Overweight and Obese Volunteers. Clinical Trial
Official title:
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.
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment