H Bokura1, S Kobayashi. 1. Department of Internal Medicine III, Shimane Medical University, Shimane, Japan. bokura@shimane-med.ar.jp
Abstract
BACKGROUND:Hypercholesterolemia is an important risk factor for cardiovascular disease. Orally administered chitosan binds lipids in the small intestine and reduces their absorption. Chitosan has been shown to decrease serum cholesterol in animal and human studies. This study investigated the effectiveness of chitosan in reducing serum cholesterol without concomitant diet therapy. METHODS:Ninety female volunteers (age 34-70 y) with confirmed mild to moderate hypercholesterolemia were enrolled into the study. They were randomly assigned to receive chitosan (1.2 g per day) or placebo in a double-blind manner. Serum lipids, body weight and adverse events were assessed at baseline and after 28 and 56 days of treatment. Subjects maintained their usual diet and documented the type and gross amount of food consumed. RESULTS:Eighty-four subjects (41 chitosan, 43placebo) were included in the analysis. Chitosan significantly (F=3.19, P=0.04) reduced total cholesterol compared to placebo. In a subgroup of subjects with over 60 y of age, chitosan group significantly reduced total and LDL cholesterol (F=4.21, P=0.02, and F=3.46, P=0.04, respectively) compared with placebo. Adverse effects were few; no serious events were reported. CONCLUSION: Our results demonstrate that chitosan is safe and effective for lowering cholesterol. However, the effect of chitosan for decreasing cholesterol is mild.
RCT Entities:
BACKGROUND:Hypercholesterolemia is an important risk factor for cardiovascular disease. Orally administered chitosan binds lipids in the small intestine and reduces their absorption. Chitosan has been shown to decrease serum cholesterol in animal and human studies. This study investigated the effectiveness of chitosan in reducing serum cholesterol without concomitant diet therapy. METHODS: Ninety female volunteers (age 34-70 y) with confirmed mild to moderate hypercholesterolemia were enrolled into the study. They were randomly assigned to receive chitosan (1.2 g per day) or placebo in a double-blind manner. Serum lipids, body weight and adverse events were assessed at baseline and after 28 and 56 days of treatment. Subjects maintained their usual diet and documented the type and gross amount of food consumed. RESULTS: Eighty-four subjects (41 chitosan, 43 placebo) were included in the analysis. Chitosan significantly (F=3.19, P=0.04) reduced total cholesterol compared to placebo. In a subgroup of subjects with over 60 y of age, chitosan group significantly reduced total and LDL cholesterol (F=4.21, P=0.02, and F=3.46, P=0.04, respectively) compared with placebo. Adverse effects were few; no serious events were reported. CONCLUSION: Our results demonstrate that chitosan is safe and effective for lowering cholesterol. However, the effect of chitosan for decreasing cholesterol is mild.