Randomised Controlled Trial, Double-blind, to Measure Efficiency and Tolerance of a New Food Supplement OMNIA on Body Fat Mass Reduction in Overweight Subjects
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Vivatech
- Enrollment
- 86
- Primary Endpoint
- Reduction of body fat mass loss measured by DEXA (Dual-energy X-ray absorptiometry)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Omnia group
After 2 weeks of run-in period, subjects take 2 Omnia pills per meal (3 meals a day) for 12 weeks.
Intervention: Omnia (Dietary Supplement)
Placebo group
After 2 weeks of run-in period, subjects take 2 Placebo pills per meal (3 meals a day) for 12 weeks.
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
Reduction of body fat mass loss measured by DEXA (Dual-energy X-ray absorptiometry)
Time Frame: 12 weeks
Secondary Outcomes
- 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)