OMNIA Efficacy on Body Fat Mass Reduction
Keywords
Abstract
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.
Dates
| Last Verified: | 09/30/2017 |
| First Submitted: | 07/27/2015 |
| Estimated Enrollment Submitted: | 08/02/2015 |
| First Posted: | 08/04/2015 |
| Last Update Submitted: | 10/30/2017 |
| Last Update Posted: | 10/31/2017 |
| Actual Study Start Date: | 07/31/2015 |
| Estimated Primary Completion Date: | 05/31/2016 |
| Estimated Study Completion Date: | 02/28/2017 |
Condition or disease
Intervention/treatment
Dietary Supplement: Omnia group
Dietary Supplement: Placebo group
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Omnia group After 2 weeks of run-in period, subjects take 2 Omnia pills per meal (3 meals a day) for 12 weeks. | Dietary Supplement: Omnia group 12weeks of treatment |
| Placebo Comparator: Placebo group After 2 weeks of run-in period, subjects take 2 Placebo pills per meal (3 meals a day) for 12 weeks. | Dietary Supplement: Placebo group 12weeks of treatment |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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 |
Outcome
Primary Outcome Measures
1. Reduction of body fat mass loss measured by DEXA (Dual-energy X-ray absorptiometry) [12 weeks]
Secondary Outcome Measures
1. change from baseline in Body Mass Index (BMI) [6, 12 weeks]
2. change from baseline on the ratio fat/lean body mass measured by DEXA [12 weeks]
3. change from baseline on weight [6, 12 weeks]
