TREAT (Time Restricted EATing) to improve cardiometabolic health

项目总结/摘要 美国成年人超重、肥胖和前驱糖尿病的患病率很高。小的体重减轻会延迟 进展为2型糖尿病并降低心血管风险，但坚持长期热量限制 很难维持。迫切需要找到有效、易于实施和维持、负担得起的生活方式 风格的干预。限制食物摄入间隔，或时间限制饮食（TRE）已显示在 小规模的试点研究，以减轻体重和改善新陈代谢，而不是挑战性 卡路里计数。我们建议通过智能手机应用程序严格评估TRE的疗效， 减肥和降低心血管风险。为了实现这一目标，代谢不健康的中年人 习惯性进食超过14小时/天的超重或肥胖患者将被随机分配至限制进食组 饮食时间窗为10 h/d（TRE）或习惯性进食时间窗（≥ 14 h，HABIT），随访12个月。 进食、睡眠、体力活动和血糖的动态测量，以及住院患者24小时良好控制 将进行研究，以确定TRE与习惯性饮食持续时间（HABIT）的影响，以及 这些影响的媒介。假设：1）TRE与HABIT将导致脂肪量减少，通过测量 定量磁共振，以及通过降低每日总能量摄入介导的效应，通过 双标记水; 2）TRE与HABIT将导致较低的胰岛素抵抗，较低的胰岛素抵抗和燃料转换 利用优先于脂质动员; 2）对TRE的坚持（通过应用程序的使用和 减少进食窗口），自我效能感将与短期效应（3个月）和 TRE对脂肪量减少的长期可持续性（12个月）。这项研究的结果将提供重要的 深入了解限制每日进食间隔之间的生理和分子相互作用 和代谢功能，并可为使用TRE干预措施改善代谢健康提供证据 并降低大量需要生活方式的中年和老年美国人的心血管风险 干预

Project Summary/Abstract American adults have a high prevalence of overweight, obesity and prediabetes. Small weight loss delays the progression to type 2 diabetes and decrease cardiovascular risk, yet adherence to long-term calorie restriction is difficult to sustain. There is an urgency to find effective, easy-to-implement and sustain, and affordable life style interventions. Restricting the food intake interval, or time restricted eating (TRE) has been shown in small-scale pilot studies to result in weight loss and improve metabolism, while being less challenging than calorie count. We propose to rigorously assess the efficacy of TRE, administered via a smartphone application, on weight loss and decreased cardiovascular risk. To achieve this goal, metabolically unhealthy mid-life adults with overweight or obesity who habitually eat for more than 14h/day, will be randomized to a restricted eating window to 10h/d (TRE) or to their habitual eating window (≥ 14h, HABIT), and followed up to 12 months. Ambulatory measures of food intake, sleep, physical activity and glucose, and in-patient 24-h well-controlled studies will be done to determine the effect of TRE versus habitual eating duration (HABIT), as well as the mediators of these effects. Hypotheses: 1) TRE vs. HABIT will result in decreased fat mass, measured by quantitative magnetic resonance, and effect mediated via decreased daily total energy intake, measured by double labeled water; 2) TRE vs. HABIT will result in lower insulin resistance, lower glycemia and shift in fuel utilization preferentially to lipid mobilization; 2) Adherence to TRE (measured by usage of the app and reduction of the eating window), and self-efficacy will associate with the short-term effect (3 months) and the long-term sustainability (12 months) of TRE on fat mass loss. Results from this study will provide important insights into understanding the physiological and molecular interactions between restricting daily eating interval and metabolic function, and could provide evidence for using TRE interventions to improve metabolic health and decrease cardiovascular risk in the large number of mid-life and older Americans in great need of life style intervention.