Title: Rehydration composition
United States Patent: 7,375,089
Issued: May 20, 2008
Inventors: Verlaan; George
(Wageningen, NL), Hageman; Robert Johan Joseph (Waddinxveen, NL), Smeets;
Rudolf Leonardus Lodewijk (Venlo, NL)
Assignee: N.V. Nutricia (Zoetermeer,
Appl. No.: 10/697,428
Filed: October 30, 2003
The invention relates to a fluid that can
be used for preventing or treating hypohydration and the secondary
consequences thereof. The fluid comprises one or more carbohydrates and
minerals and is further characterized by a low osmolarity. The invention
further relates to the use of such a fluid for medical, dietetic and other
Description of the
The invention relates to a fluid that can
be used for preventing or treating hypohydration and the secondary
consequences thereof. The invention further relates to the use of such a
fluid for medical dietetic and other applications.
Water is the most abundant component of the human and animal body. In
vivo, it is the medium in which most biochemical reactions take place.
Water homeostasis of the body is therefor of paramount importance. To
achieve this, water excretion via the urinary tract and via perspiration
(sweating) can be regulated. If a water deficiency arises, the
concentration of endogenous compounds such as minerals, glucose, amino
acids etc. will rise, which may disturb cellular processes. The total
concentration of these compounds, which may be expressed as the osmotic
value, can be regulated by selective excretion of some of these compounds
from the cell or even from the body.
Furthermore, water is an important medium for transportation of components
and for the dissipation of heat from the core of the body to the surface.
Termoregulation is extremely important since most biochemical. processes
in the body are temperature dependent, e.g. due to enzymatic activity. A
rise in temperature in the body will mostly be counteracted by sweating
and the induction of feelings of fatigue.
Hypohydration of humans and animals is a much occurring phenomenon that
can cause mechanical and chemical damage to tissue, as endogenous
compounds, such as minerals, and especially water are lost. This may
result in the feelings of physical fatigue. Severe depletion of endogenous
compounds, such as glucose, sodium, potassium and water may even disturb
the functioning of various organs, such as the liver, heart, pancreas and
kidneys, and may be accompanied by feelings of pain, which may persevere
even after the dehydration has been reverted to a normal condition of the
Hypohydration can arise acutely e.g. as the result of heavy exercise, such
as sports or labor, or due to prolonged exposure to conditions of high
temperature and humidity. Hypohydration can also be the result of a too
low consumption of water over a prolonged period of time. Such a more
chronic form of hypohydration, is often developed by the elderly and
certain other groups of people, such as long-distance travelers.
Other causes for developing a chronic form of hypohydration include the
use of certain components, e.g. drugs, that have a diuretic action and
certain clinical or metabolic disorders, such as cystic fibrous, spinal
cord injuries, coma and diarrhea. Patients may also suffer from
hypohydration before or after surgery. Loss of water may lead to a range
of secondary complications, in particular loss of water by persons who
suffer from a cardiac condition or a kidney dysfunction.
A loss of water of more than 1% of the body weight is generally considered
as leading to water deficiency, wherein biochemical processes in the
cells, the functioning of organs and tissues and the performance of the
subject may become imparted. A decrease in the water content may result in
a decrease in blood plasma volume, which leads to a decrease in the
cardiac output (stroke volume). This will cause a reduction in the blood
supply to tissues and organs, which in turn has a bad impact on the
performance thereof. The reduction of blood volume will also impart the
dissipation of heat from the core of the body to the skin, where the heat
could be dissipated to the environment.
Many drinks have been developed to supply lost water and minerals to the
body, most of which aim at the maintenance of the water homeostasis during
sports activities. These drinks typically comprise small carbohydrates,
proteins and/or amino acids, minerals and several other components.
Several drinks are reviewed by Co mbes in "Sports Med 2000; 29(3),
"Red Bull" is a hypertonic sports energy drink, comprising per 8.3 fl. oz.
(about 250 ml) 28 g carbohydrates (sucrose and glucose), 215 mg sodium (as
taurate), about 0.4% taurine, about 0.032% caffeine and less than 0.03%
inositol. It further comprises some vitamins, niacin and less than 0.4%
glucuronolactone. Red Bull has a very high energy content, mainly in the
form of free sugars (mono- and disaccharides), which may be undesirably
for dietary reasons.
"Isostar" is a energy drink comprising 15 g/l maltodextrines and 61 g/l
sucrose. It has a relatively high fructose content (fructose to glucose
ratio is approximately 0.67. The product further comprises 180 mg/l
potassium, 690 mg/l sodium and unknown amounts of calcium, magnesium and
several vitamins. Like "Red Bull" Isostar has a high level of free sugars.
A new variety of Isostar comprises 68 g of carbohydrates (66 g sucrose),
only one type of metal ion (sodium), some vitamins and an uactivator
complex", i.e. a mixture of taurine, caffeine, inositol tyrosine and
phenylalanine. The presence of the latter makes this drink unsuitable for
administration to patients suffering from PKU (phenylketonurea).
In addition to several sport drinks, some "Oral Rehydration. Solutions"
have developed, which are typically prescribed on medical indication, e.g.
after a period of diarrhoea. A well-known example of such a compound is "Oriserl
by Nutricia, which comprises 19.8 g/l glucose, 1.9 g/l citrate, 2.1 g/l
sodium, 0.8 g/l potassium and 2.9 g/l chloride.
In WO 94-15488 a rehydration composition is disclosed. The concentrations
of the individual constituents of the composition are not disclosed, nor
is any reference made to the importance of the tonicity of the serving
unit, by which the composition is administered. From the description, it
may be concluded that the composition is hypertonic. A serving unit of the
composition comprises up to 100 g of at least one carbohydrate, 2-2500 mg
of at least one electrolyte, ammonia neutralizer(s) (e.g. aspartate,
arginine, glutamate), energy enhancer(s) (e.g. branched chain amino acids,
carnitin, choline, creatine), antioxidant(s), 1-30 mg of one or more
"membrane stablizers" (e.g. choline, betaine or methionine) and a
neuromuscular function enhancer (e.g. octacosanol). Such a composition is
relatively complex (e.g. containing 30 different components) and expensive
to make. A composition with a high energy content is shown to solve
dehydration complaints better than a composition with a lower energy
content. The abundance of relatively high levels of amino acids and other
nitrogen sources are undesirable for many subjects who already have a
nitrogen rich diet and for subjects who must take care not to digest to
much nitrogen (e.g. patients suffering from kidney. disorders). Hence the
use of an "ammonia neutralizer" is necessary to avoid metabolic problems.
In WO 91/12734 a beverage is disclosed that may be used to replenish water
and to provide an energy source. The beverage comprises 3-50 mEq/l
electrolytes, 0-8wt % carbohydrates, up to 14% of a sweetener and an
edible acid. The beverage has an osmolality of 100-270 mOsm/l. The
fructose to glucose ratio is very high. Fructose in sports drinks has been
reported to be a potential cause of diarrhea. Diarrhea is not only
discomforting but also gives rise to extra dehydration.
WO 98/49906 deals with a product for pre-operative use, comprising a daily
dose of 5-130 g soluble carbohydrates and 1-30 g glutamin or equivalents.
For reasons discussed above, high levels glutamin may be undesired because
of the nitrogen content. The product may comprise N-acetylcystein, vitamin
B6, zinc and magnesium. The osmolarity may be up to 450 mOs/l
WO 91/14435 discloses a method for treating osmotic disturbances such as
hypernatremia and hyponatremia by administration of an organic osmolyte
such as a polyol, e.g. creatine or inositol certain amino acids choline,
betaine, or precursors thereof. The usefulness of consuming these
components was suggested from measuring the rise in concentrations of said
components in adrenal medulla or the brain after consumption of meals with
a high sodium level or after dehydration, without compensation for cell
volume. Effects for betaine or glycerol were not demonstrated, nor is the
use of mineral or other supplements mentioned.
Known compositions to treat dehydration are usually hypertonic and their
activity is mainly directed to the restoration of the water content, often
in combination with the administration of high levels of compounds that
are a fast energy source. Little or no attention is paid to the rate of
gastric emptying of the product or to secondary effects such as the
protection of tissue and organs against possible detrimental effects on
their functioning and the levels of endogenous compounds such as minerals,
amines and glucose in certain physiological systems (e.g. blood) of the
It is an object of the present invention to provide a fluid that after
administration contributes to the prevention from disturbances in water,
to homeostasis and to a rapid restoration of the bodily water content
after dehydration. It is further an object to provide a fluid that can be
effective in the protection against secondary effects of hypohydration and
to provide a fluid that does not give rise to a high level of undesired
Accordingly, the present invention relates to a hypotonic fluid for
preventing or treating hypohydration, comprising a methyl amine and/or a
flavanolignan, said fluid further comprising one or more digestible
carbohydrates and one or more minerals, wherein said fluid has an
essentially hypotonic osmolarity.
Osmolarity as used herein is to be understood as the number of dissolved
components per liter. 1 Osm/l means 1 mole of dissolved components per
Tonicity is a measure for the osmotic pressure (the pressure as a result
of the presence of dissolved particles) relative to the osmotic pressure
of the blood fluids of a subject.
Hypotonic as used herein means to have a osmotic pressure lower than the
osmotic pressure of the blood fluids of the person to be treated.
Isotonic is used to indicated a fluid having the same osmolarity as the
blood fluids (typically 280-310 mOsm/l).
Hypohydration is a condition wherein the content of bodily water is too
low. It may for example be caused by extensive loss of water or by
insufficient intake of water. The process leading to hypohydration is
referred to as dehydration.
The term digestible carbohydrates is used herein to indicate a
carbohydrate of which at least 60% are physiologically digestible by the
enzymes as they occur in the gastrointestinal tract of the species to be
The term oligosaccharide is used to indicate, a carbohydrate having three
to 19 monosaccharide units. The term polysaccharide is used to indicate a
molecule containing more than 19 monosaccharide units. When referred to
the presence of a specific monosaccharide, this should be interpreted as
the presence of said specific monosaccharide as a free monosaccharide or
as a part of a di, oligo- or polysaccharide unless stated otherwise.
The term subject is used to describe any living animal to which a fluid
according to the invention can be administered, including humans, mammals,
birds, reptiles and other animals.
It has been found that a fluid according to the invention is very
effective in preventing and/or treating the loss of bodily water in humans
and/or animals. A fluid according to the invention has been found to
improve the speed and efficiency of water absorption by the body. The
invention further provides a fluid that has been found to be very
effective in helping the body to maintain glucose and mineral homeostasis
and may contribute to the reduction of negative side-effects that are
associated with a disturbance in the homeostasis of water, minerals,
glucose and/or other endogenous compounds. A fluid may for example have a
modulating effect on the insulin response, which helps to maintain or
restore the glucose balance in the blood plasma. A fluid may also reduce
the risk of diarrhea as a result of the intake of high volumes of drinks,
e.g. during endurance sports, such as long distance running or cycling. A
fluid according to the invention has also been found to reduce the risk
for developing muscle cramps as a result of dehydration, e.g. during or
after heavy exercise.
A fluid according to the invention can be used for the treatment or
prophylaxis of any type of dehydration in healthy or ill subjects,
including water loss due to excessive sweating (heavy labor, sports,
prolonged exposure to a hot environment, e.g. a humid hot environment),
water loss due to diarrhea or due to the effects of diuretic drugs or too
low water consumption (e.g. during long-distance traveling, elderly,
hospital patients who stay long in bed and are staying in a warm
environment, patients in a coma).
Preferably the fluid, when ready for administration, has an osmolarity of
300 mOsm/l or less, more preferably an osmolarity of less than 280 mOsm/l
Very good results have been achieved with a fluid having a osmolarity in
the range of 70 to 275 mOsm/l.
It has been found that a low osmotic pressure has a beneficial effect on
the speed of water-uptake. In general, a low osmolarity is achieved by
using a fluid with a dry mass content of 9 wt. % or less, e.g. 5%.
A fluid with a digestible carbohydrate amount of 10-80 g/l has been found
to be very effective. The water-uptake after ingestion of such a fluid has
been found to be very fast. Preferably the digestible carbohydrate amount
is 20-75 g/l and more preferably 26-65 g/l. Carbohydrates are an energy
source, but it has also been found that a digestible carbohydrate
promotes, the water absorption by the body.
At least a part of the digestible carbohydrates may be present in the form
of oligosaccharides and/or polysaccharides. A fluid comprising oligo
and/or polysaccharide material is faster transferred from the stomach to
the intestines than a conventional fluid in which the carbohydrate content
is mainly) in the form of mono- and disaccharides Thus a faster water
uptake is promoted. Preferably the composition comprises very little
sucrose, e.g. less than 1 g/l, preferably less than 0.5 g/l, most
preferably the composition is essentially free of sucrose.
Particularly, suitable carbohydrates have been found to be polysaccharides
comprising glucose. Preferably at least one carbohydrate, such as a
maltodextrin, is present which has an average chain length in the range of
3-50 monosaccharide units. Maltodextrin is a particularly preferred
carbohydrate. A maltodextrin fraction with a dextrose equivalent (DE) in
the range of 4-30, preferably 6-25 has been found to be particularly
effective. (A DE of 1 indicates a totally non-hydrolyzed maltodextrin, a
DE of 100 a fully hydrolyzed maltodextrine.) Apart from the use of
maltodextrin to improve the anti-dehydrative effect of the product, it is
also possible to alter the taste of the product by adding a maltodextrin
with a different DE. A higher DE results in a sweeter product. It has been
found that under most physiological conditions the rate of glucose uptake
is not largely affected by varying the DE of the maltodextrin, since the
speed of digestion of the maltodextrin is not the limiting step in the
uptake of glucose into the blood plasma.
A fluid wherein at least 50 wt. %, preferably at least 75 wt. % of the
carbohydrate content is in the form of a polysaccharide has been found to
be very effective for the prevention and/or treatment of hypohydration. It
has also been found that such a fluid can be administered with decreased
risk for causing hypoglucaemia.
Glucose, inositol, ribose, galactose and mannose moieties have been found
to be stimulating the rate of water absorption by the body very
effectively. Inositol and especially glucose are preferred.
A much preferred fluid comprises more than one type of monosaccharide
units. In particular, the presence of one or more carbohydrates comprising
glucose and at least one other monosaccharide unit chosen from the group
of fructose, ribose, galactose, mannose and inositol has been found to
have a positive effect on the water uptake by the body and the glucose
metabolism (such as a rapid increase of the glucose level in blood
plasma). These two aspects may be further improved in a fluid comprising
more than two, preferably more than three different types of
monosaccharide units. The variety in monosaccharide units is believed to
promote the water uptake rate and to support the mineral homeostasis. In a
preferred embodiment the ratio of fructose and mannose to glucose is
0.05-0.6 ((mole fructose+mole mannose)/mole glucose), more preferably
0.1-0.2. For reasons of taste, the lactose content is preferably present
in a concentration between 0 and 60 wt % of the total digestible
In another preferred embodiment ribose, galactose and/or inositol are
present in an amount of at least 0.5 g/l. Inositol may be present as the
pure compound, e.g. as myo-inositol. Galactose, ribose or mannose may be
present as a free monosaccharide and/or as part of one or more di-, oligo-
and/or polysaccharides. Ribose in an embodiment of the invention is
A saccharide may be present in any isomeric form. Preferably at least part
of the saccharide is present in the physiologically active D-form or as a
Preferred methylamines are dimlethylglycine, choline, sarcosine and
betaine. Betaine is particularly preferred. The methyl amine may a natural
or synthesized methyl amine. A particularly suitable natural source for
betaine is a betaine-rich extracts from a natural source such as sugar
beet. The methyl amine concentration is preferably between 0.1 and 20 g/l,
more preferably 0.2-10 g/l. The methyl amine may be present as base or as
salt. Preferred methyl amine salts include the phosphate and chloride
salts and mixtures thereof.
Examples of suitable flavanolignans include silibin, silydianine,
silychristine, silandrin and silyhermin. Such a flavanolignan can be made
synthetically or extracted from plant material. Extraction can for example
be performed by slurrying a plant material in a polar solvent, filtrating
the slurry and purifying the filtrate. A fluid according to the invention
preferably comprises 0.1-8 g flavanolignans. Silibin is a particularly
preferred flavanolignan. It is commercially available and can be made
synthetically or extracted from a natural source. For example, Silybum
marianum (milk thistle), and particularly the fruit thereof, is rich in
silibin and other flavanolignans. A known commercially available milk
thistle extract comprising silibin is silymarin. In a preferred
embodiment, a fluid according to the invention comprises silymarin as a
source of silibin or an extract that has been standardized on silymarin,
in particular those that are normalized on 70% analogy to silymarin. It is
found that silymarin or an analogous extract in a fluid according to the
invention protects body cells against dehydrating conditions. This can be
a very important aspect of the silymarin activity, not only for
administration to subjects suffering from a medical disorder but also for
healthy subjects, since especially during heavy exercise the immune system
may be detrimentally affected. Preferably a fluid according to the
invention comprises 0.2-10 g/l silymarin, providing approximately 0.1-8 g
silibin. Silibin may also be extracted from any other plant material such
as from sugar beet.
Minerals (inorganic anions and inorganic cations) are preferably present
in a total concentration of 0.1-30 g/l, more preferably 1-20 g/l, most
preferably 1.5 to 15 g/l. Any food grade salt may be used as a mineral
source. Preferred minerals include sodium, potassium, chloride, phosphate,
magnesiurm, zinc, calcium, iron and copper, which may or may not be
present in any combination and concentration within the indicated ranges
and their solubilities.
Suitable sources for sodium, zinc, iron, magnesium, calcium and potassium
include salts thereof with chloride, phosphates and with organic acid
residues, like citrate, malate or pyruvate. Suitable sources for chloride
include their salts with sodium, potassium, zinc, magnesium, calcium, iron
and arginine hydrochloride. In particular for applications wherein large
volumes are ingested, it is preferred to not to use a salt of sulfate,
because high amounts of sulfate may cause unwanted physiological effects.
In one embodiment the total mineral content essentially consists of
sodium, potassium and chloride. Very good results have also been achieved
with a fluid comprising, at least 100 mg/l magnesium, at least 10 mg/l
zinc, at least 300 mg/l calcium, at least 5 mg/l iron, or a combination
For certain applications, such as a fluid for use during endurance sports,
it may be desired the fluid has a relatively low potassium concentration.
During endurance sports the glucose levels in the blood may drop and the
potassium levels may rise, due to the release of intracellular potassium.
An extra high potassium intake may not be desired in such a case, because
it may increase the risk of cramp. Accordingly it is conceived that for
such applications specific fluids may be prepared in which smaller amounts
of potassium are included. It has been found that a high level of calcium
and/or magnesium reduces the risk for cramp in such an application.
The presence of one ore more minerals in a fluid according to the
invention has been found to be particularly advantageous for
administration to animals or humans that regularly experience heavy
exercise (or are going to experience heavy exercise) and for subjects who
are deficient in said mineral(s).
In order not to overexpose the body to nitrogen, the content of nitrogen
is preferably not higher than 3 g/l, more preferably not higher than 2
g/l. A fluid is preferably essentially free of proteins. This may be
desirable for subjects who are on a nitrogen low diet or patients
suffering from PKU. It has also been found that the transfer-rate of a
substantially protein-free fluid from the stomach to the gut is improved,
which results in an accelerated uptake of water, glucose and minerals from
the intestines into the body.
Although the absence of proteins is preferred for many embodiments of the
invention, an embodiment such as a dairy whey drink may compris some
residual protein. Low amounts of amino acids may be included in some
embodiments to achieve specific results that are known to exist for these
amino acids. Arginine, for example, may be included in an amount of up to
2 gram per daily dose. Glucose absorption may be enhanced by the presence
of small amounts of a specific amino acid, such as methionxine. Such an
amino acid may be present in a concentration of 0.1-15 g/l, preferably
0.2-5 g/l, more preferably 0.5-4 g/l.
A fluid according to the invention may further comprise glycerol. glycerol
is preferably present in a concentration of 0.1-20 g/l and more preferably
in a concentration of 0.2-10 g/l. Glycerol may increase the osmolarity of
a body fluid, which helps to retain the water and reduce the excretion of
water via urine.
Other possible ingredients of a fluid according to the invention include
lipoic acid, one or more vitamins (e.g. tocopherol), malate, citrate,
phosphate, taurine, caffeine. Vitamins can be present for various reasons.
Some vitamins contribute to metabolic processes, e.g. the energy
household, others, such as tocopherol have antioxidative properties, which
may help to prevent damage to tissues and organs due to oxidative stress,
which often results from heavy exercise.
If present, the concentration is preferably at least 20 mg/l for lipoic
acid, preferably 0.2-2 g/l for taurine, preferably 0.1-1g/l for caffeine.
A fluid may comprise caffeine from a chemically pure quality or caffeine
from a plant material extract, such as an aqueous extract of Guarana (Paulnia
Cupana). It was found that taurine shows in particular a very positive
contribution to the effects of a fluid that is administered for prevention
Preferably a fluid according to the invention comprises no or very low
amounts of lipids with long chain fatty acids, i.e. a fatty acid with an
aliphatic chain of 18 carbon atoms or more. Medium chain fatty acids, e.g.
having 4-14 aliphatic carbon atoms, may be present to an amount providing
up to twenty energy percent of the total energy of the fluid. Emulsifier(s)
may be present to provide a clear and homogenous fluid.
The pH of a fluid is in the range of 2.5-6.8, preferably of 2.8-4.5, among
other reasons because of the desirable palatability that can thus be
achieved. The pH may be adjusted within this range by any means acceptable
to food products. Preferably phosphoric acid/phosphate, malic acid/malate
and/or citric acid/citrate is used for pH adjustment because of their
advantageous physiological effects. Phosphate is preferably used to
provide a concentration in the fluid of 0-4 g/l, more preferably 0.05-4
g/l and even more preferably 0.1-2 g/l. Citrate is preferably used to
provide a concentration in the fluid of 0-4 g/l, more preferably 0.1-4 g/l
and even more preferably 0.2-2 g/l. Malate is preferably used to provide a
concentration in the fluid of 0-4 g/l, more preferably 0.4-2 g/l. It has
been found that in particular within these ranges a rapid restoration of
water, mineral and glucose homeostasis can be achieved.
A fluid according to the invention may have any suitable form for
administration. Preferred embodiments include a fluid for oral
administration such as a fruit juice, a dairy drink (preferably low in
proteins and fat), a water 1.9 solution, a beverage and the like. Other
embodiments include fluids for tube administration and for enternal
The invention further relates to a concentrate, which itself is not
necessarily a hypotoric fluid, that can be used for the preparation of a
fluid according to the invention. Such a concentrate typically comprises
the ingredients for a hypotonic fluid according to the invention in the
proper ratio such that the hypotonic fluid can simply be made by adding
the correct amount of a palatable drink, preferably tap water, mineral
water or demineralized water. For example a concentrate may comprise 10 g
digestible carbohydrate, 0.5 g methylamine(s) (e.g. betaine), 0.1 g
glycerol and 0.5 g minerals in a dry powder or as a bar. A hypotonic fluid
according to the invention can be prepared by adding the prescribed amount
of demineralized water (e.g. 1 l ). A concentrate may also divided into a
number of different dosage units each comprising some of the ingredients
of a fluid according to the invention, e.g. a concentrate consisting of a
dosage unit comprising 60 g of digestible carbohydrates and 2 g betaine in
250 ml water that can be mixed with another dosage unit comprising 1 g
silibin, 1 g caffeine and 3 g minerals in 250 ml water to form a fluid
according to the invention.
A concentrate may for example have the form of a pre-mix, a powder, an
agglomerate, a fluid, a syrup, a gel, a tablet or a capsule. Another
aspect of the invention is a method for manufacturing a concentrate for
the preparation of a fluid, said fluid comprising betaine, one or more
digestible carbohydrates and one or more minerals, wherein said fluid has
an essentially hypotonic osmolarity, for preventing or treating
The invention further relates to a fluid according to the invention for
medical use, to the use of betaine and/or silibin in a hypotonic fluid to
provide improved prevention against hypohydration and to the use of
betaine and/or silibin in a hypotonic fluid to provide improved recovery
The invention further relates to a method for treating or preventing
hypohydration, comprising the administration of a fluid according to the
invention. The invention has found to be effective to treat low to
moderate water loss but also to treat a high water loss of 4% of the body
weight. The amount of fluid that is preferably administered per dosage
will depend upon the purpose (prevention or treatment) the physical
condition of the subject, the actual degree of water loss, and the medical
condition (e.g. diarrhoea). The concentrations of the active ingredients
may also be varied depending upon these factors and possibly the depletion
of other components, such as certain minerals. The recommended maximum
daily dose of certain compounds to be administered via a fluid according
to the invention may also be taken into account. Examples of suitable
recommended daily doses for some of the compounds that may be present in a
fluid according to the invention are 0.14-4.5 g, preferably 0.15-3 g
digestible carbohydrate/kg bodyweight/day; 0.2-20 g day betaine and max. 2
g/day for arginine. It is stressed that these figures are indications only
and may be altered within the scope of the invention. The skilled
professional will be able to deduct a suitable dose from the factors
The fluid is preferably administered orally. The invention does however
also cover a method for enteral or tube administration. Naturally for such
an application the used ingredients should be medical grade.
Of the medical applications, a method according to the invention has been
found to be particularly suitable for a subject suffering from a gut
disorder, cystic fibrosis, a cardiovascular disease and symptomatically or
physiologically related disorders.
A method according to the invention may also be of use before, during or
after surgery of a subject. It has been found that such patients often
suffer from the risk of dehydration. They are often exposed to a warm
environment, while they are not able to drink. Also elderly people may
successfully be treated with a method according to the invention.
Dehydration in elderly is often caused by the combination of living in a
warm environment and an often observed tendency to forget to drink
The invention also relates to a method for the prevention or treatment of
dehydration of subjects who are exposed to high temperatures, and/or
physical exercise, including labor and sport by administration of a fluid
according to the invention to a subject before, during or after being
exposed to said circumstance.
It is also an aspect of the invention to provide a method for
manufacturing a fluid, comprising betaine, one or more digestible
carbohydrates and one or more minerals, wherein said fluid has an
essentially hypotonic osmolarity for preventing or treating hypohydration.
Claim 1 of 31 Claims
1. A fluid for treating hypohydration,
comprising at least one methyl amine, one or more digestible carbohydrates
and one or more minerals, wherein the methyl amine is selected from
dimethylglycine and sarcosine with the amount of methyl amine being
between 0.2-10 g/l, the digestible carbohydrate is in the amount of
between 20-75 g/l, the mineral includes at least one of calcium and
magnesium, and said fluid has an essentially hypotonic osmolarity in the
range of 70 to 275 mOsm/l, and wherein the fluid treats hypohydration when
administered to a subject in need thereof.
If you want to learn more
about this patent, please go directly to the U.S.
Patent and Trademark Office Web site to access the full