Synthetic composition for treating metabolic disorders

Abstract

A method for treating metabolic disorders includes determining a treatment group comprising obese non-infant humans; formulating a composition comprising one or more synthetic non-fucosylated human milk oligosaccharides (HMOs) selected from lacto-N-tetraose (LNT), lacto-N-neotetraose (LNnT) and/or 2′-fucosyllactose (2′-FL), 3-fucosyllactose (3-FL), difucosyllactose (DFL), and lacto-N-fucopentaose I (LNFP-I), that are effective for: increasing in the gastrointestinal microbiota of a non-infant human during a treatment period, the relative abundance of Bifidobacterium adolescentis and reducing a precursor condition for a metabolic disorder associated with development of one or more of obesity-induced pre-diabetes and type 2 diabetes, the precursor condition selected from gut permeability, metabolic endotoxemia, low-grade metabolic inflammation, and body fat percentage; and reducing the precursor condition in at least one non-infant human in the treatment group by providing the composition to the at least one non-infant human during the treatment period.

What is claimed is: 
     
         1 . A method comprising:
 determining a treatment group comprising obese non-infant humans,   formulating a composition comprising an effective amount of one or more synthetic fucosylated human milk oligosaccharides (HMO) selected from 2′-fucosyllactose (2′-FL), 3-fucosyllactose (3-FL), difucosyllactose (DFL), and lacto-N-fucopentaose I (LNFP-I), that are effective for:
 increasing in the gastrointestinal microbiota of a non-infant human during a treatment period, the relative abundance of  Bifidobacterium adolescentis;  and 
 reducing a precursor condition for a metabolic disorder associated with development of one or more of obesity-induced pre-diabetes and type 2 diabetes, the precursor condition selected from gut permeability, metabolic endotoxemia, low-grade metabolic inflammation, and body fat percentage; 
   reducing the precursor condition in at least one non-infant human in the treatment group by providing the composition to the at least one non-infant human during the treatment period.   
     
     
         2 . The method of  claim 1 , wherein the reduced precursor condition for the metabolic disorder associated with development of the one or more of obesity-induced pre-diabetes and type 2 diabetes is gut permeability. 
     
     
         3 . The method of  claim 1 , wherein the reduced precursor condition for the metabolic disorder associated with development of the one or more of obesity-induced pre-diabetes and type 2 diabetes is body fat percentage. 
     
     
         4 . The method of  claim 1 , further comprising increasing, in the gastrointestinal tract of the non-infant human, a level of glucagon-like peptide selected from GLP-1 and/or GLP-2 relative to the level of the selected glucagon-like peptide prior to the treatment period. 
     
     
         5 . The method of  claim 1 , wherein:
 the treatment period comprises an initial treatment phase and a maintenance phase;   the effective amount of the selected one or more HMOs is from about 2.5 g to about 7.5 g daily during the initial treatment phase; and   the effective amount of the selected one or more HMOs is from about 1 g to about 2.5 g daily during the maintenance phase.   
     
     
         6 . The method of  claim 1 , further comprising formulating the composition in a unit dosage form. 
     
     
         7 . The method according to  claim 1 , wherein the obese non-infant human is a prepubescent child. 
     
     
         8 . A method comprising:
 determining a treatment group comprising obese non-infant humans;   formulating a composition comprising one or more synthetic non-fucosylated human milk oligosaccharides (HMOs) selected from lacto-N-tetraose (LNT), lacto-N-neotetraose (LNnT), that are effective for:
 increasing in the gastrointestinal microbiota of a non-infant human during a treatment period, the relative abundance of  Bifidobacterium adolescentis  and 
 reducing a precursor condition for a metabolic disorder associated with development of one or more of obesity-induced pre-diabetes and type 2 diabetes, the precursor condition selected from gut permeability, metabolic endotoxemia, low-grade metabolic inflammation, and body fat percentage; and 
   reducing the precursor condition in at least one non-infant human in the treatment group by providing the composition to the at least one non-infant human during the treatment period.   
     
     
         9 . The method of  claim 8 , wherein the reduced precursor condition for the metabolic disorder associated with development of the one or more of obesity-induced pre-diabetes and type 2 diabetes is gut permeability. 
     
     
         10 . The method of  claim 8 , wherein the reduced precursor condition for the metabolic disorder associated with development of the one or more of obesity-induced pre-diabetes and type 2 diabetes is body fat percentage. 
     
     
         11 . The method of  claim 8 , further comprising increasing, in the gastrointestinal tract of the non-infant human, a level of glucagon-like peptide selected from GLP-1 and/or GLP-2 relative to the level of the selected glucagon-like peptide prior to the treatment period. 
     
     
         12 . The method of  claim 8 , further comprising formulating the composition in a unit dosage form. 
     
     
         13 . The method according to  claim 8 , wherein the obese non-infant human is a prepubescent child. 
     
     
         14 . The method of  claim 8 , wherein:
 the treatment period comprises an initial treatment phase and a maintenance phase;   the effective amount of the selected one or more HMOs is from about 2.5 g to about 7.5 g daily during the initial treatment phase; and   the effective amount of the selected one or more HMOs is from about 1 g to about 2.5 g daily during the maintenance phase.   
     
     
         15 . A method comprising:
 determining a treatment group comprising obese non-infant humans;   formulating a composition comprising an effective amount of two or more synthetic neutral human milk oligosaccharides (HMOs) selected from 2′-fucosyllactose (2′FL), 3-fucosyllactose (3-FL), difucosyllactose (DFL), lacto-N-fucopentaose I (LNFP-I), lacto-N-tetraose (LNT), and lacto-N-neotetraose (LNnT), wherein the selected HMOs are effective for:
 increasing in the gastrointestinal microbiota of a non-infant human during a treatment period, the relative abundance of  Bifidobacterium adolescentis,  and 
 reducing in the non-infant human during the treatment period, a precursor condition for a metabolic disorder associated with development of one or more of obesity-induced pre-diabetes and type 2 diabetes, the precursor condition selected from gut permeability, metabolic endotoxemia, low-grade metabolic inflammation, and body fat percentage; 
   reducing the precursor condition in at least one non-infant human in the treatment group by providing the composition to the at least one non-infant human during the treatment period.   
     
     
         16 . The method of  claim 15 , wherein the reduced precursor condition for the metabolic disorder associated with development of the one or more of obesity-induced pre-diabetes and type 2 diabetes is gut permeability. 
     
     
         17 . The method of  claim 15 , wherein the reduced precursor condition for the metabolic disorder associated with development of the one or more of obesity-induced pre-diabetes and type 2 diabetes is body fat percentage. 
     
     
         18 . The method of  claim 15 , further comprising increasing, in the gastrointestinal tract of the non-infant human, a level of glucagon-like peptide selected from GLP-1 and/or GLP-2 relative to the level of the selected glucagon-like peptide prior to the treatment period. 
     
     
         19 . The method of  claim 15 , further comprising formulating the composition in a unit dosage form. 
     
     
         20 . The method of  claim 15 , wherein:
 the treatment period comprises an initial treatment phase and a maintenance phase;   the effective amount of the selected HMO mixture is from about 2.5 g to about 7.5 g daily during the initial treatment phase; and   the effective amount of the selected HMO mixture is from about 1 g to about 2.5 g daily during the maintenance phase.