OMNIA Efficacy on Body Fat Mass Reduction

Not Applicable

Terminated

• Conditions: Overweight
• Interventions: Dietary Supplement: Omnia; Dietary Supplement: Placebo

• Registration Number: NCT02516397
• Lead Sponsor: Vivatech

Brief 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.

Study Timeline

• Study First Submitted: 2015-07-28
• Study Start: 2015-08
• Study First Submitted QC: 2015-08-03
• Study First Posted: 2015-08-05
• Primary Completion: 2016-06
• Study Completion: 2017-03
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-31
• Last Update Posted: 2017-11-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

• 25≤ BMI<30 kg/m2
• excess of fat mass
• food habits : 3 meals a day and a glucides intake equivalent to at least 40% of daily energy (i.e.: glucides intake at each meal)
• Able to give a written or verbal informed consent
• Affiliated or beneficiary of social security

Exclusion Criteria

• Weight loss/gain > 2kg within the preselection period (2 weeks)
• Abnormal blood results at V0
• Physical activity (sport; lifestyle) modification planned or ongoing during the trial
• Severe pathologies/disorders (bulimia; anorexia; diabetes; cancer...) emerging
• Pregnancy during the study
• Consent withdrawal
• Allergy to Omnia
• observance <60%
• Investigator or promotor decision

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Omnia group	Omnia	After 2 weeks of run-in period, subjects take 2 Omnia pills per meal (3 meals a day) for 12 weeks.
Placebo group	Placebo	After 2 weeks of run-in period, subjects take 2 Placebo pills per meal (3 meals a day) for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Reduction of body fat mass loss measured by DEXA (Dual-energy X-ray absorptiometry)	12 weeks

Secondary Outcome Measures

Name	Time	Method
change from baseline in Body Mass Index (BMI)	6, 12 weeks
change from baseline on weight	6, 12 weeks
change from baseline on the ratio fat/lean body mass measured by DEXA	12 weeks