Polycystic Ovarian Syndrome. Polycystic ovarian syndrome
Conditions
Interventions
Intervention 1: Intervention group: For 12 weeks, they will consume 1 sachet of synbiotic from Parsi Lact Co, Iran daily. Each 2 gram sachet contains 10 to the power of 10 CFU/g of Bacillus coagulans,
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Having polycystic ovary syndrome according to Rotterdam criteria At least 2 weeks after the diagnosis and treatment of PCOS Being in the age range of 18-45 years Being in the BMI range: 18.5-35 Willingness to cooperate
Exclusion criteria
Exclusion criteria: Being pregnant Having liver disease, Kidney failure and heart failure, Infectious or inflammatory diseases, Thyroid disorders, Diabetes, Cancers, Hyperprolactinemia Take supplements or products containing synbiotics or probiotics in the past month Taking antibiotics in the last three months Consumption of corticosteroids or omega-3
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting blood glucose (FBG). Timepoint: Measurement of fasting blood sugar at the beginning of the study (before the intervention) and 90 days after the start of synbiotic consumption. Method of measurement: Enzymatic method.;Serum Insulin. Timepoint: Measurement of serum insulin at the beginning of the study (before the intervention) and 90 days after the start of synbiotic consumption. Method of measurement: Elisa method.;Serum total testosterone. Timepoint: Measurement of serum total testosterone at the beginning of the study (before the intervention) and 90 days after the start of synbiotic consumption. Method of measurement: Elisa method.;HOMA-ß: The homeostasis model assessment of pancreatic ß-cell function. Timepoint: Measurement of HOMA-ß at the beginning of the study (before the intervention) and 90 days after the start of synbiotic consumption. Method of measurement: Calculating by formula: HOMA-ß=360×Insulin (lnternational Unit/mililiter)/Fasting glucose (miligram/deciliter) - 63.;HOMA-IR: Homeostatic model assessment of insulin resistance. Timepoint: Measurement of HOMA-IR at the beginning of the study (before the intervention) and 90 days after the start of synbiotic consumption. Method of measurement: Calculating by formula: HOMA-IR = [FBG (miligram/deciliter)×Fasting Insulin (lnternational Unit/mililiter)]/405.;QUICKI: The quantitative insulin-sensitivity check index. Timepoint: Measurement of QUICKI at the beginning of the study (before the intervention) and 90 days after the start of synbiotic consumption. Method of measurement: Calculating by formula: QUICKI = 1/[log fasting insulin (lnternational Unit/mililiter)+log fasting glucose(miligram/deciliter)]. | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum triglyceride (TG). Timepoint: Measurement of serum triglyceride at the beginning of the study (before the intervention) and 90 days after the start of synbiotic consumption. Method of measurement: Enzymatic method.;Serum total cholesterol. Timepoint: Measurement of serum total cholesterol at the beginning of the study (before the intervention) and 90 days after the start of synbiotic consumption. Method of measurement: Enzymatic method.;Low density lipoprotein cholestrol (LDL-C). Timepoint: Measurement of low density lipoprotein cholestrol (LDL-C) at the beginning of the study (before the intervention) and 90 days after the start of synbiotic consumption. Method of measurement: Enzymatic method.;High density lipoprotein cholestrol (HDL-C). Timepoint: Measurement of high density lipoprotein cholestrol (HDL-C) at the beginning of the study (before the intervention) and 90 days after the start of synbiotic consumption. Method of measurement: Enzymatic method.;C reactive protein quantitive (CRP Quantitive). Timepoint: Measurement of C reactive protein quantitive (CRP Quantitive) at the beginning of the study (before the intervention) and 90 days after the start of synbiotic consumption. Method of measurement: Elisa method.;Weight. Timepoint: Measurement of weight at the beginning of the study (before the intervention) and 90 days after the start of synbiotic consumption. Method of measurement: Body weight scale.;Waist circumference. Timepoint: Measurement of waist circumference at the beginning of the study (before the intervention) and 90 days after the start of synbiotic consumption. Method of measurement: Tape meter.;Hip circumference. Timepoint: Measurement of hip circumference at the beginning of the study (before the intervention) and 90 days after the start of synbiotic consumption. Method of measurement: Tape meter.;Body mass index. Timepoint: Measurement of BMI at the beginning of the study (before the intervention) and 90 days after the start of synbioti | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactGolbon Sohrab
Shahid Beheshti University of Medical Sciences
Outcome results
None listed