Efficacy of Polyglucosamine Long Term Treatment

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Other: placebo; Device: polygucosamine

• Registration Number: NCT02682277
• Lead Sponsor: Certmedica International GmbH

Brief 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.

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2016-02-10
• Study First Submitted QC: 2016-02-10
• Study First Posted: 2016-02-15
• Primary Completion: 2016-10
• Study Completion: 2016-10-31
• Status Verified: 2017-02
• Last Update Submitted: 2017-07-21
• Last Update Posted: 2017-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• BMI >30 and < 35
• 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
• known hypersensitivity reactions to crustaceans

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	2 times daily 2 placebo tablets with the two main meals with 10 % reduction of caloric intake with no increase of physical activity
Medical device polyglucosamine	polygucosamine	2 times daily 2 polyglucosamine tablets with the two main meals with 10 % reduction of caloric intake with no increase of physical activity

Primary Outcome Measures

Name	Time	Method
Number of participants who could reduce their body weight by 10 or more per cent compared to the initial body weight.	12 months

Secondary Outcome Measures

Name	Time	Method
Change of body weight in kg	12 months
Change of BMI	12 monts
Reduction of waist circumference	12 months

Trial Locations

Locations (1)

MAP Center; 🇮🇹 Rende, Cosenza, Italy