Comparison of Weight Loss Induced by Intermittent Fasting Versus Daily Caloric Restriction in Individuals with Obesity: A 1-Year Randomized Trial

项目总结/摘要 限制每日卡路里摄入量是目前用于治疗肥胖症的主要饮食策略。但这 这种方法并不是对所有人都有效。此外，坚持每日热量限制（DCR）通常 随着时间的推移减少，许多用这种策略减肥的人会恢复。因此，新的饮食 需要采取干预措施，提供更广泛的治疗选择。这项建议的目的是 确定间歇性禁食（IMF）是否是治疗肥胖的有效饮食策略。货币基金组织是一种替代办法 一种减少能量摄入（EI）的方法，近年来作为减肥策略而受到广泛欢迎 损失短期研究表明，IMF在超重和肥胖的个体中产生3-8%的体重减轻。 然而，很少有研究将IMF与DCR进行比较，也没有研究评估IMF是否是一种有效的治疗方法。 长期（≥1年）减肥策略。一项为期8周的试点研究将IMF与DCR进行了比较， 是安全的，可耐受的，并产生类似的短期体重减轻。经过6个月无人监督的随访， 身体成分的变化往往更有利于IMF，几乎是IMF参与者的两倍 保持≥5 kg体重减轻。因此，IMF可能是一种更有效的维持减肥的饮食策略 而不是DCR。然而，需要长期数据，而且对加入货币基金组织的情况或 国际货币基金组织关于能源支出的报告。短期研究表明，坚持IMF可能上级DCR， 然而，能量摄入（EI）是基于自我报告，可能有很大的局限性。试点数据显示 静息能量消耗（REE）在IMF诱导的体重减轻过程中得以保留，这可能会降低 体重恢复然而，IMF对EE的其他组成部分，包括体力活动（PA）的影响在很大程度上 未经检查这项研究设计是一项务实的1年随机试验，比较IMF产生的体重减轻 对比DCR。目标每周能量赤字将相当于：DCR将规定30%的每日能量 限制和IMF将规定一个修改后的快速（75%的能源限制）在3个非连续天， 周假设是，基于IMF作为主要饮食策略的减肥计划将导致 与基于传统DCR的计划相比，1年时的体重减轻更大。目标1将比较减肥 以及1年时IMF和DCR诱导的身体组成和代谢参数的变化。目标2将 评估IMF（与DCR相比）对EI和饮食依从性的影响。目标3将评估 IMF（与DCR相比）对EE的组成部分和PA的模式。目标4将探索体重减轻的预测因素 在货币基金组织和难民署内。该方法是创新的，因为目标能源赤字将在以下方面匹配： 组和EI将进行客观评估（使用双标记水）， 坚持。此外，两个干预组都将接受基于指南的行为支持， 货币基金组织以更有力的方式对目前的护理标准进行调整。这项研究意义重大，因为它可以识别 一个有效的替代饮食策略，以帮助更多的人实现和维持减肥。 !

Project Summary/Abstract Restricting daily calorie intake is the primary dietary strategy currently used to treat obesity. However, this approach is not effective for all individuals. Further, adherence to daily caloric restriction (DCR) typically decreases over time and many individuals who lose weight with this strategy will regain. Thus, novel dietary interventions are needed to provide a broader range of treatment options. The objective of this proposal is to determine if intermittent fasting (IMF) is an effective dietary strategy for treatment of obesity. IMF is an alternative method of reducing energy intake (EI) which has gained lay popularity in recent years as a strategy for weight loss. Short-term studies suggest IMF produces 3-8% weight loss in individuals with overweight and obesity. However, few studies have compared IMF to DCR and no studies have evaluated whether IMF is an effective long-term (≥1 year) weight loss strategy. Data from an 8-week pilot study comparing IMF to DCR suggests IMF is safe, tolerable, and produces similar short-term weight loss. After 6 months of unsupervised follow-up, changes in body composition tended to be more favorable with IMF and almost twice as many IMF participants maintained a ≥5 kg weight loss. Thus, IMF may be a more effective dietary strategy for sustaining weight loss than DCR. However, longer-term data are needed and little is known about adherence to IMF or the impact of IMF on energy expenditure (EE). Short-term studies suggest adherence to IMF may be superior to DCR, however, energy intake (EI) was based on self-report which may have significant limitations. Pilot data suggests resting energy expenditure (REE) was preserved during IMF-induced weight loss, which could decrease risk for weight regain. However, the impact of IMF on other components of EE including physical activity (PA) is largely unexamined. The study design is a pragmatic 1-year randomized trial to compare weight loss generated by IMF vs DCR. The targeted weekly energy deficit will be equivalent: DCR will be prescribed a 30% daily energy restriction and IMF will be prescribed a modified fast (75% energy restriction) on 3 non-consecutive days per week. The hypothesis is that a weight loss program based on IMF as the primary dietary strategy will result in greater weight loss at 1 year compared to a program based on traditional DCR. Aim 1 will compare weight loss and changes in body composition and metabolic parameters induced by IMF and DCR at 1 year. Aim 2 will evaluate the impact of IMF (compared to DCR) on EI and dietary adherence. Aim 3 will evaluate the impact of IMF (compared to DCR) on components of EE and patterns of PA. Aim 4 will explore predictors of weight loss within both IMF and DCR. The approach is innovative as the targeted energy deficit will be matched between groups and EI will be assessed objectively (using doubly-labeled water) to provide an accurate comparison of adherence. In addition, both intervention groups will receive guidelines-based behavioral support to compare IMF to the current standard of care (DCR) in a more robust fashion. This study is significant as it could identify an effective alternative dietary strategy to help more people achieve and sustain weight loss. !