Time Restricted Eating for Weight Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change in body weight
研究概览
简要总结
A 12-month randomized, controlled, parallel-arm trial, divided into 2 consecutive periods: (1) 6-month weight loss period; and (2) 6-month weight maintenance, will be implemented. Adults with obesity will be randomized to 1 of 3 groups: (1) 8h-TRE, ad libitum food intake from 12pm to 8 pm, fasting from 8 pm to 12 pm daily, (2) CR, 25% energy restriction every day; or 3) control, ad libitum food intake daily, eating within more than 10 hours per day.
详细描述
Time restricted eating (TRE) has become a popular weight loss regimen. The sudden rise in popularity of TRE is mostly likely due to is its sheer simplicity, and the fact that it does not require individuals to count calories in order to lose weight. Participants are simply asked to consume all food within a specified time frame and fast with energy free beverages for the remaining hours of the day. Evidence shows that when people with obesity limit their eating window to 6 to 8 hours per day, they naturally reduce energy intake by 350-500 calories. From a clinical standpoint, these findings are paramount. One of the main reasons for subject attrition with traditional dieting, i.e. daily calorie restriction (CR), is frustration with having to count calories every day. TRE regimens are able to side-step this requirement by allowing participants to simply "watch the clock" instead of monitoring calories, while still producing significant weight loss and metabolic health improvements. This feature of TRE has the potential to improve long-term adherence to the diet, and in turn produce lasting weight control in adults with obesity.
Accordingly, we conducted a one-year, randomized, controlled trial to compare the effects of late TRE (eating all food between 12:00 pm to 8:00 pm, without calorie counting), versus CR (25% energy restriction daily), and a control group eating over a period of 10 or more hours, on body weight and metabolic risk factors in a diverse group of American adults with obesity. We hypothesized that the TRE group would achieve greater weight loss, and experience more pronounced improvements in insulin sensitivity during the 6-month weight loss phase, compared to CR and control participants. We also hypothesized that the TRE group would better maintain their weight loss and sustain their improvements in insulin sensitivity during the 6-month weight maintenance phase, when compared to the CR and control participants.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 to 65 years old
- •BMI between 30 and 50 kg/m2
- •Sedentary or lightly active (<60 minutes/week of light activity for the 3 months prior to the study)
排除标准
- •• Type 1 DM or Type 2 DM
- •History of eating disorders (anorexia, bulimia, or binge eating disorder)
- •Are not weight stable for 3 months prior to the beginning of study (weight gain or loss > 4 kg)
- •Are not able to keep a food diary or activity log for 7 consecutive days during screening
- •Are taking drugs that influence study outcomes (weight loss, glucose-lowering medications)
- •Are perimenopausal or have an irregular menstrual cycle (menses that does not appear every 27-32 days)
- •Are eating within less than a 10-hour window at baseline
- •Are pregnant, or trying to become pregnant
- •Are night shift workers
- •Are smokers
研究组 & 干预措施
8-hour Time restricted eating
Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast)
干预措施: 8-hour Time restricted eating (Other)
Calorie restriction
25% energy restriction every day
干预措施: Calorie restriction (Other)
Control
Usual diet, Ad libitum intake, eating within >10 hours per day
结局指标
主要结局
Change in body weight
时间窗: Measured at month 0, 6 and 12
Measured by an electronic scale
Change in Body Weight
时间窗: Measured at month 0 and 12
Measured by an electronic scale
次要结局
- Change in waist circumference(Measured at month 0, 6 and 12)
- Change in Blood pressure(Measured at month 0, 6 and 12)
- Change in energy and nutrient intake(Measured at month 0, 6 and 12)
- Change in sleep quality(Measured at month 0, 6 and 12)
- Change in risk of sleep apnea(Measured at month 0, 6 and 12)
- Change in appetite(Measured at month 0, 6 and 12)
- Change in testosterone levels (ng/ml)(Measured at month 0, 6 and 12)
- Change in fat mass, lean mass, visceral fat mass(Measured at month 0, 6 and 12)
- Change in bone mineral density(Measured at month 0, 6 and 12)
- Change in Fasting glucose(Measured at month 0, 6 and 12)
- Change in Fasting insulin(Measured at month 0, 6 and 12)
- Change in Plasma lipids (LDL cholesterol, HDL cholesterol, triglycerides)(Measured at month 0, 6 and 12)
- Change in estradiol levels (ng/ml)(Measured at month 0, 6 and 12)
- Change in mood(Measured at month 0, 6 and 12)
- Change in Insulin resistance(Measured at month 0, 6 and 12)
- Change in Insulin sensitivity(Measured at month 0, 6 and 12)
- Change in Heart rate(Measured at month 0, 6 and 12)
- Change in sex hormone binding globulin (SHBG) levels (ng/ml)(Measured at month 0, 6 and 12)
- Change in the daily eating window(Measured at month 0, 6 and 12)
- Adverse events(Measured at month 0, 6 and 12)
- Change in eating disorder symptoms(Measured at month 0, 6 and 12)
- Change in HbA1c(Measured at month 0, 6 and 12)
- Change in inflammatory markers (TNF-apha, IL-6, IL-10, IL-B, hs-CRP)(Measured at month 0, 6 and 12)
- Change in oxidative stress(Measured at month 0, 6 and 12)
- Change in physical activity (steps/d)(Measured at month 0, 6 and 12)
- Change in insomnia severity(Measured at month 0, 6 and 12)
- Change in quality of life(Measured at month 0, 6 and 12)
- Change in dehydroepiandrosterone (DHEA) levels (ng/ml)(Measured at month 0, 6 and 12)
- Change in progesterone levels (ng/ml)(Measured at month 0, 6 and 12)
- Change in Fat Mass(Measured at month 0 and 12)
- Change in Insulin Resistance(Measured at month 0 12)
- Change in Insulin Sensitivity(Measured at month 0 and 12)
- Change in Fasting Glucose(Measured at month 0 and 12)
- Change in HbA1c(Measured at month 0 and 12)
- Change in Fasting Insulin(Measured at month 0 and 12)
- Change in Systolic Blood Pressure(Measured at month 0 and 12)
- Change in Diastolic Blood Pressure(Measured at month 0 and 12)
- Change in LDL Cholesterol(Measured at month 0 and 12)
研究者
Krista Varady
Professor of Nutrition
University of Illinois at Chicago