禁食增强试点研究
禁食以提供帮助需要增强认知能力的成年人所需的能量(禁食增强)
研究概览
详细说明
在过去的一个世纪里,70 岁以上的人是美国人口中增长最快的部分,随着美国老年人的预期寿命稳步增长,直到 2020 年 COVID-19 爆发。 不幸的是,寿命的延长并没有伴随着健康寿命的延长,健康寿命是一个人健康且功能独立的时间段。 相反,人口老龄化伴随着患有慢性代谢和神经认知疾病的人数增加,包括肥胖、代谢综合征和阿尔茨海默病及相关疾病 (ADRD)。 此外,代谢健康不佳似乎是加速大脑老化的一个危险因素;因此,改善代谢健康可能是改善长期大脑健康的一种策略。
尽管与年龄相关的生物和代谢变化显然在慢性健康状况的发展和 ADRD 的风险中发挥作用,但越来越多的研究表明生活方式因素有助于在许多与年龄相关的慢性健康发展之前发生可改变的病理生理状态状况。 具体而言,营养过剩、久坐不动的生活方式和不良的睡眠习惯与代谢疾病以及晚年认知能力下降和 ADRD 的发展直接相关。
我们和其他人的工作表明,老年人功能下降的速度在很大程度上受到衰老过程中生物和代谢变化的影响,这些变化在很大程度上受到生活方式因素的影响,即饮食摄入、睡眠和身体活动水平。 具体来说,研究人员表明,间歇性禁食 (IF) 方案,尤其是限时饮食 (TRE),可以对中老年人的生物、代谢和功能健康指标产生积极影响,类似于卡路里限制。 这些观察结果提出了这样一种可能性,即针对人类衰老的基本生物学的干预措施有可能延缓(如果不能预防)与衰老相关的疾病(例如 ADRD)的发作。 人口老龄化的空前增长导致迫切需要有前途的干预措施,以保持老年人独立生活和正常生活的能力。
该提议的科学前提是,限时饮食干预可以针对与年龄相关的代谢和神经认知疾病状况背后的细胞和代谢改变,从而延长报告主观认知能力下降的不断增长的老年人群的健康寿命。
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Florida
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Gainesville、Florida、美国、32603
- Clinical and Translational Research Building - Institute on Aging Suite
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
纳入标准:
- 年龄≥65岁;
- 身体质量指数(BMI > 25 公斤/平方米)
- TICS-M 上正常的年龄、性别和教育调整表现
- 对主观认知衰退问卷中的问题 1(记忆力较差)、2(找词困难)或 3(计划/组织困难)回答是
- 报告过去五年出现认知困难
- 报告他们认为他们比同龄人更糟糕,或者他们已经与临床医生讨论过。
- 提供知情同意并愿意随机分配到任一干预组。
排除标准:
- 未能提供知情同意;
- 心血管疾病、糖尿病、胆石症、肝脏或肾脏疾病、癌症或进行性、退行性神经系统疾病(例如,帕金森病、多发性硬化症、ALS)的近期病史或临床表现
- 由研究医师确定的异常实验室标志物(例如,肾脏或肝脏异常、钾水平升高或血红蛋白和血细胞比容低于正常下限)。
- 严重的认知障碍,定义为低于 TICS-M 痴呆分界线的分数
- 严重的风湿病或骨科疾病(例如,等待关节置换、活动性炎症性疾病);
- 由医生确定的预期寿命少于 12 个月的绝症;
- 其他重要的共病疾病(例如 血液透析肾功能衰竭)或严重的精神疾病(例如 双极,精神分裂症);
- 目前正在使用合成代谢药物(即生长激素或睾酮)、抗抑郁药物、抗精神病药、单胺氧化酶抑制剂、抗胆碱酯酶抑制剂(即安理申)、抗凝治疗(允许使用阿司匹林)或抗生素;
- 过量饮酒(每周饮酒超过 14 次);
- 吸毒或酗酒史(即男性每天饮酒超过 5 杯,女性每天饮酒超过 4 杯);
- 计划明年永久离开该地区;
- 肺部疾病、肺炎或间质性肺病史;
- 当前吸烟者或戒烟不到 3 年;
- eGFR 肌酐清除率 < 30 毫升/分钟;
- 每天禁食>12小时
- 通过参加正式的减肥计划或显着限制卡路里摄入或在过去一个月内体重减轻 > 5 磅来积极尝试减肥
- 静息心率 > 120 次/分钟,收缩压 > 180 mmHg 或舒张压 > 100 mmHg
- 过去 3 个月内不稳定型心绞痛、心脏病发作或中风
- 持续使用补充氧气来治疗慢性肺部疾病或心力衰竭
- 类风湿性关节炎、帕金森病或目前正在接受透析
- 胰岛素依赖型糖尿病
- 服用可以禁食 16 小时的药物(例如,必须与食物至少间隔 12 小时服用)
- 在筛选/注册前 30 天内参加另一项临床试验或已收到研究产品
- 研究者认为会损害参与试验能力的任何情况。
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:限时饮食干预
在时间限制的饮食条件下,将指示参与者在 24 周内每天禁食 16 小时。
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在 TRE 干预中,参与者将被要求在 24 周内每天禁食 16 小时。 前几周将增加到完整的 16 小时禁食期(第 1 周 - 每天禁食 12-14 小时,第 2 周 - 每天禁食 14-16 小时,第 3 周 - 16 - 禁食每天 16 小时)。 参与者将被允许饮用无卡路里的饮料、茶、黑咖啡、无糖口香糖,并鼓励他们在整个干预期间多喝水。 参与者将被要求记录每天第一次和最后一次食物/饮料消费的时间。 TRE 和 Successful Aging 比较组都将进行小组调解,研究人员的接触访问次数相同,包括 24 周内的 10 次小组会议。
其他名称:
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有源比较器:成功老龄化比较组 (LEARN)
在 LEARN 组中,参与者将接受为期 24 周的与 TRE 干预类似的健康相关主题的教育。
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在成功老龄化比较小组 (LEARN) 中,参与者将参加与健康老龄化相关主题的讲座,频率与 TRE 干预中的小组会议相同。 TRE 和 Successful Aging 比较组都将进行小组调解,研究人员的接触访问次数相同,包括 24 周内的 10 次小组会议。 |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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神经心理状态评估的可重复组合 (RBANS)
大体时间:至第 24 周的基线
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RBANS 是一组神经心理学测试,有 4 种可重复的形式,可纵向用于测量认知变化。
管理需要 30 分钟,包括五个认知领域的测量,包括即时记忆、视觉空间/结构、语言、注意力和延迟记忆。
该测试在产生识别与神经退行性疾病相关的认知障碍的结果方面是可靠的。
RBANS 可用于预测认知障碍,特别强调语言和即时记忆子测试。
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至第 24 周的基线
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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蒙特利尔认知评估 (MoCA)
大体时间:至第 24 周的基线
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蒙特利尔认知评估是对轻度认知障碍的 30 分评估,评估注意力和集中力、执行功能、记忆力、语言、视觉结构技能、概念思维、计算和定向的领域。
在三个时间点给出不同版本的测试以避免重复测试之间的学习效应。
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至第 24 周的基线
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6 分钟步行测试
大体时间:至第 24 周的基线
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6 分钟步行测试测量参与者在不跑步或过度用力的情况下,在标准步行课程中可以在六分钟内完成的距离。
在众多研究中,它已被证明是衡量身体机能的有效且可靠的指标。
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至第 24 周的基线
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短期体能测试 (SPPB)
大体时间:至第 24 周的基线
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SPPB 还将用于评估不同任务的功能表现,包括定时短距离步行、重复椅子站立和平衡测试。
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至第 24 周的基线
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握力
大体时间:筛选第一天
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等距握力是一种常用的上肢骨骼功能测量方法,将使用手持式测力计进行评估
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筛选第一天
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匹兹堡睡眠质量指数
大体时间:至第 24 周的基线
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睡眠将通过匹兹堡睡眠质量指数进行评估,这是一种自我报告工具,由 19 项量表组成,提供七个组成部分分数(范围 0-3):(a)主观睡眠质量(非常好到非常差),( b) 睡眠潜伏期(≤15 至 >60 分钟),(c) 睡眠持续时间(≥7 至 <5 小时),(d) 睡眠效率(≥85% 至 <65% 睡眠时间/卧床时间),(e ) 睡眠障碍(不是在过去一个月内至每周 ≥ 3 次),(f) 使用安眠药(不至每周 ≥ 3 次),以及 (g) 日间功能障碍(不是问题到非常大的问题)全球总分在 0 到 21 之间。
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至第 24 周的基线
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认知和躯体焦虑的状态特质清单 (STICSA)
大体时间:至第 24 周的基线
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认知和躯体焦虑的状态特质量表 (STICSA) 旨在评估焦虑的认知和躯体症状,因为它们与一个人当下的情绪(状态)和总体情绪(特质)有关。
该措施已在老年人样本中得到验证。
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至第 24 周的基线
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老年抑郁量表
大体时间:至第 24 周的基线
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抑郁症的症状将通过老年抑郁量表进行评估,这是一种自我报告问卷,用于衡量老年人的抑郁症。
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至第 24 周的基线
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简表 (SF) -12 健康调查
大体时间:至第 24 周的基线
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这份包含 12 个项目的简短问卷评估与健康相关的生活质量的心理和身体组成部分。
SF-12 健康调查评估 8 个一般领域:健康问题导致的身体活动受限、身体/情绪问题导致的社交活动受限、身体健康问题导致的日常角色活动受限、身体疼痛、一般心理健康、日常角色活动受限由于情绪问题、精力和疲劳以及一般健康状况。
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至第 24 周的基线
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匹兹堡疲劳量表
大体时间:至第 24 周的基线
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将使用包含 26 个项目的匹兹堡疲劳量表来测量感知的心理和身体疲劳度。
问题分为 4 大类:中度至高强度活动(≥3.0 代谢当量 (METS))、社交活动、久坐活动(≤1.5 METS)以及生活方式或低强度活动(1.6-2.9
大都会)。
较高的分数表明较高水平的易疲劳性。
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至第 24 周的基线
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人体测量。
大体时间:第 24 周筛选的第一天
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在去除多余的衣服和鞋子后,将使用校准秤测量体重。
腰围取自参与者最低肋骨和他/她的髋骨顶部之间的中点。
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第 24 周筛选的第一天
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代谢和系统生物标志物
大体时间:至第 24 周的基线
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将评估葡萄糖调节 (HbA1C)、全身炎症(C 反应蛋白)和神经退行性疾病的生物标志物 Tau。
样品将一式两份测量,两次测量的平均值将用于数据分析。
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至第 24 周的基线
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合作者和调查者
调查人员
- 首席研究员:Stephen Anton, Ph.D.、University of Florida
出版物和有用的链接
一般刊物
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- PRO00048080 (其他标识符:UFIRST)
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