Effectiveness of Time-Restricted Feeding(TRF) on Overweight/Obese Women with Polycystic Ovarian Syndrome(PCOS): a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Change in insulin resistance
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •BMI≥24kg/m2
- •Polycystic ovary syndrome has been diagnosed
排除标准
- •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.
结局指标
主要结局
Change in insulin resistance
时间窗: Baseline and 16 weeks
Insulin resistance will be assessed by HOMA-IR
Changes in body weight (Kilograms)
时间窗: Baseline and 16 weeks
Changes in body weight (Kilograms)
次要结局
- Change in BMI(Baseline and 16 weeks)
- Changes in waist circumference (cm)(Baseline and 16 weeks)
- Change in Body fat percent(Baseline and 16 weeks)
- Changes in Waist-to-Hip Ratio(WHR)(Baseline and 16 weeks)
- Change in Fat mass(Baseline and 16 weeks)
- Change in CHO level(Baseline and 16 weeks)
- Changes in systolic pressure（SBP）(Baseline and 16 weeks)
- Changes in diastolic pressure (DBP）(Baseline and 16 weeks)
- Change in HDL level(Baseline and 16 weeks)
- Change in LDL-c level(Baseline and 16 weeks)
- Change in Fasting Blood Glucose (FBG) level(Baseline and 16 weeks)
- Change in Skeletal muscle mass(Baseline and 16 weeks)
- Change in TG level(Baseline and 16 weeks)
- Change in ALT level(Baseline and 16 weeks)
- Change in AST level(Baseline and 16 weeks)
- Change in GGT level(Baseline and 16 weeks)
- Change in Testosterone level(Baseline and 16 weeks)
- Change in Sex hormone binding globulin (SHBG) level(baseline and 16 weeks)
- Change in Free androgen index （FAI）(Basline and 16 weeks)
- Change in Ferriman-Gallway score （F-G score:）(Baseline and 16 weeks)