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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Polycystic Ovary Syndrome; Overweight
• Intervention / Treatment: Behavioral: Time-Restricted Feeding

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110004
      • Shengjing Hospital of China Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Time-Restricted Feeding; Participants will receive 16:8 TRF.	Behavioral: Time-Restricted Feeding; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Time Frame
Luteinizing hormone (LH) (mIU/mL)	5-week intervention period
Follicle-stimulating hormone (FSH) (mIU/mL)	5-week intervention period
LH/FSH	5-week intervention period
Uric acid (UA) (umol/L)	5-week intervention period
Alanine aminotransferase (ALT) (U/L)	5-week intervention period
Aspartate aminotransferase (AST) (U/L)	5-week intervention period
Total cholesterol (TC) (mmol/L)	5-week intervention period
Triglycerides (TG) (mmol/L)	5-week intervention period
Low density lipoprotein-cholesterol (LDL-C) (mmol/L)	5-week intervention period
Body weight (kg)	5-week intervention period

Collaborators and Investigators

• Sponsor: Chunzhu Li
• Collaborators: National Natural Science Foundation of China
• Investigators: Principal Investigator: Bing He, phD, Shengjing Hospital affiliated to China Medical University; Principal Investigator: Chunzhu Li, MD, Shengjing Hospital affiliated to China Medical University

Publications and helpful links

General Publications

• Li C, Xing C, Zhang J, Zhao H, Shi W, He B. Eight-hour time-restricted feeding improves endocrine and metabolic profiles in women with anovulatory polycystic ovary syndrome. J Transl Med. 2021 Apr 13;19(1):148. doi: 10.1186/s12967-021-02817-2.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2020
• Primary Completion (ACTUAL): January 16, 2021
• Study Completion (ACTUAL): January 16, 2021

Study Registration Dates

• First Submitted: September 22, 2020
• First Submitted That Met QC Criteria: October 7, 2020
• First Posted (ACTUAL): October 8, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 19, 2021
• Last Update Submitted That Met QC Criteria: April 14, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Body Weight; Polycystic Ovary Syndrome; Syndrome; Overweight
• Other Study ID Numbers: 2020161820

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No