NCT03792282.

Study name	Time‐Restricted Feeding(TRF) on overweight/obese women with Polycystic Ovarian Syndrome (PCOS) (TRF‐PCOS)
Methods	Randomised controlled trial
Participants	18 years to 50 years, fFemales Inclusion Criteria Age ≥ 18 years BMI≥ 24 kg/m2 PCOS has been diagnosed Exclusion Criteria Taking medications affecting weight or energy intake/energy expenditure in the last 6 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician The body weight fluctuated more than 5% in recent 3 months Liver and kidney dysfunction: renal impairment, creatinine clearance rate < 30 mL/min/1.73 m2, transaminase increased, more than three times higher than the normal limit History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months History of thyroid diseases Having been in pregnancy Researchers believe that there are any factors that affect assessing subjects' participation in trial History of malignant tumours History of Cushing's syndrome, hypothyroidism, acromegaly, hypothalamic obesity Currently participating in weight loss programs or weight change in the past 3 months (> 5% current body weight) Patients who cannot be followed for 16 months (due to a health situation or migration) Patients who are unwilling or unable to give informed consent
Interventions	Experimental: TRF Participants in this group will focus on time‐restricted feeding (TRF) in addition to daily calorie restriction. Active Comparator: RCD Participants in this group will focus on daily reduced calorie diet (RCD).
Outcomes	Primary Outcome Measures :Changes in body weight (Kilograms) [ Time Frame: Baseline and 16 weeks ]Changes in body weight (kg) Change in insulin resistance [ Time Frame: Baseline and 16 weeks ]Insulin resistance will be assessed by HOMA‐IR Secondary Outcome Measures:Changes in waist circumference (cm) [ Time Frame: Baseline and 16 weeks ] Changes in abdominal circumference (cm) [ Time Frame: Baseline and 16 weeks ] Changes in systolic pressure（SBP） [ Time Frame: Baseline and 16 weeks ] Changes in diastolic pressure (DBP） [ Time Frame: Baseline and 16 weeks ] Change in β cell function [ Time Frame: Baseline and 16 weeks ]β cell function will be assessed by HOMA‐β Change in LDL‐c level [ Time Frame: Baseline and 16 weeks ] Change in TG level [ Time Frame: Baseline and 16 weeks ] Change in CHO level [ Time Frame: Baseline and 16 weeks ] Change in liver fibre [ Time Frame: Baseline and 16 weeks ]liver fibre will be assessed by Controlled attenuation parameter (CAP) evaluated with transient elastography (FibroScan®) Fibroscan Changes in systemic Inflammatory biomarkers [ Time Frame: Baseline and 16 weeks ]Inflammatory biomarkers (TNFa,CRP and Interleukin‐6) are measured by ELISA (enzyme‐linked immunosorbent assay). Changes in Oxidative stress markers [ Time Frame: Baseline and 16 weeks ]Oxidative stress markers include the circulating levels of Catalase,Glutathione Peroxidase, and Malondialdehyde. Change in depressive symptoms as assessed by Patient Health Questionnaire‐9 [ Time Frame: Baseline and 16 weeks ] Change in quality of life measured by the 12‐item Short‐Form Health Survey Quality of life measured by the 12‐item Short‐Form Health Survey Questionnaire (SF‐12) [ Time Frame: Baseline and 16 weeks ] Changes in time to return to normal menstrual cycle [ Time Frame: Baseline and 16 weeks ]Changes in time to return to normal menstrual cycle
Starting date	03/01/2019
Contact information	liuchangqin@xmu.edu.cn
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