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IRCT20161022030424N14 IRCT 2025-06-14 Tabriz University of Medical Sciences Time-restricted eating (TRE) or modified alternate day fasting (MADF) diet in polycystic ovary syndrome Effect of time-restricted eating (TRE) or modified alternate day fasting (MADF) diet in comparison with calorie-restricted balanced diet on metabolic and hormonal indices in overweight/obese women with polycystic ovary syndrome 2025-07-21 anticipated 216 Recruiting https://irct.ir/trial/84100 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We will use a stratified block randomization method for allocation. The computer-generated code generated using SAS software version 8.01 will be used to create a randomized sequence by a statistician outside the project's research team. Randomization will be stratified based on age and body mass index. Serially numbered opaque sealed packets will be used to ensure allocation, Blinding description: Blinding the patients is not feasible in this trial. A trained nutritionist will ban diet-related conversations between assessors and patients during the study. Outcome assessors and the person responsible for statistical analysis will be blinded to the type of interventions received until the end of the study. 3 Polycystic ovary syndrome. Intervention 1: Time-restricted eating group: Participants are instructed to consume their diet ad libitum over 8 hours, and they are allowed to consume only calorie-free foods, non-starchy vegetables, and sugar-free gum from 7 p.m. to 11 a.m. Intervention 2: Modified intermittent fasting diet group: Participants are asked to consume a very low-calorie diet for 3 days and can eat ad libitum on the remaining days. Intervention 3: Control group: Participants consume their energy intake (500 kcal less than resting energy) according to a traditional substitution-based meal-list pattern, with breakfast, lunch, dinner, and two snacks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No further information available.
public Neda Dolatkhah
Imam Reza Educational and Medical Center, opposite the Central Organization of the University, Golgasht Street
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3334 7054 neda_dolatkhah@yahoo.com Tabriz University of Medical Sciences scientific Neda Dolatkhah
Imam Reza Educational and Medical Center, opposite the Central Organization of the University, Golgasht Street
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3334 7054 neda_dolatkhah@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Body mass index of 25 kg/m2 and above Diagnosis of polycystic ovary syndrome by a gynecologist Age between 18 tp 40 years 18 years 40 years Female Pregnancy and breastfeeding Menopause Daily calorie intake of less than 800 and more than 4200 kcal Use of dietary supplements, diuretics, or laxatives during the intervention period Participation in sports programs or changes in physical activity Use of weight-affecting medications A deviation from a specific eating pattern due to medical or other reasons E28.2 Polycystic ovarian syndrome Treatment - Other Treatment - Other Treatment - Other Time-restricted eating group: Participants are instructed to consume their diet ad libitum over 8 hours, and they are allowed to consume only calorie-free foods, non-starchy vegetables, and sugar-free gum from 7 p.m. to 11 a.m. Modified intermittent fasting diet group: Participants are asked to consume a very low-calorie diet for 3 days and can eat ad libitum on the remaining days. Control group: Participants consume their energy intake (500 kcal less than resting energy) according to a traditional substitution-based meal-list pattern, with breakfast, lunch, dinner, and two snacks. Free androgen index (FAI). Timepoint: Measurement of Free androgen index (FAI) at the beginning of the study (before the start of the intervention) and 14 weeks after the start of the intervention. Method of measurement: It is calculated by dividing the numerical value of serum free testosterone by the value of sex hormone-binding globulin. Weight. Timepoint: Weight measurement at the beginning of the study (before the start of the intervention) and 14 weeks after the start of the intervention. Method of measurement: Seca digital scale. Body fat mass. Timepoint: Body fat mass measurement at the beginning of the study (before the start of the intervention) and 14 weeks after the start of the intervention. Method of measurement: Body analyzer. Prolactin levels. Timepoint: Prolactin level measurement at the beginning of the study (before the start of the intervention) and 14 weeks after the start of the intervention. Method of measurement: Biochemical analysis. Total testosterone level. Timepoint: Total testosterone level measurement at the beginning of the study (before the start of the intervention) and 14 weeks after the start of the intervention. Method of measurement: Biochemical analysis. Luteinizing hormone level. Timepoint: luteinizing hormone level measurement at the beginning of the study (before the start of the intervention) and 14 weeks after the start of the intervention. Method of measurement: Biochemical analysis. Follicle-stimulating hormone level. Timepoint: Follicle-stimulating hormone level measurement at the beginning of the study (before the start of the intervention) and 14 weeks after the start of the intervention. Method of measurement: Biochemical analysis. Sex hormone-binding globulin level. Timepoint: Sex hormone-binding globulin level measurement at the beginning of the study (before the start of the intervention) and 14 weeks after the start of the intervention. Method of measurement: Biochemical analysis. Serum indicators of glucose metabolism. Timepoint: Serum indicators of glucose metabolism measurement at the beginning of the study (before the start of the intervention) and 14 weeks after the start of the intervention. Method of measurement: Biochemical analysis. Progesterone levels. Timepoint: Progesterone level measurement at the beginning of the study (before the start of the intervention) and 14 weeks after the start of the intervention. Method of measurement: Biochemical analysis. Estrogen levels. Timepoint: Estrogen level measurement at the beginning of the study (before the start of the intervention) and 14 weeks after the start of the intervention. Method of measurement: Biochemical analysis. Dehydroepiandrosterone sulfate level. Timepoint: Dehydroepiandrosterone sulfate level measurement at the beginning of the study (before the start of the intervention) and 14 weeks after the start of the intervention. Method of measurement: Biochemical analysis. Tabriz University of Medical Sciences Approved 2025-05-24 Ethics committee of Tabriz University of Medical Sciences Vice Chancellor for Research and Technology, Central Building No. 2, Third Floor, Tabriz University of Medical Sciences, Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)