NCT03792282

Brief Summary

The aims of the present study is to examine whether Time-Restricted Feeding (TRF) is a safe and effective regimen to improve insulin resistance and decrease body weight in overweight/obese Polycystic ovary syndrome (PCOS) patients over 16 weeks compared to reduced energy restriction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 3, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

January 7, 2019

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

February 18, 2025

Status Verified

February 1, 2025

Enrollment Period

4.5 years

First QC Date

December 30, 2018

Last Update Submit

February 14, 2025

Conditions

Polycystic Ovary Syndrome (PCOS)Overweight and Obesity

Keywords

Polycystic Ovary SyndromeOverweight and ObesityTime-Restricted FeedingIntermittent fasting regimens

Outcome Measures

Primary Outcomes (2)

  • Changes in body weight (Kilograms)

    Changes in body weight (Kilograms)

    Baseline and 16 weeks

  • Change in insulin resistance

    Insulin resistance will be assessed by HOMA-IR

    Baseline and 16 weeks

Secondary Outcomes (20)

  • Change in BMI

    Baseline and 16 weeks

  • Changes in waist circumference (cm)

    Baseline and 16 weeks

  • Changes in Waist-to-Hip Ratio(WHR)

    Baseline and 16 weeks

  • Changes in systolic pressure（SBP）

    Baseline and 16 weeks

  • Changes in diastolic pressure (DBP）

    Baseline and 16 weeks

  • +15 more secondary outcomes

Study Arms (2)

TRF

EXPERIMENTAL

Participants in this group will focus on time restricted feeding (TRF) in addition to daily calorie restriction.

Behavioral: Time Restricted Feeding

Usual care

ACTIVE COMPARATOR

Participants in this group will receive a general lifestyle counseling.

Behavioral: Usual care

Interventions

Time Restricted FeedingBEHAVIORAL

Participants will receive a diet of 1200-1500kcal/d and be instructed to eat only during a window of 8 hours (Finishing the last meal before 4pm).

TRF
Usual careBEHAVIORAL

Participants receive a general lifestyle counseling.

Usual care

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly women have the PCOS.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age ≥ 18 years
  • BMI≥24kg/m2
  • Polycystic ovary syndrome has been diagnosed

You may not qualify if:

  • Taking medications affecting weight or energy intake/energy expenditure in the last 6 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician;
  • The body weight fluctuated more than 5% in recent 3 months.
  • Liver and kidney dysfunction: renal impairment, creatinine clearance rate \< 30 mL/min/1.73 m2, transaminase increased, more than three times higher than the normal limit;
  • History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months;
  • History of thyroid diseases;
  • Having been in pregnancy.
  • Researchers believe that there are any factors that affect assessing subjects' participation in trial.
  • History of malignant tumors;
  • History of Cushing's syndrome, hypothyroidism, acromegaly, hypothalamic obesity;
  • Currently participating in weight loss programs or weight change in the past 3 months (\> 5% current body weight)
  • Patients who cannot be followed for 16 months (due to a health situation or migration)
  • Patients who are unwilling or unable to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The first afilliated hospital of Xiamen university

Xiamen, Fujian, 361003, China

Location

Related Publications (1)

  • Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.

    PMID: 33512717DERIVED

MeSH Terms

Conditions

Polycystic Ovary SyndromeOverweightObesityIntermittent Fasting

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFastingFeeding BehaviorBehavior

Study Officials

  • Changqin Liu, MD

    The first afilliated hospital of Xiamen university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2018

First Posted

January 3, 2019

Study Start

January 7, 2019

Primary Completion

June 30, 2023

Study Completion

July 31, 2023

Last Updated

February 18, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)