An interventional study of Polyglucosamine and Placebo in Overweight and Obesity, sponsored by Certmedica International GmbH. Completed at 2 sites in 2 countries. Open to participants aged 21 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-01-28.
Sponsored by Certmedica International GmbH · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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
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
ß-1,4 polymer of D-glucosamine and N-acetyl-D-glucosamine from the shells of crustaceans
Placebo tablet
Number of participants who could reduce their body weight by 5 or more per cent compared to the initial body weight.
Time frame: 24 weeks
Change of body weight in kg
Time frame: 24 weeks
Change of BMI
Time frame: 24 weeks
Reduction of waist circumference
Time frame: 24 weeks
Plan to share: No
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Certmedica International GmbH