Probiotics on Body Composition and Insulin Resistance in Patients With Obesity and Its Association With Gut Microbiota
NCT04086173 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2019-09-11
Summary
This study aims to evaluate the modifications in body composition and insulin resistance state in patients with grade II and III obesity included in an interventional lifestyle changes program and treated with probiotics (1 x 1011 CFU) or placebo for 16 weeks and its associations with intestinal microbiota behaviour
Conditions
- Obesity
- Insulin Resistance
- Microbial Colonization
Interventions
- DIETARY_SUPPLEMENT
-
Probiotics
Probiotics will be administered at night and will consist of 4 capsules
- OTHER
-
Placebo
Placebo
Sponsors & Collaborators
-
Italmex Pharma
collaborator UNKNOWN -
Medix Farma
collaborator UNKNOWN -
National Polytechnic Institute, Mexico
collaborator OTHER -
Hospital General de México Dr. Eduardo Liceaga
lead OTHER_GOV
Principal Investigators
-
Nayely Garibay-Nieto, MSc · Hospital General de Mexico Eduardo Liceaga
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-03-01
- Primary Completion
- 2019-12-30
- Completion
- 2020-07-31
Countries
- Mexico
Study Locations
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