Bioactive-rich concentrates and nutritive and therapeutic products containing same

Abstract

This invention relates generally to the field of compositions for use as nutraceuticals, food additives or adjuncts to conventional drug therapies. In particular, the invention relates to compositions derived from natural oil sources which can be used for effective and inexpensive treatment of cardiovascular diseases, hypercholesterolemia, diabetes, cerebrovascular disease, neurological disorders, or liver abnormalities.

1 . A bioactive-rich concentrate derived from the unsaponifiable fraction of an oil of rice bran or rice germ, consisting essentially of the unsaponifiable content of said oil, substantially free of rice bran contaminants; the unsaponifiable content being present in said concentrate at a concentration 10 to 100 times greater than in rice bran oil or rice germ oil. 
     
     
         2 . The concentrate of  claim 1 , wherein the unsaponifiable contents comprises a 4-dimethyl sterol component, a 4-monomethyl sterol component, a γ-oryzanol component, a polyphenol component, a tocopherol component, and a tocotrienol component. 
     
     
         3 . The concentrate of  claim 2 , wherein the amount of 4-dimethyl sterol component is 10-30%, the amount of 4-monomethyl sterol component is 4-14%, the amount of γ-oryzanol component is 20-40%, the amount of polyphenol component is 5-15%, the amount of tocopherol component is 5-20%, and the amount of tocotrienol component is 5-20%; by weight; based on total weight of the concentrate. 
     
     
         4 . A composition comprising a bioactive-rich bioactive concentrate of  claim 1  in combination with at least one of: a cholesterol lowering drug, herbs, and/or an HMG CoA reductase inhibitor. 
     
     
         5 - 7 . (canceled) 
     
     
         8 . The composition of  claim 4 , wherein the HMG CoA reductase inhibitor is selected from the group consisting of mevastatin, lovastatin, pravastatin, simvastatin, fluvastatin, cerivastatin, atorvastatin, tenivastatin, rosuvastatin, pitavastatin and combinations thereof. 
     
     
         9 . The composition of  claim 4 , further comprising one or more pharmaceutically acceptable excipients. 
     
     
         10 . (canceled) 
     
     
         11 . The composition of  claim 4 , wherein the composition is intended for oral administration. 
     
     
         12 . The composition of  claim 11 , wherein the composition is in a form selected from the group consisting of tablets, capsules, liquids, suspensions, solutions, and emulsions. 
     
     
         13 . The composition of  claim 4 , wherein the cholesterol lowering drug is a bile acid sequestrant or a fibric acid derivative. 
     
     
         14 . The composition of  claim 13 , wherein the bile acid sequestrant is selected from the group consisting of cholestyramine, colesevelam and colestipol. 
     
     
         15 . The composition of  claim 13 , wherein the fibric acid derivative is selected from the group consisting of fenofibrate and gemfibrozil. 
     
     
         16 . A method of treating a patient in need of lowering serum lipids, cholesterol, blood glucose and/or triglycerides, comprising administering to the patient the bioactive-rich concentrate of  claim 1  in a dosage regime effective to lower the patient's serum lipid level. 
     
     
         17 . A method of treating a patient in need of lowering serum lipids, cholesterol, blood glucose and/or triglycerides, comprising administering to the patient the combination product of  claim 4  in dosage regime effective to lower the patient's serum lipid level. 
     
     
         18 . A method of treating a patient in need of increasing HDL-C levels, comprising administering to the patient the combination product of  claim 4  in a dosage regime sufficient to increase the patient's HDL-C level. 
     
     
         19 . The method of  claim 17 , wherein the components of the combination therapy are simultaneously administered. 
     
     
         20 - 21 . (canceled) 
     
     
         22 . A method of treating a patient in need of treatment for hypertension, hyperlipidemia, obesity, inflammatory disease, arthritis, hypercholesterolemia, cardiovascular disease, cerebrovascular disease, arteriosclerosis, diabetes mellitus, immune dysfunction or cancer, neurological disorders, or liver abnormalities comprising administering to the patient the bioactive-rich concentrate of  claim 1 , in a dosage regime effective to treat the patient. 
     
     
         23 . A method of treating a patient in need of treatment for total serum cholesterol, LDL-C, apolipoprotein B, triglycerides, improving HDL-C levels, inhibiting platelet aggregation and dissolving aortic streaks, comprising administering to the patient the bioactive-rich concentrate of  claim 1 , in a dosage regime effective to treat the patient. 
     
     
         24 . A food product comprising the bioactive-rich concentrate of  claim 1  and a food substance. 
     
     
         25 - 27 . (canceled) 
     
     
         28 . The food product of  claim 22 , which contains from about 0.1% to 15% of the bioactiverich concentrate. 
     
     
         29 . The bioactive-rich concentrate of  claim 1 , wherein said bioactive-rich concentrate is in its natural matrix. 
     
     
         30 - 31 . (canceled)