Efficacy of Polyglucosamine Long Term Treatment

Obesity Clinical Trial

Official title: Efficacy of Polyglucosamine for Weight Loss - in a Randomized, Double-blind, Placebo-controlled Clinical Investigation

Status Completed

Clinical Trial Summary

The polyglucosamine, specification L112, is a medical device and in this clinical trial used for weight reduction in moderately obese participants following a long term treatment lasting 12 months. The rationale for this study is to show that overweight can be reduced by taking 2 times daily 2 tablets with the main meals.

Clinical Trial Description

Two groups of subjects were compared. A comparable diet condition, consisting of 10 % reduction of caloric intake was followed, according to a questionnaire based on the weekly number of servings. No modification of physical activity was requested.

One group had to take the polyglucosamine tablets and the other group placebo tablets for at least 12 months. It is known, that polyglucosamine is a fat binder acting in a physical-chemical manner, the positive charged fiber is bound to the negative charged dietary fat and this complex is unable to pass the gut wall into the body but is naturally excreted,hence this energy is not available. Therefore, this medical device should show a measurable reduction in body weight. ;

Related Conditions & MeSH terms

• Obesity

• NCT number: NCT02682277
• Study type: Interventional
• Source: Certmedica International GmbH
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Completion date: October 31, 2016