Effects of 16:8 Time-restricted Feeding on the Endocrine and Metabolic Profile in Overweight Women With Polycystic Ovary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Insulin resistance
研究概览
简要总结
Intermittent fasting is an increasingly popular diet pattern of alternating eating and dieting.One particular form of intermittent fasting is the so-called time-restricted feeding (TRF). TRF allows for ad libitum feeding within a large window of time each day, and does not require any calorie counting. There is growing evidence that it can lose weight, reduce insulin resistance and improve cardiometabolic health. Polycystic ovary syndrome (PCOS) is the most common reproductive endocrine and metabolic disease affecting women of childbearing age. PCOS shows anovulation or oligoovulation, hyperandrogenemia and ovarian polycystic changes. Insulin resistance and obesity are common features of PCOS. Whether the TRF impacts women with PCOS is still unknown due to the paucity of data in this area. To explore the effects of TRF on the endocrine and metabolic profile in overweight women with PCOS, a 6-week single-arm trial, divided into 2 consecutive periods: (1) 1-week baseline period; and (2) 5-week TRF period, will be implemented.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years; BMI≥24kg/m2; Anovulation; Rott-PCOS.
排除标准
- •Taking weight loss or regulate hormone secretion medications in recent 6 months; The body weight fluctuated more than 5% in the past 3 months; Preparation for pregnancy, having been in pregnancy or lactation; Perimenopausal; Night-shift workers; Fasting more than 16 hours a day; Hypotension; Patients with other diseases (such as congenital adrenal hyperplasia, Cushing syndrome, androgen-secreting tumors, hyperprolactinemia, diabetes, thyroid diseases, severe serious cardiovascular, gastrointestinal, kidney or liver diseases); Alcohol intake more than 100g per week; Smoking within 3 months; Engaging in high-intensity exercise.
结局指标
主要结局
Insulin resistance
时间窗: 5-week intervention period
Will be assessed by homeostasis model assessment-insulin resistance (HOMA-IR)
Waist-to-Hip Ratio (WHR)
时间窗: 5-week intervention period
Waist and hip will be combined to report WHR
Area under the curve (AUC) for insulin/Area under the curve (AUC) for glucose
时间窗: 5-week intervention period
Glucose tolerance test will be conducted
Free androgen index (FAI) (%)
时间窗: 5-week intervention period
Area under the curve (AUC) for insulin
时间窗: 5-week intervention period
Insulin release test will be conducted
Area under the curve (AUC) for glucose
时间窗: 5-week intervention period
Glucose tolerance test will be conducted
Sex hormone-binding globulin (nmol/L)
时间窗: 5-week intervention period
Body Mass Index (BMI) (kg/m^2)
时间窗: 5-week intervention period
Weight (kg) and height (m) will be combined to report BMI
Total testosterone (TT) (ng/mL)
时间窗: 5-week intervention period
Fasting blood glucose (FBG) (mmol/L)
时间窗: 5-week intervention period
Fasting insulin (FINS) (mU/L)
时间窗: 5-week intervention period
次要结局
- Body fat (kg)(5-week intervention period)
- Body fat percentage (%)(5-week intervention period)
- Skeletal muscle content (kg)(5-week intervention period)
- High-sensitivity C-reactive protein (hs-CRP) (mg/L)(5-week intervention period)
- Dietary behavior(5-week intervention period)
- Insulin-like growth factor 1 (IGF-1) (ng/mL)(5-week intervention period)
- Time to return to normal menstrual cycle(5-week intervention period)
- Visceral fat area (cm^2)(5-week intervention period)
研究者
Chunzhu Li
Clinical Professor
Shengjing Hospital