Time Restricted Eating for the Treatment of Polycystic Ovarian Syndrome (PCOS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Change in percent body weight
研究概览
简要总结
BACKGROUND:
Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility among young women. This syndrome is a reproductive and endocrinological disorder that affects up to 18% of reproductive-aged women. To date, the only strategy shown to reverse PCOS is sustained weight loss of 5-10%. At present, daily calorie restriction (CR) is the main diet prescribed to patients with PCOS for weight loss. However, some women find it difficult to adhere to CR because calorie intake must be vigilantly monitored every day. Considering these problems with CR, another approach that limits timing of food intake, instead of number of calories consumed, has been developed. This diet is called "time restricted eating" (TRE) and involves confining the period of food intake to 6-8 h per day. TRE allows individuals to self-select foods and eat ad libitum during a large part of the day, which can increase compliance to these protocols. Recent findings show that TRE significantly reduces body weight and insulin resistance in adults with obesity. However, no randomized controlled trials have studied the role of TRE in treating PCOS.
OBJECTIVE:
We conducted a 6-month, randomized, controlled trial comparing the effects of 6-h TRE (eating all food between 1:00 pm to 7:00 pm, without calorie counting), versus CR (25% energy restriction daily), and a control group (eating over a period of 10 or more hours per day), on body weight and PCOS symptoms in a racially-ethnically diverse group of females with PCOS.
METHODS:
A 6-month randomized, controlled, parallel-arm trial will be implemented. Females with overweight/obesity and PCOS will be randomized to 1 of 3 groups: (1) 6-h TRE (eating all food between 1:00 pm to 7:00 pm, without calorie counting); (2) CR (25% energy restriction daily); or (3) control group (eating over a period of 10 or more hours per day).
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •4.1 Inclusion criteria:
- •Diagnosed with PCOS based on the Rotterdam criteria in which two of three of the following criteria are present: (i) androgen excess skin manifestations (hirsutism, acne, and seborrhea) and/or hyperandrogenemia (total testosterone >55 pg/ml, free testosterone >9.4 pg/ml, androstenedione >2.1 ng/ml or DHEA-S >340 ug/dl); (ii) polycystic ovarian morphology on ultrasound (ovarian volume >10 cc and /or antral follicle count 20 in at least one ovary); and (iii) chronic oligo-amenorrhea (intermenstrual intervals >35 days or 7 periods/year)
- •BMI between 25-50 kg/m2
- •Age between 18-45 years
排除标准
- •Postmenopausal (absence of menses for >2 y)
- •Diagnosed type 1 diabetes or type 2 diabetes
- •Previously diagnosed with a mood depressive disorder (by a doctor or psychologist)
- •Have a history of eating disorders (anorexia, bulimia, or binge eating disorder)
- •Are not weight stable for 3 months prior to the beginning of the study
- •Are taking drugs that affect study outcomes, such as oral contraceptives, weight loss, insulin-sensitizing agents, androgen antagonists, anti-seizure, or antipsychotic medication (within 2 months of starting study)
- •Are currently following a TRE protocol
- •Are athletes or those engaging in >1 hour of high-intensity training on more than 5 days/week
- •Are active smokers (within 3 months of starting the study)
- •Do not have a Wi-Fi connection at home (needed for zoom calls)
- •Pregnant or trying to become pregnant
研究组 & 干预措施
6-hour Time restricted eating (TRE)
Ad libitum food intake from 1-7 pm every day Fasting from 7-1 pm every day (18-h fast)
干预措施: 6-h Time restricted eating (TRE) (Other)
Calorie restriction (CR)
25% energy restriction every day
干预措施: Calorie restriction (CR) (Other)
Control
Usual diet, eating over >10 h per day
干预措施: Control (Other)
结局指标
主要结局
Change in percent body weight
时间窗: Measured at month 0 and 6
Measured by an electronic scale
次要结局
- Change in insulin resistance(Measured at month 0 and 6)
- Change in plasma lipids (LDL cholesterol, HDL cholesterol, triglycerides)(Measured at month 0 and 6)
- Change in menstrual regularity and blood loss(Measured at month 0 and 6)
- Change in waist circumference(Measured at month 0 and 6)
- Change in fat mass, lean mass, visceral fat mass(Measured at month 0 and 6)
- Change in insulin sensitivity(Measured at month 0 and 6)
- Change in fasting glucose(Measured at month 0 and 6)
- Change in fasting insulin(Measured at month 0 and 6)
- Change in HbA1c(Measured at month 0 and 6)
- Change in blood pressure(Measured at month 0 and 6)
- Change in heart rate(Measured at month 0 and 6)
- Change in reproductive hormones (testosterone, DHEA, SHBG)(Measured at month 0 and 6)
- Change in free androgen index (FAI)(Measured at month 0 and 6)
- Change in energy and nutrient intake(Measured at month 0 and 6)
- Change in dietary adherence(Measured at month 0 and 6)
- Change in physical activity (steps/d)(Measured at month 0 and 6)
- Change in PCOS symptoms(Measured at month 0 and 6)
- Change in hirsutism(Measured at month 0 and 6)
- Change in acne severity(Measured at month 0 and 6)
- Change in seborrhea(Measured at month 0 and 6)
- Occurences of adverse events(Measured at month 0 and 6)
研究者
Krista Varady
Professor of Nutrition
University of Illinois at Chicago