Effects of early vs. late time restricted eating vs. daily caloric restriction on weight loss and metabolic outcomes in adults with obesity

早期与晚期限制饮食与每日热量限制对肥胖成人体重减轻和代谢结果的影响

• 批准号: 10585523
• 负责人: Elizabeth Anne Thomas
• 金额: $ 69.46万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-04-05 至 2028-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10585523
• 关键词: Adherence; Adult; Attention; Behavior Therapy; Behavioral; Blood Pressure; Body Composition; Body Weight; Body Weight Changes; Body Weight decreased; Caloric Restriction; Clinical Data; Control Groups; Desire for food; Diet; Dietary Intervention; Eating; Effectiveness; Energy Intake; Failure; Fatty acid glycerol esters; Glucose; Goals; Guidelines; Health; Individual; Intervention Trial; Literature; Metabolic; Nutritional; Obesity; Outcome; Overweight; Participant; Persons; Physical activity; Pilot Projects; Public Health; Randomized; Recommendation; Sample Size; Sleep; Time; Time-restricted feeding; Weight; adult obesity; blood lipid; cardiometabolism; clinically significant; design; dietary; dietary adherence; dietary restriction; effectiveness evaluation; evidence base; follow-up; food restriction; improved; improvement on sleep; insight; insulin sensitivity; novel; obesity treatment; pre-clinical; primary outcome; sedentary; standard of care; treatment guidelines; trial design; weight loss program

PROJECT SUMMARY The goal of this proposal is to determine the optimal time restricted eating (TRE) window to produce weight loss in adults with overweight or obesity. Daily caloric restriction (DCR), the current standard of care dietary strategy for weight loss, produces 5-7% weight loss in the context of a guidelines-based behavioral weight loss program, yet adherence is challenging and weight regain is common. Thus, rigorous evaluation of the effectiveness of novel dietary interventions is needed to provide a range of evidence-based options to effectively treat obesity. TRE involves restriction of energy intake (EI) to a limited window of time each day and has been widely promoted in the lay press, but TRE studies to date have shown only minimal (0-4%) weight loss. However, prior TRE studies have several substantial limitations, including lack of standard of care DCR control groups, small sample sizes, short duration, and failure to provide appropriate obesity treatment guidelines-based behavioral support. While several different dietary strategies can be used to achieve energy restriction, behavioral support is critical to enhancing adherence to both diet and physical activity (PA) recommendations and thus weight loss outcomes, yet no prior studies have provided behavioral support for TRE. Further, most TRE studies to date have utilized late TRE windows (L-TRE, e.g., eating window 12-8 PM), often providing the rationale that participants are more likely to adhere to L-TRE rather than early TRE (E-TRE, e.g. eating window 8AM-4PM). However, there is strong rationale from mechanistic studies to suggest E-TRE may result in greater weight loss and cardiometabolic benefits than L-TRE. We have shown that E-TRE results in improvements in glucose variability and insulin sensitivity, clinically significant weight loss (6.3 ± 4.1% at 12 weeks), as well as improvements in dietary quality, increased PA, reduced sedentary time and subjective improvements in sleep. However, we did not include a L-TRE control, so it is unclear whether the E-TRE window or the provision of behavioral support enhanced weight loss outcomes as compared to prior TRE studies. Thus, a rigorously designed trial is needed to evaluate the impact of E-TRE, L-TRE and DCR delivered in the context of a guidelines-based behavioral intervention on weight loss and cardiometabolic outcomes. In this study, 162 adults with overweight or obesity will be randomized 1:1:1 to E-TRE (8-hr window starting 1-2 hrs after waking), L-TRE (8-hr window starting 5-6 hrs after waking) or DCR (25% caloric restriction) for 26 weeks (primary outcome), with follow up at 52 weeks. Our aims are to compare the effects of E-TRE, L-TRE, and DCR on: 1) Changes in body weight and composition and markers of cardiometabolic health; 2) Dietary adherence, EI and dietary quality; and 3) PA and sleep. Our overall hypothesis is that E-TRE will result in greater weight loss and improvements in cardiometabolic outcomes as compared to L-TRE and will be non-inferior to our current standard of care (DCR). In addition, we hypothesize that adherence to E-TRE and L-TRE will be greater than adherence to DCR, and E- TRE will result in greater adherence to PA and improved sleep duration/quality as compared to L-TRE and DCR.

项目摘要 这项建议的目的是确定最佳的时间限制饮食（TRE）窗口，以产生减肥 超重或肥胖的成年人。每日热量限制（DCR），目前的标准护理饮食策略 对于减肥，在基于指南的行为减肥计划的背景下产生5-7%的体重减轻， 然而坚持是具有挑战性的，并且体重反弹是常见的。因此，严格的有效性评估 需要一系列新的饮食干预措施，以提供一系列基于证据的选择， 肥胖TRE涉及将能量摄入（EI）限制在每天有限的时间窗口内，并已广泛应用于 在平压机中推广，但迄今为止的TRE研究仅显示最小（0-4%）的重量损失。但是现有 TRE研究有几个实质性的局限性，包括缺乏护理标准DCR对照组，小 样本量大，持续时间短，未能提供适当的肥胖治疗指南， 支持.虽然可以使用几种不同的饮食策略来实现能量限制， 对于加强对饮食和身体活动（PA）建议的遵守，从而减轻体重至关重要 结果，但没有先前的研究提供了TRE的行为支持。此外，迄今为止的大多数TRE研究 已经利用了后期TRE窗口（L-TRE，例如，进食窗口12-晚上8点），通常提供的理由， 参与者更可能坚持L-TRE而不是早期TRE（E-TRE，例如进食窗口8AM-4PM）。 然而，有很强的理由，从机制的研究表明，E-TRE可能会导致更大的体重减轻 和心脏代谢方面的好处我们已经证明，E-TRE导致葡萄糖代谢的改善， 变异性和胰岛素敏感性，临床显著体重减轻（12周时为6.3 ± 4.1%），以及 改善饮食质量，增加PA，减少久坐时间和主观改善 睡吧但是，我们没有包括L-TRE控件，因此不清楚E-TRE窗口或规定 与之前的TRE研究相比，行为支持增强了减肥效果。因此，严格地 需要设计试验来评估E-TRE、L-TRE和DCR在 基于指南的行为干预对体重减轻和心脏代谢结果的影响。在这项研究中，162名成年人 超重或肥胖的患者将以1：1：1的比例随机分配至E-TRE组（从清醒后1-2小时开始的8小时窗口）、L-TRE组（从清醒后1-2小时开始的8小时窗口）、 (8-hr从清醒后5-6小时开始的窗口）或DCR（25%热量限制）持续26周（主要结局）， 第52周随访。我们的目的是比较E-TRE，L-TRE和DCR对以下方面的影响：1）身体变化 体重和组成以及心脏代谢健康的标志物; 2）饮食依从性、EI和饮食质量;以及 3)PA和睡眠。我们的总体假设是，E-TRE将导致更大的体重减轻和改善， 心脏代谢结局与L-TRE相比，不劣于我们目前的标准治疗（DCR）。 此外，我们假设对E-TRE和L-TRE的依从性将大于对DCR的依从性，并且E-TRE和L-TRE的依从性将大于对DCR的依从性。 与L-TRE和DCR相比，TRE将导致更大的PA依从性和改善的睡眠持续时间/质量。