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 randomized 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.