The Effect of Timed Restricted Eating With or Without Intermittent Energy Restriction on Measures of Body Composition, Resting Energy Expenditure, Cardiovascular Modulation, and Blood Biomarkers Over 12 Weeks
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
研究概览
简要总结
This study is looking at whether eating all meals within a 6-hour window each day (called Time-Restricted Eating, or TRE) can improve body composition, metabolism, heart health, and blood markers over 12 weeks. The study also wants to find out whether allowing participants to eat normally on weekends makes the diet easier to follow long-term.
Adults aged 18-65 with a BMI of 26 or higher who do not have heart disease or diabetes may be eligible. Participants will be randomly placed into one of two groups: (1) TRE every day for 12 weeks, or (2) TRE on weekdays with normal eating on weekends. All participants will visit the lab twice - once at the start and once at the end - for measurements of body fat, resting calorie burn, heart function, and blood tests. Between visits, participants will log their meals and steps at home and check in with the research team every two weeks.
详细描述
This randomized, two-arm parallel study examines the effects of Timed Restricted Eating (TRE) with or without Intermittent Energy Restriction (IER) on body composition, resting energy expenditure (REE), cardiometabolic blood markers, cardiovascular modulation, psychosocial well-being, dietary adherence, and spontaneous physical activity over a 12-week intervention in adults with overweight or obesity.
Study Design and Participants Sixty adults (30 male, 30 female) aged 18-65 years with a BMI ≥26 kg/m² will be enrolled. The target sample accounts for an anticipated one-third attrition rate, yielding a final expected sample of 40 participants (20 per group), based on a power analysis using an effect size of f=0.25 and power of 0.80. Eligible participants must be weight-stable (no more than 5 kg change in the prior 3 months), physically inactive (≤150 min/week of moderate-intensity activity), free of cardiovascular disease and diabetes, and not taking medications that could influence study outcomes. Individuals with implanted electronic devices (e.g., pacemakers, ICDs) are excluded due to the use of bioimpedance spectroscopy.
Randomization Following baseline assessments, participants will be randomly assigned in a 1:1 ratio to one of two groups using sex-stratified permuted block randomization (block sizes of 2 and 4), generated a priori using the blockrand package in R.
Intervention Groups Group 1 (TRE Only): Participants restrict all calorie-containing food and beverages to a 6-hour afternoon eating window (e.g., 2-8 pm) every day for 12 weeks.
Group 2 (TRE + IER): Participants follow the same 6-hour eating window Monday-Friday, but return to unrestricted eating on weekends (Saturday-Sunday) to test whether periodic diet breaks improve long-term adherence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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
- •Between 18 and 65 years of age
- •Body mass index (BMI) of 26 kg/m² or higher (overweight or obese range)
- •Physically inactive, defined as 150 minutes or less of moderate-intensity physical activity per week for the 3 months prior to enrollment
- •No previous history of cardiovascular disease or Type 1 or Type 2 Diabetes Mellitus
- •Not currently taking medications that may affect blood sugar, cholesterol, or body weight (e.g., glucose-lowering drugs, statins, or weight loss medications)
- •Weight stable, defined as no more than 5 kg (about 11 lbs.) of body weight change in the 3 months prior to enrollment
- •Willing and able to follow the study requirements, provide voluntary consent, and complete all study procedures
排除标准
- •Younger than 18 or older than 65 years of age
- •BMI below 26 kg/m²
- •More than 150 minutes per week of moderate-intensity physical activity in the past 3 months
- •History of cardiovascular disease or Type 1 or Type 2 Diabetes Mellitus
- •Currently taking medications that may impact study outcomes
- •Weight change of more than 5 kg in the past 3 months
- •Pregnant, breastfeeding, or planning to become pregnant during the study
- •History of an eating disorder
- •Previous weight loss surgery (e.g., gastric bypass or sleeve gastrectomy)
- •Unable to fast for approximately 18 hours at a time due to a medical condition
- •Currently working night shifts
- •Has a pacemaker or any implanted electronic device (due to bioimpedance spectroscopy testing)
- •Any health condition the research team determines would put the participant at risk
研究组 & 干预措施
TRE + Weekend Ad Libitum (TRE+IER)
Participants restrict all calorie-containing food and beverages to the same 6-hour afternoon eating window Monday through Friday. On Saturday and Sunday, participants return to their regular, unrestricted eating habits. This arm tests whether periodic weekend diet breaks improve long-term dietary adherence while maintaining a meaningful weekly calorie deficit.
干预措施: Time-Restricted Eating with Intermittent Energy Restriction (TRE+IER) (Behavioral)
TRE Only
Participants restrict all calorie-containing food and beverages to a 6-hour afternoon eating window (e.g., 2-8 pm) every day for 12 weeks. Outside of this window, only water, black coffee, and plain tea are permitted.
干预措施: Time-Restricted Eating (TRE) (Behavioral)
研究者
Matthew Barenie
Assistant Professor
University of South Alabama