NCT02529631

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Certmedica International GmbH · Industry
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Overweight
• Obesity

Interventions

Type	Name	Description
DRUG	orlistat 60 mg	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.
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 blue placebo capsules plus two placebo tablets (morning) and four polyglucosamine tablets (noon and evening).

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-06-01
• Completion: 2013-08-01
• First posted: 2015-08-20
• Last updated: 2015-08-20

Locations

2 sites across 2 countries: Germany, Italy