Efficacy of Polyglucosamine for Weight Loss

Not Applicable

Completed

• Conditions: Overweight and Obesity
• Interventions: Other: Placebo; Device: Polyglucosamine

• Registration Number: NCT02410785
• Lead Sponsor: Certmedica International GmbH

Brief 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.

Study Timeline

• Study Start: 2009-08
• Primary Completion: 2009-10
• Study Completion: 2010-10
• Status Verified: 2015-03
• Study First Submitted: 2015-03-27
• Study First Submitted QC: 2015-04-02
• Study First Posted: 2015-04-08
• Last Update Submitted: 2016-01-26
• Last Update Posted: 2016-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

Inclusion Criteria

• BMI > 26 and < 45
• waist circumference of more than 88 cm for women and greater than 102 for men.

Exclusion Criteria

• pregnancy or breast-feeding, alcohol abuse, drug abuse or drug addiction, inability to fulfill the criteria of the trial protocol, cancer diseases, malignant tumors, pre-existence of chronic intestinal disease and known hypersensitivity reactions to crustaceans

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	2 times daily 2 tablets with the two main meals with the highest fat content. Participants follow the German guideline with a hypo-caloric (-500 kcal daily) lifestyle and increased physical activity.
Medical device polyglucosamine	Polyglucosamine	2 times daily 2 tablets with the two main meals with the highest fat content. Participants follow the German guideline with a hypo-caloric (-500 kcal daily) lifestyle and increased physical activity.

Primary Outcome Measures

Name	Time	Method
Number of participants who could reduce their body weight by 5 or more per cent compared to the initial body weight.	24 weeks

Secondary Outcome Measures

Name	Time	Method
Reduction of waist circumference	24 weeks
Change of body weight in kg	24 weeks
Change of BMI	24 weeks

Trial Locations

Locations (2)

Salztal Klinik GmbH; 🇩🇪 Bad Soden-Salmünster, Hessia, Germany

MAP Center; 🇮🇹 Rende, Cosenza, Italy