Clinical trial · Interventional
Time-Restricted Feeding(TRF) on Overweight/Obese Women with Polycystic Ovarian Syndrome (PCOS)
Effectiveness of Time-Restricted Feeding(TRF) on Overweight/Obese Women with Polycystic Ovarian Syndrome(PCOS): a Randomized Controlled Trial
NCT03792282CI-TRIAL-00086152TRF-PCOScompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Overweight and Obesity | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome (PCOS) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Time Restricted Feeding | Behavioral | — | UNRESOLVED |
| Usual care | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TRF
- description
- Participants in this group will focus on time restricted feeding (TRF) in addition to daily calorie restriction.
- interventionNames
- Behavioral: Time Restricted Feeding
- type
- ACTIVE_COMPARATOR
- label
- Usual care
- description
- Participants in this group will receive a general lifestyle counseling.
- interventionNames
- Behavioral: Usual care
Primary outcomes (2)
- measure
- Changes in body weight (Kilograms)
- timeFrame
- Baseline and 16 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * BMI≥24kg/m2 * Polycystic ovary syndrome has been diagnosed Exclusion Criteria: * 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.
References
Publications (1)
- DERIVEDAllaf 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 33512717