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

• ClinicalTrials.gov Identifier: NCT04086173
• Recruitment Status: Recruiting
• First Posted: September 11, 2019
• Last Update Posted: September 11, 2019
• Sponsor: Hospital General de México Dr. Eduardo Liceaga
• 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: March 5, 2019
• First Posted Date: September 11, 2019
• Last Update Posted Date: September 11, 2019
• Actual Study Start Date: March 1, 2018
• Estimated Primary Completion Date: December 30, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: 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: Probiotics on Body Composition and Insulin Resistance in Patients With Obesity and Its Association With Gut Microbiota
• 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
• 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: Interventional
• Study Phase: Not Applicable

Study Design

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

• Obesity
• Insulin Resistance
• Microbial Colonization

Intervention

• Dietary Supplement: Probiotics
  Probiotics will be administered at night and will consist of 4 capsules
• Other: Placebo
  Placebo

Study Arms

• 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 *

• Banegas JR, López-García E, Gutiérrez-Fisac JL, Guallar-Castillón P, Rodríguez-Artalejo F. A simple estimate of mortality attributable to excess weight in the European Union. Eur J Clin Nutr. 2003 Feb;57(2):201-8.
• Neish AS. Microbes in gastrointestinal health and disease. Gastroenterology. 2009 Jan;136(1):65-80. doi: 10.1053/j.gastro.2008.10.080. Epub 2008 Nov 19. Review.
• Hooper LV, Wong MH, Thelin A, Hansson L, Falk PG, Gordon JI. Molecular analysis of commensal host-microbial relationships in the intestine. Science. 2001 Feb 2;291(5505):881-4.
• Jalanka J, Mattila E, Jouhten H, Hartman J, de Vos WM, Arkkila P, Satokari R. Long-term effects on luminal and mucosal microbiota and commonly acquired taxa in faecal microbiota transplantation for recurrent Clostridium difficile infection. BMC Med. 2016 Oct 11;14(1):155.
• Ley RE, Turnbaugh PJ, Klein S, Gordon JI. Microbial ecology: human gut microbes associated with obesity. Nature. 2006 Dec 21;444(7122):1022-3.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 9, 2019): 80
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 31, 2020
• Estimated Primary Completion Date: December 30, 2019 (Final data collection date for primary outcome measure)

Eligibility 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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 64 Years (Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Nayely Garibay, MSc; +525546037000; gngaribay@hotmail.com

Contact: Alejandro Velasco, MSc; +525541449172; jano_vm@yahoo.com

• Listed Location Countries: Mexico

Administrative Information

• NCT Number: NCT04086173
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Nayely Garibay Nieto, Hospital General de México Dr. Eduardo Liceaga
• Study Sponsor: Hospital General de México Dr. Eduardo Liceaga

Collaborators

• Italmex Pharma
• Medix Farma
• National Polytechnic Institute, Mexico

Investigators

• 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