NCT02682277

Efficacy of Polyglucosamine Long Term Treatment

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Certmedica International GmbH · Industry
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Obesity

Interventions

Type	Name	Description
DEVICE	polygucosamine	2 times daily 2 polyglucosamine tablets with the two main meals with 10 % reduction of caloric intake with no increase of physical activity.
OTHER	placebo	2 times daily 2 placebo tablets with the two main meals with 10 % reduction of caloric intake with no increase of physical activity.

Timeline

• Start date: 2014-05-01
• Primary completion: 2016-10-01
• Completion: 2016-10-31
• First posted: 2016-02-15
• Last updated: 2017-07-25

Locations

1 site across 1 country: Italy