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

Not Applicable

Completed

• Conditions: Polycystic Ovary Syndrome; Overweight; Obesity
• Interventions: Behavioral: Time-Restricted Feeding

• Registration Number: NCT04580433
• Lead Sponsor: Chunzhu Li

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-22
• Study First Submitted QC: 2020-10-07
• Study First Posted: 2020-10-08
• Study Start: 2020-11-01
• Primary Completion: 2021-01-16
• Study Completion: 2021-01-16
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-14
• Last Update Posted: 2021-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Time-Restricted Feeding	Time-Restricted Feeding	Participants will receive 16:8 TRF.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shengjing Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China