This trial compares two treatment methods: 1. Orlistat 60 mg to be taken three times daily one capsule; indicated for weight loss in overweight adults. Important is also that it is taken along with a reduced-calorie and low-fat diet. 2. Polyglucosamine tablets to be taken two times daily two tablets, taken with the two main meals with the highest fat content, indicated for weight maintenance and weight loss.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
64
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).
Diabetological Center
Dreieich, Hesse, Germany
MAP Center
Rende, Cosenza, Italy
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
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