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

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

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

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

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.

Neither the participant nor the Care provider administrating treatment will know the type of treatment.

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.

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.

Evaluate changes in fat mass kilograms after probiotics treatment in patients with obesity, by bioelectrical impedance analysis

Evaluate changes in fat percentage after probiotics treatment in patients with obesity, by bioelectrical impedance analysis

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

Evaluate changes in lean body mass kilograms after probiotics treatment in patients with obesity, by bioelectrical impedance analysis

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).

Evaluate changes in percentage glycated haemoglobin after treatment with probiotics in patients with obesity. Obtain by capillary electrophoresis system

Evaluate changes in total cholesterol (mg/dL) after treatment with probiotics in patients with obesity

Evaluate changes in aspartate aminotransferase (U/L) after treatment with probiotics in patients with obesity

Evaluate changes in alanine aminotransferase (U/L) after treatment with probiotics in patients with obesity

Evaluate differences in basic taste thresholds (sour, salty, sweet and bitter) after treatment with probiotics in patients with obesity

Evaluate differences in intestinal microbiota behaviour after treatment with probiotics in patients with obesity

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).

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