NCT02516397

OMNIA Efficacy on Body Fat Mass Reduction

Randomised Controlled Trial, Double-blind, to Measure Efficiency and Tolerance of a New Food Supplement OMNIA on Body Fat Mass Reduction in Overweight Subjects

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Vivatech · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this clinical trial is to evaluate the safety and efficacy of a food supplement OMNIA compared to a placebo in reducing the body fat mass in 70 overweight subjects during 12 weeks treatment.

Detailed description

Overweight and obesity represent a serious public health issue. These conditions are characterized by an abnormal or excessive accumulation of body fat mass and they are related to an increase risk of developing chronic diseases such as cardiovascular, diabetes, arthrosis and certain kind of cancer (breast; colon). It's thus necessary to find new products able to counteract both overweight and obesity. Omnia is a food supplement based on a Phaseolus vulgaris extract. It has pancreatic amylase inhibition properties. In the following clinical trial, OMNIA will be administrated to a group of overweight subjects in order to evaluate its efficacy on reducing the body fat mass. Its action will be compared to a placebo administered to a second group of overweight volunteers with the same modalities as OMNIA.

Conditions

• Overweight

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Omnia	12weeks of treatment
DIETARY_SUPPLEMENT	Placebo	12weeks of treatment

Timeline

• Start date: 2015-08-01
• Primary completion: 2016-06-01
• Completion: 2017-03-01
• First posted: 2015-08-05
• Last updated: 2017-11-01