Insulin Resistance, Microbial Colonization, Obesity
Conditions
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.
Interventions
DIETARY_SUPPLEMENTProbiotics
Probiotics will be administered at night and will consist of 4 capsules
OTHERPlacebo
Placebo
Sponsors
Italmex Pharma
Medix Farma
National Polytechnic Institute, Mexico
Hospital General de México Dr. Eduardo Liceaga
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Masking description
Neither the participant nor the Care provider administrating treatment will know the type of treatment.
Intervention model description
Double-blinded randomized placebo-controlled clinical assay
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Insulin resistance indexes | 16 weeks | Modification in HOMA index after probiotics treatment in patients with obesity |
| Changes in Insulin sensitivity indexes | 16 weeks | Modification in insulin sensitivity index after probiotics treatment in patients with obesity |
| Changes in Quicki insulin sensitivity index | 16 weeks | Modification in Quicki index after probiotics treatment in patients with obesity |
| Changes in fat mass in patients with obesity | 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 | 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 | 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 | 16 weeks | Evaluate changes in weight kilograms after probiotics treatment in patients with obesity |
| Changes in lean body mass in patients with obesity | 16 weeks | Evaluate changes in lean body mass kilograms after probiotics treatment in patients with obesity, by bioelectrical impedance analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in alanine aminotransferase | 16 weeks | Evaluate changes in alanine aminotransferase (U/L) after treatment with probiotics in patients with obesity |
| Changes in leptin | 16 weeks | Evaluate changes in leptin (ng/mL) after treatment with probiotics in patients with obesity |
| Changes in aspartate aminotransferase | 16 weeks | Evaluate changes in aspartate aminotransferase (U/L) after treatment with probiotics in patients with obesity |
| Changes in glucose tolerance test | 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 | 16 weeks | Evaluate changes in percentage glycated haemoglobin after treatment with probiotics in patients with obesity. Obtain by capillary electrophoresis system |
| Changes in triglycerides | 16 weeks | Evaluate changes in triglycerides (mg/dL) after treatment with probiotics in patients with obesity |
| Changes in total cholesterol | 16 weeks | Evaluate changes in total cholesterol (mg/dL) after treatment with probiotics in patients with obesity |
| Changes in HDL cholesterol | 16 weeks | Evaluate changes in HDL cholesterol (mg/dL) after treatment with probiotics in patients with obesity |
| Changes in LDL cholesterol | 16 weeks | Evaluate changes in LDL cholesterol (mg/dL) after treatment with probiotics in patients with obesity |
| Changes in uric acid | 16 weeks | Evaluate changes in uric acid (mg/dL) after treatment with probiotics in patients with obesity |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in microRNAs | 16 weeks | Evaluate changes in miR-133 and miR-27 after treatment with probiotics in patients with obesity |
| Changes in intestinal microbiota | 16 weeks | Evaluate differences in intestinal microbiota behaviour after treatment with probiotics in patients with obesity |
| Compare threshold for basic tastes | 16 weeks | Evaluate differences in basic taste thresholds (sour, salty, sweet and bitter) after treatment with probiotics in patients with obesity |
Countries
Mexico
Contacts
Primary ContactNayely Garibay, MSc
Backup ContactAlejandro Velasco, MSc
Outcome results
None listed