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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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20161022030424N14
Enrollment
216
Registered
2025-06-14
Start date
2025-07-21
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic ovary syndrome. Polycystic ovarian syndrome

Interventions

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

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Body mass index of 25 kg/m2 and above Diagnosis of polycystic ovary syndrome by a gynecologist Age between 18 tp 40 years

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNeda Dolatkhah

Tabriz University of Medical Sciences

neda_dolatkhah@yahoo.com+98 41 3334 7054

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026