health and fitness. 10 A number of illnesses such as fever, severe diarrhea, vomiting and gastrointestinal disorders may lead to mild to severe dehydration. The beverage composition of the first or fourth aspect may be consumed by a subject suffering from an illness that results in dehydration in order to re-establish electrolyte balance and replace lost fluid. The present inventor has also discovered that the beverage composition of the first, is second or fourth aspect is useful in reducing the blood alcohol concentration in a subject. Accordingly, in another aspect, the present invention relates to a method of reducing the blood alcohol concentration in a subject comprising administration of an effective amount of the composition of the first, second, fourth or fifth to fourteenth aspects. In one embodiment, the method involves the consumption by a subject of an amount 20 of the composition of the first, second, fourth or fifth to fourteenth aspects, prior to consuming a first alcoholic drink, wherein the alcoholic drink comprises between approximately 1 and 3 standard drinks. For example, between approximately 150 mL and 600 mL, or between about 150 mL and 550 mL, or between about 150 mL and 500 mL, or between about 150mL and about 450 mL, or between about 150 mL and about 400 mL, or 25 between about 150 mL and about 350 mL, or between about 175 mL and about 350 mL, or between about 180 mL and about 300 mL, or between about 200mL and about 300 mL, or between about 225 mL and about 275 mL, or between about 240 mL and about 260 mL, or between about 250 mL and about 300 mL of the composition may be consumed between about 15 minutes and 1 hour, or between about 20 minutes and 50 minutes, or between 30 about 25 minutes and 45 minutes, or between about 25 minutes and 40 minutes, or between about 25 and 35 minutes, or about 30 minutes prior to consuming a first alcoholic drink. In WO 2008/113114 PCT/AU2008/000371 - 22 one embodiment, the composition of the first, second, fourth or fifth to fourteenth aspects may be added to the first alcoholic beverage. After consumption of the first alcoholic drink and before consumption of a second alcoholic drink, the method may comprise consumption of between approximately 150 mL 5 and 600 mL, or between about 150 mL and 550 mL, or between about 150 mL and 500 mL, or between about 150mL and about 450 mL, or between about 150 mL and about 400 mL, or between about 150 mL and about 350 mL, or between about 175 mL and about 350 mL, or between about 180 mL and about 300 mL, or between about 200mL and about 300 mL, or between about 225 mL and about 275 mL, or between about 240 mL and about 260 10 mL, of the composition. Consumption of the composition in this manner in the above amounts may be continued after consumption of each subsequent alcoholic drink, or alternatively after every second or third subsequent alcoholic drink. In one embodiment, 250 mL of the composition may be consumed 30 minutes prior to consuming a first alcoholic drink (which comprises between approximately 1 and 3 ]5 standard drinks), followed by a further 250 mL of the composition after consuming the first alcoholic drink, and prior to consuming a second alcoholic drink. Consumption of the composition in this way leads to a reduction in the blood alcohol concentration of the subject as compared to drinking the same amount of water prior to, and after, the first alcoholic drink. 20 In another embodiment, 250 mL to 300 mL of the composition may be consumed before drinking an alcoholic beverage, followed by a further 250 mL after consumption of a final alcoholic beverage. Those skilled in the art will realise that the amount of the beverage composition consumed, and the number of discreet consumptions per alcoholic beverage will vary 25 depending on the nature of the alcoholic beverage, as well as the age, sex, nationality, weight, general health of the subject, and also how regularly the subject consumes alcohol. The present invention also relates to a method for supplementing the meals or replacing the meals of a subject undergoing medical treatment comprising administration to said subject of an effective amount of the composition of the first, second, fourth or fifth 30 to fourteenth aspects. The present invention further relates to a method for enhancing the response of a WO 2008/113114 PCT/AU2008/000371 -23 subject to cancer therapy, said method comprising administration to said subject of an effective amount of the composition of the first, second, fourth or fifth to fourteenth aspects. The present invention still further relates to the use of the composition of the first, 5 second, fourth or fifth to fourteenth aspects as an adjunct to cancer therapy. Subjects undergoing medical treatment such as cancer therapy (for example surgery, radiation therapy, chemotherapy, hormone therapy and/or biological therapy (immunotherapy)) often suffer from side effects including reduced appetite, nausea and vomiting. In certain circumstances, the subject is unable to consume an adequate amount io of food, or in extreme cases no food, as a result of continuous vomiting. It has been found that the compositions of the first, second, fouith or fifth to fourteenth aspects may be used as an effective meal supplement in persons undergoing cancer therapy as the compositions do not cause vomiting. The compositions may also be used to replace meals where the subject is able to only consume minimal (if any) food. It is to be noted however that the 15 use of the compositions as a meal supplement or meal replacement is not limited to subjects undergoing cancer therapy but may be used in a subject undergoing any type of medical therapy or intervention wherein the subject is unable to consume an adequate amount of food or no food at all. A situation where a subject is unable to consume an adequate amount of food when 20 undergoing cancer therapy is problematic for a number of reasons, one reason being that the response of the body to the cancer therapy may be less then optimum if the body is not receiving adequate nutrition, as a lack of nutrition can lead to suppression of the immune system. By providing the body with hydration, vitamins and electrolytes, the compositions of the first, second, fourth or fifth to fourteenth aspects may be used to enhance the body's 25 response to cancer therapy by limiting suppression of the immune system that occurs as a result of a lack of nutrition or nutritional imbalance. This method may be of particular relevance where the subject is undergoing' a biological therapy wherein the goal is to stimulate the immune system to fight cancer. Accordingly, the compositions of the first, second, fourth or fifth to fourteenth aspects may form an integral part of cancer treatment 30 methods when used in conjunction with known therapies, for example immunotherapy, chemotherapy and radiotherapy.

WO 2008/113114 PCT/AU2008/000371 - 24 The compositions of the invention have been found to be particularly effective when administered to subjects undergoing therapy for cancers of the head and neck, throat cancer and esophageal cancer who experience trouble swallowing and/or taking solid food. The amount of the composition that may be given to the subject may be between about 500 5 mL and about 1.5 litres per day, or as required. In one embodiment, the amount of the composition given to a subject per day is about 1 litre. Additional vitamins and/or minerals may also be added to the compositions where appropriate. Those skilled in the art will realise that additional components included as we all as the amount of the composition consumed by a subject will vary depending on the age, sex, weight and io general health of the subject, as well as the medical treatment that they are undergoing. In a further aspect, the present invention provides a method for reducing or preventing cramps, said method comprising administration of an effective amount of the composition of the first, second, fourth or fifth to fourteenth aspects. In one embodiment, the cramp is a leg cramp. In one embodiment, in order to treat or prevent cramps, a subject 15 may consume about 250 mL to 300 mL of the composition, or alternatively about 40 g to 50 g of the composition in a concentrate forn (e.g. as a powder in accordance with the second aspect). Examples Example I - Use of the composition of the invention in reducing blood alcohol 20 concentration A test was conducted in order to demonstrate the ability of the composition of the invention to reduce blood alcohol concentration. The test involved a total of 10 subjects- (a mixture of males and females) having an average age of 22 years, an average weight of 87 kg and an average height of 1.86 metres. 25 The subjects took no anti-hangover medication during the test and were all healthy, having no history of serious illness. The test method was as follows: " To avoid stomach irritation, each test individual was given an equal amount of food containing a minimal amount of fat prior to consuming an alcoholic 30 beverage. " Each individual was given 250 mL of a composition (composition X) comprising WO 2008/113114 PCT/AU2008/000371 - 25 the following components in the amounts indicated per 250mL of composition: (i) glucose 40 g; (ii) sodium ions 125 mg; (iii) potassium ions 165 ng; 5 (iv) magnesium ions 40 mg; (v) phosphate ions 250 mg; (vi) vitamin C 120 mg; (vii) vitamin B6 5 mg; and (viii) citrate ions 450 mg. 10 * Following this, within 30 minutes, each individual then consumed 2 x 100 mL of 56 proof Chinese liquor. * A second 250 mL of composition X was given to each individual after consumption of the first 100 mL of liquor. * Heart rate in a period of 30 seconds was measured every 10 minutes after the first 15 100 mL of liquor was consumed. * A breath test for alcohol content was perfonned 10, 30, 50, 70 and 90 minutes after the first 100 mL of liquor was consumed. * Seven days later, the above experiment was repeated wherein each individual was given water instead of composition X. 20 The breath test results are depicted below in Table 1 and graphically represented in Figure 1. Heart rate measurements were also performed and are depicted in Table 2 and represented graphically in Figure 2. TABLE 1 - Blood alcohol concentrations (mg/L) after a given time in individuals consuming a combination of (i) alcohol and composition X, and (ii) alcohol and water 10 minutes 30 minutes 50 minutes 70 minutes 90 minutes Composition X / 82.1 ±35.3 72.7±27.0 107.7 ±32.6 100.9 25.7 93.1 ±25.5 alcohol alcohol/water 85.9 28.4 128.4± 33.2* 141.6 ±36.1* 128.6 27.7* 121.8 26.8* 25 *Statistically significant (p > 0.05) after 30 minutes continue until end of experiment TABLE 2 - Heart rate measurement performed every 10 minutes after first 100 mL of alcohol consumed Heart rate / minute Composition X / alcohol Water WO 2008/113114 PCT/AU2008/000371 - 26 Resting 0 min. 75.91 4.7 74.2 ± 4.9 10 min. 93.3 16.0 95 + 16.6 20 min. 90.6± 16.0 98.6± 18.2* 30 min. 94± 14.2 102 ±16.8 40 min. 94.4 + 12.6 100.7 17.6* 50 min. 91.5 ±15.3 100.6 ±15.6* 60 min. 84.5 ±18.2 98.9 ± 15.9* 70 min. 90.4 ± 17.8 97.9 ± 14.5* 80 min. 86.8± 13.7 91.9± 10.7* 90 min. 85.2 11.9 89.3 ± 8.9 100 min. 82.5 12.0 86.6 ± 9.8 *Statisitical significance (p > 0.05) Example 2 - Use of the composition of the invention as a food supplement A subject suffering from nasopharyngeal carcinoma (nose cancer) was undergoing an intensive course of medical treatment that combined both chemotherapy and radiotherapy 5 at the Queen Mary Hospital of Hong Kong. As a result of the medical treatment, the subject suffered severe throat pain which made eating and drinking extremely difficult and painful. Hot drinks in particular caused severe throat pain. In addition, the chemotherapy also affected the subject's appetite and caused a considerable amount of vomiting. The treating physician recommended that the subject drink nutritional milk as a daily meal, 10 however the milk also caused vomiting. The subject was then given the composition of the second aspect in water as a meal supplement. The components included in the composition, and their amounts per 250 mL of the composition were as follows: (i) glucose 40 g; 15 (ii) sodium ions 125 mg;, (iii) potassium ions 165 mg; (iv) magnesium ions 40 mg; (v) phosphate ions 250 mg; (vi) vitamin C 250 mg; 20 (vii) vitamin B6 10 mg; and (viii) citrate ions 450 mg.

WO 2008/113114 PCT/AU2008/000371 - 27 The subject was able to consume the above composition without vomiting, and the composition was successfully used throughout the subject's remaining treatment as the sole meal supplement. As a result, the subject experienced a significant decrease in the number of vomiting episodes, and benefited from the electrolytes, vitamins and carbohydrate 5 present in the composition. Example 3 - Use of the composition of the invention in the treatment of symptoms associated with altitude sickness The composition of the second aspect in water was consumed by a small group of 1o professional mountaineers at 6500 metres whilst ascending Mt. Everest. The mountaineers found that following consumption of the composition, the symptoms associated with high altitude sickness were reduced. The components included in the composition, and their amounts per 250 mL of the composition were as follows: (i) glucose 40 g; 15 (ii) sodium ions 125 mg; (iii) potassium ions 165 mg; (iv) magnesium ions 40 mg; (v) phosphate ions 250 mg; (vi) vitamin C 120 mg; 20 (vii) vitamin B6 5 mg; and (viii) citrate ions 450 mg. This finding was recently confirmed by the inventor on a trip to the base camp of Mount Everest, which is at an altitude of 5200 meters. The inventor has also found that consumption of the composition of the second 25 aspect whilst travelling on the Xining to Lhasa railway, the majority of which is 3200 metres above sea level, resulted in no observed symptoms of altitude sickness. The components included in the composition, and their amounts per 250 mL of the composition were as follows: (i) glucose 40 g; 30 (ii) sodium ions 125 mg; (iii) potassium ions 165 mg; (iv) magnesium ions 40 mg; WO 2008/113114 PCT/AU2008/000371 - 28 (v) phosphate ions 250 mg; (vi) vitamin C 120 mg; (vii) vitamin B6 10 mg; and (viii) citrate ions 450 mg

Claims

1. A method for supplementing the meals or replacing the meals of a subject undergoing medical treatment, said method comprising administration to said subject of an effective amount of a composition comprising: sodium ions, potassium ions, magnesium 5 ions, phosphate ions, citrate ions, vitamin B6 and carbohydrate.

2. A method for enhancing the response of a subject to cancer therapy, said method comprising administration to said subject of an effective amount of a composition comprising sodium ions, potassium ions, magnesium ions, phosphate ions, citrate ions, vitamin B6 and carbohydrate. 10

3. A method for the treatment of cancer in a subject in need of said treatment, said method comprising administering to said subject a composition comprising sodium ions, potassium ions, magnesium ions, phosphate ions, citrate ions, vitamin B6 and carbohydrate, together with chemotherapy and/or radiotherapy and/or biological therapy.

4. The method of any one of claims 1 to 3, wherein the composition is an 15 aqueous beverage composition.

5. The method of claim 4, wherein the sodium ions are present in an amount between about 10 meq. and about 35 meq. per litre of the beverage composition.

6. The method of claim 4 or claim 5, wherein the potassium ions are present in an amount between about 5 meq. and about 30 meq. per litre of the beverage composition. 20

7. The method of any one of claims 4 to 6, wherein the magnesium ions are present in the composition in an amount between about 5 meq. and about 25 meq. per litre of the beverage composition.

8. The method of any one of claims 4 to 7, wherein the phosphate ions are present in an amount between about 1 meq. and about 55 meq. per litre of the beverage 25 composition.

9. The method of any one of claims 4 to 8, wherein the citrate ions are present in an amount between about 0.1 meq. and about 45 meq. per litre of the beverage composition,

10. The method of any one of claims 4 to 9, wherein the vitamin B6 is present in 30 an amount between about 0.1 mg and about 200 mg per litre of the beverage composition. WO 2008/113114 PCT/AU2008/000371 -30

11. The method of any one of claims 4 to 10, wherein the carbohydrate is present in an amount between about 2% and about 20% by weight of the total beverage composition (w/w).

12. The method of any one of claims 4 to 11, wherein the carbohydrate is a 5 monosaccharide, or a disaccharide, or a mixture thereof.

13. The method of claim 12, wherein the monosaccharide is glucose, fructose, mannose, galactose, or a mixture thereof.

14. The method of any one of claims 4 to 13, wherein the composition further comprises vitamin C. 10

15. The method of claim 14, wherein the vitamin C is present in an amount between about 30 mg and about 2000 mg per litre of the beverage composition.

16. The method of any one of claims 4 to 15, wherein the pH of the composition is between about 3.0 and about 5.0.

17. The method of any one of claims 4 to 16, wherein the composition is in a 15 dehydrated form selected from the group consisting of: a powder, granules or tablets.

18. The method of claim 4, wherein the composition comprises: between about 12 meq. and about 32 meq. per litre of sodium ions, between about 10 meq. and about 25 meq. per litre of potassium ions, between about 7 meq. and about 20 meq. per litre of magnesium ions, between about 5 meq. and 25 meq. per litre of phosphate ions, between 1 20 and 15 meq. per litre of citrate ions, between 20 mg and 40 mg per litre of vitamin B6 and between 10% and 20% glucose (w/w).

19. The method of claim 18, wherein the composition further comprises vitamin C in an amount between about 250 mg and about 1200 mg per litre.

20. The method of claim 18, wherein the composition comprises: about 22 meq. 25 per litre of sodium ions, about 17 meq. per litre of potassium ions, about 13 meq. per litre of magnesium ions, about 10 meq. per litre of phosphate ions, about 5 meq. per litre of citrate ions, about 20 mg per litre of vitamin B6 and about 16% glucose (w/w).

21. The method of claim 18, wherein the composition comprises: about 22 meq. per litre of sodium ions, about 17 meq. per litre of potassium ions, about 13 meq. per litre 30 of magnesium ions, about 10 meq. per litre of phosphate ions, about 5 meq. per litre of citrate ions, about 40 mg per litre of vitamin B6 and about 16% glucose (w/w). WO 2008/113114 PCT/AU2008/000371 -31

22. The method of claim 20 or claim 21, wherein the composition further comprises about 480 mg per litre of vitamin C.

23. The method of claim 20 or claim 21, wherein the composition further comprises about 1000 mg per litre of vitamin C. 5

24. The method of claim 4, wherein the composition comprises: between about 12 meq. and about 32 meq. per litre of sodium ions, between about 10 meq. and about 25 meq. per litre of potassium ions, between about 12 meq. and about 22 meq. per litre of magnesium ions, between about 10 meq. and about 20 meq. per litre of phosphate ions, between 0.1 meq. and about 8 meq. per litre of citrate ions, between about 50 mg and about 10 200 mg per litre of vitamin C, between about 10 and 80 mg per litre of vitamin B6, and between about 10% and about 20% glucose (w/w).

25. The method of claim 24, wherein the composition comprises: between about 17 meq. and about 27 meq. per litre of sodium ions, between about 13 meq. and about 21 meq. per litre of potassium ions, between about 13 meq. and about 21 meq. per litre of 15 magnesium ions, between about 11 meq. and about 17 meq. per litre of phosphate ions, between about 0.25 meq. and about 5 meq. per litre of citrate ions, between about 100 mg and about 200 mg per litre of vitamin C, between about 20 and 60 mg per litre of vitamin B6, and between about 14% and about 18% glucose (w/w)

26. The method of claim 24, wherein the composition comprises: about 22 meq. 20 per litre of sodium ions, about 17 meq. per litre of potassium ions, about 17 meq. per litre of magnesium ions, about 15 meq. per litre of phosphate ions, about 1 meq. per litre of citrate ions, about 160 mg per litre of vitamin C, about 40 mg per litre of vitamin B6, and about 16% glucose (w/w).

27. The method of claim 4, wherein the beverage composition is prepared by 25 adding: sodium phosphate monobasic (400 to 550 mg), sodium chloride (60 to 80 mg), sodium citrate dihydrate (100 to 140 mg), potassium chloride (270 to 350 mg), magnesium sulfate (230 to 290 mg), vitamin C (30 to 50 mg), vitamin B6 (5 to 15 mg) and glucose (about 35 to 45 grams), to 250 mL of water, or other suitable liquid.

28. The method of claim 4, wherein the beverage composition is prepared by 30 adding: sodium phosphate monobasic (470.0 mg), sodium chloride (69.0 mg), sodium citrate dihydrate (120.0 mg), potassium chloride (318.0 mg), magnesium sulfate (260.0 WO 2008/113114 PCT/AU2008/000371 - 32 mg), vitamin C (40.0 mg), vitamin B6 (10.0 mg) and glucose (about 40 grams), to 250 mL of water, or other suitable liquid.

29. The method of claim 4, wherein the beverage composition comprises: glucose (30 to 50 grams), sodium ions (100 mg to 150 mg), potassium ions (120 mg to 180 5 mg), magnesium ions (20 mg to 55 mg), phosphate ions (200 mg to 800 mg), vitamin C (80 mg to 1000 mg), vitamin B6 (1 mg to 20 mg) and citrate ions (200 mg to 900 mg), per 250 mL of composition.

30. The method of any one of clairns 18 to 29, wherein the composition has a pH of between about 3.0 and 5.0. 10

31. The method of claim 30, wherein the composition has a pH of between about 3.4 and 3.8.

32. Use of a composition as defined in any one of claims 3 to 30 as an adjunct to cancer therapy.

33. The method of claim 1, wherein the medical treatment is cancer therapy.