Overweight and Obesity Clinical Trial
— TRF-PCOSOfficial title:
Effectiveness of Time-Restricted Feeding(TRF) on Overweight/Obese Women With Polycystic Ovarian Syndrome(PCOS): A Randomized Controlled Trial
Verified date | August 2023 |
Source | The First Affiliated Hospital of Xiamen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 93 |
Est. completion date | July 31, 2023 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | The first afilliated hospital of Xiamen university | Xiamen | Fujian |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital of Xiamen University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in body weight (Kilograms) | Changes in body weight (Kilograms) | Baseline and 16 weeks | |
Primary | Change in insulin resistance | Insulin resistance will be assessed by HOMA-IR | Baseline and 16 weeks | |
Secondary | Changes in waist circumference (cm) | Baseline and 16 weeks | ||
Secondary | Changes in abdominal circumference (cm) | Baseline and 16 weeks | ||
Secondary | Changes in systolic pressure(SBP) | Baseline and 16 weeks | ||
Secondary | Changes in diastolic pressure (DBP) | Baseline and 16 weeks | ||
Secondary | Change in ß cell function | ß cell function will be assessed by HOMA-ß | Baseline and 16 weeks | |
Secondary | Change in LDL-c level | Baseline and 16 weeks | ||
Secondary | Change in TG level | Baseline and 16 weeks | ||
Secondary | Change in CHO level | Baseline and 16 weeks | ||
Secondary | Change in liver fiber | liver fiber will be assessed by Controlled attenuation parameter (CAP) evaluated with transient elastography (FibroScan®) Fibroscan | Baseline and 16 weeks | |
Secondary | Changes in systemic Inflammatory biomarkers | Inflammatory biomarkers (TNFa,CRP and Interleukin-6) are measured by ELISA (enzyme-linked immunosorbent assay). | Baseline and 16 weeks | |
Secondary | Changes in Oxidative stress markers | Oxidative stress markers include the circulating levels of Catalase,Glutathione Peroxidase, and Malondialdehyde. | Baseline and 16 weeks | |
Secondary | Change in depressive symptoms as assessed by Patient Health Questionnaire-9 | Baseline and 16 weeks | ||
Secondary | Change in quality of life measured by the 12-item Short-Form Health Survey Quality of life measured by the 12-item Short-Form Health Survey Questionnaire (SF-12) | Baseline and 16 weeks | ||
Secondary | Changes in time to return to normal menstrual cycle | Changes in time to return to normal menstrual cycle | Baseline and 16 weeks |
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