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

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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

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

Condition or disease Intervention/treatment Phase
Obesity Insulin Resistance Microbial Colonization Dietary Supplement: Probiotics Other: Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
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
Official Title: 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
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : July 31, 2020

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.
Dietary Supplement: Probiotics
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.
Other: Placebo
Placebo




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Changes in weight in patients with obesity [ Time Frame: 16 weeks ]
    Evaluate changes in weight kilograms after probiotics treatment in patients with obesity

  5. 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

  6. Changes in Insulin resistance indexes [ Time Frame: 16 weeks ]
    Modification in HOMA index after probiotics treatment in patients with obesity

  7. Changes in Insulin sensitivity indexes [ Time Frame: 16 weeks ]
    Modification in insulin sensitivity index after probiotics treatment in patients with obesity

  8. Changes in Quicki insulin sensitivity index [ Time Frame: 16 weeks ]
    Modification in Quicki index after probiotics treatment in patients with obesity


Secondary Outcome Measures :
  1. 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).

  2. 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

  3. Changes in triglycerides [ Time Frame: 16 weeks ]
    Evaluate changes in triglycerides (mg/dL) after treatment with probiotics in patients with obesity

  4. Changes in total cholesterol [ Time Frame: 16 weeks ]
    Evaluate changes in total cholesterol (mg/dL) after treatment with probiotics in patients with obesity

  5. Changes in HDL cholesterol [ Time Frame: 16 weeks ]
    Evaluate changes in HDL cholesterol (mg/dL) after treatment with probiotics in patients with obesity

  6. Changes in LDL cholesterol [ Time Frame: 16 weeks ]
    Evaluate changes in LDL cholesterol (mg/dL) after treatment with probiotics in patients with obesity

  7. Changes in uric acid [ Time Frame: 16 weeks ]
    Evaluate changes in uric acid (mg/dL) after treatment with probiotics in patients with obesity

  8. Changes in aspartate aminotransferase [ Time Frame: 16 weeks ]
    Evaluate changes in aspartate aminotransferase (U/L) after treatment with probiotics in patients with obesity

  9. Changes in alanine aminotransferase [ Time Frame: 16 weeks ]
    Evaluate changes in alanine aminotransferase (U/L) after treatment with probiotics in patients with obesity

  10. Changes in leptin [ Time Frame: 16 weeks ]
    Evaluate changes in leptin (ng/mL) after treatment with probiotics in patients with obesity


Other Outcome Measures:
  1. Changes in microRNAs [ Time Frame: 16 weeks ]
    Evaluate changes in miR-133 and miR-27 after treatment with probiotics in patients with obesity

  2. 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

  3. Changes in intestinal microbiota [ Time Frame: 16 weeks ]
    Evaluate differences in intestinal microbiota behaviour after treatment with probiotics in patients with obesity



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04086173


Contacts
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Contact: Nayely Garibay, MSc +525546037000 gngaribay@hotmail.com
Contact: Alejandro Velasco, MSc +525541449172 jano_vm@yahoo.com

Locations
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Mexico
Hospital General de México "Dr. Eduardo Liceaga" Recruiting
Mexico City, Mexico
Contact: Alejandro Velasco Medina, MSc    5541449172    jano_vam@yahoo.com.mx   
Sponsors and Collaborators
Hospital General de México Dr. Eduardo Liceaga
Italmex Pharma
Medix Farma
National Polytechnic Institute, Mexico
Investigators
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Principal Investigator: Nayely Garibay-Nieto, MSc Hospital General de Mexico Eduardo Liceaga

Publications:
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Responsible Party: Nayely Garibay Nieto, Head Child and Adolescent Obesity Clinic, Hospital General de México Dr. Eduardo Liceaga
ClinicalTrials.gov Identifier: NCT04086173     History of Changes
Other Study ID Numbers: 00000
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Communicable Diseases
Infection
Obesity
Insulin Resistance
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs