Obesity. Overweight and obesity
Conditions
Interventions
Intervention 1: Intervention group 1: herbal capsule manufactured by Dineh pharmaceutical company, Twice a day with hypocaloric diet (500 kcal less than patients' energy requirements ), for 2 months.
Sponsors
National Institute for Medical Research Development (NIMAD)
Eligibility
Sex/Gender
Female
Age
20 Years to 45 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAhmad-Reza Soroush
Tehran University of Medical Sciences
Outcome results
None listed