Clinical trial · Interventional
Comparison of Intermittent Fasting and Caloric Deficit for Weight Loss in Women With Polycystic Ovarian Syndrome
Intermittent Fasting and Polycystic Ovarian Syndrome
NCT04452968CI-TRIAL-00048505completedN/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)
Time restricted feeding (TRF) has been emerging as a potential weight loss strategy that avoids major dietary changes but achieves strong effects. It also improves insulin sensitivity through increased human growth hormone. This effect helps to improve the root cause of weight gain and has additional benefits for women with PCOS.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intermittent Fasting | — | UNRESOLVED | — |
| Polycystic Ovarian Syndrome | — | UNRESOLVED | — |
| Weight Loss | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Caloric restriction | Behavioral | — | UNRESOLVED |
| intermittent fasting | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- intermittent fasting
- description
- Daily caloric requirement was calculated using basal metabolic rate (BMR) calculator. All women were directed to decrease calorie intake by 500 calories. Women were told about timed restricted feeding. They were required to fast for 16 hours and consume their allotted calories during the remaining 8 hours.
- interventionNames
- Behavioral: intermittent fasting
- Behavioral: Caloric restriction
- type
- ACTIVE_COMPARATOR
- label
- caloric restriction
- description
- Daily caloric requirement was calculated using basal metabolic rate (BMR) calculator. All women were directed to decrease calorie intake by 500 calories.
- interventionNames
- Behavioral: Caloric restriction
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 35 Years
Show eligibility criteria text
Inclusion Criteria: * PCOS as described by Rotterdam's criteria Exclusion Criteria: * endocrine disorders * diabetic * hypertensive * 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; * pregnant * 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 (0)
Data not yet available
No reference posted for this study.