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

NCT04580433 | Completed

• 1 other identifier: 2020161820
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome; Overweight; Obesity

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (8)

• Dietary behavior

  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)

  5-week intervention period

• Body fat percentage (%)

  5-week intervention period

Other Outcomes (10)

• 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

Study Arms (1)

Time-Restricted Feeding

EXPERIMENTAL

Participants will receive 16:8 TRF.

Behavioral: Time-Restricted Feeding

Interventions

Time-Restricted Feeding BEHAVIORAL

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.

Time-Restricted Feeding

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Only women with PCOS.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age ≥ 18 years; BMI≥24kg/m2; Anovulation; Rott-PCOS.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chunzhu Li: lead
• National Natural Science Foundation of China: collaborator

Study Sites (1)

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

Location

Related Publications (1)

• 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.

  PMID: 33849562 DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Overweight; Obesity

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bing He, phD

  Shengjing Hospital

  PRINCIPAL INVESTIGATOR

• Chunzhu Li, MD

  Shengjing Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: October 8, 2020
• Study Start: November 1, 2020
• Primary Completion: January 16, 2021
• Study Completion: January 16, 2021
• Last Updated: April 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)