NCT02410785

Efficacy of Polyglucosamine for Weight Loss

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Certmedica International GmbH · Industry
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The polyglucosamine, specification L112 is a medical device and in this clinical trial used for weight reduction of overweight and obese participants. The rationale for this study is to show that overweight can be reduced by taking 2 times daily 2 tablets with the main meals with the highest fat content.

Detailed description

To have a comparable diet condition, all participants in both groups had to follow the recommendations of the German clinical practice guidelines on the management and prevention of obesity. One group had to take the polyglucosamine tablets and the other group placebo tablets for at least 24 weeks. 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 in 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.

Conditions

• Overweight and Obesity

Interventions

Type	Name	Description
DEVICE	Polyglucosamine	ß-1,4 polymer of D-glucosamine and N-acetyl-D-glucosamine from the shells of crustaceans
OTHER	Placebo	Placebo tablet

Timeline

• Start date: 2009-08-01
• Primary completion: 2009-10-01
• Completion: 2010-10-01
• First posted: 2015-04-08
• Last updated: 2016-01-28

Locations

2 sites across 2 countries: Germany, Italy