OMNIA Efficacy on Body Fat Mass Reduction

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02516397

Acronym

PEPOLUS

Enrollment

Registered

2015-08-05

Start date

2015-08-31

Completion date

2017-03-31

Last updated

2017-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight

Keywords

body fat mass reduction

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.

Interventions

DIETARY_SUPPLEMENTOmnia

12weeks of treatment

DIETARY_SUPPLEMENTPlacebo

12weeks of treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026