Randomized, double-blind trial of chitosan for body weight reduction

Background: Overweight and obesity is a prevalent and costly threat to publ ic health. Compelling evidence links overweight and obesity with serious di sorders such as cardiovascular diseases and diabetes. Dietary regimen are n otoriously burdened with poor compliance. Chitosan is promoted in the US an d other countries as an oral remedy to reduce fat absorption and has now be en incorporated as a major constituent into several over-the-counter remedi es. The primary aim of this study is to investigate the clinical effectiven ess of oral chitosan for body weight reduction. Methods: Thirty-four overweight volunteers were included in a randomized pl acebo-controlled double-blind trial. Subjects were assigned to receive eith er four capsules of chitosan or indistinguishable placebo twice daily for 2 8 consecutive days. Measurements were taken at baseline, after 14 and 28 d of treatment. Subjects maintained their normal diet and documented the type and amount of food consumed. Adverse effects were assessed and compliance monitored. Results: Data from 30 subjects were entered into an intention-to-treat anal ysis. After four weeks of treatment, body mass index, serum cholesterol, tr iglycerides, vitamin A, D, E and beta-carotene were not significantly diffe rent in subjects receiving chitosan compared to those receiving placebo. Vi tamin K was significantly increased after four weeks in the chitosan group compared with placebo (P<0.05). Compliance was 91.5% and 96.0% for chitosan and placebo groups respectively. Conclusion: The above data suggest that chitosan in the administered dosage , without dietary alterations, does not reduce body weight in overweight su bjects. No serious adverse effects were reported.