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

September 9, 2019 updated by: Nayely Garibay Nieto, Hospital General de México Dr. Eduardo Liceaga

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

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

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Mexico City, Mexico
        • Recruiting
        • Hospital General de México "Dr. Eduardo Liceaga"
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with grade II y III obesity (IMC > or = 35 Kg/m2), who receive the initial evaluation at the Integral Attention Clinic for Diabetes and Obesity at Hospital General de México
  • Patients who signed informed consent.

Exclusion Criteria:

  • Diabetes mellitus 2
  • Secondary causes of obesity (hypothyroidism, Cushing syndrome).
  • Patients receiving pharmacological treatment that may affect lipid or glucose metabolism.
  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
Subjects will be randomly assigned to receive a daily nightly dose (4 capsules) of probiotics for 16 weeks. Probiotics (LACTIPAN®) include 2.5 billion CFU of 6 different strains of live microorganisms, such as Lactobacillus acidophilus (1.0 x 109 CFU), Lactobacillus casei (1.0 x 109 CFU), Lactobacillus rhamnosus (4.4 x 108 CFU), Lactobacillus plantarum (1.76 x 108 CFU), Bifidobacterium infantis (2.76 x 107 CFU), Streptococcus thermophilus (6.66 x 105 CFU) and 50 mg of oligofructose enriched inulin.
Probiotics will be administered at night and will consist of 4 capsules
Placebo Comparator: Control group
Subjects will be randomly assigned to receive a daily nightly dose (4 capsules) of placebo for 16 weeks. Placebo presentation will have the same aspect as those of the probiotic treatment.
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in fat mass in patients with obesity
Time Frame: 16 weeks
Evaluate changes in fat mass kilograms after probiotics treatment in patients with obesity, by bioelectrical impedance analysis
16 weeks
Changes in fat percentage in patients with obesity
Time Frame: 16 weeks
Evaluate changes in fat percentage after probiotics treatment in patients with obesity, by bioelectrical impedance analysis
16 weeks
Changes in body mass index in patients with obesity
Time Frame: 16 weeks
Evaluate changes in body mass index after probiotics treatment in patients with obesity. Calculated with the weight in kilograms divided by the square of the height in meters
16 weeks
Changes in weight in patients with obesity
Time Frame: 16 weeks
Evaluate changes in weight kilograms after probiotics treatment in patients with obesity
16 weeks
Changes in lean body mass in patients with obesity
Time Frame: 16 weeks
Evaluate changes in lean body mass kilograms after probiotics treatment in patients with obesity, by bioelectrical impedance analysis
16 weeks
Changes in Insulin resistance indexes
Time Frame: 16 weeks
Modification in HOMA index after probiotics treatment in patients with obesity
16 weeks
Changes in Insulin sensitivity indexes
Time Frame: 16 weeks
Modification in insulin sensitivity index after probiotics treatment in patients with obesity
16 weeks
Changes in Quicki insulin sensitivity index
Time Frame: 16 weeks
Modification in Quicki index after probiotics treatment in patients with obesity
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in glucose tolerance test
Time Frame: 16 weeks
Evaluate changes in glucose tolerance test after treatment with probiotics in patients with obesity. By using plasma concentrations of insulin and glucose obtained during 120 min of a standard (75 g glucose).
16 weeks
Changes in glycated haemoglobin
Time Frame: 16 weeks
Evaluate changes in percentage glycated haemoglobin after treatment with probiotics in patients with obesity. Obtain by capillary electrophoresis system
16 weeks
Changes in triglycerides
Time Frame: 16 weeks
Evaluate changes in triglycerides (mg/dL) after treatment with probiotics in patients with obesity
16 weeks
Changes in total cholesterol
Time Frame: 16 weeks
Evaluate changes in total cholesterol (mg/dL) after treatment with probiotics in patients with obesity
16 weeks
Changes in HDL cholesterol
Time Frame: 16 weeks
Evaluate changes in HDL cholesterol (mg/dL) after treatment with probiotics in patients with obesity
16 weeks
Changes in LDL cholesterol
Time Frame: 16 weeks
Evaluate changes in LDL cholesterol (mg/dL) after treatment with probiotics in patients with obesity
16 weeks
Changes in uric acid
Time Frame: 16 weeks
Evaluate changes in uric acid (mg/dL) after treatment with probiotics in patients with obesity
16 weeks
Changes in aspartate aminotransferase
Time Frame: 16 weeks
Evaluate changes in aspartate aminotransferase (U/L) after treatment with probiotics in patients with obesity
16 weeks
Changes in alanine aminotransferase
Time Frame: 16 weeks
Evaluate changes in alanine aminotransferase (U/L) after treatment with probiotics in patients with obesity
16 weeks
Changes in leptin
Time Frame: 16 weeks
Evaluate changes in leptin (ng/mL) after treatment with probiotics in patients with obesity
16 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in microRNAs
Time Frame: 16 weeks
Evaluate changes in miR-133 and miR-27 after treatment with probiotics in patients with obesity
16 weeks
Compare threshold for basic tastes
Time Frame: 16 weeks
Evaluate differences in basic taste thresholds (sour, salty, sweet and bitter) after treatment with probiotics in patients with obesity
16 weeks
Changes in intestinal microbiota
Time Frame: 16 weeks
Evaluate differences in intestinal microbiota behaviour after treatment with probiotics in patients with obesity
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nayely Garibay-Nieto, MSc, Hospital General de Mexico Eduardo Liceaga

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Anticipated)

December 30, 2019

Study Completion (Anticipated)

July 31, 2020

Study Registration Dates

First Submitted

March 5, 2019

First Submitted That Met QC Criteria

September 9, 2019

First Posted (Actual)

September 11, 2019

Study Record Updates

Last Update Posted (Actual)

September 11, 2019

Last Update Submitted That Met QC Criteria

September 9, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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