NCT02246699

Efficacy and Safety of a Fungal Chitosan on the Body Weight Reduction in Overweight and Obesity Volunteers

A Study to Evaluate the Efficacy and the Safety of a Fungal Chitosan on the Body Weight Reduction in Overweight and Obesity Volunteers: a Randomized, Double-blind, Parallel Groups and Placebo Controlled Clinical Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Kitozyme · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The prevalence of overweight and obesity is getting more and more important in developed as well as in emerging countries. It can be defined according to the degree of fat storage by measurement of fat mass. No clinical studies have been conducted so far for that intended use on KiOnutrime®-Cs, a fungal chitosan from the mycelium of non-genetically modified Aspergillus niger. KiOnutrime®-Cs has been recognized as substantially equivalent to animal chitosan. The purpose of this clinical trial is to determine if KiOnutrime®-Cs-containing medical device, which is a CE-marked medical device manufactured by KitoZyme, has an effect on body weight reduction after 3 months of intake in overweight and obese men and women. Furthermore, effects on anthropometric measurements, body fat mass percentage, serum lipids and safety parameters will be investigated.

Detailed description

The study duration per subject will be 3 months and 1 week maximum. Subjects will be screened at visit V1 and will start a 1-week run-in period, during which subjects will ingest 2 capsules of placebo 3 times a day. The subjects will then be randomized to receive the investigational medical device or placebo (1:1) for a 3 months product intake period.

Conditions

• Overweight and Obese Volunteers.

Interventions

Type	Name	Description
DEVICE	KiOnutrime®-Cs	The product will be taken orally within 15 minutes before main meals (breakfast, lunch and dinner) with a large glass of water. Subjects will have to take 2 capsules of 500mg, 3 times per day.
OTHER	Placebo	The product will be taken orally within 15 minutes before main meals (breakfast, lunch and dinner) with a large glass of water. Subjects will have to take 2 capsules, 3 times per day.

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2014-09-23
• Last updated: 2015-03-31

Locations

1 site across 1 country: France