Chitosan is a natural product that is produced commercially through the deacetylation of chitin, which is found in the exoskeleton of crustaceans. It has been suggested that chitosan has a lipid-lowering effect by binding to fatty acids and cholesterol in the gastrointestinal tract and restricting their absorption.~This study was designed to determine if HEP-40 chitosan (Enzymatic Polychitosamine Hydrolysate - 40kDa), a short-chained chitosan with a molecular weight of 40 kDa, is safe and effective in lowering LDL-cholesterol levels in patients who have not been previously treated with lipid-lowering agents and who have cholesterol levels that are mild to moderately above the levels recommended by the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guidelines.~This is a multi-centre, randomized, double-blind, placebo-controlled study. Following a 4-week Pre-Randomization Phase where patients will be instructed to maintain a stable diet, patients will be randomized to one of the following study groups for a 12-week Active Treatment Phase:~HEP-40 400 mg three times a day (400 mg TID)~HEP-40 800 mg twice a day (800 mg BID)~HEP-40 800 mg three times a day (800 mg TID)~HEP-40 2400 mg once a day (2400 mg QD)~Placebo, three times a day (placebo)~The primary objective is to evaluate the clinical benefit of administering HEP-40 chitosan at different doses and at different dosing regimens compared with placebo. Clinical benefit will be defined as the reduction in LDL-cholesterol after 4 weeks of active treatment.
Chitosan is a natural product that is produced commercially through the deacetylation of chitin, which is found in the exoskeleton of crustaceans. It has been suggested that chitosan has a lipid-lowering effect.~This study was designed to determine if HEP-40 chitosan (Enzymatic Polychitosamine Hydrolysate - 40kDa), a short-chained chitosan with a molecular weight of 40 kDa, is safe and effective in lowering LDL-cholesterol levels in patients with mild to moderately elevated cholesterol levels and who have not been previously treated with other lipid-lowering agents.