OMNIA Efficacy on Body Fat Mass Reduction

Overweight Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02516397
• Other study ID #: ID : 2014 -A01889-38
• Status: Terminated
• Phase: N/A
• First received: July 28, 2015
• Last updated: October 31, 2017
• Start date: August 2015
• Est. completion date: March 2017

Study information

• Verified date: October 2017
• Source: Vivatech
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 86
• Est. completion date: March 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight

Intervention

Dietary Supplement:
• Omnia
12weeks of treatment
• Placebo
12weeks of treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vivatech

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of body fat mass loss measured by DEXA (Dual-energy X-ray absorptiometry)		12 weeks
Secondary	change from baseline in Body Mass Index (BMI)		6, 12 weeks
Secondary	change from baseline on the ratio fat/lean body mass measured by DEXA		12 weeks
Secondary	change from baseline on weight		6, 12 weeks