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

No results posted yet for this study

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

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04086173 on ClinicalTrials.gov