An interventional study of polygucosamine and placebo in Obesity, sponsored by Certmedica International GmbH. Completed at 1 site in Italy. Open to participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-25.
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 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.
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.
6,578 studies on the registry are indexed under Obesity; 1,718 are open to participants now.
This study's enrollment of 100 is above the median of 77 across 5,084 interventional studies indexed under Obesity.
Browse Obesity studies →Certmedica International GmbH is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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
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
2 times daily 2 polyglucosamine tablets with the two main meals with 10 % reduction of caloric intake with no increase of physical activity.
Also known as: ß-1,4 polymer of D-glucosamine and N-acetyl-D-glucosamine
2 times daily 2 placebo tablets with the two main meals with 10 % reduction of caloric intake with no increase of physical activity.
Number of participants who could reduce their body weight by 10 or more per cent compared to the initial body weight.
Time frame: 12 months
Change of body weight in kg
Time frame: 12 months
Change of BMI
Time frame: 12 monts
Reduction of waist circumference
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2014 to primary completion in Oct 2016, 29 months.
Of 98 industry-sponsored interventional studies with no phase under Obesity, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 29. This study's 29 months is above that.
Counting every sponsor, half of 2,351 studies reached it within 26 months; a quarter within 11 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Certmedica International GmbH