NCT02516397

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

November 1, 2017

Status Verified

October 1, 2017

Enrollment Period

10 months

First QC Date

July 28, 2015

Last Update Submit

October 31, 2017

Conditions

Overweight

Keywords

body fat mass reduction

Outcome Measures

Primary Outcomes (1)

  • Reduction of body fat mass loss measured by DEXA (Dual-energy X-ray absorptiometry)

    12 weeks

Secondary Outcomes (3)

  • 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

Study Arms (2)

Omnia group

EXPERIMENTAL

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

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.

Dietary Supplement: Placebo

Interventions

OmniaDIETARY_SUPPLEMENT

12weeks of treatment

Omnia group
PlaceboDIETARY_SUPPLEMENT

12weeks of treatment

Placebo group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≤ 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2015

First Posted

August 5, 2015

Study Start

August 1, 2015

Primary Completion

June 1, 2016

Study Completion

March 1, 2017

Last Updated

November 1, 2017

Record last verified: 2017-10