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IRCT20121110011421N5 IRCT 2022-10-03 Tehran University of Medical Sciences The effects of intermittent fasting diet alone or in combination with probiotic supplementation in comparison with calorie-restricted diet in patients with polycystic ovary syndrome The effects of intermittent fasting diet alone or in combination with probiotic supplementation in comparison with calorie-restricted diet on anthropometric indices, lipid profile, glycemic status, hormonal parameters, inflammatory- and oxidative stress biomarkers in patients with polycystic ovary syndrome: a randomize clinical trial 2022-10-23 anticipated 90 Complete https://irct.ir/trial/65926 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A stratified randomized permuted block (with block size 6) will be generated by an independent bio-statistician. Subjects will be stratified according to BMI (between 25 and 30 and 30 and 35). Random assignment will be done by the use of a table of random numbers. The enrolling of participants, and assigning participants to the groups will be carried out by a trained nutritionist. Researchers will not be informed about the randomization process until the completion of data analyses (concealment), Blinding description: This study is not blinded in terms of diet but will be blinded in terms of supplements. The BioFem probiotic supplement and its placebo will be produced by Tak Gen Zist Company. All probiotic and its placebo supplements will provided by Tak Gen Zist Company in prepacked boxes numbered for each patient according to the randomization sequence.The probiotic supplement and its placebo will be in the same form package. The researcher and patients will not be aware of the pack's content until the end of the trial. N/A Polycystic ovary syndrome. 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 Takgene Zist Company (Tehran, Iran). Intervention 2: The second intervention group: will receive the intermittent fasting diet (14:10) along with the placebo supplement for 8 weeks. The placebo supplement will be manufactured by Takgene Zist Company (Tehran, Iran). Intervention 3: Control group: They will receive a calorie-restricted diet along with a placebo for 8 weeks. The placebo supplement will be manufactured by Takgene Zist Company (Tehran, Iran). Yes - There is a plan to make this available What will be shared: The collected deidentified for the primary outcome measure only will be shared. When: Starting 12 months after publication. To whom: Available for people working in academic institutions Conditions: The data will provide for educational use. Where to obtain: Kurosh djafarian kdjafarian@tums.ac.ir How to obtain: The data will send as soon as possible, after receiving the request. Comments:
public Sepide Talebi
Keshavarz Boulevard Ave
Tehran Iran (Islamic Republic of) 1417653761 +98 21 8898 4837 talebisepide7@gmail.com Tehran University of Medical Sciences scientific Kurosh djafarian
No: 44 Hojjat-dost Alley, Naderi St, Keshavarz Blvd.
Tehran Iran (Islamic Republic of) 1416643931 +98 21 8898 4837 kdjafarian@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) 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 18 years 40 years Female 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 E28.2 Polycystic ovarian syndrome Treatment - Other Treatment - Other N/A 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 Takgene Zist Company (Tehran, Iran). The second intervention group: will receive the intermittent fasting diet (14:10) along with the placebo supplement for 8 weeks. The placebo supplement will be manufactured by Takgene Zist Company (Tehran, Iran). Control group: They will receive a calorie-restricted diet along with a placebo for 8 weeks. The placebo supplement will be manufactured by Takgene Zist Company (Tehran, Iran). 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. 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-β; homeostatic model assessment of beta cell function. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: HOMA-β=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 weeks after intervention. Method of measurement: Calculation. Total antioxidant capacity. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA). Total oxidant status. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA). Systolic blood pressure. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Sphygmomonometer. Diastolic blood pressure. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Sphygmomonometer. Waist Circumference. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Non-stretching tape measure. Body Mass Index. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Dividing the weight into kilograms by squared height by meter. Body fat percentage. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Bioimpedance. Depression score. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Depression Anxiety and Stress Scales (DASS-21). Anxiety score. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Depression Anxiety and Stress Scales (DASS-21). Stress score. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Depression Anxiety and Stress Scales (DASS-21). Appetite. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Visual Analogue Scale. Pittsburgh Sleep Quality Index (PSQI). Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Pittsburgh Sleep Quality Index (PSQI). Scoring systems in acne. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Global acne grading system. C-reactive protein. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA). Eating Behavior. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: The three factor eating questionnaire -R18. Food Craving. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Food Craving Questionnaire. Tehran University of Medical Sciences Approved 2022-09-03 Ethics Committee of Tehran University of Medical Sciences Ghods street., Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)