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Polycystic Ovary Syndrome (PCOS)TRF-PCOSNCT03792282

Time-Restricted Feeding(TRF) on Overweight/Obese Women with Polycystic Ovarian Syndrome (PCOS)

A study testing Time Restricted Feeding in people with Polycystic Ovary Syndrome (PCOS) and Overweight and Obesity, run by The First Affiliated Hospital of Xiamen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years, women only
What is being tested?
Time Restricted Feeding
Could I receive a placebo?
No, everyone receives an active treatment
How many people
93 participants
Where
1 siteChina
Study dates
7 Jan 2019to 31 Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The first afilliated hospital of Xiamen university

    Xiamen, Fujian, 361003

Other trials in China

About this study

Official title: Effectiveness of Time-Restricted Feeding(TRF) on Overweight/Obese Women with Polycystic Ovarian Syndrome(PCOS): a Randomized Controlled Trial

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.

Read the detailed description

Intermittent fasting regimens involve periods fasting followed by periods of eating freely. Time-Restricted Feeding (TRF) is a new form of intermittent fasting and involves shortening the eating window to 4-10 h/day. TRF is a safe lifestyle intervention for weight loss in adults with obesity. Accumulating evidence suggests that TRF is an effective means of decreasing body weight and improving insulin resistance but did not have any negative impact on eating disorder symptoms, body image perception, or eating behaviors. Polycystic ovary syndrome (PCOS) is the most common endocrine condition in productive-aged women. About 60-70 % of women with PCOS are obese or overweight, and obesity is associated with insulin resistance. Since many women with PCOS seem to have insulin resistance, compensatory hyperinsulinemia is thought to contribute to hyperandrogenism by direct stimulation of ovarian production of androgens and by inhibition of liver synthesis of SHGB. It is important to ameliorate insulin resistance in PCOS patients.The aims of the present study is to examine whether TRF is a safe and effective regimen to improve insulin resistance and decrease body weight in overweight/obese PCOS patients.

Being tested
Time Restricted Feeding, Usual care
Keywords
Polycystic Ovary Syndrome, Overweight and Obesity, Time-Restricted Feeding, Intermittent fasting regimens
Medical subject headings
Polycystic Ovary Syndrome, Overweight, Obesity, Intermittent Fasting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Time Restricted FeedingBehavioural

    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).

  • Usual careBehavioural

    Participants receive a general lifestyle counseling.

Study groups in NCT03792282
Study groupRoleWhat they receive
TRFExperimentalParticipants in this group will focus on time restricted feeding (TRF) in addition to daily calorie restriction.
Receives: Behavioral: Time Restricted Feeding
Usual careActive comparatorParticipants in this group will receive a general lifestyle counseling.
Receives: Behavioral: Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in body weight (Kilograms)

    Changes in body weight (Kilograms)

    Measured: Baseline and 16 weeks

  2. Change in insulin resistance

    Insulin resistance will be assessed by HOMA-IR

    Measured: Baseline and 16 weeks

Secondary outcomes (20)

  1. Change in BMI

    Measured: Baseline and 16 weeks

  2. Changes in waist circumference (cm)

    Measured: Baseline and 16 weeks

  3. Changes in Waist-to-Hip Ratio(WHR)

    Measured: Baseline and 16 weeks

  4. Changes in systolic pressure（SBP）

    Measured: Baseline and 16 weeks

  5. Changes in diastolic pressure (DBP）

    Measured: Baseline and 16 weeks

  6. Change in Body fat percent

    Measured: Baseline and 16 weeks

  7. Change in Fat mass

    Measured: Baseline and 16 weeks

  8. Change in Skeletal muscle mass

    Measured: Baseline and 16 weeks

  9. Change in CHO level

    Measured: Baseline and 16 weeks

  10. Change in TG level

    Measured: Baseline and 16 weeks

  11. Change in HDL level

    Measured: Baseline and 16 weeks

  12. Change in LDL-c level

    Measured: Baseline and 16 weeks

  13. Change in Fasting Blood Glucose (FBG) level

    Measured: Baseline and 16 weeks

  14. Change in ALT level

    Measured: Baseline and 16 weeks

  15. Change in AST level

    Measured: Baseline and 16 weeks

  16. Change in GGT level

    Measured: Baseline and 16 weeks

  17. Change in Testosterone level

    Measured: Baseline and 16 weeks

  18. Change in Sex hormone binding globulin (SHBG) level

    Measured: baseline and 16 weeks

  19. Change in Free androgen index （FAI）

    Measured: Basline and 16 weeks

  20. Change in Ferriman-Gallway score （F-G score:）

    Measured: Baseline and 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jan 2019
  2. Study start7 Jan 2019
  3. Primary completion30 Jun 2023
  4. Study completion31 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03792282
Sponsor's protocol ID
KYH2018-017
Acronym
TRF-PCOS
Status last verified
Feb 2025
First submitted
30 Dec 2018
Last updated
18 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33512717

Questions about this trial

What is this clinical trial studying?

A study testing Time Restricted Feeding in people with Polycystic Ovary Syndrome (PCOS) and Overweight and Obesity, run by The First Affiliated Hospital of Xiamen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in body weight (Kilograms) (time frame: Baseline and 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03792282, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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