Summary: The trial was conducted to evaluate the efficacy and tolerabi-lity of a new chitosan dietary fiber (a mixture of chitosan, Guars meal, ascorbic acid and others micronutrients) associated with low caloric diet in a weight-reducing program of 86 obese subjects. In the randomized, double-blind, placebo controlled trial, subjects were treated with hypoca-loric diet plus 4 tablets/day of chitosan dietary fiber or with hypocaloric diet plus 4 tablets/day of placebo for 4 weeks. At the end of the study a statistically significant reduction in body weight, overweight, total and LDL cholesterol, and triglycerides in both the groups and an increase of HDL cholesterol in the group treated with diet+chitosan were observed, but in diet+chitosan group the variations were statistically greater than in diet+placebo group.

In order to verify the possible interference of chitosan with intestinal absorption of mineral salts or fat-soluble vitamins we determined blood concentration of sodium, potassium, calcium, magnesium, zinc, iron, copper, and vitamins A, D and E. No significant changes were noted in blood concentrations of these substances after the treatment and there was no difference between the two treatment groups. Mild and transient adverse effects were reported in 5% of the chitosan--treated subjects (flatulence) and in 18.4% of subjects in the placebo group (nausea and/or constipation), without any statistically significant diffe-rence between the two groups. Our findings suggest that diet plus the new chitosan dietary fiber is a very useful treatment of the overweight in obese subjects and that the weight loss is associated with an evident reduction in hyperlipidemia without any significant interference on intestinal absorption of mineral salts or fat-soluble vitamins.

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