An interventional study of orlistat 60 mg and polyglucosamine in Overweight and Obesity, sponsored by Certmedica International GmbH. Completed at 2 sites in 2 countries. Open to participants aged 21 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-08-20.
Sponsored by Certmedica International GmbH · Not applicable, Interventional, and Prevention
This trial compares two treatment methods:
Exclusion Criteria:
A tailored blister-strip for one day contains * three capsules with orlistat 60mg Administration: 3 times daily 1 capsule with each meal containing fat concomitant with * six placebo tablets Administration: 3 times daily 2 tablets with each main meal
Drug: orlistat 60 mg
A tailored blister-strip for one day contains * three placebo capsules Administration: 3 times daily 1 capsule with each meal containing fat concomitant with * six tablets Administration: 3 times daily 2 tablets (whereas the 2 tablets in the mold "breakfast" are placebo tablets and the remaining 4 tablets for lunch and dinner contains poliglucosamine
Device: polyglucosamine
In order to have comparable calorie intakes, all participants followed the recommendations of the German clinical practice guidelines on the management and prevention of obesity. Due to the different appearance of tablets and capsules, a double dummy design was chosen, a blister strip for each day and each participant had to take the same amount of capsules and tablets per day. The content of the blister strips: three orlistat 60 g capsules plus six placebo tablets.
In order to have comparable calorie intakes, all participants followed the recommendations of the German clinical practice guidelines on the management and prevention of obesity. Due to the different appearance of tablets and capsules, a double dummy design was chosen, a blister strip for each day and each participant had to take the same amount of capsules and tablets per day. The content of the blister strips: three blue placebo capsules plus two placebo tablets (morning) and four polyglucosamine tablets (noon and evening).
Number of participants in both groups with a weight reduction of >= 5 per cent compared to the initial weight.
Time frame: 12 weeks
BMI reduction
Achieved change of the BMI (cm/m²) of all participants in each group compared to the initial average BMI
Time frame: 12 weeks
Waist circumference reduction
Achieved change of the waist circumference of all participants in each group compared to the initial average WC
Time frame: 12 weeks
This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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Certmedica International GmbH