RCT to Compare Orlistat and Polyglucosamine for the Management of Overweight and Obesity

Study Overview
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Brief Summary
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This trial compares two treatment methods: 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. 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.

Official Title
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Randomized, Double-blind, Clinical Investigation to Compare Orlistat 60 mg and a Customized Polyglucosamine, Two Treatment Methods for the Management of Overweight and Obesity

Conditions
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Overweight, Obesity

Intervention / Treatment
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* Drug: orlistat 60 mg
* Device: polyglucosamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI ≥ 28 kg/m² and < 45 kg/m² Waist circumference > 80 cm (women) > 94 cm (men) Exclusion Criteria: Energy intake lower than the standard value according to Miffin St-Jeor equation Pregnancy or breast-feeding Addiction to alcohol Inability to fulfil the requirement of the trial protocol Cancer ,malignant tumour Hypersensitivity reactions to crustaceans or ingredient of the study medication Chronic diseases not under control with adequate therapy Diabetes

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Drug: orlistat 60mg capsules<br>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<br>* 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.<br>|
| Active Comparator: Medical device: polyglucosamine<br>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<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants in both groups with a weight reduction of >= 5 per cent compared to the initial weight. |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI reduction | Achieved change of the BMI (cm/m²) of all participants in each group compared to the initial average BMI | 12 weeks | 
| Waist circumference reduction | Achieved change of the waist circumference of all participants in each group compared to the initial average WC | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polyglucosamine, L 112, overweight,, obesity, orlistat, weight reduction