OMNIA Efficacy on Body Fat Mass Reduction

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Overweight

Intervention / Treatment
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* Dietary Supplement: Omnia
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omnia group<br>After 2 weeks of run-in period, subjects take 2 Omnia pills per meal (3 meals a day) for 12 weeks. | Dietary Supplement: Omnia<br>* 12weeks of treatment<br>|
| Placebo Comparator: Placebo group<br>After 2 weeks of run-in period, subjects take 2 Placebo pills per meal (3 meals a day) for 12 weeks. | Dietary Supplement: Placebo<br>* 12weeks of treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of body fat mass loss measured by DEXA (Dual-energy X-ray absorptiometry) |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in Body Mass Index (BMI) |  | 6, 12 weeks | 
| change from baseline on the ratio fat/lean body mass measured by DEXA |  | 12 weeks | 
| change from baseline on weight |  | 6, 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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body fat mass reduction