Time-restricted Feeding for Treating Polycystic Ovary Syndrome (PCOS)

Study Overview
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Brief Summary
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Intermittent fasting is an increasingly popular diet pattern of alternating eating and dieting.One particular form of intermittent fasting is the so-called time-restricted feeding (TRF). TRF allows for ad libitum feeding within a large window of time each day, and does not require any calorie counting. There is growing evidence that it can lose weight, reduce insulin resistance and improve cardiometabolic health. Polycystic ovary syndrome (PCOS) is the most common reproductive endocrine and metabolic disease affecting women of childbearing age. PCOS shows anovulation or oligoovulation, hyperandrogenemia and ovarian polycystic changes. Insulin resistance and obesity are common features of PCOS. Whether the TRF impacts women with PCOS is still unknown due to the paucity of data in this area. To explore the effects of TRF on the endocrine and metabolic profile in overweight women with PCOS, a 6-week single-arm trial, divided into 2 consecutive periods: (1) 1-week baseline period; and (2) 5-week TRF period, will be implemented.

Official Title
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Effects of 16:8 Time-restricted Feeding on the Endocrine and Metabolic Profile in Overweight Women With Polycystic Ovary Syndrome

Conditions
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Polycystic Ovary Syndrome, Overweight, Obesity

Intervention / Treatment
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* Behavioral: Time-Restricted Feeding


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years; BMI≥24kg/m2; Anovulation; Rott-PCOS. Exclusion Criteria: Taking weight loss or regulate hormone secretion medications in recent 6 months; The body weight fluctuated more than 5% in the past 3 months; Preparation for pregnancy, having been in pregnancy or lactation; Perimenopausal; Night-shift workers; Fasting more than 16 hours a day; Hypotension; Patients with other diseases (such as congenital adrenal hyperplasia, Cushing syndrome, androgen-secreting tumors, hyperprolactinemia, diabetes, thyroid diseases, severe serious cardiovascular, gastrointestinal, kidney or liver diseases); Alcohol intake more than 100g per week; Smoking within 3 months; Engaging in high-intensity exercise.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Time-Restricted Feeding<br>Participants will receive 16:8 TRF. | Behavioral: Time-Restricted Feeding<br>* The trial consists of a 1-week baseline weight stabilization period followed by a 5-week TRF intervention period. Participants will be instructed to eat freely from 8 a.m. to 4 p.m. daily and fast from 4 p.m. to 8 a.m. the next day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin resistance | Will be assessed by homeostasis model assessment-insulin resistance (HOMA-IR) | 5-week intervention period | 
| Sex hormone-binding globulin (nmol/L) |  | 5-week intervention period | 
| Body Mass Index (BMI) (kg/m^2) | Weight (kg) and height (m) will be combined to report BMI | 5-week intervention period | 
| Waist-to-Hip Ratio (WHR) | Waist and hip will be combined to report WHR | 5-week intervention period | 
| Free androgen index (FAI) (%) |  | 5-week intervention period | 
| Total testosterone (TT) (ng/mL) |  | 5-week intervention period | 
| Area under the curve (AUC) for insulin | Insulin release test will be conducted | 5-week intervention period | 
| Area under the curve (AUC) for glucose | Glucose tolerance test will be conducted | 5-week intervention period | 
| Area under the curve (AUC) for insulin/Area under the curve (AUC) for glucose | Glucose tolerance test will be conducted | 5-week intervention period | 
| Fasting insulin (FINS) (mU/L) |  | 5-week intervention period | 
| Fasting blood glucose (FBG) (mmol/L) |  | 5-week intervention period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dietary behavior | Measured by the Three Factor Eating Questionnaire Revised 21 Item (TFEQ-R21) questionnaire | 5-week intervention period | 
| Time to return to normal menstrual cycle |  | 5-week intervention period | 
| Insulin-like growth factor 1 (IGF-1) (ng/mL) |  | 5-week intervention period | 
| Body fat (kg) | Measured by InBody, a body composition analyzer | 5-week intervention period | 
| Body fat percentage (%) | Measured by InBody, a body composition analyzer | 5-week intervention period | 
| Visceral fat area (cm^2) | Measured by InBody, a body composition analyzer | 5-week intervention period | 
| Skeletal muscle content (kg) | Measured by InBody, a body composition analyzer | 5-week intervention period | 
| High-sensitivity C-reactive protein (hs-CRP) (mg/L) | A kind of inflammatory biomarker | 5-week intervention period |