Compositions and methods for inducing satiety and treating non-insulin dependent diabetes mellitus, pre-diabetic symptoms, insulin resistance and related disease states and conditions

Abstract

The invention provides methods of treatment that induce satiety in a subject for a period of at least around twenty-four hours by once-daily administration to the subject of a controlled release dosage form, wherein the dosage form is administered while the subject is in the fasted state and at a time of around six to around nine hours prior to the subject's next intended meal, and wherein the dosage form comprises a controlled release composition, which comprises an enterically-coated, ileum hormone-stimulating amount of a nutritional substance and releases the majority of the nutritional substance in vivo upon reaching the subject's ileum. The invention also provides a diagnostic tool for probing the health and disease state of the ileal hormones, excess or deficiencies. The invention provides a safe vehicle for targeted deliveries of chemical, pharmaceuticals, natural substances and nutrition to the ileum. The present invention also provides a method for treating noninsulin dependent diabetes mellitus, pre-diabetic symptoms, and insulin resistance, as well as a number of disease states and conditions including gastrointestinal disorders as otherwise described herein.

1 . A method of treatment comprising inducing satiety in a subject for a period of at least around twelve hours, preferably at least around twenty-four hours by once-daily administration to the subject of a delayed and/or controlled release dosage form, wherein the dosage form is administered while the subject is in the fasted state and at a time of around four and one half to around ten hours, preferably around six hours to around nine hours prior to the subject's next intended meal, and wherein the dosage form comprises an enterically-coated ileum hormone-stimulating amount of a nutritional substance and releases the majority of the nutritional substance in vivo upon reaching the subject's ileum. 
     
     
         2 . The method of  claim 1 , wherein the dosage form comprises an enterically-coated tablet, troche, lozenge, dispersible powder or granule, a hard or soft capsule, or an emulsion or microemulsionmicro emulsion formulated for releasing the majority of the nutritional substance in vivo upon reaching the subject's ileum. 
     
     
         3 . The method of  claim 1 , wherein the dosage form is made by coating the nutritional substance with a material which has a pH dissolution or time delayed profile that delays the release in vivo of the majority of the nutritional substance until the dosage form reaches the subject's ileum. 
     
     
         4 . The method of  claim 4 , wherein the material having a pH dissolution profile that delays the release in vivo of the majority of the nutritional substance until the dosage form reaches the subject's ileum is selected from the group consisting of cellulose acetate trimellitiate (CAT), hydroxypropylmelhyl cellulose phthalate (HPMCP), hydroxypropylmethyl cellulose, ethyl cellulose and mixtures of hydroxypropylmethyl cellulose and ethyl cellulose each of which contains a subcoating, polyvinyl acetale phthalate (PVAP), cellulose acetale phthalate (CAP), shellac, copolymers of methacrylic acid and ethyl acrylate, and copolymers of methacrylic acid and ethyl acrylate to which a monomer of methylacrylate has been added during polmerization. 
     
     
         5 . The method of  claim 5 , wherein the copolymers of methacrylic acid and ethyl acrylate, and copolymers of methacrylic acid and ethyl acrylate to which a monomer of methylacrylate has been added during polymerization, are substantially insoluble in gastric fluid and in intestinal fluid at a pH of below around  7 .
 Also hydroxypopyl methylcellulose, as well as ethyl cellulose, each with its own subcoating   
     
     
         6 . The method of  claim 5 , wherein the nutritional substance is coated by a shellac Eudragit® Eudragit L. Eudragit S, Eudragit L or S with Eudragit RL, Eudragit L or S with Eudragit RSpolymer or mixtures thereof coating. 
     
     
         7 . The method of  claim 1  wherein the dosage form is a capsule that contains multiparticulates, each of which comprise an enterically-coated nutritional substance core. 
     
     
         8 . The method of  claim 7 , wherein the nutritional substance core is coated by a material having a pH dissolution profile that delays release in vivo of the majority of the nutritional substance until the multiparticulate reaches the subject's ileum. 
     
     
         10 . The method of  claim 1 , wherein the nutritional substance is selected from the group consisting of sugars, free fatty acids, lipids, polypeptides, amino acids, and compositions that yield sugars, free fatty acids, polypeptides, or amino acids upon digestion. 
     
     
         11 . The method of  claims 10 , wherein the nutritional substance is glucose. 
     
     
         12 . The method of  claim 1 , wherein the delayed and/or controlled release dosage form is administered once-daily at bedtime. 
     
     
         13 . The method of  claim 12 , wherein the dosage form is administered nocturnally. 
     
     
         14 . The method of  claim 1 , further comprising monitoring the subject's blood levels of one or more of the following: GLP-1, GLP-2, PYY, C-peptide, glucagon, blood sugar, insulin, leptin, IGF-1 and IGF-2. 
     
     
         15 . The method of  claim 14 , wherein the subject's blood level of GLP-1, GLP-2, PYY, C-peptide, blood sugar, glucagon, insulin. IGF-1, IGF-2, and/or leptin is monitored before administration of the dosage form and at a time of around six to around nine 10 hours after administration of the dosage form. 
     
     
         16 . The method of  claim 15 , wherein the amount or frequency of administration of the nutritional substance is adjusted depending upon the subject's blood levels of GLP-1, GLP-2. PYY, C-peptide, blood sugar, glucagons, insulin, IGF-1, IGF-2 and/or leptin. 
     
     
         17 . A method of treatment comprising stabilizing a subject's blood sugar and insulin levels for a period of at least around twenty-four hours by once-daily administration to the subject of a delayed and/or controlled release oral dosage form, wherein the dosage form is administered while the subject is in the fasted state and at a time of around four to around twelve hours, preferably about six hours to about ten hours, prior to the subject's next intended meal, and wherein the dosage form comprises an enterically-coated, ileum hormone-stimulating amount of a nutritional substance and releases the majority of the nutritional substance in vivo upon reaching the subject's ileum. 
     
     
         18 . The method of  claim 17 , wherein the dosage form comprises an enterically-coated tablet, troche, lozenge, dispersible powder or granule, a hard or soft capsule, or an emulsion or microemulsion formulated for releasing the majority of the nutritional substance in vivo upon reaching the subject's ileum. 
     
     
         19 . The method of  claim 17 , wherein the dosage form is made by coating the nutritional substance with a material which has a pH dissolution or time delay profile that delays the release in vivo of the majority of the nutritional substance until the dosage form reaches the subject's ileum. 
     
     
         20 . The method of  claim 19 , wherein the material having a pH dissolution profile that delays the release in vivo of the majority of the nutritional substance until the dosage form reaches the ileum a selected from the group consisting of cellulose acetate trimellitiate (CAT), hydroxypropylmethyl cellulose phthalate (HPMCP), hydroxypropylmethyl cellulose, ethyl cellulose or mixtures of hydroxypropylmethyl cellulose and ethyl cellulose containing a subcoating, polyvinyl acetate phthalate (PVAP), cellulose acetate phthalate (CAP), shellac, copolymers of methacrylic acid and ethyl acrylate, and copolymers of methacrylic acid and ethyl acrylate to which a monomer of methylacrylate has been added during polymerization. 
     
     
         21 . The method of  claim 20 , wherein the copolymers of methacrylic acid and ethyl to correct for the new coating acrylate, and copolymers of methacrylic acid and ethyl acrylate to which a monomer of methylacrylate has been added during polymerization, are substantially insoluble in gastric fluid and in intestinal fluid at a pH of below around 7. 
     
     
         22 . The method of  claim 21 , wherein the nutritional substance is coated by a Eudragit® polymer coating. 
     
     
         23 . The method of  claim 17  wherein the dosage form is a capsule that contains multiparticulates, each of which comprise an enterically-coated nutritional substance core. 
     
     
         24 . The method of  claim 17  wherein the dosage form is a capsule that contains multiparticulates, each of which comprise a nutritional substance which is coated by a material having a pH dissolution profile that delays release in vivo of the majority of the nuiritional substance until the multiparticulate reaches the ileum. 
     
     
         25 . The method of  claims 17 . wherein the nuiritional substance is selected from the group consisting of sugars, free fatty acids, lipids and root extract, polypeptides, amino acids, and foods that yield sugars, free fatly acids, polypeptides, or amino acids upon digestion. 
     
     
         26 . The method of  claims 17 , wherein the nutritional substance is glucose. 
     
     
         27 . The method of  claim 17 , wherein the delayed and/or controlled release dosage form is administered once-daily at bedtime. 
     
     
         28 . The method of  claim 17 , wherein the dosage form is administered nocturnally. 
     
     
         29 . The method of  claim 17 , further comprising monitoring the subjects blood levels of one or more of the following: GLP-1, GLP-2, PYY, C-peptide, blood sugar, sugar and insulin and other peptides 
     
     
         30 . The method of  claim 17 , wherein the subject's blood level of GLP-1. GLP-2. PYY, C-peptide. blood sugar, or insulin is monitored before administration of the dosage form and at a time of around nine hours after administration of the dosage form. 
     
     
         31 . The method of  claim 30 , wherein the amount or frequency of administration of the nutritional substance is adjusted depending upon the subject's blood levels of GLP-1, GLP-2, PYY, C-peptide, blood sugar, or insulin. 
     
     
         32 . A method of treating a subject who suffers from a gastrointestinal disorder comprising once-daily administration to the subject of a delayed and or controlled release oral dosage form, wherein the dosage form is administered while the subject is in the fasted state and at a time of around six to around nine hours prior to the subject's next intended meal, and wherein the dosage form comprises an enterically-coated. ileum hormone-stimulating amount of a nutritional substance and releases the majority of the nutritional substance in vivo upon reaching the subject's ileum. 
     
     
         33 . The method of  claim 32 , wherein the dosage form comprises an enterically-coated tablet, troche, lozenge, dispersible powder or granule, a hard or soft capsule, or an emulsion or microemulsion formulated for releasing the majority of the nutritional substance in vivo upon reaching the subject's ileum. 
     
     
         34 . The method of  claim 32 , wherein the dosage form is made by coating the nutritional substance with a material which has a pH dissolution profile that delays the release in vivo of the majority of the nutritional substance until the dosage form reaches the subject's ileum. 
     
     
         35 . The method of  claim 34 , wherein the material having a pH dissolution or time delay profile that delays the release in vivo of the majority of the nutritional substance until the dosage form reaches the ileum is selected from the group consisting of cellulose acetate trimellitiate (CAT), hydroxypropylmethyl cellulose phthalate (HPMCP), hydroxypropylmethyl cellulose, ethyl cellulose or mixtures of hydroxypropylmethyl cellulose and ethyl cellulose containing a subcoating sub coating, polyvinyl acetate phthalate (PVAP). cellulose acetate phthalate (CAP), shellac, copolymers of methacrylic acid and ethyl acrylate, and copolymers of methacrylic acid and ethyl acrylate to which a monomer of methylacrylate has been added during polymerization. Also hydroxypopyl methyl cellulose, as well as ethyl cellulose each cellulose each with its own subcoating own subcoating 
     
     
         36 . The method of  claim 35 , wherein the copolymers of methacrylic acid and ethyl acrylate, and copolymers of methacrylic acid and ethyl acryiate to which a monomer of methylacrylate has been added during polymerization, are substantially insoluble in gastric fluid and in intestinal fluid at a pH of below around 7. 
     
     
         37 . The method of  claim 36 , wherein the nutritional substance is coated by a Eudragit polymer coating. 
     
     
         38 . The method of  claim 36  wherein said Eudragit polymer coating comprises Eudragit L, Eudragit S, Eudragit L or S with Eudragit RL, Eudragit L or S with Eudragit RS or mixtures thereof. 
     
     
         38 . The method of  claim 32  wherein the dosage form is a capsule that contains multiparticulates, each of which comprise an enterically-coated nutritional substance core. 
     
     
         39 . The method of  claim 38 , wherein the nutritional substance core is coated by a material having a pH dissolution profile that delays release in vivo of the majority of the nutritional substance until the multiparticulate reaches the subject's ileum. 
     
     
         40 . The method of  claims 32 , wherein the nutritional substance is selected from the group consisting of sugars, free fatly acids, polypeptides, amino acids, and compositions that yield sugars, free fatty acids, polypeptides, or amino acids upon digestion. 
     
     
         41 . The method of  claims 40 , wherein the nutritional substance is D-glucose. 
     
     
         42 . The method of  claim 32 , wherein the delayed and/or controlled release dosage form is administered once-daily at bedtime or in the morning (AM). 
     
     
         43 . The method of  claim 42 , wherein the dosage form is administered nocturnally or upon awakening. 
     
     
         44 . A method of treatment comprising inducing satiety in a subject for a period of at least around twenty-four hours by once-daily administration to the subject of a delayed and/or controlled release dosage form, wherein the dosage form is administered while the subject is in the fasted state and at a time of around four to around ten hours prior to the subject's next intended meal, and wherein the dosage form comprises an emulsion or microemulsion an ileum hormone-stimulating amount of a nutritional substance and releases the majority of the nutritional substance in vivo upon reaching the subject's ileum. 
     
     
         45 . The method of  claim 1  wherein the subject is overweight, obese or suffers from an obesity-related disorder. 
     
     
         46 . The method of  claim 1  wherein the delayed and/or controlled release dosage form is a hard or soft capsule or tablet formed by coating glucose with a Eudragit®polymer coating. 
     
     
         47 . The method of  claim 1  wherein the delayed and/or controlled release dosage form is a capsule formed by coating glucose with a shellac coating, which optionally includes an emulsifier. 
     
     
         48 . The method of  claim 48  wherein the emulsifier is hypromellose, triacetin or a mixture thereof. 
     
     
         49 . The method of  claim 1  wherein the delayed and/or controlled release dosage form is a capsule formed by coating glucose with elhylcellulose. 
     
     
         50 . A method of diagnosing whether a subject suffers from an abnormally responsive ileal hormone release disorder, the method comprising:
 (a) administering a dosage form comprising a delayed and/or controlled release ileum hormone-stimulating amount of a nutritional substance to the subject while the subject is in the fasted state and at a time of around four to around ten hours prior to the subject's next intended meal;   (b) measuring the subject's levels of blood sugar and insulin at regular intervals over a period subsequent to administration of the nutritional substance; and   (c) comparing measured levels of blood sugar and insulin to healthy (normal) levels of blood sugar and insulin over an identical period that have been determined by administering an equivalent delayed and/or controlled release ileum hormone-stimulating amount of a nutritional substance to a control subject, wherein a level of insulin and or blood sugar which decreases in said patient compared to said healthy level is evidence of an abnormally responsive ileal hormone release disorder.   
     
     
         50 . A method of diagnosing whether a subject suffers from an obesity-related, or abnormally responsive ileal hormone release disorder, the method comprising
 (a) measuring one or more of the subject's levels of ileal hormones selected from the group of at least GLP1, GLP2. PYY and enteroglucagon after a period of fasting:   (b) administering a dosage form comprising a controlled release, ileum hormone-stimulating amount of a nutritional substance to the subjec. while the subject is in the fasted state and at a time of around four hours to around ten hours prior to the subject's next intended meal;   (c) measuring the subject's levels of said hormones and optionally blood sugar and insulin at regular intervals subsequent to administration of the nutritional substance, and   (d) comparing measured levels of said hormones and optional levels of blood sugar and insulin to healthy levels of hormones and blood sugar and insulin that have been determined by administering an equivalent controlled release ileum hormone-stimulating amount of a nutritional substance to a control subject; and   (e) determining based upon said comparing step the likelihood that said tested subject suffers from an obesity-related, or abnormally responsive ileal hormone release disorder.   
     
     
         51 . The method according to  claim 47  or  48  wherein said nutritional substance is D-glucose in an amount ranging from about 500 mg to about 12.5 grams. 
     
     
         52 . A method of treating a gastrointestinal disease or disorder in a patient in need thereof comprising administering to said patient an effective amount of a controlled release composition comprising an ileum hormone stimulating nutritional substance which releases about 50% by weight of said nutritional substance in the ileum of said patient wherein said gastrointestinal disease or disorder selected from the group consisting of atrophic gastritis, post chemotherapy disorder, intestinal motility disorder (gut dismotility), mild reflux, chronic pancreatitis, malnutrition, malabsorption, voluntary or involuntary long term starvation, post infectious syndrome, short bowel syndrome, irritable bowel, malabsorption, diarrheal states, post chemotherapy gastrointestinal disorder, post infectious syndrome, radiation enteritis, celiac disease, fatty liver disease, cirrhosis, radiation, inflammatory bowel disease and Crohn's disease. 
     
     
         53 . A method of treating a disease or disorder selected from the group consisting of metabolic syndrome, pre-diabetic symptoms, noninsulin dependent diabetes mellitus, glucose intolerance or insulin resistance or a disease state or condition which occurs secondary to said disease or disorder comprising administering to said patient or subject an effective amount of a nutritional substance and releasing at least about 50% of the nutritional substance in said composition in the ileum of said patient or subject. 
     
     
         54 . The method according to  claim 53  wherein said secondary disease state is polycystic (fibrous) ovaries, arteriosclerosis, fatty liver or cirrhosis. 
     
     
         55 . A method of treating a patient or subject to improve the health of the liver, pancreas and/or intestine of said patient or subject comprising administering to said patient or subject an effective amount of a nutritional substance and delivering at least about 50% of the nutritional substance in said composition in the ileum of said patient or subject. 
     
     
         56 . A method of treating a patient or subject to decrease fatty liver, increase the size of beta cells in the pancreas or increase the size of absorptive villae of the small bowel of said patient or subject comprising administering to said patient or subject an effective amount of a nutritional substance and releasing at least about 50% of the nutritional substance in said composition in the ileum of said patient or subject. 
     
     
         57 . A method of treating a patient or subject to decrease body fat and/or increase muscle mass comprising administering to said patient or subject an effective amount of a nutritional substance and releasing at least about 50% of said nutritional substance in said composition upon reaching the ileum of said patient of subject. 
     
     
         58 . The method according to any of  claims 52 - 56  wherein said nutritional substance is D-glucose. 
     
     
         59 . A method of stimulating IGF-1, IGF-2, leptin or mixtures thereof in the gastrointestinal tract of a patient or subject said method composing administering to said patient or subject an effective amount of a nutritional substance and delivering at least about 50% of the nutritional substance in said composition in the ileum of said patient or subject. 
     
     
         60 . A method of treatment comprising administering a nutritional supplement composition containing GRAS ingredients for treating noninsulin dependent diabetes mellitus, pre-diabetic symptoms, and insulin resistance, the nutritional supplement composition containing an effective amount of a nutritional substance, optionally combined with one or more of Alfalfa leaf, chlorella algae, chlorophyllin and barley grass juice concentrate, and further formulated into a delayed release form adapted to release the nutritional supplement in the lower gut or ileum. 
     
     
         61 . The method according to  claim 60  wherein said nutritional substance is D-glucose 
     
     
         62 . The method of  claim 59  or  60  wherein the dosage form is administered while the subject is in the fasted state and at a time of around four to around ten hours, preferably around six hours to around nine hours prior to the subject's next intended meal, and wherein the dosage form comprises a controlled release insulin regulating amount of the nutritional substance and releases at least about 50% by weight of the nutritional substance in vivo upon reaching the subject's ileum. 
     
     
         63 . The method of  claim 60 , wherein the dosage form comprises a nutritional substance core and an enterically-coated tablet, troche, lozenge, dispersible powder or granule, a hard or soft capsule, or an emulsion or microemulsion. 
     
     
         64 . The method of  claim 60 , wherein the dosage form is made by coating the nutritional substance with a material which has a pH dissolution or time delayed profile that delays the release in vivo of the majority of the nutritional substance until the dosage form reaches the subject's ileum. 
     
     
         65 . The method of  claim 64 , wherein the material having a pH dissolution profile that delays the release in vivo of the majority of the nutritional substance until the dosage form reaches the subject's ileum is selected from the group consisting of cellulose acetate trimellitiate (CAT), hydroxypropylmethyl cellulose pthalate (HPMCP), hydroxypropylmethyl cellulose, ethyl cellulose, color con, food glaze and mixtures of hydroxypropylmethyl cellulose and ethyl cellulose each of which contains a subcoating. polyvinyl acetate phthalate (PVAP), cellulose acetate phthalate (CAP), shellac, copolymers of methacrylic acid and ethyl acrylate, and copolymers of methacrylic acid and ethyl acrylate to which a monomer of methylacrylate has been added during polymerization. 
     
     
         66 . The method of  claim 65 , wherein the copolymers of methacrylic acid and ethyl acrylate, and copolymers of methacrylic acid and ethylacrylate to which a monomer of methylacrylate has been added during polymerization, are substantially insoluble in gastric fluid and in intestinal fluid at a pH of below around 7. 
     
     
         67 . The method of  claim 65 , wherein the nutritional substance is coated by Eudragit L, Eudragit S, Eudragit L or S with Eudragit RL, Eudragit L or S with Eudragit RS or mixtures thereof. 
     
     
         68 . The method of  claim 63  wherein said nutritional substance is coated with shellac. 
     
     
         69 . The method of  claim 63  wherein the dosage form is a capsule that contains multiparticulates, each of which comprise an enterically-coated nutritional substance core. 
     
     
         70 . The method of  claim 69 , wherein the nutritional substance core is coated by a material having a pH dissolution profile that delays release in vivo of the majority of the nutritional substance until the multiparticulate reaches the subject's ileum. 
     
     
         71 . The method of  claim 60  wherein said nutritional substance is dextrose present at from about 500 to 3000 mg. 
     
     
         72 . The method of  claim 60 , wherein the nntritional substance is selected from the group consisting of sugars, free fatty acids, polypeptides, amino acids, and compositions that yield sugars, free fatty acids, polypeptides, or amino acids upon digestion. 
     
     
         73 . The method of  claims 72 , wherein the nutritional substance is glucose. 
     
     
         74 . The method of  claim 60 , further comprising administering the nutritional supplement once-daily at bedtime. 
     
     
         75 . The method of  claim 60 , further composing administering the nutritional supplement nocturnally. 
     
     
         76 . The method of  claim 60 , further comprising monitoring the subject's blood levels of one or more of the following: GLP-1, GLP-2. PYY, C-peptide. blood sugar, insulin, leptin, enteroglucagon and glucagon. 
     
     
         77 . The method of  claim 60 , further comprising monitoring the subject's blood levels of one or more of the following: GLP-1,GLP-2, PYY, C-peptide, blood sugar, insulin, leptin and glucagon before administering the dosage form and at a time of around four to around ten hours after administering the dosage form. 
     
     
         78 . The method of  claim 77 , further composing adjusting an amount or a frequency of administration of the nutritional supplement depending upon the subject's blood levels of GLP-1, GLP-2, PYY, C-peptide, blood sugar, insulin, leptin and glucagon. 
     
     
         79 . The method of any of  claims 60 - 78  wherein the nutritional substance comprises Alfalfa Leaf, 3.00 mg, Chlorella Algae, 3.00 mg., Chlorophyllin, 3.00 mg, Barley Grass Juice Concentrate, 3.00 mg, and Dextrose, 1429.00 mg. 
     
     
         80 . A delayed/controlled release composition comprising an effective amount of a nutritional substance, optionally combined with one or more of Alfalfa leaf, chlorella algae, chlorophyllin and barley grass juice concentrate, and further formulated into a delayed or controlled release form adapted to release at least 50% by weight of the nutritional substance upon reaching the lower gut or ileum. 
     
     
         81 . The composition of  claim 80 , wherein the dosage form comprises a nutritional substance core and an enterically-coated tablet troche, lozenge, dispersible powder or granule, a hard or soft capsule, or an emulsion or microemulsion. 
     
     
         82 . The composition of  claim 80  or  81 , wherein the dosage form is made by coating the nutritional substance with a material which has a pH dissolution or time delayed profile that delays the release in vivo of the majority of the nutritional substance until the dosage form reaches the subject's ileum. 
     
     
         83 . The composition of  claim 82 , wherein the material having a pH dissolution profile that delays the release in vivo of the majority of the nutritional substance until the dosage form reaches the subject's ileum is selected from the group consisting of cellulose acetate trimellitiate (CAT), hydroxypropylmethyl cellulose pthalate (HPMCP), hydroxypropylmethyl cellulose, ethyl cellulose, color con, food glaze and mixtures of hydroxypropylmethyl cellulose and ethyl cellulose each of which contains a subcoating, polyvinyl acetate phthalate (PVAP), cellulose acetate phthalate (CAP), shellac, copolymers of methacrylic acid and ethyl acrylate. and copolymers of methacrylic acid and ethyl acrylate to which a monomer of methylacrylate has been added during polymerization. 
     
     
         84 . The composition of  claim 83 , wherein the copolymers of methacrylic acid and ethyl acrylate, and copolymers of methacrylic acid aad ethyl acrylate to which a monomer of methylacrylate has been added during polymerization or shellac, are substantially insoluble in gastric fluid and in intestinal fluid at a pH of below around 7. 
     
     
         85 . The composition of  claim 84  wherein the nutritional substance is coaled by Eudragit L, Eudragit S, Eudragit L or S with Eudragit RL, Eudragit L or S with Eudragit RS, mixtures thereof or shellac. 
     
     
         86 . The composition of  claim 85  wherein said nutritional substance is coated with shellac. 
     
     
         87 . The composition of  claim 80  wherein the dosage form is a capsule that contains multiparticulates, each of which comprises an enterically-coated nutritional substance core. 
     
     
         88 . the composition of  claim 81 , wherein the nutritional substance core is coated by a material having a pH dissolution profile that delays release in vivo of the majority of the nutritional substance until the multiparticulate reaches the subject's ileum. 
     
     
         89 . The composition according to  claim 88  wherein the material is shellac. 
     
     
         90 . The composition according to any of  claims 80 - 89  wherein said nutritional substance is dextrose (D-glucose) present at from 500 to 3000 mg. 
     
     
         91 . The composition according to  claim 80 , wherein the nutritional substance is selected from the group consisting of sugars, free fatty acids, polypeptides, amino acids, and compositions that yield sugars, free fatty acids, polypeptides, or amino acids upon digestion. 
     
     
         92 . The composition according to any of  claims 80 - 91  further comprising an effective amount of an antibiotic, antispasmodic agent, non-specific chelating agent, antidiabetes agent, laxative or mixture thereof. 
     
     
         93 . A delayed/controlled release composition comprising a core and an enteric coating, said core comprising an effective amount of glucose optionally combined with one or more of alfalfa leaf, chlorella algae, chlorophyllin and barley grass juice concentrate in combination with corn starch, stearic acid, magnesium stearate and silicone dioxide, and said coating comprising shellac, hypromellose and triacetin, wherein said composition is adapted to release at least about 50% by weight of the nutritional substance in the ileum. 
     
     
         94 . A delayed-controlled release composition according to formulation II of example 3 hereof. 
     
     
         95 . The composition according to any of  claims 80 - 94  further comprising an effective amount of a plant or animal oil, an animal or vegetable fat, a seed or nut oil or fat, a stimulant selected from the group consisting of caffeine, an herb, tea and mixtures thereof, an ingredient that increases post receptor activities at the cellular level, an extract or food product or a natural or synthetic chemical, including a metabolite. 
     
     
         96 . A method of improving muscle function and coordination in a patient in need, comprising administering an effective amount of an ileum hormone-stimulating amount of a nutritional substance which releases the majority of the nutritional substance in vivo upon reaching the subject's ileum as otherwise described herein. 
     
     
         97 . A method of improving the action of diabetes medications in a patient taking such medications comprising administering to said patient an effective amount of an ileum hormone-stimulating amount of a nutritional substance which releases the majority of the nutritional substance in vivo upon reaching the subject's ileum as otherwise described herein. 
     
     
         98 . The method according to  claim 97  wherein said diabetes medication is DDPI 4 inhibitor. 
     
     
         99 . A method of improving the structure of the basal membrane of the gastrointestinal tract of a patient in need thereof said method composing administering to said patient an effective amount of an ileum hormone-stimulating amount of a nutritional substance which releases the majority of the nutritional substance in vivo upon reaching the subject's ileum as otherwise described herein. 
     
     
         100 . The method according to  claim 99  which results in a diminution of the risk of multiple sclerosis in said patient. 
     
     
         101 . A method of enhancing the recovery of the GI tract of a patient injured by radiation, chemotherapy or other toxins comprising administered to said patient an effective amount of an ileum hormone-stimulating amount of a nutritional substance which releases the majority of the nutritional substance in vivo upon reaching the subject's ileum as otherwise described herein. 
     
     
         102 . A method of treating, inhibiting or reducing the likelihood of a liver disease in a patient said method comprising administering an effective amount of an ileum hormone-stimulating amount of a nutritional substance which releases the majority of the nutritional substance in vivo upon reaching the subject's ileum as otherwise described herein. 
     
     
         103 . The method according to  claim 102  wherein said liver disease is fatty liver disease or hepatitis. 
     
     
         104 . The method according to  claim 103  wherein said hepatitis is hepatitis from viral infections, including Hepatitis A, B,C, D and E. Herpes simplex, Cytomegalovirus. Epstein-Barr virus, yellow fever virus, adenoviruses; non-viral infections, alcohol, toxins, drugs, ischemic hepatitis (circulatory insufficiency); pregnancy; autoimmune conditions, including Systemic Lupus Erythematosus (SLE); metabolic diseases, e.g. Wilson's disease, hemochromatosis and alpha one antitrypsin deficiency; and steatohepatitis, including non-alcoholic steatohepatitis 
     
     
         105 . A method of treating hyperlipidemia, including hyperlipidemia associated with high triglycerides, in a patient in need thereof comprising administering to said patient an effective amount of an ileum hormone-stimulating amount ofa nutritional substance which releases the majority of the nutritional substance in vivo upon reaching the subject's ileum as otherwise described herein.