Efficacy of Polyglucosamine for Weight Loss

Sponsor

Certmedica International GmbH (Industry)

Overall Status

Completed

CT.gov ID

NCT02410785

Collaborator

(none)

115

Enrollment

Locations

Arms

Duration (Months)

57.5

Patients Per Site

4.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity	Device: Polyglucosamine Other: Placebo	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

115 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2009

Actual Primary Completion Date :

Oct 1, 2009

Actual Study Completion Date :

Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Medical device 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.	Device: Polyglucosamine ß-1,4 polymer of D-glucosamine and N-acetyl-D-glucosamine from the shells of crustaceans
Placebo Comparator: 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.	Other: Placebo Placebo tablet

Arm

Intervention/Treatment

Active Comparator: Medical device 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.

Device: Polyglucosamine

ß-1,4 polymer of D-glucosamine and N-acetyl-D-glucosamine from the shells of crustaceans

Placebo Comparator: 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.

Other: Placebo

Placebo tablet

Outcome Measures

Primary Outcome Measures

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

Change of body weight in kg [24 weeks]
Change of BMI [24 weeks]
Reduction of waist circumference [24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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