Clinical Study July 2006, Proactol Fat Binder Clinical Data

Efficiency of patented fibre complex from Opuntia ficus indica on blood lipids parameters considered as risk factors for Metabolic Syndrome (Syndrome X)

Purpose:
The clinical study was aimed at evaluating the efficiency of the patented fibre complex from Opuntia ficus indica on blood lipid parameters.

Sixty-eight females with Metabolic Syndrome (Syndrome X) and a BMI (Body Mass Index) between 25 and 40 participated in this mono-centric randomised, placebo-controlled, parallel double-blind study.

Methods:
During 6 weeks, half of the females consumed 1.6g of patented fibre complex from Opuntia ficus indica per meal and the other half consumed a placebo. The entire group followed a well-balanced diet with a controlled lipid input. The placebo and patented fibre complex from Opuntia ficus indica were given in the form of capsules.

The efficiency of the tested product was evaluated, on day 14 and on day 42 of the study. Several lipid parameters were measured: changes in LDL cholesterol, HDL cholesterol, serum triglycerides, and at the end of the study, the participants were re-evaluated for metabolic syndrome.

Results:
On and after the 14th day of the study, patented fibre complex from Opuntia ficus indica showed a decrease in LDL cholesterol levels by 10%, compared to a 3% decrease in the placebo group. The HDL cholesterol levels in the group, which consumed patented fibre complex from Opuntia ficus indica, showed an upward significant trend throughout the course of the study, where else the placebo group showed a downward trend. Overall, patented fibre complex from Opuntia ficus indica showed a beneficial effect on good cholesterol, which is generally associated with a reduced cardiovascular risk.

During the first 14 days of the study, the number of volunteers with Metabolic Syndrome decreases in both groups. However, after 42 days of treatment, 39% of the volunteers from the patented fibre complex from Opuntia ficus indica group were diagnosed to be free from Metabolic Syndrome, in comparison to 8% in the placebo group.

On a receptive population, near than 60% of women who consumed patented fibre complex from Opuntia ficus indica were diagnosed to be free of Metabolic Syndrome.

No particular side effects were observed when taking patented fibre complex from Opuntia ficus indica.

Conclusion:
These results suggest patented fibre complex from Opuntia ficus indica could regulate blood lipid levels and thus participate in reducing cardiovascular risk. Therefore, patented fibre complex from Opuntia ficus indica is efficient in applications related to cardiovascular risks prevention, when associated with overweight problems.