Indian Patents. 258316:POLYPHENOL/PEPTIDE COMPOSITION AND USE THEREOF FOR PROMOTING GASTRIC HEALTH

Title of Invention	POLYPHENOL/PEPTIDE COMPOSITION AND USE THEREOF FOR PROMOTING GASTRIC HEALTH
Abstract	The present invention relates to a composition which comprises a first component from the group of the polyphenols and a second component from the group of the lactic peptides. Furthermore, the invention relates to a process for the preparation of the composition and to the use of the composition for the preparation of products which are used either as pharmaceuticals or as dietetic foodstuffs.

Full Text	FORM 2 THE PATENTS ACT, 1970 (39 of 1970) & THE PATENTS RULES, 2003 COMPLETE SPECIFICATION [See section 10, Rule 13] POLYPHENOL/PEPTIDE COMPOSITION AND USE THEREOF FOR PROMOTING GASTRIC HEALTH; HUMANA MILCHUNION EG, A CORPORATION ORGANIZED AND EXISTING UNDER THE LAWS OF GERMANY, WHOSE ADDRESS IS MUNSTERSTRASSE 31, 48351 EVERSWINKEL, GERMANY THE FOLLOWING SPECIFICATION PARTICULARLY DESCRIBES THE INVENTION AND THE MANNER IN WHICH IT IS TO BE PERFORMED. 1 The present invention relates to a composition comprising a first component from the group of polyphenols and a second component from the group of lactic peptides. Furthermore, the invention relates to a process for the preparation of the composition and the use of the composition for the preparation of products used either as pharmaceuticals or as dietetic foodstuff. Reducing substances having one or more phenolic groups in their carbon skeleton, such as for example diphenols, phenolic acids, flavonols, and lignans, are referred to as polyphenols. They include as a subgroup the so-called flavonoids, which are, in turn, subdivided in procyanidins and catechins (A. Scalbert and G. Williamson, Dietary Intake and Bioavailability of Polyphenols, J. Nutr. 130: 2073S-2085S (2000)). Natural sources of polyphenols are black or green tea, various fruits (apples and grapes), and particularly cacao. The Indians of Central America have already been using cacao (here as source of polyphenols) for several centuries (since the 15th century) for medicinal purposes (T.L. Dillinger, P. Barriga, S. Escarcega, M. Jimenez, D.S. Lowe and L.E. Grivetti, Food of the Gods: Cure for Humanity? A Cultural History of the Medicinal and Ritual Use of Chocolate, J. Nutr. 130: 2057S - 2072S (2000)). One application was the treatment of diarrheal diseases. Only in the last few years it has become apparent that the so-called polyphenols are among the most potent substances in cacao. Intensive research on the individual substances has been done by several research groups in the last few years; and in particular the so-called flavonols and from this group, in turn, the so-called catechins have been intensively tested for their biological effects. Only in recent years, the catechins, in particular the substance epicatechin, have been intensively tested for their biological effects. For about a year, the mechanism of action of epicatechin on the intestinal cell 2 wall has been investigated more closely and unlocked. It has emerged that epicatechin acts directly on a transport system in the intestinal cells that effects the water transport into the lumen of the intestine. The main problem in the treatment of diarrheal diseases is the enormous loss of water that is caused by the efflux of water from the body into the intestine. Transport systems of the intestinal cells play a key role here, in this connection, the important chloride channel {CFTR = Cystic Fibrosis Transmembrane Conductance Regulator) has to be mentioned, which is important for water transport into the lumen of the intestine. For epicatechin, it has now been found that it suppresses precisely this transport system (M. Schuier, H. Sies, B. Illek and H. Fischer, Cocoa-related Flavonoids inhibit CFTR-mediated Chloride Transpott across T8 4 Human colon epithelia, J. Nutr. 135: 2320-2325 (2005)). In this context, it was also pointed out that the most important source of epicatechin in our food is cacao and chocolate. Furthermore, it has already been described in patent literature that flavonoids can be used for health-promoting products (DE 196 27 344 Al, US 6,599,553 B2) and also for the treatment of intestinal diseases {DE 299 08 634 Ul, DE 100 16 771 C2, US 2003/0113290 Al) , however, the effect has never been specifically enhanced by a peptide component. The polyphenols of cacao are in a unique position since an antibacterial effect of cacao on enterohemorrhagic Escherichia coli {E. coli) bacteria has also been found. (T. Takahashi, H. Taguchi, H. Yamaguchi, T. Osaki, S. Sato, M. Kamei, S. Hashizume and S. Kamiya, Antibacterial effects of cacao mass an enterohemorrhagic Escherichia coli 0157:H7, Kansenshogaku Zasshi 73:694-701 (1999)). Peptides from milk have become of interest for research in recent years, in particular because of their biological functions and effects. Most peptides from milk are produced 3 by hydrolysis from larger lactoproteins. In the production of cheese, the so-called glycomacropeptide is cleaved from casein by the hydrolytic activity of the so-called rennet enzyme. This peptide is produced in very large quantities during cheese production and is contained in the whey obtained in cheese production. In recent years, several research groups have investigated the biological functions of this glycomacropeptide. Interestingly, an antimicrobial effect could also be proven (K. Nakaj ima, N. Tamura, K. Kobayashi-Hattor, T. Yoshida, Y. Hara-Kudo, M. Ikedo, Y. Sugata-Konishi and M. Hattori, Prevention of Intestinal Infection by Glycomacropeptide, Biosci. Biotechnol. Biochem. 69: 2294-2301 (2005)). Growth-retarding action was found particularly with bacteria that are frequently present with diarrheas, namely E. coli (in particular the strain EHEC 0157). In this context, it is worth mentioning that glycosylation plays a certain role in this function of the glycomacropeptide. A function is for example attributed to the sialic acid on glycomacropeptide. Although it is already known, as explained above, that different components from food show a growth-retarding effect on diarrhea-causing bacteria and"viruses and, apart from that, are also beneficial for intestinal health, there is still a need for a preparation for promoting intestinal health that is easy to administer, low-cost, has few side effects, and can also effectively combat diarrheas. The object of the present invention is to provide such a preparation. The present invention therefore relates to a polyphenol/peptide composition comprising a component from the group of polyphenols and a second component from the group of lactic peptides. As polyphenol component, a polyphenol isolated from black or green tea, various fruits (e.g. apples or grapes), red wine, and/or from cacao is used according to the invention. The polyphenol component is preferably a flavonol, and from this group, in turn, preferably a catechin, particularly preferably an epicatechin from various food sources, in particular from cacao. According to the invention, a lactic peptide or a hydrolyzed lactoprotein is used as peptide component. It is preferably a peptide from whey, particularly preferably glycomacropeptide. Surprisingly, it has now emerged that the effect on diarrhea is significantly more pronounced with a combination of polyphenols (preferably epicatechin) and a peptide from milk {preferably glycomacropeptide) than the effect of the individual components. In studies by the inventors it has for example been discovered that when a conventional glucose/electrolyte solution (A) is administered, with addition of only polyphenols (B) or only lactic peptides (C) compared to the composition in the form of a combination of polyphenols and lactic peptides according to the invention (D), a significant shortening of the duration of the diarrhea could be detected (A = 66 hours, B = 47 hours, C - 55 hours, D = 30 hours). In the form of this polyphenol/peptide composition, a biologically highly effective form of a substance mixture is therefore available for the treatment of diarrheas. This component can be used both therapeutically in pharmaceuticals and supportingly in the form of dietetic foodstuffs. In principle, the polyphenol/peptide composition can be used for the preparation of products in a liquid, solid, powdery, compacted state or in any other state of aggregation. The state of aggregation of the product determines the form of administration of the product. Oral or rectal administration is preferred. However, intragastric (directly into the stomach), nasogastric 5 (through the nose into the stomach using a tube) , parenteral (directly into the body circumventing the gastrointestinal tract) or intravenous (directly into a blood vein) administration is also possible. Furthermore, the composition according to the invention can comprise the adjuvants, fillers, and additives customary in the pharmaceutical industry or food industry. Carbohydrates, proteins, mineral substances, salts and/or vitamins can also be comprised. As examples, products used in the field of dietetic foodstuffs are described below. However, products classified as pharmaceutical products may also be prepared. According to the invention, the composition can be used in pharmaceutical products for the treatment of diarrheas and in dietetic products to promote intestinal health and in measures for prophylaxis and after-treatment of diarrheas. According to the invention, the following daily dosages for adults or toddlers/infants of the desired ingredients have proven of value: Ingredient For Infants For Toddlers For Adults Polyphenol: (preferably: epicatechin) 0.05 to 30 mg, preferred: 0.1 to 25 mg, particularly preferred: 5 to 20 mg 5 to 7 0 mg, preferred: 10 to 50 mg, particularly preferred: 15 to 40 mg 1 to 300 mg, preferred: 10 to 100 mg, particularly preferred: 15 to 80 mg Lactic peptide (preferably: glycomacro-peptide) 0.1 to 8 g, preferred: 0.2 to 6 g, particularly preferred: 0.5 to 5 g 0.1 to 15 g, preferred: 0.2 to 12 g, particularly preferred: 0.5 to 10 g 0.1 to 30 g, preferred: 0.2 to 20 g, particularly preferred: 0.5 to 10 g 6 The invention is described below by means of examples, which are to be interpreted as non-limiting. Example 1: electrolyte, a dietetic foodstuff for the treatment of diarrheal diseases; as powder Composition, suitable for the treatment of infants: Ingredient per 100 g of powder per portion {250 ml) Epicatechin in mg 80 5 Glycomacropeptide in mg 8000 500 Glucose in g 40 2.5 Maltodextrin in g 2.9 0.2 Sodium in mg 5552 347 Potassium in mg 3120 195 Chloride in mg 7040 440 Citrate in mg 7472 467 Formulation: Glucose 40.2 g Cacao powder 25 g GMP 8 g Sodium chloride 11.6 g Maltodextrin 2.9 g Potassium citrate 8.15 g Sodium citrate 4.18 g Specification for preparation: weigh-in components individually mix package Example 2: electrolyte, a dietetic foodstuff for the treatment of diarrheal diseases; in liquid form 7 Composition suitable for adults: Ingredient per 100 ml per portion (250 ml) Epicatechin in mg 10 25 Glycomacropeptide in mg 800 2000 Glucose in g 1.6 4 Maltodextrin in g 0.28 0.7 Sodium in mg 139 347 Potassium in mg 78 195 Chloride in mg 176 440 Citrate in mg 187 467 Formulation: Demineralized water 94.2 Cacao powder 3.2 g Glucose 1.6 g GMP (purity 66 %) 1.2 g Maltodextrin 0.3 g Sodium chloride 0.3 g Potassium citrate 0.2 g Specification for preparation: introduce water into mixing vessel add powdered components individually to the -mixing vessel while agitating mix thoroughly until a homogeneous distribution of the components has been achieved package Example 3: therapeutic food, liquid Formulation: 8 Demineralized water 54.6 g Skimmed milk 25 g Banana puree 11 g Glucose syrup 3.4 g Cacao powder 3.2 g Pregelatinized starch 2.5 g Vegetable fat 2.0 g GMP (purity 66 %) 1.2 g Calcium caseinate 0.9 g Rice flour 0.6 g Mineral substance mixture (potassium citrate, calcium carbonate, sodium citrate, sodium carbonate, sodium chloride, magnesium carbonate, iron diphosphate, zinc sulfate, copper sulfate, potassium iodate, sodium molybdate, sodium selenate, chromium chloride) 156.1 mg Emulsifier: soy lecithin 30 mg Vitamin mixture (vitamin C, vitamin E, niacin, pantothenate, vitamin Bl, vitamin B2, vitamin B6, vitamin A, folic acid, vitamin K, biotin, vitamin D3, vitamin B12) 22.5 mg Specification for preparation: introduce water and skimmed milk into the mixing vessel incorporate banana puree add powdered components individually to the mixing vessel while agitating incorporate fat mix thoroughly until a homogeneous distribution of the components has been achieved homogenizing cooling of emulsion packaging 9 Example 4: therapeutic food as powder Formulation: Skimmed milk 127 g Banana puree 67.0 g Glucose syrup 22.6 g Pregelatinized starch 12.2 g Vegetable oil 13.3 g Calcium caseinate 8.1 g Rice flour 2.5 g Cacao powder 4.6 g Maltodextrins 2.5 g Demineralized whey powder 2.5 g GMP (purity 66 %) 2.1 g Mineral substance mixture (potassium citrate, sodium citrate, calcium carbonate, sodium chloride, magnesium carbonate, iron diphosphate, zinc oxide, copper sulfate, potassium iodate, sodium molybdate, chromium chloride, sodium selenate) 1.6 g Vitamin mixture (vitamin C, vitamin E, niacin, pantothenate, vitamin Bl, vitamin B2, vitamin B6, vitamin A, folic acid, vitamin K, biotin, vitamin D3, vitamin B12) 140 mg Emulsifier: soy lecithin 360 mg Specification for preparation: add powdered components individually to the mixing vessel while agitating mix thoroughly until a homogeneous distribution of the components has been achieved package 10 Example 5: proving the action in a study- In a study with infants and toddlers ranging in age from 6 to 48 month, the following electrolyte solutions were used: 1. a conventional glucose/electrolyte solution (analogous to Example 2 but without polyphenols and lactic peptides} = group A 2. a glucose/electrolyte solution (analogous to Example 2 but only with polyphenols) = group B 3. a glucose/electrolyte solution (analogous to Example 2 but only with lactic peptides) = group C 4. a glucose/electrolyte solution (Example 2, complete with polyphenols and lactic peptides, composition according to the invention) = group D 50 ml of the solution per kg of body weight each were orally administered in four hours. The treatment was continued until only two non-watery stools were passed in a period of 24 hours {= end of diarrhea). The following time periods until the signs of illness ended resulted: group A = 66 hours; group B = 47 hours; group C = 55 hours; group D = 30 hours. Besides the significantly shorter duration of the illness compared to the additive-free electrolyte solution or the single additives, the combination according to the invention also showed a significantly improved weight gain within 24 hours (+5.4 %), a faster reduction of acidoses (15 hours shorter), and a faster reduction of noticeably watery stools already after 24 hours. Solely in group D (with the combination according to the invention), a significant decrease of pathogenic bacteria 11 (E. coli) and viruses (rotaviruses) could be detected in the stool already after 2 4 hours. This decrease was not observed at all in groups A and B and was much lower in comparison and seen significantly later (48 hours) in group C. The synergistic effect of the combination according to the invention could thus be impressively demonstrated. 12 WE CLAIM 1. A composition comprising a first component from the group of polyphenols and a second component from the group of lactic peptides. 2. A composition according to claim 1 wherein the polyphenol component comes from cacao. 3. A composition according to claim 1 or claim 2 wherein the polyphenol component epicatechin comes from cacao. 4. A composition according to claim 1 wherein the lactic peptide is a whey peptide. 5. A composition according to claim 1 or claim 4 wherein the lactic peptide glycomacropeptide comes from whey. 6. A composition according to any one of claims 1 to 5 wherein as polyphenol component, the polyphenol epicatechin is included in a quantity of 0.1 to 80 mg per 100 g of product, and as peptide component, the whey peptide glycomacropeptide is included in a quantity of 0.5 to 10 g per 100 g of product. 7. A composition according to any one of claims 1 to 6 wherein carbohydrates, proteins, mineral substances, salts and/or vitamins are also included. 8. A composition according to any one of the preceding claims, the composition, which is mixed with other components, being used in a liquid, solid, powdery, compacted or any other state of aggregation for a finished product. 9. The use of the composition according to any one of claims 1 to 8 in pharmaceutical products for the 13 treatment of diarrheas. The use of the composition according to any one of claims 1 to 8 in dietetic products for promoting intestinal health and in measures for prophylaxis and after-treatment of diarrheas. A process for the preparation of a composition according to any one of claims 1 to 8 wherein a polyphenol component is mixed with a lactic peptide component and optionally additional adjuvants, fillers and/or additives. ed this 2nd day of January, 2009 FOR HUMANA M1LCHUNION EG By their Agent (MADHURI RAMESHCHANDRA TAWRI) KRISHNA & SAURASTRI 14

Full Text

FORM 2
THE PATENTS ACT, 1970 (39 of 1970)
& THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
[See section 10, Rule 13]

POLYPHENOL/PEPTIDE COMPOSITION
AND USE THEREOF FOR PROMOTING GASTRIC HEALTH;
HUMANA MILCHUNION EG, A
CORPORATION ORGANIZED AND
EXISTING UNDER THE LAWS OF
GERMANY, WHOSE ADDRESS IS
MUNSTERSTRASSE 31, 48351
EVERSWINKEL, GERMANY

THE FOLLOWING SPECIFICATION
PARTICULARLY DESCRIBES THE
INVENTION AND THE MANNER IN WHICH IT IS TO BE PERFORMED. 1

The present invention relates to a composition comprising a first component from the group of polyphenols and a second component from the group of lactic peptides. Furthermore, the invention relates to a process for the preparation of the composition and the use of the composition for the preparation of products used either as pharmaceuticals or as dietetic foodstuff.
Reducing substances having one or more phenolic groups in their carbon skeleton, such as for example diphenols, phenolic acids, flavonols, and lignans, are referred to as polyphenols. They include as a subgroup the so-called flavonoids, which are, in turn, subdivided in procyanidins and catechins (A. Scalbert and G. Williamson, Dietary Intake and Bioavailability of Polyphenols, J. Nutr. 130: 2073S-2085S (2000)). Natural sources of polyphenols are black or green tea, various fruits (apples and grapes), and particularly cacao. The Indians of Central America have already been using cacao (here as source of polyphenols) for several centuries (since the 15th century) for medicinal purposes (T.L. Dillinger, P. Barriga, S. Escarcega, M. Jimenez, D.S. Lowe and L.E. Grivetti, Food of the Gods: Cure for Humanity? A Cultural History of the Medicinal and Ritual Use of Chocolate, J. Nutr. 130: 2057S - 2072S (2000)). One application was the treatment of diarrheal diseases. Only in the last few years it has become apparent that the so-called polyphenols are among the most potent substances in cacao. Intensive research on the individual substances has been done by several research groups in the last few years; and in particular the so-called flavonols and from this group, in turn, the so-called catechins have been intensively tested for their biological effects. Only in recent years, the catechins, in particular the substance epicatechin, have been intensively tested for their biological effects. For about a year, the mechanism of action of epicatechin on the intestinal cell
2

wall has been investigated more closely and unlocked. It has emerged that epicatechin acts directly on a transport system in the intestinal cells that effects the water transport into the lumen of the intestine. The main problem in the treatment of diarrheal diseases is the enormous loss of water that is caused by the efflux of water from the body into the intestine. Transport systems of the intestinal cells play a key role here, in this connection, the important chloride channel {CFTR = Cystic Fibrosis Transmembrane Conductance Regulator) has to be mentioned, which is important for water transport into the lumen of the intestine. For epicatechin, it has now been found that it suppresses precisely this transport system (M. Schuier, H. Sies, B. Illek and H. Fischer, Cocoa-related Flavonoids inhibit CFTR-mediated Chloride Transpott across T8 4 Human colon epithelia, J. Nutr. 135: 2320-2325 (2005)). In this context, it was also pointed out that the most important source of epicatechin in our food is cacao and chocolate.
Furthermore, it has already been described in patent literature that flavonoids can be used for health-promoting products (DE 196 27 344 Al, US 6,599,553 B2) and also for the treatment of intestinal diseases {DE 299 08 634 Ul, DE 100 16 771 C2, US 2003/0113290 Al) , however, the effect has never been specifically enhanced by a peptide component.
The polyphenols of cacao are in a unique position since an antibacterial effect of cacao on enterohemorrhagic Escherichia coli {E. coli) bacteria has also been found. (T. Takahashi, H. Taguchi, H. Yamaguchi, T. Osaki, S. Sato, M. Kamei, S. Hashizume and S. Kamiya, Antibacterial effects of cacao mass an enterohemorrhagic Escherichia coli 0157:H7, Kansenshogaku Zasshi 73:694-701 (1999)).
Peptides from milk have become of interest for research in recent years, in particular because of their biological functions and effects. Most peptides from milk are produced
3

by hydrolysis from larger lactoproteins. In the production of cheese, the so-called glycomacropeptide is cleaved from casein by the hydrolytic activity of the so-called rennet enzyme. This peptide is produced in very large quantities during cheese production and is contained in the whey obtained in cheese production. In recent years, several research groups have investigated the biological functions of this glycomacropeptide. Interestingly, an antimicrobial effect could also be proven (K. Nakaj ima, N. Tamura, K. Kobayashi-Hattor, T. Yoshida, Y. Hara-Kudo, M. Ikedo, Y. Sugata-Konishi and M. Hattori, Prevention of Intestinal Infection by Glycomacropeptide, Biosci. Biotechnol. Biochem. 69: 2294-2301 (2005)). Growth-retarding action was found particularly with bacteria that are frequently present with diarrheas, namely E. coli (in particular the strain EHEC 0157). In this context, it is worth mentioning that glycosylation plays a certain role in this function of the glycomacropeptide. A function is for example attributed to the sialic acid on glycomacropeptide.
Although it is already known, as explained above, that different components from food show a growth-retarding effect on diarrhea-causing bacteria and"viruses and, apart from that, are also beneficial for intestinal health, there is still a need for a preparation for promoting intestinal health that is easy to administer, low-cost, has few side effects, and can also effectively combat diarrheas. The object of the present invention is to provide such a preparation.
The present invention therefore relates to a polyphenol/peptide composition comprising a component from the group of polyphenols and a second component from the group of lactic peptides.
As polyphenol component, a polyphenol isolated from black or green tea, various fruits (e.g. apples or grapes), red

wine, and/or from cacao is used according to the invention. The polyphenol component is preferably a flavonol, and from this group, in turn, preferably a catechin, particularly preferably an epicatechin from various food sources, in particular from cacao.
According to the invention, a lactic peptide or a hydrolyzed lactoprotein is used as peptide component. It is preferably a peptide from whey, particularly preferably glycomacropeptide.
Surprisingly, it has now emerged that the effect on diarrhea is significantly more pronounced with a combination of polyphenols (preferably epicatechin) and a peptide from milk {preferably glycomacropeptide) than the effect of the individual components. In studies by the inventors it has for example been discovered that when a conventional glucose/electrolyte solution (A) is administered, with addition of only polyphenols (B) or only lactic peptides (C) compared to the composition in the form of a combination of polyphenols and lactic peptides according to the invention (D), a significant shortening of the duration of the diarrhea could be detected (A = 66 hours, B = 47 hours, C - 55 hours, D = 30 hours). In the form of this polyphenol/peptide composition, a biologically highly effective form of a substance mixture is therefore available for the treatment of diarrheas. This component can be used both therapeutically in pharmaceuticals and supportingly in the form of dietetic foodstuffs.
In principle, the polyphenol/peptide composition can be used for the preparation of products in a liquid, solid, powdery, compacted state or in any other state of aggregation. The state of aggregation of the product determines the form of administration of the product. Oral or rectal administration is preferred. However, intragastric (directly into the stomach), nasogastric
5

(through the nose into the stomach using a tube) , parenteral (directly into the body circumventing the gastrointestinal tract) or intravenous (directly into a blood vein) administration is also possible.
Furthermore, the composition according to the invention can comprise the adjuvants, fillers, and additives customary in the pharmaceutical industry or food industry. Carbohydrates, proteins, mineral substances, salts and/or vitamins can also be comprised.
As examples, products used in the field of dietetic foodstuffs are described below. However, products classified as pharmaceutical products may also be prepared. According to the invention, the composition can be used in pharmaceutical products for the treatment of diarrheas and in dietetic products to promote intestinal health and in measures for prophylaxis and after-treatment of diarrheas.
According to the invention, the following daily dosages for adults or toddlers/infants of the desired ingredients have proven of value:

Ingredient For Infants For Toddlers For Adults
Polyphenol: (preferably: epicatechin) 0.05 to 30 mg, preferred: 0.1 to 25 mg, particularly preferred: 5 to 20 mg 5 to 7 0 mg, preferred: 10 to 50 mg, particularly preferred: 15 to 40 mg 1 to 300 mg, preferred: 10 to 100 mg, particularly preferred: 15 to 80 mg
Lactic peptide (preferably: glycomacro-peptide) 0.1 to 8 g, preferred: 0.2 to 6 g, particularly preferred: 0.5 to 5 g 0.1 to 15 g, preferred: 0.2 to 12 g, particularly preferred: 0.5 to 10 g 0.1 to 30 g, preferred: 0.2 to 20 g, particularly preferred: 0.5 to 10 g
6

The invention is described below by means of examples, which are to be interpreted as non-limiting.
Example 1: electrolyte, a dietetic foodstuff for the treatment of diarrheal diseases; as powder
Composition, suitable for the treatment of infants:

Ingredient per 100 g of powder per portion {250 ml)
Epicatechin in mg 80 5
Glycomacropeptide in mg 8000 500
Glucose in g 40 2.5
Maltodextrin in g 2.9 0.2
Sodium in mg 5552 347
Potassium in mg 3120 195
Chloride in mg 7040 440
Citrate in mg 7472 467
Formulation:
Glucose 40.2 g
Cacao powder 25 g
GMP 8 g
Sodium chloride 11.6 g
Maltodextrin 2.9 g
Potassium citrate 8.15 g
Sodium citrate 4.18 g
Specification for preparation:
weigh-in components individually
mix
package
Example 2: electrolyte, a dietetic foodstuff for the treatment of diarrheal diseases; in liquid form
7

Composition suitable for adults:

Ingredient per 100 ml per portion (250 ml)
Epicatechin in mg 10 25
Glycomacropeptide in mg 800 2000
Glucose in g 1.6 4
Maltodextrin in g 0.28 0.7
Sodium in mg 139 347
Potassium in mg 78 195
Chloride in mg 176 440
Citrate in mg 187 467
Formulation:

Demineralized water 94.2
Cacao powder 3.2 g
Glucose 1.6 g
GMP (purity 66 %) 1.2 g
Maltodextrin 0.3 g
Sodium chloride 0.3 g
Potassium citrate 0.2 g
Specification for preparation:
introduce water into mixing vessel
add powdered components individually to the -mixing
vessel while agitating
mix thoroughly until a homogeneous distribution of the
components has been achieved
package
Example 3: therapeutic food, liquid
Formulation:
8

Demineralized water 54.6 g
Skimmed milk 25 g
Banana puree 11 g
Glucose syrup 3.4 g
Cacao powder 3.2 g
Pregelatinized starch 2.5 g
Vegetable fat 2.0 g
GMP (purity 66 %) 1.2 g
Calcium caseinate 0.9 g
Rice flour 0.6 g
Mineral substance mixture (potassium citrate, calcium carbonate, sodium citrate, sodium carbonate, sodium chloride, magnesium carbonate, iron diphosphate, zinc sulfate, copper sulfate, potassium iodate, sodium molybdate, sodium selenate, chromium chloride) 156.1 mg
Emulsifier: soy lecithin 30 mg
Vitamin mixture (vitamin C, vitamin E, niacin, pantothenate, vitamin Bl, vitamin B2, vitamin B6, vitamin A, folic acid, vitamin K, biotin, vitamin D3, vitamin B12) 22.5 mg
Specification for preparation:
introduce water and skimmed milk into the mixing
vessel
incorporate banana puree
add powdered components individually to the mixing
vessel while agitating
incorporate fat
mix thoroughly until a homogeneous distribution of the
components has been achieved
homogenizing
cooling of emulsion
packaging
9

Example 4: therapeutic food as powder
Formulation:

Skimmed milk 127 g
Banana puree 67.0 g
Glucose syrup 22.6 g
Pregelatinized starch 12.2 g
Vegetable oil 13.3 g
Calcium caseinate 8.1 g
Rice flour 2.5 g
Cacao powder 4.6 g
Maltodextrins 2.5 g
Demineralized whey powder 2.5 g
GMP (purity 66 %) 2.1 g
Mineral substance mixture (potassium citrate, sodium citrate, calcium carbonate, sodium chloride, magnesium carbonate, iron diphosphate, zinc oxide, copper sulfate, potassium iodate, sodium molybdate, chromium chloride, sodium selenate) 1.6 g
Vitamin mixture (vitamin C, vitamin E, niacin, pantothenate, vitamin Bl, vitamin B2, vitamin B6, vitamin A, folic acid, vitamin K, biotin, vitamin D3, vitamin B12) 140 mg
Emulsifier: soy lecithin 360 mg
Specification for preparation:
add powdered components individually to the mixing
vessel while agitating
mix thoroughly until a homogeneous distribution of the
components has been achieved
package
10

Example 5: proving the action in a study-
In a study with infants and toddlers ranging in age from 6 to 48 month, the following electrolyte solutions were used:
1. a conventional glucose/electrolyte solution
(analogous to Example 2 but without polyphenols and lactic peptides} = group A
2. a glucose/electrolyte solution (analogous to Example 2 but only with polyphenols) = group B
3. a glucose/electrolyte solution (analogous to Example 2 but only with lactic peptides) = group C
4. a glucose/electrolyte solution (Example 2, complete with polyphenols and lactic peptides, composition according to the invention) = group D
50 ml of the solution per kg of body weight each were
orally administered in four hours. The treatment was
continued until only two non-watery stools were passed in a
period of 24 hours {= end of diarrhea). The following time
periods until the signs of illness ended resulted:
group A = 66 hours; group B = 47 hours; group C = 55 hours; group D = 30 hours.
Besides the significantly shorter duration of the illness compared to the additive-free electrolyte solution or the single additives, the combination according to the invention also showed a significantly improved weight gain within 24 hours (+5.4 %), a faster reduction of acidoses (15 hours shorter), and a faster reduction of noticeably watery stools already after 24 hours.
Solely in group D (with the combination according to the invention), a significant decrease of pathogenic bacteria
11

(E. coli) and viruses (rotaviruses) could be detected in the stool already after 2 4 hours. This decrease was not observed at all in groups A and B and was much lower in comparison and seen significantly later (48 hours) in group C.
The synergistic effect of the combination according to the invention could thus be impressively demonstrated.
12

WE CLAIM
1. A composition comprising a first component from the group of polyphenols and a second component from the group of lactic peptides.
2. A composition according to claim 1 wherein the polyphenol component comes from cacao.
3. A composition according to claim 1 or claim 2 wherein the polyphenol component epicatechin comes from cacao.
4. A composition according to claim 1 wherein the lactic peptide is a whey peptide.
5. A composition according to claim 1 or claim 4 wherein the lactic peptide glycomacropeptide comes from whey.
6. A composition according to any one of claims 1 to 5 wherein as polyphenol component, the polyphenol epicatechin is included in a quantity of 0.1 to 80 mg per 100 g of product, and as peptide component, the whey peptide glycomacropeptide is included in a quantity of 0.5 to 10 g per 100 g of product.
7. A composition according to any one of claims 1 to 6 wherein carbohydrates, proteins, mineral substances, salts and/or vitamins are also included.
8. A composition according to any one of the preceding claims, the composition, which is mixed with other components, being used in a liquid, solid, powdery, compacted or any other state of aggregation for a finished product.
9. The use of the composition according to any one of claims 1 to 8 in pharmaceutical products for the
13

treatment of diarrheas.
The use of the composition according to any one of claims 1 to 8 in dietetic products for promoting intestinal health and in measures for prophylaxis and after-treatment of diarrheas.
A process for the preparation of a composition according to any one of claims 1 to 8 wherein a polyphenol component is mixed with a lactic peptide component and optionally additional adjuvants, fillers and/or additives.
ed this 2nd day of January, 2009
FOR HUMANA M1LCHUNION EG By their Agent
(MADHURI RAMESHCHANDRA TAWRI) KRISHNA & SAURASTRI
14

Documents:

245-mumnp-2009-abstract.doc

245-mumnp-2009-abstract.pdf

245-MUMNP-2009-CLAIMS(AMENDED)-(1-4-2013).pdf

245-MUMNP-2009-CLAIMS(MARKED COPY)-(1-4-2013).pdf

245-mumnp-2009-claims.doc

245-mumnp-2009-claims.pdf

245-MUMNP-2009-CORRESPONDENCE(1-11-2010).pdf

245-MUMNP-2009-CORRESPONDENCE(16-6-2009).pdf

245-MUMNP-2009-CORRESPONDENCE(17-1-2012).pdf

245-MUMNP-2009-CORRESPONDENCE(20-4-2009).pdf

245-MUMNP-2009-CORRESPONDENCE(28-5-2010).pdf

245-MUMNP-2009-CORRESPONDENCE(29-7-2010).pdf

245-MUMNP-2009-CORRESPONDENCE(30-8-2013).pdf

245-MUMNP-2009-CORRESPONDENCE(5-9-2013).pdf

245-mumnp-2009-correspondence.pdf

245-mumnp-2009-description(complete).doc

245-mumnp-2009-description(complete).pdf

245-MUMNP-2009-EP DOCUMENT(15-1-2013).pdf

245-MUMNP-2009-FORM 1(20-4-2009).pdf

245-mumnp-2009-form 1.pdf

245-MUMNP-2009-FORM 18(28-5-2010).pdf

245-mumnp-2009-form 2(title page).pdf

245-mumnp-2009-form 2.doc

245-mumnp-2009-form 2.pdf

245-MUMNP-2009-FORM 3(1-11-2010).pdf

245-MUMNP-2009-FORM 3(15-1-2013).pdf

245-MUMNP-2009-FORM 3(17-1-2012).pdf

245-MUMNP-2009-FORM 3(20-4-2009).pdf

245-MUMNP-2009-FORM 3(29-7-2010).pdf

245-MUMNP-2009-FORM 3(5-9-2013).pdf

245-mumnp-2009-form 3.pdf

245-mumnp-2009-form 5.pdf

245-MUMNP-2009-OTHER DOCUMENT(1-11-2010).pdf

245-MUMNP-2009-OTHER DOCUMENT(5-9-2013).pdf

245-mumnp-2009-pct-ib-304.pdf

245-mumnp-2009-pct-ib-306.pdf

245-MUMNP-2009-PCT-IB-338(16-6-2009).pdf

245-mumnp-2009-pct-isa-210.pdf

245-MUMNP-2009-PCT-ISA-237(16-6-2009).pdf

245-mumnp-2009-pct-isa-237.pdf

245-mumnp-2009-pct-ro-101.pdf

245-MUMNP-2009-PETITION UNDER RULE 137(15-1-2013).pdf

245-MUMNP-2009-POWER OF ATTORNEY(20-4-2009).pdf

245-MUMNP-2009-REPLY TO EXAMINATION REPORT(1-4-2013).pdf

245-MUMNP-2009-REPLY TO EXAMINATION REPORT(15-1-2013).pdf

245-mumnp-2009-wo international publication report a2.pdf

245-mumnp-2009-wo international publication report a3.pdf

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Patent Number

258316

Indian Patent Application Number

245/MUMNP/2009

PG Journal Number

01/2014

Publication Date

03-Jan-2014

Grant Date

30-Dec-2013

Date of Filing

02-Feb-2009

Name of Patentee

HUMANA MILCHUNION EG

Applicant Address

MUNSTERSTRASSE 31, 48351 EVERSWINKEL,

Inventors:

#	Inventor's Name	Inventor's Address
1	SELL MARCO	LANGSTEEVEN 48, 25866 MILDSTEDT,
2	SAWATZKI GUNTHER	RICARDA HUCH STR. 13, 35516 MUNZENBERG,

PCT International Classification Number

A23C9/15

PCT International Application Number

PCT/EP2007/006631

PCT International Filing date

2007-07-26

PCT Conventions:

#	PCT Application Number	Date of Convention	Priority Country
1	10 2006 034 924.5	2006-07-28	Germany
2	10 2006 052 915.4	2006-11-08	Germany