Efficacy of Polyglucosamine Long Term Treatment

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 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
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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.

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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Obesity

Intervention / Treatment
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* Device: polygucosamine
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 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 polyglucosamine tablets with the two main meals with 10 % reduction of caloric intake with no increase of physical activity | Device: polygucosamine<br>* 2 times daily 2 polyglucosamine tablets with the two main meals with 10 % reduction of caloric intake with no increase of physical activity.<br>* Other names: ß-1,4 polymer of D-glucosamine and N-acetyl-D-glucosamine;|
| Placebo Comparator: Placebo<br>2 times daily 2 placebo tablets with the two main meals with 10 % reduction of caloric intake with no increase of physical activity | Other: placebo<br>* 2 times daily 2 placebo tablets with the two main meals with 10 % reduction of caloric intake with no increase of physical activity.<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 10 or more per cent compared to the initial body weight. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of body weight in kg |  | 12 months | 
| Change of BMI |  | 12 monts | 
| Reduction of waist circumference |  | 12 months | 

 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