Time-Restricted Feeding(TRF) on Overweight/Obese Women With Polycystic Ovarian Syndrome (PCOS)

Study Overview
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Brief Summary
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The aims of the present study is to examine whether Time-Restricted Feeding (TRF) is a safe and effective regimen to improve insulin resistance and decrease body weight in overweight/obese Polycystic ovary syndrome (PCOS) patients over 16 weeks compared to reduced energy restriction.

Detailed Description
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Intermittent fasting regimens involve periods fasting followed by periods of eating freely. Time-Restricted Feeding (TRF) is a new form of intermittent fasting and involves shortening the eating window to 4-10 h/day. TRF is a safe lifestyle intervention for weight loss in adults with obesity. Accumulating evidence suggests that TRF is an effective means of decreasing body weight and improving insulin resistance but did not have any negative impact on eating disorder symptoms, body image perception, or eating behaviors. Polycystic ovary syndrome (PCOS) is the most common endocrine condition in productive-aged women. About 60-70 % of women with PCOS are obese or overweight, and obesity is associated with insulin resistance. Since many women with PCOS seem to have insulin resistance, compensatory hyperinsulinemia is thought to contribute to hyperandrogenism by direct stimulation of ovarian production of androgens and by inhibition of liver synthesis of SHGB. It is important to ameliorate insulin resistance in PCOS patients.The aims of the present study is to examine whether TRF is a safe and effective regimen to improve insulin resistance and decrease body weight in overweight/obese PCOS patients.

Official Title
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Effectiveness of Time-Restricted Feeding(TRF) on Overweight/Obese Women With Polycystic Ovarian Syndrome(PCOS): A Randomized Controlled Trial

Conditions
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Polycystic Ovary Syndrome (PCOS), Overweight and Obesity

Intervention / Treatment
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* Behavioral: Time Restricted Feeding
* Behavioral: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years BMI≥24kg/m2 Polycystic ovary syndrome 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 tumors; 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TRF<br>Participants in this group will focus on time restricted feeding (TRF) in addition to daily calorie restriction. | Behavioral: Time Restricted Feeding<br>* Participants will receive a diet of 1200-1500kcal/d and be instructed to eat only during a window of 8 hours (Finishing the last meal before 4pm).<br>|
| Active Comparator: Usual care<br>Participants in this group will receive a general lifestyle counseling. | Behavioral: Usual care<br>* Participants receive a general lifestyle counseling.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in body weight (Kilograms) | Changes in body weight (Kilograms) | Baseline and 16 weeks | 
| Change in insulin resistance | Insulin resistance will be assessed by HOMA-IR | Baseline and 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in waist circumference (cm) |  | Baseline and 16 weeks | 
| Changes in abdominal circumference (cm) |  | Baseline and 16 weeks | 
| Changes in systolic pressure（SBP） |  | Baseline and 16 weeks | 
| Changes in diastolic pressure (DBP） |  | Baseline and 16 weeks | 
| Change in β cell function | β cell function will be assessed by HOMA-β | Baseline and 16 weeks | 
| Change in LDL-c level |  | Baseline and 16 weeks | 
| Change in TG level |  | Baseline and 16 weeks | 
| Change in CHO level |  | Baseline and 16 weeks | 
| Change in liver fiber | liver fiber will be assessed by Controlled attenuation parameter (CAP) evaluated with transient elastography (FibroScan®) Fibroscan | Baseline and 16 weeks | 
| Changes in systemic Inflammatory biomarkers | Inflammatory biomarkers (TNFa,CRP and Interleukin-6) are measured by ELISA (enzyme-linked immunosorbent assay). | Baseline and 16 weeks | 
| Changes in Oxidative stress markers | Oxidative stress markers include the circulating levels of Catalase,Glutathione Peroxidase, and Malondialdehyde. | Baseline and 16 weeks | 
| Change in depressive symptoms as assessed by Patient Health Questionnaire-9 |  | 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) |  | Baseline and 16 weeks | 
| Changes in time to return to normal menstrual cycle | Changes in time to return to normal menstrual cycle | Baseline and 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polycystic Ovary Syndrome, Overweight and Obesity, Time-Restricted Feeding, Intermittent fasting regimens