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

Not Applicable

Completed

• Conditions: Overweight; Obesity
• Interventions: Drug: orlistat 60 mg; Device: polyglucosamine

• Registration Number: NCT02529631
• Lead Sponsor: Certmedica International GmbH

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Primary Completion: 2010-06
• Study Completion: 2013-08
• Study First Submitted: 2015-07-24
• Status Verified: 2015-08
• Study First Submitted QC: 2015-08-19
• Last Update Submitted: 2015-08-19
• Study First Posted: 2015-08-20
• Last Update Posted: 2015-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug: orlistat 60mg capsules	orlistat 60 mg	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
Medical device: polyglucosamine	polyglucosamine	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

Primary Outcome Measures

Name	Time	Method
Number of participants in both groups with a weight reduction of >= 5 per cent compared to the initial weight.	12 weeks

Secondary Outcome Measures

Name	Time	Method
BMI reduction	12 weeks	Achieved change of the BMI (cm/m²) of all participants in each group compared to the initial average BMI
Waist circumference reduction	12 weeks	Achieved change of the waist circumference of all participants in each group compared to the initial average WC

Trial Locations

Locations (2)

MAP Center; 🇮🇹 Rende, Cosenza, Italy

Diabetological Center; 🇩🇪 Dreieich, Hesse, Germany