Evaluating efficacy of a chitosan product using a double-blinded, placebo-controlled protocol.

OBJECTIVE

To examine the safety and efficacy of a chitosan dietary supplement on body composition under free-living conditions.

DESIGN

In a randomized, double-blinded, placebo-controlled dietary intervention protocol, subjects were assigned to a treatment group (TRT), a placebo group (PLA) and a control group (CTL).

SUBJECTS

A total of 150 overweight adults enrolled; 134 (89.3%) completed the study; 111 (82.8%) were women who were similarly distributed in the three groups.

INTERVENTION

The TRT group took six 500 mg chitosan capsules per day and both TRT and PLA groups wore pedometers during their waking hours and recorded daily step totals. The CTL group followed weight loss programs of their choice, and took the same baseline and ending tests.

MEASURES OF OUTCOME

Outcome measures were Dual Energy X-ray Absorptiometry tests, fasting blood chemistries, and self-reported daily activity levels and caloric intakes.

RESULTS

Compared to CTL, the TRT group lost more weight (-2.8 lbs vs. +0.8 lbs, p < 0.001) and fat mass (-2.6 lbs vs. +0.1 lbs, p = 0.006). Compared to PLA, the TRT group lost more weight (-2.8 lbs. vs. -0.6 lbs, p = 0.03), % fat (-0.8% vs. +0.4%, p = 0.003), fat mass (-2.6 lbs vs. +0.6 lbs, p = 0.001) and had a greater body composition improvement index (BCI) (+2.4 lbs vs. -1.9 lbs, p = 0.002).

CONCLUSIONS

These data provide evidence for the efficacy of a chitosan compound to facilitate the depletion of excess body fat under free-living conditions with minimal loss of fat-free or lean body mass.