US2015246090A1PendingUtilityA1

Non-digestible oligosaccharides for oral induction of tolerance against dietary proteins

Assignee: NUTRICIA NVPriority: Jun 4, 2010Filed: May 18, 2015Published: Sep 3, 2015
Est. expiryJun 4, 2030(~3.8 yrs left)· nominal 20-yr term from priority
A23L 33/40A61K 31/733A61K 38/10A61K 38/17A23L 33/19A23L 33/17A61K 31/702A23L 33/21A23V 2002/00A23L 33/185A61K 39/0005A23L 33/18A61K 38/018A61K 2039/577A61K 39/35
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Claims

Abstract

Compositions and methods for providing infant nutrition with partially hydrolysed proteins and non-digestible oligosaccharides for use in induction of oral tolerance against native dietary proteins.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . An enteral composition comprising non-digestible oligosaccharides and at least one partial protein hydrolysate, wherein the non-digestible oligosaccharides are at least one non-digestible oligosaccharide selected form the group consisting of fructo-oligosaccharide, non-digestible dextrin, galacto-oligosaccharide, xylo-oligosaccharide, arabino-oligosaccharide, arabinogalacto-oligosaccharide, gluco-oligosaccharide, glucomanno-oligosaccharide, galactomanno-oligosaccharide, mannan-oligosaccharide, chito-oligosaccharide, uronic acid oligosaccharide, sialyloligosaccharide, fuco-oligosaccharide and mixtures thereof and wherein the partial protein hydrolysate is partial whey protein hydrolysate for inducing oral tolerance against dietary proteins or the prevention of food allergy or inflammatory bowel disease. 
     
     
         2 . The enteral composition according to  claim 1 , wherein the partial whey protein hydrolysate is a partial beta-lactoglobulin hydrolysate. 
     
     
         3 . The enteral composition according to  claim 1 , wherein the partial whey protein hydrolysate is natural or synthetic. 
     
     
         4 . The enteral composition according to  claim 1 , wherein the partial whey protein hydrolysate comprises at least 3 wt. % of peptides with a size of 5 kDa or above and at least 50 wt. % of peptides with a size below 5 kDa. 
     
     
         5 . The enteral composition according to  claim 1 , wherein the size distribution of the peptides in the partial whey protein hydrolysate is 60 to 90%<1 kDa, 5 to 20% 1 to <2 kDa, 2 to 16% 2 to <5 kDa, 0.6 to 3% 5 to <10 kDa, 0.5 to 2% 10 to 20 kDa and 1 to 3%>20 kDa, based on dry weight of peptides present in partial protein hydrolysate. 
     
     
         6 . The enteral composition according to  claim 1 , wherein the partial whey protein hydrolysate comprises a ratio of the relative amount (wt %) of peptides with a size from 2 to <5 kDa to the relative amount (wt %) of peptides with a size of at least 5 kDa is (5 to 1):1. 
     
     
         7 . The enteral composition according to  claim 1 , wherein the composition comprises a protein component, a lipid component and digestible carbohydrates and wherein the protein component is present in an amount of 5 to 25% based on total calories of the composition. 
     
     
         8 . The enteral composition according to  claim 1 , wherein the composition comprises 0.05 to 20 wt. % non-digestible oligosaccharide based on dry weight of the composition. 
     
     
         9 . The enteral composition according to  claim 1 , comprising
 a) at least 5 wt. % partial whey protein hydrolysate, each based on dry weight of the composition and   b) at least 1 wt % of the at least one non-digestible oligosaccharide based on dry weight of the composition.   
     
     
         10 . The enteral composition according to  claim 1 , which is an infant formula or follow-on-formula. 
     
     
         11 . A process for the preparation of the enteral composition of  claim 1 , wherein at least one partial whey protein hydrolysate and at least one non-digestible oligosaccharide are mixed and the composition is obtained, said composition having an enhanced oral tolerance inducing effect, wherein the non-digestible oligosaccharide is at least one non-digestible oligosaccharide selected form the group consisting of fructo-oligosaccharide, non-digestible dextrin, galacto-oligosaccharide, xylo-oligosaccharide, arabino-oligosaccharide, arabinogalacto-oligosaccharide, gluco-oligosaccharide, glucomanno-oligosaccharide, galactomanno-oligosaccharide, mannan-oligosaccharide, chito-oligosaccharide, uronic acid oligosaccharide, sialyloligosaccharide, fuco-oligosaccharide and mixtures thereof 
     
     
         12 . A method for enhancing a partial protein hydrolysate-induced oral immune tolerance against dietary proteins in a subject in need thereof, said method comprising administering to said subject at least one non-digestible oligosaccharide selected from the group consisting of fructo-oligosaccharide, non-digestible dextrin, galacto-oligosaccharide, xylo-oligosaccharide, arabino-oligosaccharide, arabinogalacto-oligosaccharide, gluco-oligosaccharide, glucomanno-oligosaccharide, galactomanno-oligosaccharide, mannan-oligosaccharide, chito-oligosaccharide, uronic acid oligosaccharide, sialyloligosaccharide and fuco-oligosaccharide, wherein the partial protein hydrolysate is partial whey protein hydrolysate, such that partial protein hydrolysate-induced oral immune tolerance against dietary proteins is enhanced in said subject. 
     
     
         13 . The method according to  claim 12 , wherein the partial whey protein hydrolysate comprises at least one beta-lactoglobulin peptide comprising a sequence selected from the group consisting of SEQ ID NO 1, SEQ ID NO 2, SEQ ID NO 3 and SEQ ID NO 4. 
     
     
         14 . The method according to  claim 12 , wherein the partial whey protein hydrolysate comprises at least 3 wt. % of peptides with a size of 5 kDa or above and at least 50 wt. % of peptides with a size below 5 kDa. 
     
     
         15 . The method according to  claim 12 , wherein the size distribution of the peptides in the partial whey protein hydrolysate is 60 to 90%<1 kDa, 5 to 20% 1 to <2 kDa, 2 to 16% 2 to <5 kDa, 0.6 to 3% 5 to <10 kDa, 0.5 to 2 % 10 to 20 kDa and 1 to 3%>20 kDa, based on dry weight of peptides present in partial protein hydrolysate. 
     
     
         16 . The method according to  claim 12 , wherein the partial whey protein hydrolysate comprises a ratio of the relative amount (wt %) of peptides with a size from 2 to <5 kDa to the relative amount (wt %) of peptides with a size of at least 5 kDa is (5 to 1):1. 
     
     
         17 . The method according to  claim 12 , wherein the non-digestible oligosaccharide is selected from the group consisting of fructo-oligosaccharide, galacto-oligosaccharide and uronic acid oligosaccharide. 
     
     
         18 . The method according to  claim 12 , wherein the non-digestible oligosaccharide is a mixture of galacto-oligosaccharides, fructo-oligosaccharides and galacturonic acid oligosaccharides. 
     
     
         19 . A method for inducing oral immune tolerance against dietary proteins in a subject in need thereof, said method comprising administering to said subject an enteral composition comprising at least one non-digestible oligosaccharide selected from the group consisting of fructo-oligosaccharide, non-digestible dextrin, galacto-oligosaccharide, xylo-oligosaccharide, arabino-oligosaccharide, arabinogalacto-oligosaccharide, gluco-oligosaccharide, glucomanno-oligosaccharide, galactomanno-oligosaccharide, mannan-oligosaccharide, chito-oligosaccharide, uronic acid oligosaccharide, sialyloligosaccharide and fuco-oligosaccharide and at least one partial protein hydrolysate, wherein the partial protein hydrolysate is partial whey hydrolysate. 
     
     
         20 . The method according to  claim 19 , wherein the composition comprises at least one beta-lactoglobulin peptide comprising a sequence selected from the group consisting of SEQ ID NO 1, SEQ ID NO 2, SEQ ID NO 3 and SEQ ID NO 4. 
     
     
         21 . The method according to  claim 19 , wherein the partial whey protein hydrolysate comprises at least 3 wt. % of peptides with a size of 5 kDa or above and at least 50 wt. % of peptides with a size below 5 kDa. 
     
     
         22 . The method according to  claim 19 , wherein the size distribution of the peptides in the partial whey protein hydrolysate is 60 to 90%<1 kDa, 5 to 20% 1 to <2 kDa, 2 to 16 % 2 to <5 kDa, 0.6 to 3 % 5 to <10 kDa, 0.5 to 2 % 10 to 20 kDa and 1 to 3%>20 kDa, based on dry weight of peptides present in partial protein hydrolysate. 
     
     
         23 . The method according to  claim 19 , wherein the partial whey protein hydrolysate comprises a ratio of the relative amount (wt %) of peptides with a size from 2 to <5 kDa to the relative amount (wt %) of peptides with a size of at least 5 kDa is (5 to 1):1. 
     
     
         24 . The method according to  claim 19 , wherein the non-digestible oligosaccharide is selected from the group consisting of fructo-oligosaccharide, galacto-oligosaccharide and uronic acid oligosaccharide. 
     
     
         25 . The method according to  claim 19 , wherein the non-digestible oligosaccharide is a mixture of galacto-oligosaccharides, fructo-oligosaccharides and galacturonic acid oligosaccharides. 
     
     
         26 . The method according to  claim 19 , wherein the enteral composition comprises:
 a) at least 5 wt. % partial whey protein hydrolysate or at least 5 wt.-% of the at least one beta-lactoglobulin peptide, each based on dry weight of the composition and   b) at least 1 wt % of the at least one non-digestible oligosaccharide based on dry weight of the composition.   
     
     
         27 . The method according to  claim 19 , wherein the enteral composition comprises a protein component, a lipid component and digestible carbohydrates and wherein the protein component is present in an amount of 5 to 25% based on total calories of the composition. 
     
     
         28 . The method according to  claim 19 , wherein the enteral composition comprises 0.05 to 20 wt. % non-digestible oligosaccharide based on dry weight of the composition. 
     
     
         29 . The method according to  claim 19 , wherein the enteral composition is an infant formula or follow-on-formula. 
     
     
         30 . A method for preventing inflammatory bowel disease in a subject in need thereof, said method comprising administering to said subject an enteral composition comprising at least one non-digestible oligosaccharide selected from the group consisting of fructo-oligosaccharide, non-digestible dextrin, galacto-oligosaccharide, xylo-oligosaccharide, arabino-oligosaccharide, arabinogalacto-oligosaccharide, gluco-oligosaccharide, glucomanno-oligosaccharide, galactomanno-oligosaccharide, mannan-oligosaccharide, chito-oligosaccharide, uronic acid oligosaccharide, sialyloligosaccharide and fuco-oligosaccharide and at least one partial protein hydrolysate, wherein the partial protein hydrolysate is partial whey hydrolysate. 
     
     
         31 . The method according to  claim 30 , wherein the composition comprises at least one beta-lactoglobulin peptide comprising a sequence selected from the group consisting of SEQ ID NO 1, SEQ ID NO 2, SEQ ID NO 3 and SEQ ID NO 4. 
     
     
         32 . The method according to  claim 30 , wherein the partial whey protein hydrolysate comprises at least 3 wt. % of peptides with a size of 5 kDa or above and at least 50 wt. % of peptides with a size below 5 kDa. 
     
     
         33 . The method according to  claim 30 , wherein the size distribution of the peptides in the partial whey protein hydrolysate is 60 to 90%<1 kDa, 5 to 20% 1 to <2 kDa, 2 to 16 % 2 to <5 kDa, 0.6 to 3 % 5 to <10 kDa, 0.5 to 2 % 10 to 20 kDa and 1 to 3%>20 kDa, based on dry weight of peptides present in partial protein hydrolysate. 
     
     
         34 . The method according to  claim 30 , wherein the partial whey protein hydrolysate comprises a ratio of the relative amount (wt %) of peptides with a size from 2 to <5 kDa to the relative amount (wt %) of peptides with a size of at least 5 kDa is (5 to 1):1. 
     
     
         35 . The method according to  claim 30 , wherein the non-digestible oligosaccharide is selected from the group consisting of fructo-oligosaccharide, galacto-oligosaccharide and uronic acid oligosaccharide. 
     
     
         36 . The method according to  claim 30 , wherein the non-digestible oligosaccharide is a mixture of galacto-oligosaccharides, fructo-oligosaccharides and galacturonic acid oligosaccharides. 
     
     
         37 . The method according to  claim 30 , wherein the enteral composition comprises:
 a) at least 5 wt. % partial whey protein hydrolysate or at least 5 wt.-% of the at least one beta-lactoglobulin peptide, each based on dry weight of the composition and   b) at least 1 wt % of the at least one non-digestible oligosaccharide based on dry weight of the composition.   
     
     
         38 . The method according to  claim 30 , wherein the enteral composition comprises a protein component, a lipid component and digestible carbohydrates and wherein the protein component is present in an amount of 5 to 25% based on total calories of the composition. 
     
     
         39 . The method according to  claim 30 , wherein the enteral composition comprises 0.05 to 20 wt. % non-digestible oligosaccharide based on dry weight of the composition. 
     
     
         40 . The method according to  claim 30 , wherein the enteral composition is an infant formula or follow-on-formula.

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