Polycystic ovary syndrome. Polycystic ovarian syndrome
Conditions
Interventions
Intervention 1: The first intervention group: Intermittent fasting diet (14:10) combined with probiotic supplement (BioFem) will receive for 8 weeks. The probiotic supplement will be manufactured by T
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: Diagnosis of PCOS based on Rotterdam criteria for the first time Body mass index between 25 and 35 kg/m2 People who definitely eat breakfast (early breakfast) Have a smartphone Age range between 18 and 40 years
Exclusion criteria
Exclusion criteria: Smoking Alcohol drinking Taking OCP drugs, anti-androgens, metformin, lipid and blood pressure lowering drugs Pregnancy and breastfeeding Women who intend to become pregnant or take drugs such as chloramifel, letrozole and gonadotropin Menopausal women Antibiotic use in the last three months Consumption of probiotic products Night shift workers Intestinal malabsorption (history of bariatric surgery, inflammatory bowel disease, celiac disease) Inability to fast due to overnight medication Suffering from other diseases such as kidney disease, liver disease, cancer, heart disease and acute and chronic infectious diseases, type 1 and 2 diabetes, Cushing's disease, acromegaly, gigantism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Digital scale.;HOMA- IR. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: HOMA- IR= insulin × glucose/405. | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting blood sugar. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Colorimetric.;Insulin. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA).;QUICKI; Quantitative insulin sensitivity check index. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: QUICKI= 1 / (log fasting blood glucose [mg/dl] + log fasting plasma insulin [µU / mL]).;HOMA-ß; homeostatic model assessment of beta cell function. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: HOMA-ß=360 × insulin/[glucose – 63].;Total cholesterol. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Enzymatic method.;Triglyceride. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Enzymatic method.;Low density lipoprotein-cholestrol. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Enzymatic method.;High density lipoprotein-cholestrol. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Enzymatic method.;Testosterone. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA).;SHBG; Sex hormone-binding globulin. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA).;DHEA; Dehydroepiandrosterone. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA).;Anti-Müllerian hormone. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA).;Hirsutism. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Ferriman-Gallway score.;FAI; Free Androgen Index. Timepoint: Before intervention and 8 wee | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSepide Talebi
Tehran University of Medical Sciences
Outcome results
None listed