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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Obesity, Insulin Resistance, Microbial Colonization

Intervention / Treatment
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* Dietary Supplement: Probiotics
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double-blinded randomized placebo-controlled clinical assay
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>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<br>* Probiotics will be administered at night and will consist of 4 capsules<br>|
| Placebo Comparator: Control group<br>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<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in fat mass in patients with obesity | 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 | 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 | 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 | Evaluate changes in weight kilograms after probiotics treatment in patients with obesity | 16 weeks | 
| Changes in lean body mass in patients with obesity | 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 | Modification in HOMA index after probiotics treatment in patients with obesity | 16 weeks | 
| Changes in Insulin sensitivity indexes | Modification in insulin sensitivity index after probiotics treatment in patients with obesity | 16 weeks | 
| Changes in Quicki insulin sensitivity index | 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 | 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 | Evaluate changes in percentage glycated haemoglobin after treatment with probiotics in patients with obesity. Obtain by capillary electrophoresis system | 16 weeks | 
| Changes in triglycerides | Evaluate changes in triglycerides (mg/dL) after treatment with probiotics in patients with obesity | 16 weeks | 
| Changes in total cholesterol | Evaluate changes in total cholesterol (mg/dL) after treatment with probiotics in patients with obesity | 16 weeks | 
| Changes in HDL cholesterol | Evaluate changes in HDL cholesterol (mg/dL) after treatment with probiotics in patients with obesity | 16 weeks | 
| Changes in LDL cholesterol | Evaluate changes in LDL cholesterol (mg/dL) after treatment with probiotics in patients with obesity | 16 weeks | 
| Changes in uric acid | Evaluate changes in uric acid (mg/dL) after treatment with probiotics in patients with obesity | 16 weeks | 
| Changes in aspartate aminotransferase | Evaluate changes in aspartate aminotransferase (U/L) after treatment with probiotics in patients with obesity | 16 weeks | 
| Changes in alanine aminotransferase | Evaluate changes in alanine aminotransferase (U/L) after treatment with probiotics in patients with obesity | 16 weeks | 
| Changes in leptin | Evaluate changes in leptin (ng/mL) after treatment with probiotics in patients with obesity | 16 weeks |