Feasibility of implementing time-restricted eating in women with mild cognitive impairment

对轻度认知障碍女性实施限时饮食的可行性

• 批准号: 10711172
• 负责人: Julie S Pendergast
• 金额: $ 38.08万
• 依托单位: UNIVERSITY OF KENTUCKY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-01 至 2026-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10711172
• 关键词: Adherence; Administrative Supplement; Affect; Age; Alzheimer' s Disease; Alzheimer' s disease related dementia; American; Award; Behavior Therapy; Body Composition; Brain; Circadian Rhythms; Clinical Research; Cognition; Cognitive aging; Consumption; Data; Dementia; Development; Diet; Disease Progression; Dyslipidemias; Eating; Energy-Generating Resources; Fasting; Feasibility Studies; Future; Goals; Health; Human; Hypertension; Impaired cognition; Impairment; Individual; Intervention; Kentucky; Ketones; Knowledge; Learning; Letters; Longitudinal Studies; Measures; Memory; Metabolic; Metabolic dysfunction; Mus; Neurodegenerative Disorders; Non-Insulin-Dependent Diabetes Mellitus; Obesity; Outcome; Outcome Study; Participant; Persons; Phase; Pilot Projects; Population; Postmenopause; Protocols documentation; Randomized; Regimen; Research; Risk; Role; Sleep; Sleep disturbances; System; Testing; Text Messaging; Therapeutic; Time; Time Study; Time-restricted feeding; Universities; Woman; Work; cardiometabolism; circadian; cohort; design; efficacy clinical trial; efficacy study; efficacy testing; improved; lifetime risk; men; mild cognitive impairment; pharmacologic; pre-clinical; preclinical study; prevent; primary outcome; randomized, clinical trials; recruit

Project Summary Alzheimer’s disease (AD) is an incurable neurodegenerative disease affecting 6.5 million Americans above the age of 65. Currently, no pharmacological therapy prevents AD or markedly slows the progression to severe dementia. Women have twice the lifetime risk of developing AD compared to men, so it is critical to study disease progression and develop interventions in women. Clinical studies show that circadian rhythm and sleep disruption are associated with cognitive impairment and preclinical markers of AD. Thus, therapeutics that improve circadian rhythms and sleep may prevent AD development and progression. Numerous preclinical and clinical studies have shown that time-restricted eating (TRE), a circadian behavioral intervention that aligns food intake to the active phase, improves cardiometabolic health outcomes. Recent studies have shown that TRE can also improve cognition. Thus, TRE is a promising intervention strategy for AD, but no study has investigated its efficacy at improving cognition in cognitively impaired individuals. A first step toward our long- term goal of studying TRE efficacy for cognition is to determine whether TRE is feasible in a population with cognitive impairment. This feasibility study will examine the implementation of an 8-week 10-h TRE intervention in postmenopausal women with mild cognitive impairment (MCI). We will recruit 15 women with MCI from an ongoing longitudinal study of cognitive aging at the University of Kentucky. Cognitive impairment, sleep and activity rhythms, diet composition, metabolic assessment, body composition, and anthropometric measures will be assessed at baseline and after the 8-week TRE intervention. For the duration of the study, the times of first and last meals will be collected from participants with an SMS texting system that we developed. Participants will be instructed to eat during a 10-h eating window and fast at night. The primary outcome of this study will be adherence to the TRE protocol regimen. This pilot study will also provide preliminary data about the effects of TRE on cognition, which are essential for powering a future randomized clinical efficacy trial.

项目摘要 阿尔茨海默病（AD）是一种无法治愈的神经退行性疾病，影响650万美国人， 年六十五岁。目前，没有药物治疗可以预防AD或显著减缓AD向重度AD的进展。 痴呆与男性相比，女性一生中患AD的风险是男性的两倍，因此研究 疾病进展，并制定妇女干预措施。临床研究表明，昼夜节律和 睡眠中断与认知障碍和AD临床前标志物相关。因此， 改善昼夜节律和睡眠可以预防AD的发展和进展。许多临床前 临床研究表明，时间限制饮食（TRE），一种昼夜行为干预， 食物摄入到活跃期，改善心脏代谢健康结果。最近的研究表明 TRE还可以改善认知。因此，TRE是一种有前途的AD干预策略，但没有研究表明， 研究了它在改善认知受损个体的认知方面的功效。向我们长久以来的- 研究TRE认知功效的长期目标是确定TRE在具有以下特征的人群中是否可行： 认知障碍这项可行性研究将探讨实施为期8周、10小时的培训课程 对绝经后轻度认知障碍（MCI）妇女的干预。我们将招募15名女性， MCI来自肯塔基州大学正在进行的认知老化纵向研究。认知障碍， 睡眠和活动节律、饮食组成、代谢评估、身体组成和人体测量 将在基线和8周TRE干预后评估这些指标。在研究期间， 参加者的第一餐和最后一餐的时间将通过短信系统收集， 开发将指导参与者在10小时的进食窗口期间进食，并在夜间禁食。主 本研究的结果将是对TRE方案的依从性。这项试点研究还将提供 关于TRE对认知的影响的初步数据，这对于为未来的随机 临床疗效试验。