Overview

This trial is active, not recruiting.

Condition overweight
Treatments omnia, placebo
Phase phase 3
Sponsor Vivatech
Start date August 2015
End date May 2016
Trial size 70 participants
Trial identifier NCT02516397, ID : 2014 -A01889-38

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
After 2 weeks of run-in period, subjects take 2 Omnia pills per meal (3 meals a day) for 12 weeks.
omnia
12weeks of treatment
(Placebo Comparator)
After 2 weeks of run-in period, subjects take 2 Placebo pills per meal (3 meals a day) for 12 weeks.
placebo
12weeks of treatment

Primary Outcomes

Measure
Reduction of body fat mass loss measured by DEXA (Dual-energy X-ray absorptiometry)
time frame: 12 weeks

Secondary Outcomes

Measure
change from baseline in Body Mass Index (BMI)
time frame: 6, 12 weeks
change from baseline on the ratio fat/lean body mass measured by DEXA
time frame: 12 weeks
change from baseline on weight
time frame: 6, 12 weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Randomised Controlled Trial, Double-blind, to Measure Efficiency and Tolerance of a New Food Supplement OMNIA on Body Fat Mass Reduction in Overweight Subjects
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Vivatech.