Status:
COMPLETED
Time-Restricted Feeding(TRF) on Overweight/Obese Women with Polycystic Ovarian Syndrome (PCOS)
Lead Sponsor:
The First Affiliated Hospital of Xiamen University
Conditions:
Polycystic Ovary Syndrome (PCOS)
Overweight and Obesity
Eligibility:
FEMALE
18-50 years
Phase:
NA
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 ...
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 windo...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- BMI≥24kg/m2
- Polycystic ovary syndrome has been diagnosed
Exclusion
- 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.
Key Trial Info
Start Date :
January 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2023
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT03792282
Start Date
January 7 2019
End Date
July 31 2023
Last Update
February 18 2025
Active Locations (1)
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1
The first afilliated hospital of Xiamen university
Xiamen, Fujian, China, 361003