Assessment of body weight, blood pressure, quality of life, cholesterol levels, and serum vitamin 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.