Overweight and Obesity
Conditions
Keywords
obesity,, body weight,, overweight,, weight loss,, polyglucosamine,, L112, caloric restriction, physical activity
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.
Interventions
ß-1,4 polymer of D-glucosamine and N-acetyl-D-glucosamine from the shells of crustaceans
Placebo tablet
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Change of body weight in kg | 24 weeks |
| Change of BMI | 24 weeks |
| Reduction of waist circumference | 24 weeks |
Countries
Germany, Italy