Status:
COMPLETED
Study of the Intestinal Microbiota During a Real Life Dietary Intervention in Subjects With Overweight or Obesity
Lead Sponsor:
Integrative Phenomics
Collaborating Sponsors:
RNPC (Rééducation Nutritionnelle et Psycho-Comportementale) Network
Conditions:
Overweight and Obesity
Eligibility:
All Genders
18-65 years
Brief Summary
Worldwide, 13% of the population had obesity in 2016 and overweight and obesity are recognized as the fifth leading risk factor for death (roughly 5 million deaths per year). In the United States alon...
Eligibility Criteria
Inclusion
- Subject having signed the informed consent
- Male or female, 18 to 65 years of age
- Body Mass Index (BMI) greater than or equal to 25 kg/m²
Exclusion
- Pregnant woman (positive serum pregnancy test for selection) or breastfeeding,
- Infected subject under anti-retroviral treatment
- Subject with severe hepatic and / or renal insufficiency (awaiting transplant)
- Subject with anemia \<10 g / dl
- Subject with known gastrointestinal illness
- Subject having undergone bariatric surgery
- Subject with a weight loss \> 10% of body weight during the last 3 months (special diet: low calorie diet (slimming diet), special diet (vegetarians, vegans, nutritional supplements) before treatment),
- Subject taking pro or prebiotics before treatment
- Subject having taken antibiotics in the 2 months preceding inclusion
- Subject participating in another clinical study,
- Subject not enrolled in the French national healthcare system
- Subject not compliing with the exclusion period from the study in which he/she has previously participated
Key Trial Info
Start Date :
June 6 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 15 2020
Estimated Enrollment :
1855 Patients enrolled
Trial Details
Trial ID
NCT04822948
Start Date
June 6 2018
End Date
December 15 2020
Last Update
April 8 2021
Active Locations (1)
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1
RNPC
Marseille, France