Clinical studies.
Weight loss. In a randomized, double-blind, placebo- controlled trial in 34 volunteers, Pittler et al.assessed chitosan for weight reduction in the absence of other dietary alterations.
Participants ranged from 18 to 60 years of age, and body mass indices (BMIs) ranged from 23.9 to 29.9 kg/m.
The subjects were ran- domized to receive either four 250-mg chitosan capsules or four placebo cap- sules twice daily for 28 days.
Assessment of body weight, blood pressure, quality of life, cholesterol levels, and serum vita- min levels occurred at baseline, 14 days, and 28 days.
Four participants withdrew from the trial (reasons not given), so the calculated statistical power of 80% was not met. The researchers found no signif- icant differences between groups in any outcome measures except serum vitamin K concentration, which was higher (0.56 ng/mL versus 0.33 ng/mL) in the chitosan group. No serious adverse effects were reported for either group. A poststudy analysis of the chitosan preparation used showed that the capsules contained only 42% of the labeled amount of chitosan.