Efficacy of Polyglucosamine for Weight Loss

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Device: Polyglucosamine
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Medical device polyglucosamine<br>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<br>* ß-1,4 polymer of D-glucosamine and N-acetyl-D-glucosamine from the shells of crustaceans<br>|
| Placebo Comparator: Placebo<br>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<br>* Placebo tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of body weight in kg |  | 24 weeks | 
| Change of BMI |  | 24 weeks | 
| Reduction of waist circumference |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity,, body weight,, overweight,, weight loss,, polyglucosamine,, L112, caloric restriction, physical activity