Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
86 participants
INTERVENTIONAL
2015-08-31
2017-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Omnia group
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 group
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
Interventions
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Omnia
12weeks of treatment
Placebo
12weeks of treatment
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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Vivatech
INDUSTRY
Responsible Party
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Other Identifiers
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ID : 2014 -A01889-38
Identifier Type: -
Identifier Source: org_study_id