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

NCT ID: NCT04580433

Last Updated: 2021-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2021-01-16

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Time-Restricted Feeding

Participants will receive 16:8 TRF.

Group Type: EXPERIMENTAL

Time-Restricted Feeding

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Natural Science Foundation of China

OTHER_GOV

Sponsor Role: collaborator

Chunzhu Li

OTHER

Sponsor Role: lead

Responsible Party

Chunzhu Li

Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Bing He, phD

Role: PRINCIPAL_INVESTIGATOR

Shengjing Hospital

Chunzhu Li, MD

Role: PRINCIPAL_INVESTIGATOR

Shengjing Hospital

Locations

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 33849562 (View on PubMed)

Other Identifiers

2020161820

Identifier Type: -

Identifier Source: org_study_id