Pilot Clinical Study, Proactol Fat Binder Clinical Data

Summary Of Pilot Clinical Study Of Patented Fibre Complex Of Opuntia Ficus Indica On Fat Binding

Purpose:
This clinical study was aimed at observing the effects of patented fibre complex from Opuntia ficus indica on fat binding.

Ten healthy volunteers (5 women and 5 men with a Body Mass Index of 23.3 kg/m2; standard deviations 3.1) participated in a mono-centric double-blind placebo-controlled crossover study.

Methods:
The test participants were randomly divided into two groups, one receiving the test material (patented fibre complex of Opuntia ficus indica) and one receiving placebo. All the volunteers consumed 1.6g of test material per meal in the form of capsule; during one week and placebo during the same time with a washout period between these two test periods.

A strict diet with standardised meals was followed by the volunteers to ensure a standardised intake of lipids. The effect of the product dose in intestinal absorption was evaluated by measuring steatorrhea in 3-day-old faeces, at the end of the two 7-day product consumption periods.

Results:
The quantity of fat content excreted compared to the quantity ingested increased on average by 27.4% in-group volunteers with the dose of test material compared with the placebo. No side effects or particular discomfort were observed with the dose of test material.

The results indicate the patented fibre complex from Opuntia ficus indica affects the assimilation of fat following a heavy meal and causes an increase in elimination of fat in faeces in subjects having a normal BMI (Body Mass Index).

Conclusion:
These results suggest effectiveness for an application of patented fibre complex from Opuntia ficus indica within the framework of meals rich in fat content.