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
Overview
- Phase
- Not Applicable
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Changes in body mass index in patients with obesity
Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Care Provider)
Masking Description
Neither the participant nor the Care provider administrating treatment will know the type of treatment.
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Outcomes
Primary Outcomes
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 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 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 Quicki insulin sensitivity index
Time Frame: 16 weeks
Modification in Quicki index after probiotics treatment in patients with obesity
Changes in Insulin resistance indexes
Time Frame: 16 weeks
Modification in HOMA index after probiotics treatment in patients with obesity
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 weight in patients with obesity
Time Frame: 16 weeks
Evaluate changes in weight kilograms 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
Secondary Outcomes
- Changes in glucose tolerance test(16 weeks)
- Changes in uric acid(16 weeks)
- Changes in leptin(16 weeks)
- Changes in glycated haemoglobin(16 weeks)
- Changes in triglycerides(16 weeks)
- Changes in total cholesterol(16 weeks)
- Changes in HDL cholesterol(16 weeks)
- Changes in LDL cholesterol(16 weeks)
- Changes in alanine aminotransferase(16 weeks)
- Changes in aspartate aminotransferase(16 weeks)
Investigators
Nayely Garibay Nieto
Head Child and Adolescent Obesity Clinic
Hospital General de México Dr. Eduardo Liceaga