The effect of metformin and prebiotic on gut microbiota composition in obesity

Phase 3

Conditions: Obesity.
Overweight and obesity

Registration Number: IRCT20090420001825N2

Lead Sponsor: ational Institute for Medical Research Development (NIMAD)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Female

Target Recruitment: 60

Inclusion Criteria

Women aged 20 to 45 years;
BMI in the range of 30-40 kg/m2;
Interest in participating in the study

Exclusion Criteria

Pregnancy and lactation;
Smoking;
Chronic cardiovascular disease (history of CHF and using digoxin and warfarin drugs), kidney disorders, liver disorders, inflammatory bowel disease, diabetes, cancer and history of digestive tract surgery;
A history of acute and chronic diarrhea over a month before the start of the study;
The incidence of acute gastrointestinal disorder;
Antibiotic therapy within the two months prior to or during the study;
Multivitamin supplementation during the study;
Routine use of probiotics and prebiotics products over a month before the start of the study;
Routine use of anti-inflammatory drugs within a month prior to the start of the study;
Taking weight loss drugs over the past 3 months;
History of specific weight loss diet over the past 3 months;
History of mental illness

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gut microbiota. Timepoint: baseline, endpoint. Method of measurement: Real time PCR, 16S rRNA sequencing.;Weight. Timepoint: baseline, endpoint. Method of measurement: Digital scale.;Body mass index. Timepoint: baseline, endpoint. Method of measurement: Formula.;Waist and hip circumferences. Timepoint: baseline, endpoint. Method of measurement: Tape.;Fecal short-chain fatty acids concentrations. Timepoint: baseline, endpoint. Method of measurement: gas chromatography.

Secondary Outcome Measures

Name	Time	Method
Glucose. Timepoint: baseline, endpoint. Method of measurement: autoanalyzer.;Insulin. Timepoint: baseline, endpoint. Method of measurement: ELISA.;Total cholesterol. Timepoint: baseline, endpoint. Method of measurement: spectrophotometric method.;Triglycerides. Timepoint: baseline, endpoint. Method of measurement: spectrophotometric method.;LDL cholesterol. Timepoint: baseline, endpoint. Method of measurement: spectrophotometric method.;HDL cholesterol. Timepoint: baseline, endpoint. Method of measurement: spectrophotometric method.;Liver enzymes. Timepoint: baseline, endpoint. Method of measurement: colorimetric tests.;HsCRP. Timepoint: baseline, endpoint. Method of measurement: ELISA.;Lipoprotein lipase. Timepoint: baseline, endpoint. Method of measurement: ELISA.;Fasting induced adipose factor. Timepoint: baseline, endpoint. Method of measurement: ELISA.;GLP1. Timepoint: baseline, endpoint. Method of measurement: ELISA.