BEFORE Study, Efficacy of Refigura

Overweight and Obesity Clinical Trial

Official title: BEFORE-Study for the Evaluation of Safety and Efficacy of Polyglucosamin and Glucomannan Combination.

Status Completed

Clinical Trial Summary

The BEFORE study ((B) EFficacy Of REfigura) is designed to demonstrate the efficacy of REFIGURA®. It is a double-blind, randomized, monocentric study.

Clinical Trial Description

Core data from the BEFORE study:

Sponsor: Heilpflanzenwohl AG Product: REFIGURA® Title: BEFORE study: Demonstrating the efficacy of REFIGURA® through a double-blind, three-arm, randomized, monocentric study Study duration: 8 weeks (56 days) Study location: MIT Gesundheit GmbH, Stechbahn 20-22, 47533 Kleve CRO: MIT Health GmbH, Stechbahn 20-22, 47533 Kleve Number of study participants: 165 (55 patients per treatment arm)

Summary:

REFIGURA® (manufactured by KITOZYME, Parc Industriel des Hauts-Sarts, Zone 2, Rue de Milmort, 680, BE-4040 Herstal, Belgium, Distribution: Heilpflanzenwohlkraft GmbH), is an approved medical device containing a combination of chitosan (a polyglucosamine ) and glucomannan. Chitosan is a vegetable fiber that binds fats in the intestinal lumen. Both substances are already approved and show few side effects. They are not absorbed into the body, but work directly in the intestine.

The investigational medicinal products are used to treat obesity (weight loss) and to control weight. The effect is based on a reduction in caloric intake, by increasing the feeling of satiety and at the same time the appetite is reduced. As a result, the amount of food consumed is reduced and excessive food (cravings attacks) is prevented. It also reduces the intake of dietary fats.

The study compares three treatment arms:

1. placebo

2. Verum (in the normal, approved dose)

3. Verum (in the double dose)

The patients are weighed, their body fat content is measured and the body size is measured. All measurement methods are non-invasive. ;

Related Conditions & MeSH terms

• Efficacy, Self
• Overweight
• Overweight and Obesity
• Weight Loss

• NCT number: NCT03557424
• Study type: Interventional
• Source: Heilpflanzenwohl AG
• Status: Completed
• Phase: Phase 4
• Start date: April 26, 2017
• Completion date: April 16, 2018