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This trial compares two treatment methods:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug: orlistat 60mg capsules | Active Comparator | A tailored blister-strip for one day contains
|
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| Medical device: polyglucosamine | Active Comparator | A tailored blister-strip for one day contains
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| orlistat 60 mg | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manfred Stoll, MD | Diabetological centre, Dreieich, Germany | Principal Investigator |
| Umberto Cornelli, MD | CorCon, Mailand, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diabetological Center | Dreieich | Hesse | 63303 | Germany | ||
| MAP Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28097013 | Derived | Stoll M, Bitterlich N, Cornelli U. Randomised, double-blind, clinical investigation to compare orlistat 60 milligram and a customized polyglucosamine, two treatment methods for the management of overweight and obesity. BMC Obes. 2017 Jan 11;4:4. doi: 10.1186/s40608-016-0130-4. eCollection 2017. |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D000077403 | Orlistat |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| polyglucosamine | Device | 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). |
|
| 12 weeks |
| Rende |
| Cosenza |
| 87036 |
| Italy |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |