Polycystic ovarian syndrome (PCOS). Polycystic ovarian syndrome
Conditions
Interventions
Intervention 1: Intervention group 1: one melatonin capsule of 6 mg per day for eight weeks + 8-hour time-restricted feeding diet (participants are allowed to consume food from 10:00 in the morning to
and they are not allowed to eat except for water, tea, coffee, and zero-Calorie drinks for the rest of the day. The calories received from the diet will be calculated based on weight, height, and dail
Sponsors
Shiraz University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 35 Years
Inclusion criteria
Inclusion criteria: Women aged 18 to 35 years, diagnosed with Polycystic Ovary Syndrome (PCOS) according to the Rotterdam criteria, who have not yet initiated any pharmacological treatment. BMI between 25 and 35 kg/m². Ability to read and write in the language of the study materials. Ownership of a mobile phone and proficiency in its use.
Exclusion criteria
Exclusion criteria: Pregnant, lactating, or postmenopausal women. Individuals working night shifts or with irregular work hours that disrupt circadian rhythms. History of smoking, alcohol consumption, or drug abuse. Inability to fast due to specific medical conditions or intolerance to fasting. Individuals who have taken melatonin supplements or any antioxidant or anti-inflammatory supplements within three months prior to the intervention. Adherence to a specific diet for medical, ethical, or personal reasons. Individuals with diabetes, hypertension, kidney or liver disorders, cancer, infectious diseases, severe gastrointestinal diseases, Cushing's syndrome, adrenal disorders, acromegaly, or severe eating disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body weight. Timepoint: At the beginning of the study and 8 weeks after the intervention. Method of measurement: Using digital weighing scale with an accuracy of 0.1 kg.;Insulin resistance (Homa-IR). Timepoint: At the beginning of the study and 8 weeks after the intervention. Method of measurement: Using following formula: HOMA-IR= fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5. | — |
Secondary
| Measure | Time frame |
|---|---|
| Glycemic indices (Fasting blood sugar, Fasting Insulin, HbA1c). Timepoint: At the beginning of the study and 8 weeks after the intervention. Method of measurement: Using a special kit and an autoanalyzer device.;QUICKI. Timepoint: At the beginning of the study and 8 weeks after the intervention. Method of measurement: Using the following formula: ((QUICKI=1/[log(10) + log(G0)] (10 = fasting insulin (µU/ml), G0 = fasting glucose (mg/dl.;Lipid profile (HDL, LDL, Total cholesterol, Triglycerides). Timepoint: At the beginning of the study and 8 weeks after the intervention. Method of measurement: Using a special kit and an autoanalyzer device.;Hormonal indices (LH, FSH, Testosterone, 17-OH progesterone, DHEA-SO4). Timepoint: At the beginning of the study and 8 weeks after the intervention. Method of measurement: Using a special kit and an autoanalyzer device.;Blood pressure. Timepoint: At the beginning of the study and 8 weeks after the intervention. Method of measurement: Using a sphygmomanometer.;Anthropometric indices. Timepoint: At the beginning of the study and 8 weeks after the intervention. Method of measurement: Using meter, body analyzer device and special formulas.;Acne. Timepoint: At the beginning of the study and 8 weeks after the intervention. Method of measurement: Using Global Acne Grading System (GAGS).;Hirsutism. Timepoint: At the beginning of the study and 8 weeks after the intervention. Method of measurement: Using the Ferriman-Gallwey scoring system.;Menstrual cycle regulation. Timepoint: At the beginning of the study and 8 weeks after the intervention. Method of measurement: Using general questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactFaranak TaghipourSheshdeh
Shiraz University of Medical Sciences
Outcome results
None listed