Back to resultsOMNIA Efficacy on Body Fat Mass Reduction (PEPOLUS)
Primary Purpose
Overweight
Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Omnia
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Overweight focused on measuring body fat mass reduction
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Omnia group
Placebo group
Arm Description
After 2 weeks of run-in period, subjects take 2 Omnia pills per meal (3 meals a day) for 12 weeks.
After 2 weeks of run-in period, subjects take 2 Placebo pills per meal (3 meals a day) for 12 weeks.
Outcomes
Primary Outcome Measures
Reduction of body fat mass loss measured by DEXA (Dual-energy X-ray absorptiometry)
Secondary Outcome Measures
change from baseline in Body Mass Index (BMI)
change from baseline on the ratio fat/lean body mass measured by DEXA
change from baseline on weight
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02516397
Brief Title
OMNIA Efficacy on Body Fat Mass Reduction
Acronym
PEPOLUS
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated because of conflicting results from intermediate analysis.
Study Start Date
August 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vivatech
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
body fat mass reduction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Omnia group
Arm Type
Experimental
Arm Description
After 2 weeks of run-in period, subjects take 2 Omnia pills per meal (3 meals a day) for 12 weeks.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
After 2 weeks of run-in period, subjects take 2 Placebo pills per meal (3 meals a day) for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Omnia
Intervention Description
12weeks of treatment
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
12weeks of treatment
Primary Outcome Measure Information:
Title
Reduction of body fat mass loss measured by DEXA (Dual-energy X-ray absorptiometry)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
change from baseline in Body Mass Index (BMI)
Time Frame
6, 12 weeks
Title
change from baseline on the ratio fat/lean body mass measured by DEXA
Time Frame
12 weeks
Title
change from baseline on weight
Time Frame
6, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
12. IPD Sharing Statement
Learn more about this trial
OMNIA Efficacy on Body Fat Mass Reduction
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