OMNIA Efficacy on Body Fat Mass Reduction (PEPOLUS)

VivaTech

Status: Terminated

Conditions: Overweight

Treatments: Dietary Supplement: Omnia; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02516397

ID : 2014 -A01889-38

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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86 participants in 2 patient groups, including a placebo group

Omnia group

Experimental group

Description:

After 2 weeks of run-in period, subjects take 2 Omnia pills per meal (3 meals a day) for 12 weeks.

Treatment:

Dietary Supplement: Omnia

Placebo group

Placebo Comparator group

Description:

After 2 weeks of run-in period, subjects take 2 Placebo pills per meal (3 meals a day) for 12 weeks.

Treatment:

Dietary Supplement: Placebo