CA2152784C - Rehydration drink - Google Patents

Abstract

A liquid composition to be used as a rehydration drink, particularly suited for the administration to people who do heavy work under severe conditions, e.g. at high temperatures, and to sportspeople and athletes, as well as to patients who exhibit dehydration symptoms due to severe illnesses such as diarrhoea or vomiting, contains per serving unit water at least 1 to 100 g of at least one carbohydrate, such as glucose polymers, maltodextrin and fructose: 2 to 2500 mg of at least one electrolyte, such as an alkali and/or earth alkali salt: 0,1 to 750 mg of at least one ammonia neutralizer, such as D,L-magnesium aspartate, L-arginine and glutamate: at least one energy enhancer, such as members of the vitamin B group and branched chain amino acids; at least one antioxidant such as .beta.-carotene, vitamin C, vitamin E and selenium: 1 to 30 mg of at least one membrane stabilizer, such as choline, betaine and methionine; and 1 to 200 µg of at least one neuromuscular function enhancer such as octacosanol.

Description

Wn 94/15488 ~ 15 2'~ 8 4 ~T~~4/00040 REHYDRATION DRINK
BACKGROUND OF THE INVENTION
l.Field of the Invention The present invention relates to a new liquid composition, a method for producing this composition and the use of this composition as rehydration drink.

2.Description of the Related Art There are a number of liquid compositions or diluted mixtures on the market.by the name of "Activity Drinks", "Sports Drinks" or "Nutrient Drinks" which intend to solve problems with respect to the loss of sugars, electrolytes, vitamins, minerals, amino acids, and other important nutrients due to sweating.
These drinks, however, show concentrations of electrolytes, kinds of sugars, and osmotic characteristics which are not sufficient to be totally effective in replacing the tremendous sweat losses incurred e.g.by chronically ill patients, strenuous physical activity, or the harsh-conditions of tropical or desert environment. US Patent 4,626,527 describes a similar intent but discloses only the use of choline.
Several groups of people, including factory and farm workers and athletes can lose one to two liters of sweat per hour with heavy clothing.Chronically ill patients or patients who rely on others to care for them may lose more fluid than what they consume. Newcomers to the desert, with clothing and heavy packs, can lose up to four liters per hour.
There are a number of serious symptoms of heat exhaustion which may develop as one loses from as little as one liter WO 94/15488 ~ PCT/EP94/00040 .

to as much as four liters or more of sweat. These symptoms include e.g. vertigo/dizziness, lightheadedness, fatigue and muscle cramps. Most of the symptoms are obvious to the in-dividual, but sometimes lightheadedness is not, because a lightheaded individual is unable to think or act appropriately.
Thus, most of these people lose sweat which contains not only water, but more importantly, sugars, electrolytes, vitamins, minerals, amino acids, and other important nutrients. Each of these are vital for proper cellular function, including brain function.
Drinking water alone will not replace the vital nutrients and will also cause stomach cramps because of the difference of the osmotic properties of water on the one hand and stomach fluids on the other hand, and because it requires time for the body to assimilate the water.
The use of salt tablets is not recommendable because the excess sodium withdraws water or suppresses more of the other vital electrolytes from the body.
OBJECT OF THE INVENTION
Since the related art did not solve the problems properly, there was a need for a proper medical formulation which will protect people and promote their well being under various adverse conditions connected with excessive loss of water, e.g. excessive perspiration.
The present invention is thus specifically concerned with the provision of a new rehydration drink. It is therefore the object of the present invention to provide a liquid composition which overcomes all the above mentioned disadvantages, and which reduces vertigo/dizziness, lightheadedness, fatigue and muscle cramps caused by excessive water loss. Fatigue as used herein means the subjective feeling of tiredness as well as .the objective fatigue of muscles and the actual decrease of performance.
SUMMARY OF THE INVENTION
The solution for the objects of the invention was found in a new liquid composition comprising per serving unit:
a) 1 to 100 g of at least one carbohydrate, b) 2 to 2500 mg of at least one electrolyte, c) 0,1 to 750 mg of at least one ammonia neutralizer, d) at least one energy enhancer, preferably selected from d1) i-2'000 ug vitamins of the vitamin B group, d2) 10-40'000 mg L-carnitine, creative and choline, and d3) 1-100 mg branched-chain amino acids, e) at least one antioxidant, preferably selected from e1) ~-carotene in a quantity of 2 erg - 200 mg, e2) vitamin C in a quantity of 10-250 mg, e3) vitamin E in a quantity of 8-30 I.U., and e4) selenium in a quantity of 10-300 ug, f) 1 to 30 mg of at least one membrane stabilizer, g) 1 to 200 ~sg of at least one neuromuscular enhancer, and h) water in a quantity at least sufficient to provide a solution wherein components a) to g) are substantially dissolved and which is ready for consumption by drinking.
The ingredients of the above components a) to g) as well as the water for dissolving these ingredients (component h) should, of course, be physiologically acceptable.
The present invention also relates to a composition which is suitable for producing the above liquid composition, i.e. a solid composition containing the above components a) to g), which solid composition can be obtained by homogeneously mixing the components a) to g), and which can be converted WO 94/IS488 ~ PCT/EP94/00040 ' to the above liquid composition by adding water (component h) in a quantity at least sufficient to substantially dissolve all of components a) to g) to form a drinkable solution.
S
DESCRIPTION OF THE PREFERRED EMBODIMENTS
Among the carbohydrates of component a) are various sugars, monosaccharides as well as oligosaccharides. Typical ex-i0 amples are N-acetyl-D-galactosamine, D-glucose (dextrose, grape sugar, corn sugar), D-glucosamine, N-acetyl-D-glucos-amine, N-methyl-D-glucosamine, D-mannose, D-ribose, D-xylose D-fructose, D-galactose, D-galactosamine, cellobiose, malt-ose, galactose, and sucrose.

These carbohydrates are either in the form of monomers like D-fructose or in the form of polymers e.g. glucose polymers, such as maltose or maltodextrin, in which a series of gluc-ose molecules is bond together chemically. Such polymers can 20 be made from any of the above sugars, which are cleaved en-zymatically in the body; this process consequently provides a constant source of energy made available to the body over a course of one to two hours.
2S The preferred carbohydrates are the glucose polymers, malto-dextrin and fructose in crystalline pure form; most prefer-red are the glucose polymers. The preferred range of the carbohydrates is 7 to 35 mg.
30 The component b) is an electrolyte, paricularly mineral -salt. Preferred electrolytes are salts of a metal of the group I and II of the Periodic System, preferably the in-organic and organic salts of sodium, potassium, calcium and/or magnesium. Examples of such salts are sodium acetate, 35 acidic sodium citrate, acidic sodium phosphate, sodium amino salicylate, sodium bicarbonate, sodium bromide, sodium W~1 94115488 PGT/EP94/80040 chloride, sodium citrate, sodium lactate, sodium phosphate, sodium salicylate, sodium sulphate (anhydrous), sodium sulphate (Glauber's salt), potassium acetate, potassium bicarbonate, potassium bromide, potassium chloride, potassium citrate, potassium-D-gluconate, mono-and dibasic potassium phosphate, calcium acetate, calcium chloride, calcium citrate, calcium-D-gluconate, calcium lactate, calcium laevulinate, dibasic calcium phosphate, magnesium chloride and magnesium sulphate.
The preferred salts are sodium bicarbonate, sodium phos-phate, potassium bicarbonate, potassium chloride, dibasic potassium phosphate, calcitua carbonate and magnesium carb-onate. The electrolytes are present in amounts of 2 to 2500 15 mg, preferably in amounts of 5 to i'000 mg.
Ammonia neutralizers of component c) are mainly amino acids e.g. a-alanine, arginine, asparagine, cystine, cysteine, aspartic acid, glutamic acid, glutamine, glycine, histidine, 20 b-hydroxylysine, hydroxyproline, lysine, 3-monoiodotyrosine, leucine, methionine, norleucine, phenylalanine, proline, threonine, serine, tyrosine, tryptophan and the salts thereof, e.g. the potassium, magnesium and the phosphate salts.
Preferred amino acids or salts thereof are D,L-magnesium aspartate, L-arginine and glutamate. The preferred range of the amino acids is 5 to 250 mg.
Energy enhancers of component d) are preferably vitamins of the vitamin B group, e.g. vitamin B1 (thiamin, aneurin), vitamin B2 (riboflavin), vitamin PP (niacinamide), vitamin B6 (pyridoxine), pantothenic acid and L-carnitine; creatine, choline (bitartrate or its other forms); and branched chain amino acids, particularly leucine, valine and isoleucine.
Preferred quantities of vitamins of the B group (component WO 94115488 ~ ~ ~ ~ PCTJEP94/00040 ' di) are i0-500 pg, preferred quantities of Z-carnitine, creatine and choline (component d2) are 50-500 mg and preferred quantities of branched-chain amino acids (leucine, isoleucine and valinej are 3-10 mg.
Preferred quantities of antioxidants (component e) are as follows: ~-carotene: 5-100 pg, vitamin C: 20-i00 mg, vitamin E: 10-20 I.U., and selenium: 50-200 ug.
70 Membrane stabilizers of component f) are preferably betain and methionine in a range of 1-30 mg, preferably 4 to 10 mg.
An example of a neuromuscular enhancer (component g) is the choline (choline bitartratej already referred to under d) i5 above. Preferred neuromuscular enhancers are higher saturated fatty alcohols, particularly C25 - C30 fatty alcohols, preferably octacosanol (cerotyl alcohol] which can be used in quantities of 1-2'000 pg, preferably 3-20 ug, most preferably about 5 ug.
Within the broad scope of the invention described above, two lines of more specific compositions have been developed, which constitute preferred embodiments of the invention. The first line embraces compositions which are particularly suited for the administration to people who do heavy Work under severe conditions and particularly at high ambient temperatures and to sports enthusiasts and athletes. This line is represented by the compositions under the heading "Drink A" in Table 1 below. The second line embraces compositions which are particularly suited for patients who exhibit dehydration symptoms due to severe diarrhoea or vomiting for a variety of causes such as gastrointestinal disorders, cardiovascular disorders, and chronic illnesses, such as cancer. Compositions of this type are represented by those set forth under the heading "Drink B" in Table 1 below. Figures underlined in Table 1 (such as "32" relating V "194!15488 ~ 1 ~ 2 ~ $ 4 PCT/EP94/00040 to "Glucose Polymers" in-the left column) refer to the specific "Drink A" and "Drink B", respectively, administered in the course of the tests which will be described later-on.
The compositions containing these underlined quantities of ingredients are particularly preferred.
The quantities of the various components of the compositions according to the present invention relate, throughout the specification and the claims, in each case to serving units or rations, i.e. to quantities of drink served, administered or consumed at one time. It will be well understood that such serving units are commonly not prepared individually.
For the sake of simplicity and economy greater quantities are usually prepared which are composed of multiples of such i5 serving units. Accordingly, it must be kept in mind that the figures relating to these serving units must be extrapolated by multiplication by any desired multiplicator so that any desired quantity of a composition is included. Thus, although the figures shown in Table i and elsewhere in the specification as well as in the claims relate to a serving unit, they have to be understood as comprising any multiple thereof .
In preparing the various liquid compositions, the components listed in Table i are homogeneously mixed and dissolved in a sufficient quantity of water to provide a solution ready for consumption by drinking.
TABLE 1:
Ingredients Drink A Drink B
CARBOHYDRATES
Glucose Polymers (g) 20-26-32-50-100 7-10-14-40-80 Maltodextrin (mg) 10-20-30-50-15 - 10-15-25-50-100 Fructose {g) 1-i.5-2-5-15 1-1.5-2-5-15 ELECTROLYTES
KFiC03 (mg) 100-500-X60-1500-2500 50-100-200-500 WO 94!15488 PCT/EP94/00040 _ g _ NaHC03 (mg) 20-30-40-5-60 2-3-4-5-10 KC1 (mg) 100-150-200-500-2'000 20-30-40-800-1500 K3P04 (mg) 700-150-200-500-2'000 20-30-40-800-1500 Na3P04 (mg) 50-150-300-500-750 5-15-30-50-75 CaC03 (mg) 5-15-20-40-200 5-15-20-40-200 MgC03.(mg) 5-15-20-40-200 5-15-20-40-200 AI~I~A NEUTRALIZERS

D,L-Aspartic Acid or Magnesium Aspartate 1-10-20-50-75 (mg) 10-100-200-500-750 L-Arginine (ug) 20-100-200-500-750 2-10-20-50-75 Glutamate (mg) 1-5-10-30-100 1-5-10-30-50 ENERGY ENHANCERS _ Vitamin B1 (~sg) 1-3-~-50-500 ~ i-3-_5-50-500 Vitamin 82 (ug) 10-50-100-500-2'000 10-50-100-500-Niacinamide (ug) 10-50-100-500-2'000 10-50-100-500-Vitamin E6 (ug) 10-50-i00-500-2'000 10-50-100-500-Pantothenic Acid (ug) 10-50-100-500-2'000 10-50-100-500-L-Carnitine (mg) 10-50-100-500-2'000 1-50-10-50-200 Creatine (mg) 10-50-100-500-1'000 5-8-10-50-200 Choline bitartrate(mg)4-200-400-4000-40'000 4-20-40-400-4'000 BRANCHED CBAIrT AMINO
ACIDS

Leucine (mg) 1-3-5-10-50 1-3-~-10-50 Isoleucine (mg) 1-3-5-10-100 1-3-5-10-100 Valine (mg) 1-3-5-10-100 1-3-_5-10-100 ANTIOXIDANTS

Beta-Carotene (ug) 5-8-10-100-200 2-3-5-10-100 'Vitamin C (mg) 20-30-60-120-250 10-30-60-70-90 Vitamin E (I.U.) 10-12-i5-20-30 8-9-10-12-15 Selenium (ug) 10-50-100-200-300 10-20-50-100-200 MEMBRANE STABILIZERS METHYLDONORS
or Betaine chloride (y~g) 1-3-5-10-25 1-3-5-10-25 Methionine (ug) 3-4-5-20-30 1-3-5-10-20 J

ERSAT~8Er4TT

wo~~~s~8 212784 _ g _ NEUROMUSCOLAR ENHANCERS
Octacosanol (ug) 1-3-_5-i00-200 ~ i-3-_5-10-20 The preferred liquid composition of the present invention combines about 30 different macronutrients and micronutri-ents. Very surprisingly, a truly spectacular result is obtained, eliminating nearly completely all fatigue and dehydration symptoms, in both the sports and with dehydrated patients.
The new liquid composition according to the present invention can be manufactured by known methods, e.g.
powdering each compound a) through g), mixing them together in the ranges of the amounts given, diluting the resulting mixture with water, and homogenising.
In view of the specific qualitative and quantitative combination of the components a) through g), the liquid composition is useful as rehydration drink. This drink repietes the nutrients and water losses which occur while sweating during physical exertion or water losses due to diarrhoea or vomiting. This drink can be administered to a human body with no restriction concerning age, sex, medical history, drug therapy and food consumption, who lost water and nutrients in different ways and for different reasons, especially patients who e.g. clinically exhibit dehydration symptoms, sports enthusiasts and people who require sus-tained energy. The drink is also useful for patients in nursing homes and hospitals, patients with diarrhoea, people who work outdoors, professional athletes, or those who require sustained energy while working. Finally the drink is effective under tropical or desert conditions to compensate for the quantity of liquid lost. The drink may be given a pleasant taste to stimulate consumption.
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Two groups of people (group I and II) were analysed. Group I
was composed of 25 people who were active athletes involved in many sports, particularly basketball, soccer and American football. Group II was composed of 20 patients who clinical-ly exhibited dehydration symptoms secondary to severe diar-rhoea or vomiting from a variety of causes including cancer, gastrointestinal disorders, and chronically institutional-ized patients.
"Quality of life scales", a term which is used for describ-ing a series of qualities of life, are an acceptable way of evaluating any treatment not by the physician, but rather by the patient himself/herself. The patient decides Whether the treatment is beneficial or not. These scales have been iS successfully used to evaluate cardiovascular treatments, cancer treatments, and treatments of other chronic illnesses.
The scoring system is simple. The person decides if the .._ treatment has improved, worsened, or has made no change in his/her life during the treatment period. Each person is asked to score themselves before and after using the drink.
The amount served was 1 cup (1 serving unit) of Drink A
containing about 33 g of carbohydrates and about 554 kJ (132 ?5 calories), and 1 cup (1 serving unit) of Drink B containing about 15 g of carbohydrates and about 252 kJ (60 calories.).
Either drink would have been alright for either group, but athletes need more energy .and drink A has more energy calor-ies as well as enhancing agents. The results of these tests are shown in Table 2.
~R~END~D S~

940107 21 ~ 2 '~ 8 4 Pc~~~S

Quality of Life Scales Group I/Drink A Group II/Drink B
Improve/No /Worsen Improve/No /Worsen Change Change Physical Symptoms 25 19 1 Fatigue Dizziness, Vertigo Lightheadedness Muscle cramps Performance 23 2 i 8 2 General Well Being 25 20 Cognitive Abilities 25 17 3 Life Satisfaction 25 20 Further tests were made with Group I and Group II people and with Drink A and Drink B. Blood values were obtained of all patients in Group I (athletes) and all 20 patients in Group II (patients) before and after administration of the rehydration drink A to Group I and Drink B to Group II.
?5 Group I- Active Athletes:
A blood sample was obtained on all athletes half way through the end of the strenuous exercise. For example, this was at half time of the basketball, soccer, or. American football -- game, or half way through (at least 45 minutes) a strenuous exercise work-out for others (body-builders, runners, etc.).
After the blood was obtained, the athletes began to drink 113 to 169 g (four to six oz.) of Drink A every 15 to 20 minutes until the games or exercises were completed, at which time a second blood sample was obtained. The two sets of blood values were compared (Tables 3 to 6).

WO 94/15488 215 2 7 ~ 4 The first blood samples were analysed and consistently revealed a picture of Type A i,actic Acidosis due to hypo-xemia in this group. Lactic acidosis is characterized by:
1) Increased Anion Gap (A.G.) (>25 mEq/1; normal range =
8-16 mEq/1). The Anion Gap is defined as:
Sodium (Na) - [Chloride (Cl) + Bicarbonate (HC03)]
2) Decreased serum bicarbonate (normal range 24-26 mEq/1) 3) Increased serum potassium (> 5,5; normal 3,5-5,3 mEq/1) 4) ?~ow or normal serum chloride (normal 96-i09 mEq/1) 5) Increased serum uric acid (normal range = 3-9 mg/dl) 61 Increased serum phosphorus (normal range 2,5-4,5 mg/dl) 7) Increased serum SGOT (normal range 0-40 Units/liter) 8) Increased serum LDH (normal range 100-225 Units/liter) 9) Decreased urine pH (normal range 5,i-9,0) 10) Increased lactate (>5, normal range 0-1,6 mEq/liter) TABLE 3: Hallmarks of lactic acidosis seen in athletes, especially type A Which is due to hypoxemia, the number of athletes with those values and the range.
blood parameter hallmark of number of range of lactic athletes athletes acidosis with this blood values value anion gap (A.G.) >25 mEq/lt 23 of 25 22-31 lactate level >S,O mEq/lt All 25 5,1-7,1 urine pH <5,2 All 25 4,0-5,0 chloride level low or <96 23 of 25 92-100 mEq/lt bicarbonate level <24 mEq/lt All 25 20-23 potassium level >5,6 mEq'/lt All 25 5,6-6,3 uric acid level >9 mg/dl 24 of 25 8-17 phosphorus _ >4,5 mg/dl All 25 4,5-5,1 S-GOT >40 IU/1 22 of 25 35-47 LDH >225 IU/1 24 of 25 225-246 ~1~2784 ~ 94/15488 PCTIEP94I00040 TABLE 4: Blood Values (a. normal range, and of Athletes No.
1 through 25 at half-time of exercise, before rehydration drink A was administered:
S No Na C1 HC03 A.G. >;act K Uric P Urin SGOT LDH
Acid pH
a. 135- 96- 24- 8-16 0-16 3.5- 3-9 2.5- 5.2- 0-40 100-147 109 26 5.3 4.5 9.0 225 1 140 93 20 27 6,1 5,8 11 4,7 5,0 41 230 2 146 96 23 27 7,7 5,6 12 4,9 4,0 42 227 ' 3 147 100 22 25 5,5 5,7 9 5,1 5,0 40 232 4 741 95 22 24 5,1 5,9 10 4,6 5,0 35 234 5 137 95 20 22 5,2 5,7 8 4,8 5,0 42 224 6 138 93 22 23 5,6 6,i ii 5,0 5,0 45 226 7 142 95 21 26 5,9 6,0 13 4,7 5,0 39 229 8 745 94 20 31 6,8 5,7 i5 4,8 4,0 44 246 9 144 95 21 28 6,3 6,0 14 4,6 4,0 43 241 70 142 93 27 28 6,2 5,6 15 4,5 4,0 42 229 ii 139 92 20 27 6,2 6,1 i3 4,7 4,0 44 225 12 746 94 23 29 6,3 5,8 16 4,8 4,0 42 232 13 145 95 21 29 6,6 5,9 74 5,0 4,0 41 234 14 744 93 22 29 6,6 5,7 13 4,9 4,0 47 227 15 146 94 21 31 7,1 6,2 77 5,0 4,0 45 239 16 139 94 27 24 S, 5, 11 4, 5, 41 235 17 145 93 22 30 7,0 6,1 76 4,9 4,0 46 239 18 143 94 21 28 6,4 6,0 12 5,0 4,0 42 241 19 142 95 22 25 5,9 5,7 9 4,6 5,0 36 235 20 145 94 20 31 6,8 6,3 13 4,9 4,0 47 236 21 739 92 20 27 5,9 6,1 15 4,9 5,0 44 228 22 740 94 21 25 5,4 5,6 9 5,0 4,0 42 226 23 146 93 23 30 6,8 6,1 16 5,1 4,0 46 234 24 143 92 20 31 6,7 6,3 14 4,8 4,0 45 237 25 147 97 22 28 6,6 5,9 13 4,7 4,0 47 231 WO 94/15488 ~ PCT/EP94/00040 TABLE 5: Blood values of group I athletes at the end of game/exercise .after administration of rehydration drink A
No Na C1 HC03 A.G. lact K uric P urin SGOT LDH
-ate acid pH
a. 135- 96- 24- 8-16 0-76 3.5- 3-9 2.5- 5.2- 0-40 100-.147 109 26 5.3 4.5 9.0 225 1 140 105 25 10 0,8 3,9 8,0 4,1 8,0 31 109 i0 2 142 106 24 12 1,2 5,0 7,0 4,0 8,0 27 201 3 139 103 26 10 1,1 4,9 7,0 3,7 6,0 36 217 4 141 10i 25 15 1,5 5,1 8,0 2,9 8,0 26 222 747 108 26 13 0,5 3,8 3,0 3,i 8,0 29 199 6 137 99 26 12 1,4 4,7 5,0 3,9 7,0 40 109 7 140 108 24 8 1,1 4,5 8,0 4,3 6,0 19 216 8 136 101 25 10 1,2 3,9 4,0 3,0 7,0 26 i93 9 139 99 26 14 1,5 4,2 7,0 2,7 9,0 37 129 i0 142 105 24 13 0,9 4,8 5,0 3,6 8,0 24 147 11 137 96 25 16 1,3 4,1 3,0 3,3 8,0 19 192 i2 145 107 26 12 0,2 3,7 5,0 4,2 6,0 26 178 13 140 99 26 15 1,4 5,0 4,0 2,8 7,0 30 201 i 147 108 25 14 0,7 4,3 8,0 4,7 8,0 27 219 15 137 96 25 16 0,3 4,0 6,0 3,6 6,0 16 184 16 135 97 24 14 1,2 5,0 4,0 2,5 6,0 32 191 i7 i39 99 24 16 0,9 5,2 7,0 2,7 8,0 22 217 18 140 105 25 10 0,6 3,7 4,0 3,7 7,0 12 157 19 145 i08 24 13 0,4 5,1 8,0 4,0 6,0 25 152 20 138 103 26 9 1,4 3,9 3,0 3,2 8,0 8 183 21 742 106 25 11 0,8 4,7 4,0 2,9 6,0 36 222 22 143 107 24 12 i,3 4,4 7,0 2,7 7,0 25 766 23 137 702 24 71 0,6 3,6 5,0 4,5 6,0 30 200 24 140 99 26 15 1,3 4,8 7,0 3,9 8,0 17 226 25 145 104 25 i6 0,7 5,1 8,0 3,1 6,0 39 196 940107 ~~1~2'~~4 TABLE 6 shows that all 25 athletes had normal blood values after drinking rehydration drink A:
blood parameter hallmark of number range of of lactic athletes athletes' acidosis with blood values nor-l l ma ues va anion gap >25 mEq/lt all 25 8-16 lactate level >5,0 mEq/lt all 25 0,2-1,5 urine pH <5,2 all 25 6-9 chloride level low or <96 all 25 96-108 mEq/lt bicarbonate level <24 mEq/lt all 25 24-26 potassium level >5,6 mEq/lt all 25 3,6-5,2 uric acid level >9 mg/dl all 25 3-8 phosphorus >4,5 mg/dl all 25 2,5-4,5 S-GOT >40 IU/1 all 25 8-40 ZDFi >225 IU/1 all 25 109-226 Group II - Patients A blood sample was obtained of all 20 patients with various illnesses listed in Table 7. After drinking 113 to 169 g (four to six ounces) of the rehydration drink B every 20 ~o 30 minutes for two and a half to three hours, a second blood specimen was obtained. The two sets of blood values were compared.
Three'patients had diarrhoea which produces a metabolic acidosis characterized by low bicarbonate, a normal to low chloride, and unlike lactic acidosis, a low potassium, and a low sodium. These features are shown in Table 7.
Two patients had nausea and vomiting which produces a meta-bolic alkalosis characterized by an elevated bicarbonate, an elevated sodium, a low potassium, and a normal to low chloride. Both patients had these blood changes.
~t~~ND~I1 SHEET

WO 94/15488 . ~ PCT/EP94/00040 - i6 -Lactic acidosis Type B (no clinical tissue hypoxia) seen with Infections, Diabetes, Cancer, and Alcohol use; Lactic acidosis Type A (due to clinically apparent hypoxia) seen with dehydration in nursing home patients.
TABLE 7: Blood Values (a.: normal, and of 20 Group II
patients before the administration of rehydration drink B
(Diar = diarrhoea; Naus = nausea, vomiting; Alc = Alcohol;
Inf = infections; Diab = diabetes; Canc = cancer; Home =
70 dehydrated nurse home patients) Na C1HC03 A.G. Lact K Uric P Urin SGOT LDH
Acid pH
a. 135- 96- 24- 8-16 0-16 3.5- 3-9 2.5- 5.2- 0-40 100-147 109 26 5.3 4.5 9.0 225 Diar 129 95 17 i? 5,2 3,3 18,0 4,9 4 46 236 Diar 130 96 15 i9 4,9 3,4 17 5,1 4 41 241 Diar 127 94 15 18 5,3 3,i 15,0 4,7 5 48 229 Naus 150 94 28 28 0,8 3,2 16,0 4,6 9 40 226 Naus 151 93 30 28 1,1 3,0 18,0 4,7 9 47 230 Inf 141 93 23 25 2,4 5,8 i2 5,1 3 40 240 Inf i43 94 21 28 2,7 6,2 13 4,9 4 46 237 Diab 146 99 20 27 5,1 5,6 11 5,2 4 40 245 Diab 144 95 21 28 5,2 5,9 19 5,0 3 44 235 Diab 139 93 20 26 5,7 5,7 i2 4,8 3 42 228 Canc 140 91 2i 28 5,9 5,8 15 5,3 4 53 317 Canc 142 95 22 25 6,2 5,9 17 4,9 5 49 300 Canc 137 92 22 23 5,6 6,1 13 4,6 3 52 278 Canc i38 94 21 23 6,0 6,2 16 5,1 4 67 259 Alc i47 101 27 25 5,0 5,9 14 4,9 4 59 266 Home 145 93 22 30 7,0 6,1 i6 4,9 4 46 242 Home 139 92 20 27 6,2 6,i 13 4,7 4 49 225 Home 143 92 20 31 6,5 6,0 i4 4,9 5 47 236 Home 142 95 22 25 7,0 5,6 16 5,1 3 36 226 Home 136 92 21 23 4,6 6,0 12 4,8 4 45 233 - ~ 94/15488 21 ~ 2 '~ 8 4 - 77 _ All 20 patients demonstrate the characteristic blood changes seen with the disorders listed, whether it be metabolic acidosis associated with diabetes, metabolic alkalosis associated with nausea and vomiting, or lactic acidosis associated with infections, diabetes, cancer, alcohol, or dehydration seen in nursing home patients who are not well attended and who forget to drink on a regular basis.
Each blood parameter became normal for all patients studied after the rehydration drink B was given to them as shown in:
TABLE 8: and 20 Group II
Blood of Values (a.:
normal, patients stration ion B
after of drink the rehydrat admini (Diar = diarrhoea; nausea, ol;
Naus vomiting;
= Alc =
Alcoh Inf infec tions;Diab diabetes; Canc can cer; =
= = = Home dehydrated nursehome ients) pat Na C1HC03 A.G. Lact K Uric P Urin SGOTLDH

Acid pH

a. 135- 96- 24- 8-i6 0-16 3.5-3-9 5.2- 0-40100-2.5-147 109 26 5.3 4.5 9.0 225 Diar 141 99 26 16 0,9 5,1 8 4,2 8 _ 148 Diar 139 103 24 12 i,3 4,9 3 2,9 6 22 2i7 Diar i43 105 25 13 1,0 4,6 6 3,6 9 31 i96 Naus 140 107 24 9 0,8 5,2 9 4,1 5 19 i54 Naus 145 108 26 11 1,4 5,0 5 2,6 6 27 219 Inf 142 104 24 14 0,7 3,7 7 4,0 7 12 201 Inf 136 102 25 9 0,4 4,9 4 2,8 8 25 224 Diab 144 106 26 12 1,5 5,4 8 3,5 6 36 133 Diab 135 101 25 9 1,2 4,7 9 4,4 7 33 168 Diab 146 109 24 13 1,4 5,2 3 2,9 9 34 214 Canc 137 98 25 14 0,9 4,0 4 3,3 7 55 309 Canc 139 97 26 16 1,1 4,7 8 4,3 6 47 294 Canc 142 105 24 13 0,8 5,0 5 3,9 8 60 281 Canc 147 108 26 13 1,6 5,3 7 4,5 6 59 262 Alc 138 99 25 14 1,5 4,2 ? 2,7 9 38 199 WO 94!15488 ~ ~ ~ PCT/EP94/00040 _ 18 _ Home 140 107 24 9 1,3 3,9 3 4,2 8 19 209 Home 145 109 26 10 0,8 3,6 4 3,0 6 20 200 Home 139 i00 24 15 1,5 5,7 6 3,7 7 40 155 Home 141 i03 25 13 i,1 4,5 9 2,6 6 35 205 Home 143 106 24 13 7,0 3,7 8 4,4 9 15 186 CaDNCLUSION: For both groups of athletes (Group I) and patients (Group II) it was demonstrated that their initial blood values were consistent with the acid-base disorder characteristic for those specific grougs. It was further demonstrated that the blood abnormalities became normalized after each person drank rehydration drink A or B
respectively.

Claims (22)

The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:

1. A liquid composition to be used as a rehydration drink, containing per serving unit at least the following components:
a) 1 to 100 g of at least one carbohydrate;
b) 2 to 2500 mg of at least one electrolyte;
c) 0.1 to 750 mg of at least one ammonia neutralizer;
d) at least one energy enhancer;
e) at least one antioxidant;
f) 1 to 30 mg of at least one membrane stabilizer;
g) 1 to 200µg of at least one neuromuscular function enhancer selected from the group consisting of choline and a higher saturated fatty alcohol; and h) water in a quantity at least sufficient for provide a solution wherein components a) to g) are substantially dissolved and which solution is ready for consumption by drinking.

2. A composition according to claim 1, wherein the carbohydrate is selected from the group consisting of monosaccharides, oligosaccharides, glucose polymers, maltodextrin and fructose.

3. A composition according to claim 1 or 2, wherein the electrolyte is selected from the group consisting of salts of a metal of Group I and II of the periodic system.

4. A composition according to claim 3, wherein the electrolyte is selected from the group consisting of sodium bicarbonate, sodium phosphate, acidic sodium phosphate, potassium bicarbonate, potassium chloride, dibasic potassium phosphate, calcium carbonate and magnesium carbonate.

5. A composition according to any one of claims 1 to 4, wherein the ammonia neutralizer is selected from the group consisting of amino acids and their salts.

6. A composition according to claim 5, wherein the ammonia neutralizer is selected from the group consisting of D,L-magnesium aspartate, L-arginine and glutamate.

7. A composition according to any one of claims 1 to 6, wherein the energy enhancer is selected from the group consisting of vitamins of vitamin B group and branched chain amino acids.

8. A composition according to claim 7, wherein the energy enhancer is selected from the group consisting of vitamins of the vitamin B group in a quantity of 1-2,000 µg; L-carnitine, creative and choline in a quantity of 10,000-40,000 mg, and branched-chain amino acids in a quantity of 1-100 mg.

9. A composition according to claim 8, wherein the energy enhancer comprises at least one compound selected from the group consisting of vitamin B1, vitamin B2, niacinamide, vitamin B6, pantothenic acid, L-carnitine, creative, choline chloride, leucine, isoleucine and valine.

10. A composition according to any one of claims 1 to 9, wherein the antioxidant is selected from the group consisting of .beta.-carotene in a quantity of 2 µg-200 mg, vitamin C in a quantity of 10-250 mg, vitamin E in a quantity of 8-30 I.U., and selenium in a quantity of 10-300 µg.

11. A composition according to any one of claims 1 to 10, wherein the membrane stabilizer is selected from the group consisting of choline chloride, betaine chloride and methionine.

12. A composition according to any one of claims 1 to 11, wherein the neuromuscular enhancer is octacosanol in quantities of 1-200 µg.

13. A liquid composition according to claim 1, containing per serving unit water at least the following components:
a) 1 to 35 g of at least one carbohydrate;
b) 2 to 2500 mg of at least one electrolyte;
c) 5 to 250 mg of at least one ammonia neutralizer;
d1)50-500 µg vitamins of the vitamin B group:
d2)50-500 mg L-carnitine, creatine and choline:
d3) 5-50 mg of branched-chain amino acids;
e1) 5-100 µg .beta.-carotene;
e2) 30-120 mg vitamin C;
e3) 10-20 I.U. vitamin E;
e9) 50-100 µg selenium;
f) 3 to 10 mg of at least one membrane stabilizer;
g) 3 to 100 µg of at least one neuromuscular function enhancer.

14. A liquid composition to be used as a rehydration drink, containing per serving unit at least the following components:
20-100 g Glucose Polymers;
10-150 mg Maltodextrin;
1-15 g Fructose;
100-2,500 mg Potassium Bicarbonate;
20-60 mg Sodium Bicarbonate;
100-2,000 mg Potassium Chloride;
100-2,000 mg Potassium Phosphate;
50-750 mg Sodium Phosphate;
5-200 mg Calcium Carbonate:
5-200 mg Magnesium Carbonate;
10-750 g D,L-Aspartic Acid (Magnesium Aspartate);
20-750 µg L-Arginine;
1-100 mg Glutamate;
1-500 µg Vitamin B1;
10-2,000 µg Vitamin B2;
10-2,000 µg Niacinamide;
10-2,000 µg Vitamin B6;
10-2,000 µg Pantothenic Acid;
10-2,000 mg L-Carnitine:
10-1,000 mg Creatine;
4-40,000 mg Choline (chloride);
1-50 mg Leucine;
1-100 mg Isoleucine;
1-100 mg Valine;
5-200 µg .beta.-Carotene:
20-250 mg Vitamin C;

10-30 I.U. Vitamin E;
10-300 µg Selenium;
1-25 mg Betaine (chloride);
3-30 mg Methionine; and 1-200 µg Octacosanol.

15. A liquid composition to be used as a rehydration drink, containing per serving unit at least the following components:

7-80 g Glucose Polymers;
10-100 mg Maltodextrin;
1-15 g Fructose;
50-1,500 mg Potassium Bicarbonate;
2-10 mg Sodium Bicarbonate;
20-1,500 mg Potassium Chloride;
20-1,500 mg Potassium Phosphate;
5-75 mg Sodium Phosphate;
5-200 mg Calcium Carbonate;
5-200 mg Magnesium Carbonate;
1-75 g D,L-Aspartic Acid (Magnesium Aspartate);
2-75 µg L-Arginine;
1-50 mg Glutamate;
1-500 µg Vitamin B1;
10-2,000 µg Vitamin B2;
10-2,000 µg Niacinamide;
10-2,000 µg Vitamin B6;
10-2,00 µg Pantothenic Acid;
1-200 mg L-Carnitine;
5-100 mg Creatine;

4-4000 mg Choline (chloride);

1-50 mg Leucine:

1-100 mg Isoleucine:

1-100 mg Valine;

2-100 µg .beta.-Carotene:

10-90 mg Vitamin C;

8-15 I.U. Vitamin E;

10-200 µg Selenium;

1-25 mg Betaine (chloride);

1-20 mg Methionine: and 1-20 µg Octacosanol.

16. A composition suited for preparing a rehydration drink by dissolving in water a liquid composition containing at least the following components:
a) 1 to 100 g of at least one carbohydrate;
b) 2 to 2500 mg of at least one electrolyte;
c) 0.1 to 750 mg of at least one ammonia neutralizer;
d) at least one energy enhancer;
e) at least one antioxidant:
f) 1 to 30 mg of at least one membrane stabilizer; and g) 1 to 200 µg of at least one neuromuscular function enhancer selected from the group consisting of choline and a higher saturated fatty alcohol, per serving unit of water.

17. Process for the manufacture of a liquid composition to be used as a rehydration drink, wherein components a)-g) set forth in claim 1 are mixed, the resulting mixture being dissolved in a quantity of water at least sufficient to provide a solution wherein components a)-g) are substantially dissolved to provide a liquid composition ready for consumption by drinking.

18. Use of a composition as claimed in any one of claims 1 to 16, for the treatment of the human body to replete losses of water and nutrients.

19. Use according to claim 18, wherein the human body is subjected to clinical dehydration symptoms comprising vertigo/dizziness, lightheadedness, fatigue and muscle cramps.

20. Use according to claim 18, wherein the human body is subjected to sustained energy requirement.

21. Use according to claim 20, wherein the sustained energy requirement results from work or sport.

22. Use according to claim 18, wherein the losses of water and nutrients are due to tropical or desert conditions, sweating, vomiting and/or diarrhoea.