NCT04086173

Probiotics on Body Composition and Insulin Resistance in Patients With Obesity and Its Association With Gut Microbiota

Effects of Probiotic Treatment on Body Composition and Insulin Resistance in Patients With Obesity Grade II and III and Its Association With Changes in Intestinal Microbiota

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Hospital General de México Dr. Eduardo Liceaga · Other Government
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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

Detailed description

A randomized placebo-controlled clinical trial will take place in which both arms will be included in an interventional lifestyle changes program at the Clinic for Integral Treatment of patients with Diabetes and Obesity. The study group will be treated with probiotics (1 x 1011 CFU) for 16 weeks and will be compared to a control group who will receive placebo. Changes in body composition (weight, BMI, fat percentage, fat mass, lean body mass) and insulin resistance indexes (HOMA, insulin sensitivity index and Quicki) will be evaluated in patients with obesity receiving probiotics (1 x 1011 CFU) for 16 weeks, and compared to a placebo group. Changes in metabolic profile (glucose tolerance test, glycosylated haemoglobin, lipid profile, leptin and transaminases) in patients with obesity receiving probiotics (1 x 1011 CFU) for 16 weeks, and compared to a placebo group. Changes in microRNAs profile (miR-133 and miR-27 in patients with obesity receiving probiotics (1 x 1011 CFU) for 16 weeks, and compared to a placebo group. The threshold for basic tastes will be evaluated (salted, bitter, acid, sweet) and will be evaluated in those patients receiving probiotics (1 x 1011 CFU) for 16 weeks, and compared to the group receiving only placebo. Changes in intestinal microbiota behaviour will be evaluated in participants with obesity receiving probiotics (1 x 1011 CFU) for 16 weeks, and compared to the group receiving placebo.

Conditions

• Obesity
• Insulin Resistance
• Microbial Colonization

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotics	Probiotics will be administered at night and will consist of 4 capsules
OTHER	Placebo	Placebo

Timeline

• Start date: 2018-03-01
• Primary completion: 2019-12-30
• Completion: 2020-07-31
• First posted: 2019-09-11
• Last updated: 2019-09-11

Locations

1 site across 1 country: Mexico