OverweightPEPOLUSNCT02516397
OMNIA Efficacy on Body Fat Mass Reduction
A study testing Omnia in people with Overweight, run by Vivatech.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- Omnia
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Allergy to Omnia
- observance <60%
- Investigator or promotor decision
About this study
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
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.
Read the 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.
- Conditions
- Overweight
- Being tested
- Omnia, Placebo
- Keywords
- body fat mass reduction
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmniaDietary supplement
12weeks of treatment
PlaceboDietary supplement
12weeks of treatment
| Study group | Role | What they receive |
|---|---|---|
| Omnia group | Experimental | After 2 weeks of run-in period, subjects take 2 Omnia pills per meal (3 meals a day) for 12 weeks. Receives: Dietary Supplement: Omnia |
| Placebo group | Placebo comparator | After 2 weeks of run-in period, subjects take 2 Placebo pills per meal (3 meals a day) for 12 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of body fat mass loss measured by DEXA (Dual-energy X-ray absorptiometry)
Measured: 12 weeks
Secondary outcomes (3)
change from baseline in Body Mass Index (BMI)
Measured: 6, 12 weeks
change from baseline on the ratio fat/lean body mass measured by DEXA
Measured: 12 weeks
change from baseline on weight
Measured: 6, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionJun 2016
- Study completionMar 2017
Why it stopped: Study was terminated because of conflicting results from intermediate analysis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vivatech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02516397
- Sponsor's protocol ID
- ID : 2014 -A01889-38
- Acronym
- PEPOLUS
- Status last verified
- Oct 2017
- First submitted
- 28 Jul 2015
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02516397
- Acronym / sponsor ID
- PEPOLUS / ID : 2014 -A01889-38
- Conditions
- Overweight
- Keywords
- body fat mass reduction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated because of conflicting results from intermediate analysis.
- Enrolment
- 86 participants (actual)
- Lead sponsor
- VivatechIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 5 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omnia group | Experimental | Dietary Supplement: OmniaAfter 2 weeks of run-in period, subjects take 2 Omnia pills per meal (3 meals a day) for 12 weeks. |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboAfter 2 weeks of run-in period, subjects take 2 Placebo pills per meal (3 meals a day) for 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omnia12weeks of treatment | Dietary supplement | Omnia group |
| Placebo12weeks of treatment | Dietary supplement | Placebo group |
Primary outcome
Reduction of body fat mass loss measured by DEXA (Dual-energy X-ray absorptiometry)
Time frame: 12 weeks
3 secondary outcomes
change from baseline in Body Mass Index (BMI)
Time frame: 6, 12 weeks
change from baseline on the ratio fat/lean body mass measured by DEXA
Time frame: 12 weeks
change from baseline on weight
Time frame: 6, 12 weeks
Results and safety
The study was stopped early (reason given: Study was terminated because of conflicting results from intermediate analysis.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Omnia in people with Overweight, run by Vivatech.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study was terminated because of conflicting results from intermediate analysis.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of body fat mass loss measured by DEXA (Dual-energy X-ray absorptiometry) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2017; AzTrials last refreshed its copy on 30 Oct 2026.