Method of using punicic acid to enhance immune response and prevent metabolic disorders

Abstract

Disclosed is a method of enhancing the immune response of an animal, including mammals and humans, to prevent or ameliorate immunoinflammatory diseases such as Inflammatory Bowel Disease, increase immune system development, maintain or increase CD4 + and CD8 + T lymphocyte levels, increase immune function, increase immune response against viruses and prevent or ameliorate the Metabolic Syndrome, Type 2 diabetes and obesity by administering orally or parentally a therapeutically effective amount of punicic acid to the animal.

1 . A method of enhancing immune response in an animal, the method comprising administering a therapeutically effective amount of a compound selected from the group consisting of: punicic acid, esters thereof, pharmaceutically suitable salts thereof, metabolites thereof, and combinations thereof, the compound administered in a single dose or a multiple dose to the animal.  
     
     
         2 . The method of  claim 1 , comprising administering a free form of punicic acid to the animal.  
     
     
         3 . The method of  claim 1 , comprising administering the compound in combination with a pharmaceutically suitable carrier.  
     
     
         4 . The method of  claim 1 , comprising administering the compound to a mammal.  
     
     
         5 . The method of  claim 4 , wherein the mammal is a human.  
     
     
         6 . The method of  claim 1 , comprising administering the compound orally in combination with a pharmaceutically suitable oral carrier.  
     
     
         7 . The method of  claim 1 , comprising administering the compound parenterally.  
     
     
         8 . The method of  claim 7 , comprising administering the compound by injection.  
     
     
         9 . The method of  claim 7 , comprising administering the compound rectally.  
     
     
         10 . The method of  claim 9 , comprising administering the compound rectally in combination with a pharmaceutically acceptable excipient.  
     
     
         11 . The method of  claim 1 , comprising administering the compound in combination with active ingredients.  
     
     
         12 . The method of  claim 11 , wherein the compound is administered in combination with one or more vitamins or fatty acids.  
     
     
         13 . The method of  claim 1 , comprising administering the compound in a supplemented nutritional product.  
     
     
         14 . The method of  claim 13 , wherein the nutritional product is selected from the group consisting of: fiber bars, energy bars, cereals, breads, milk, cheese, carbohydrate-low foods, infant formulas, children products, yogurt, kefir, geriatric formulas, weight management formulas, sports nutrition formulas, fruit drinks and foods.  
     
     
         15 . The method of  claim 1 , comprising administering the compound in combination with animal food.  
     
     
         16 . The method of  claim 15 , wherein the animal food is dog food, cat food and horse food.  
     
     
         17 . The method of  claim 1 , wherein the effective amount of punicic acid is between about 10 mg per kg body weight per day and 10,000 mg per kg body weight per day.  
     
     
         18 . The method of  claim 1 , wherein the amount of the compound administered is effective to increase CD4 +  and CD8 +  T cell levels in the animal.  
     
     
         19 . The method of  claim 1 , wherein the amount of the compound administered is effective to increase resistance to viral antigens in the animal.  
     
     
         20 . The method of  claim 19 , wherein the viral antigens are influenza viral antigens.  
     
     
         21 . The method of  claim 1 , wherein the amount of the compound administered is effective to treat inflammatory bowel disease.  
     
     
         22 . The method of  claim 21 , wherein the inflammatory bowel disease is Crohn's disease.  
     
     
         23 . The method of  claim 21 , wherein the inflammatory bowel disease is ulcerative colitis.  
     
     
         24 . The method of  claim 1 , wherein the amount of the compound administered is effective to enhance development of immune system in the animal.  
     
     
         25 . The method of  claim 24 , wherein the immune system includes primary and secondary lymphoid organs and immune cells.  
     
     
         26 . The method of  claim 25 , wherein the primary and secondary lymphoid organs are thymus, spleen, lymph nodes, bronchi-associated lymphoid tissue, and gut-associated lymphoid tissue.  
     
     
         27 . A method of treating immunoinflammatory disorders in a mammal, the method comprising administering a therapeutically effective amount of a compound selected from the group consisting of punicic acid, esters thereof, pharmaceutically-suitable salts thereof, metabolites thereof, and combinations thereof, the compound administered in a single dose or a multiple dose to the mammal.  
     
     
         28 . The method of  claim 27 , comprising administering a free form of punicic acid to the mammal.  
     
     
         29 . The method of  claim 27 , comprising administering the compound orally in combination with a pharmaceutically suitable oral carrier.  
     
     
         30 . The method of  claim 27 , comprising administering the compound parenterally.  
     
     
         31 . The method of  claim 27 , comprising administering the compound in combination with active ingredients.  
     
     
         32 . The method of  claim 31 , wherein the compound is administered in combination with one or more vitamins or fatty acids.  
     
     
         33 . The method of  claim 27 , wherein the amount of the compound administered is effective to treat inflammatory bowel disease.  
     
     
         34 . The method of  claim 33 , wherein the inflammatory bowel disease is Crohn's disease.  
     
     
         35 . The method of  claim 33 , wherein the inflammatory bowel disease is ulcerative colitis.  
     
     
         36 . The method of  claim 27 , wherein the effective amount of punicic acid is between about 10 mg per kg body weight per day and 10,000 mg per kg body weight per day.  
     
     
         37 . The method of  claim 27 , wherein the mammal is a human.  
     
     
         38 . A composition of matter for treating inflammatory bowel disorder, the composition comprising an amount of punicic acid in combination with a pharmaceutically-acceptable carrier, wherein the amount of punicic acid is effective to treat inflammatory bowel disorder in an animal.  
     
     
         39 . The composition of matter of  claim 38  wherein the punicic acid is present in its free acid form.  
     
     
         40 . The composition of matter of  claim 38  wherein the punicic acid is selected from the group consisting of non-toxic salts, active esters, structural lipids containing punicic acid, methyl and ethyl esters, active metabolites and other active chemical derivatives thereof and mixtures thereof.  
     
     
         41 . The composition of matter of  claim 38  wherein the pharmaceutically acceptable carrier is suitable for parental administration.  
     
     
         42 . The composition of matter of  claim 38  wherein the pharmaceutically acceptable carrier is suitable for oral administration.  
     
     
         43 . The composition of matter of  claim 42  wherein the pharmaceutically acceptable carrier is present in the form of capsules, cachets, tablets, boluses or lozenges.  
     
     
         44 . The composition of matter of  claim 38  wherein the effective amount is between about 10 mg per day and 10,000 mg per day.  
     
     
         45 . A method of treating or preventing Metabolic Syndrome, Type 2 diabetes, and obesity in a mammal, the method comprising administering a therapeutically effective amount of a compound selected from the group consisting of punicic acid, esters thereof, pharmaceutically-suitable salts thereof, metabolites thereof, and combinations thereof, the compound administered in a single dose or a multiple dose to the mammal.  
     
     
         46 . The method of  claim 45 , comprising administering a free form of punicic acid to the mammal.  
     
     
         47 . The method of  claim 45 , comprising administering the compound orally in combination with a pharmaceutically suitable oral carrier.  
     
     
         48 . The method of  claim 45 , comprising administering the compound parenterally.  
     
     
         49 . The method of  claim 45 , comprising administering the compound in combination with active ingredients.  
     
     
         50 . The method of  claim 45 , wherein the compound is administered in combination with one or more vitamins or fatty acids.  
     
     
         51 . The method of  claim 45 , wherein the amount of the compound administered is effective to treat and prevent hyperinsulinemia.  
     
     
         52 . The method of  claim 45 , wherein the amount of the compound administered is effective to treat and prevent hyperglycemia.  
     
     
         53 . The method of  claim 45 , wherein the amount of the compound administered is effective to treat and prevent abdominal fat accumulation.  
     
     
         54 . The method of  claim 45 , wherein the amount of the compound administered is effective to normalize impaired glucose tolerance.  
     
     
         55 . The method of  claim 45 , wherein the effective amount of punicic acid is between about 10 mg per kg body weight per day and 10,000 mg per kg body weight per day.  
     
     
         56 . The method of  claim 45 , wherein the mammal is a human.  
     
     
         57 . A composition of matter for treating Type 2 diabetes and abdominal obesity in an animal, comprising an amount of punicic acid effective to treat Type 2 diabetes and abdominal obesity in combination with a pharmaceutically acceptable carrier.  
     
     
         58 . The composition of matter of  claim 57  wherein the punicic acid is in its free acid form.  
     
     
         59 . The composition of matter of  claim 57  wherein the punicic acid is selected from the group consisting of non-toxic salts, active esters, structural lipids containing punicic acid, methyl and ethyl esters, active metabolites and other active chemical derivatives thereof and mixtures thereof.  
     
     
         60 . The composition of matter of  claim 57  wherein the pharmaceutically acceptable carrier is suitable for parental administration.  
     
     
         61 . The composition of matter of  claim 57  wherein the pharmaceutically acceptable carrier is suitable for oral administration.  
     
     
         62 . The composition of matter of  claim 61  wherein the pharmaceutically acceptable carrier is present in the form of capsules, cachets, tablets, boluses or lozenges.  
     
     
         63 . The composition of matter of  claim 57  wherein the effective amount is between about 10 mg per day and 10,000 mg per day.  
     
     
         64 . A method of preventing or treating a viral and/or a bacterial infection in a mammal comprising administering a therapeutically effective amount of a compound selected from the group consisting of: punicic acid, esters thereof, pharmaceutically suitable salts thereof, metabolites thereof, and combinations thereof, the compound administered in a single dose or a multiple dose to the mammal.  
     
     
         65 . The method of  claim 64 , wherein the preventing or treating a viral and/or a bacterial infection comprises increasing immune function in the mammal.  
     
     
         66 . A composition of matter for preventing or treating a viral and/or a bacterial infection, the composition comprising an amount of punicic acid in combination with a pharmaceutically-acceptable carrier, wherein the amount of punicic acid is effective to treat the viral and/or bacterial infection in an animal.  
     
     
         67 . A composition of matter for preventing or ameliorating an intestinal immunoinflammatory disorder, the composition comprising an amount of punicic acid in combination with a pharmaceutically-acceptable carrier, wherein the amount of punicic acid is effective to treat the intestinal immunoinflammatory disorder.  
     
     
         68 . The composition of matter of  claim 67 , wherein the intestinal disorder is selected from the group consisting of irritable bowel syndrome, Crohn's disease and ulcerative colitis.  
     
     
         69 . A composition of matter for increasing immune system development, the composition comprising an amount of punicic acid in combination with a pharmaceutically-acceptable carrier, wherein the amount of punicic acid is effective to increase immune system development.  
     
     
         70 . The composition of matter of  claim 69 , wherein the composition is in the form of a food supplement, a pharmaceutical composition or a food composition.  
     
     
         71 . The composition of matter of  claim 69 , wherein the composition is a pharmaceutical composition in the form of a tablet, capsule, solution or emulsion.  
     
     
         72 . The composition of matter of  claim 69 , wherein the composition is a foodstuff selected from the group consisting of margarines, fat continuous or water continuous or bicontinuous spreads, fat reduced spreads, confectionery products such as chocolate or chocolate coatings or chocolate fillings or bakery fillings, ice creams, ice cream coatings, ice cream inclusions, dressings, mayonnaises, cheeses, cream alternatives, dry soups, drinks, cereal bars, sauces, snack bars, dairy products, clinical nutrition products and infant formulations.  
     
     
         73 . The composition of matter of  claim 69 , wherein the composition is a food supplement in the form of a soft gel or a hard capsule comprising an encapsulating material selected from the group consisting of gelatin, starch, modified starch, starch derivatives such as glucose, sucrose, lactose and fructose.