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

Last updated: September 9, 2019
Sponsor: Hospital General de México Dr. Eduardo Liceaga
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes (Pediatric)

Diabetes Prevention

Hormone Deficiencies

Treatment

N/A

Clinical Study ID

NCT04086173
00000
  • Ages 18-64
  • All Genders

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with grade II y III obesity (IMC > or = 35 Kg/m2), who receive the initialevaluation at the Integral Attention Clinic for Diabetes and Obesity at HospitalGeneral de México

  • Patients who signed informed consent.

Exclusion

Exclusion Criteria:

  • Diabetes mellitus 2

  • Secondary causes of obesity (hypothyroidism, Cushing syndrome).

  • Patients receiving pharmacological treatment that may affect lipid or glucosemetabolism.

  • Patients who received broad-spectrum antibiotics during the 4 previous weeks.

  • Ingestion of products that contain probiotics.

  • Relevant changes in diet habits during the 4 previous weeks

  • Intestinal Malabsorption disorders ( inflammatory bowel disease, chronic diarrhea, C.difficile infection).

Study Design

Total Participants: 80
Study Start date:
March 01, 2018
Estimated Completion Date:
July 31, 2020

Study 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.

Connect with a study center

  • Hospital General de México "Dr. Eduardo Liceaga"

    Mexico City,
    Mexico

    Active - Recruiting

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