Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04086173
Recruitment Status : Recruiting
First Posted : September 11, 2019
Last Update Posted : September 11, 2019
Sponsor:
Collaborators:
Italmex Pharma
Medix Farma
National Polytechnic Institute, Mexico
Information provided by (Responsible Party):
Nayely Garibay Nieto, Hospital General de México Dr. Eduardo Liceaga

Tracking Information
First Submitted Date  ICMJE March 5, 2019
First Posted Date  ICMJE September 11, 2019
Last Update Posted Date September 11, 2019
Actual Study Start Date  ICMJE March 1, 2018
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2019)
  • 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
  • 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
  • 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
  • Changes in weight in patients with obesity [ Time Frame: 16 weeks ]
    Evaluate changes in weight kilograms after probiotics treatment in patients with obesity
  • 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
  • Changes in Insulin resistance indexes [ Time Frame: 16 weeks ]
    Modification in HOMA index after probiotics treatment in patients with obesity
  • Changes in Insulin sensitivity indexes [ Time Frame: 16 weeks ]
    Modification in insulin sensitivity index after probiotics treatment in patients with obesity
  • Changes in Quicki insulin sensitivity index [ Time Frame: 16 weeks ]
    Modification in Quicki index after probiotics treatment in patients with obesity
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2019)
  • 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).
  • 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
  • Changes in triglycerides [ Time Frame: 16 weeks ]
    Evaluate changes in triglycerides (mg/dL) after treatment with probiotics in patients with obesity
  • Changes in total cholesterol [ Time Frame: 16 weeks ]
    Evaluate changes in total cholesterol (mg/dL) after treatment with probiotics in patients with obesity
  • Changes in HDL cholesterol [ Time Frame: 16 weeks ]
    Evaluate changes in HDL cholesterol (mg/dL) after treatment with probiotics in patients with obesity
  • Changes in LDL cholesterol [ Time Frame: 16 weeks ]
    Evaluate changes in LDL cholesterol (mg/dL) after treatment with probiotics in patients with obesity
  • Changes in uric acid [ Time Frame: 16 weeks ]
    Evaluate changes in uric acid (mg/dL) after treatment with probiotics in patients with obesity
  • Changes in aspartate aminotransferase [ Time Frame: 16 weeks ]
    Evaluate changes in aspartate aminotransferase (U/L) after treatment with probiotics in patients with obesity
  • Changes in alanine aminotransferase [ Time Frame: 16 weeks ]
    Evaluate changes in alanine aminotransferase (U/L) after treatment with probiotics in patients with obesity
  • Changes in leptin [ Time Frame: 16 weeks ]
    Evaluate changes in leptin (ng/mL) after treatment with probiotics in patients with obesity
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 9, 2019)
  • Changes in microRNAs [ Time Frame: 16 weeks ]
    Evaluate changes in miR-133 and miR-27 after treatment with probiotics in patients with obesity
  • 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
  • Changes in intestinal microbiota [ Time Frame: 16 weeks ]
    Evaluate differences in intestinal microbiota behaviour after treatment with probiotics in patients with obesity
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Probiotics on Body Composition and Insulin Resistance in Patients With Obesity and Its Association With Gut Microbiota
Official Title  ICMJE 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
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Double-blinded randomized placebo-controlled clinical assay
Masking: Double (Participant, Care Provider)
Masking Description:
Neither the participant nor the Care provider administrating treatment will know the type of treatment.
Primary Purpose: Supportive Care
Condition  ICMJE
  • Obesity
  • Insulin Resistance
  • Microbial Colonization
Intervention  ICMJE
  • Dietary Supplement: Probiotics
    Probiotics will be administered at night and will consist of 4 capsules
  • Other: Placebo
    Placebo
Study Arms  ICMJE
  • 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.
    Intervention: Dietary Supplement: Probiotics
  • 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.
    Intervention: Other: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 9, 2019)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2020
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nayely Garibay, MSc +525546037000 gngaribay@hotmail.com
Contact: Alejandro Velasco, MSc +525541449172 jano_vm@yahoo.com
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04086173
Other Study ID Numbers  ICMJE 00000
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nayely Garibay Nieto, Hospital General de México Dr. Eduardo Liceaga
Study Sponsor  ICMJE Hospital General de México Dr. Eduardo Liceaga
Collaborators  ICMJE
  • Italmex Pharma
  • Medix Farma
  • National Polytechnic Institute, Mexico
Investigators  ICMJE
Principal Investigator: Nayely Garibay-Nieto, MSc Hospital General de Mexico Eduardo Liceaga
PRS Account Hospital General de México Dr. Eduardo Liceaga
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP