Clinical trial NCT03792282: Time-Restricted Feeding(TRF) on Overweight/Obese Women with Polycystic Ovarian Syndrome (PCOS)
Official title: Effectiveness of Time-Restricted Feeding(TRF) on Overweight/Obese Women with Polycystic Ovarian Syndrome(PCOS): a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome (PCOS)
Overweight and Obesity
Keywords: Polycystic Ovary Syndrome
Overweight and Obesity
Time-Restricted Feeding
Intermittent fasting regimens
Lead sponsor: The First Affiliated Hospital of Xiamen University
Sponsor class: OTHER
First posted: 2019-01-03
Enrollment: 93
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 ovary syndrome (PCOS) patients over 16 weeks compared to reduced energy restriction.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in body weight (Kilograms)
timeFrame: Baseline and 16 weeks
measure: Change in insulin resistance
timeFrame: Baseline and 16 weeks
Secondary outcomes:
measure: Change in BMI
timeFrame: Baseline and 16 weeks
measure: Changes in waist circumference (cm)
timeFrame: Baseline and 16 weeks
measure: Changes in Waist-to-Hip Ratio(WHR)
timeFrame: Baseline and 16 weeks
measure: Changes in systolic pressure（SBP）
timeFrame: Baseline and 16 weeks
measure: Changes in diastolic pressure (DBP）
timeFrame: Baseline and 16 weeks
measure: Change in Body fat percent
timeFrame: Baseline and 16 weeks
measure: Change in Fat mass
timeFrame: Baseline and 16 weeks
measure: Change in Skeletal muscle mass
timeFrame: Baseline and 16 weeks
measure: Change in CHO level
timeFrame: Baseline and 16 weeks
measure: Change in TG level
timeFrame: Baseline and 16 weeks
measure: Change in HDL level
timeFrame: Baseline and 16 weeks
measure: Change in LDL-c level
timeFrame: Baseline and 16 weeks
measure: Change in Fasting Blood Glucose (FBG) level
timeFrame: Baseline and 16 weeks
measure: Change in ALT level
timeFrame: Baseline and 16 weeks
measure: Change in AST level
timeFrame: Baseline and 16 weeks
measure: Change in GGT level
timeFrame: Baseline and 16 weeks
measure: Change in Testosterone level
timeFrame: Baseline and 16 weeks
measure: Change in Sex hormone binding globulin (SHBG) level
timeFrame: baseline and 16 weeks
measure: Change in Free androgen index （FAI）
timeFrame: Basline and 16 weeks
measure: Change in Ferriman-Gallway score （F-G score:）
timeFrame: Baseline and 16 weeks
Other outcomes:
Locations:
city: Xiamen
country: China
facility: The first afilliated hospital of Xiamen university
state: Fujian
Study officials:
affiliation: The first afilliated hospital of Xiamen university
name: Changqin Liu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.