AUTHOR:
GIROLA M.*, DE BERNARDI M.**, CONTOS S.**, TRIPODI S.**, VENTURA P.*, GUARINO C.***, MARLETTA M.****
*III Divisione Medica Ospedale di Bergamo **Cattedra di Tossicologia II, Istituto di Farmacologia -Universita' di Pavia ***Ministero della Sanita -Direzione Sanita Marittima -Roma Civitavecchia ****Divisione II Ministero Sanita -Direzione Generale Ospedali Roma
PUBLISHED:
Act* Toxicol. Ther., Vol, XVII, n. 1, 1996
Summary: The trial was conducted to determine the dose effect in lipid lowering activity of a new dietary integrator (capsules containing chitosan 240 mg, Garcinia cambogia extract 55 mg and chrome 19 mg) in a weight-reducing program of 150 obese subjects. The study was a. randomized, double-blind, placebo controlled trial, in which the subjects were treated with (1) a hypocaloric diet plus 2 capsules/day of placebo (50 subjects), (2) a hypocaloric diet plus I capsule of dietary integrator plus 1 capsule of placebo (50 subjects), or (3) a hypocaloric diet plus 2 capsules/day of dietary integrator (50 subjects), for 4 weeks.
The study showed in all testing groups a statistically significant, dietary integrator dose-related, reduction in overweight, in total and LDL cholesterol, in triglycerides and an augmentation of HDL cholesterol.
In the placebo group, overweight reduction was 4.3%, total cholesterol reduction was 10.7%, LDL cholesterol reduction was 15.2%, triglycerides reduction was 13.2%, and HDL cholesterol augmentation was 6.3%.
In the group treated with I cps of dietary integrator overweight reduction was 7.9%, total cholesterol reduction was 19.8%, LDL cholesterol reduction was 22.9%, triglycerides reduction was 18.3%, HDL cholesterol augmentation was 9.0%,
In the group treated with 2 cps of dietary integrator overweight reduction was 12.5%, total cholesterol reduction was 28.7%, LDL cholesterol reduction was 35, 1%, triglycerides reduction was 26.6%, HDL cholesterol augmentation was 14.1%.
Adverse events were reported in 6.4% of the placebo-treated subjects (nausea and/or constipation), in 6.1% of subjects in the group treated with I cps/day of integrator (nausea), and in 2. 1 % of subjects in the group treated with 2 cps/day of integrator (headache) without any statistic-ally significant difference between the three groups.
No pathologic or clinically significant change in blood chemistry or haematological assay was observed.
The data obtained in our study suggest that diet plus the new dietary integrator containing chitosan, Garcinia cambogia extract and chrome is a very useful antilipemic treatment in obese subjects and that the lipid-lowering effect of dietary fiber is dose-related.
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