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

肥胖个体间歇性禁食与每日热量限制引起的体重减轻的比较：一年随机试验

• 批准号: 9981732
• 负责人: VICTORIA A CATENACCI
• 金额: $ 65.8万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-15 至 2022-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9981732
• 关键词: Adherence; Adult; Appetite Regulation; Attention; Behavioral; Biological; Blood Pressure; Body Composition; Body Weight; Body Weight Changes; Body Weight decreased; Caloric Restriction; Calories; Clinical Data; Data; Desire for food; Diet; Dietary Intervention; Effectiveness; Energy Intake; Energy Metabolism; Fatty acid glycerol esters; Foundations; Guidelines; Health; Hormones; Hour; Individual; Intake; Intermittent fasting; Intervention; Intervention Trial; Lipids; Literature; Maintenance; Measures; Mediating; Metabolic; Methods; Obesity; Outcome; Overweight; Participant; Patient Self-Report; Patients; Pattern; Physical activity; Pilot Projects; Public Health; Research; Research Design; Rest; Risk; Thinness; Time; Weight; base; clinically significant; clinically translatable; design; dietary adherence; dietary approach; doubly-labeled water; energy balance; evidence base; follow-up; group intervention; improved; innovation; insulin sensitivity; moderate-to-vigorous physical activity; novel; obesity treatment; oxidation; pragmatic trial; preservation; programs; psychosocial; randomized trial; responders and non-responders; sedentary; sedentary lifestyle; standard of care; success; total energy expenditure; treatment strategy; trial design; weight loss program

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. !

项目概要/摘要 限制每日热量摄入是目前治疗肥胖的主要饮食策略。 该方法并非对所有人都有效。此外，通常要遵守每日热量限制 (DCR)。 随着时间的推移，体重会减少，许多通过这种策略减肥的人会重新获得新的饮食习惯。 需要采取干预措施来提供更广泛的治疗选择。该提案的目的是： 确定间歇性禁食（IMF）是否是治疗肥胖的有效饮食策略。 减少能量摄入（EI）的方法近年来作为一种减肥策略而受到人们的欢迎 短期研究表明，IMF 可使超重和肥胖者的体重减轻 3-8%。 然而，很少有研究将 IMF 与 DCR 进行比较，也没有研究评估 IMF 是否是一种有效的方法。 一项为期 8 周的试点研究比较 IMF 和 DCR 的数据表明 IMF 是长期（≥1 年）减肥策略。 是安全的、可耐受的，并在 6 个月的无人监督的随访后产生类似的短期体重减轻。 身体成分的变化往往对国际货币基金组织更有利，而且国际货币基金组织参与者的数量几乎是其两倍 保持体重减轻≥5公斤因此，IMF可能是维持体重减轻的更有效的饮食策略。 然而，我们需要长期数据，而且对于遵守国际货币基金组织的情况或其影响知之甚少。 IMF 关于能源支出 (EE) 的短期研究表明，遵守 IMF 可能优于 DCR。 然而，能量摄入（EI）是基于自我报告，试点数据表明可能存在很大的局限性。 在 IMF 引起的体重减轻过程中，静息能量消耗 (REE) 得以保留，这可以降低以下风险： 然而，IMF 对 EE 的其他组成部分（包括体力活动 (PA)）的影响很大。 该研究设计是一项为期 1 年的实用随机试验，旨在比较 IMF 产生的体重减轻情况。 与 DCR 的目标每周能量赤字相等：DCR 将规定每日能量的 30% 限制和国际货币基金组织将被规定在每 3 个非连续的天进行修改后的禁食（75％的能量限制） 假设以 IMF 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，目标 1 的体重减轻幅度更大。 目标 2 时 IMF 和 DCR 引起的身体成分和代谢参数的变化。 评估 IMF（与 DCR 相比）对 EI 和饮食依从性的影响。 IMF（与 DCR 相比）关于 EE 组成部分和 PA 模式将探索体重减轻的预测因素。 在 IMF 和 DCR 中，这种方法是创新的，因为目标能源赤字将在两者之间进行匹配。 组和 EI 将进行客观评估（使用双标记水），以提供准确的比较 此外，两个干预组都将接受基于指南的行为支持以进行比较。 IMF 以更稳健的方式调整当前的护理标准 (DCR) 这项研究意义重大，因为它可以确定。 一种有效的替代饮食策略，可以帮助更多的人实现并维持减肥效果。 ！