限时进食对老年人脑微血管的影响
2026年6月25日 更新者:University of Oklahoma
这项研究的中心假设是,更严格地坚持限时饮食 (TRE) 将改善内皮功能、神经血管 (NVC) 反应,从而提高认知能力,这可能是通过激活 SIRT1 依赖性血管保护通路实现的。
研究概览
详细说明
该假设将通过评估 TRE(每天不超过 10 小时进食窗口,持续 6 个月)对健康成人(≥21 岁)的影响来检验。
将参加 TRE 组的受试者组与对照组进行比较。
所有参与者将被随机分配到研究的任一组。
研究类型
介入性
注册 (实际的)
11
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Oklahoma
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Oklahoma City、Oklahoma、美国、73117
- University of Oklahoma Health Sciences Center
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-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
21年 及以上 (成人、年长者)
接受健康志愿者
是的
描述
纳入标准:
- ≥21岁的健康成年人
排除标准:
-无法用英语阅读或写作
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Time restricted eating
14 h of fasting daily (10 h of free eating)
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14:10 daily fasting regimen
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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 |
|---|---|---|
|
Neurovascular Coupling Using Functional Near Infrared Spectroscopy (fNIRS)
大体时间:Baseline, 6 months
|
Functional near infrared spectroscopy (fNIRS) will be performed during the cognitive n-back task.
fNIRS approach generates data that represent a relative change in oxygenated hemoglobin measured over the cortical brain tissues.
fNIRS data is analyzed using a pipeline based on the General Linear Model (GLM) approach created using the Brain AnalyzIR toolbox and implemented in MatLab.
At the subject level, regression coefficients (beta values) are extracted to characterize individual neurovascular coupling response in the prefrontal cortex across all n-back blocks.
It is expected that more difficult cognitive tasks will lead to increased neurovascular coupling responses in healthy individuals, but no clinically relevant ranges exist for this measure.
|
Baseline, 6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Neurovascular Coupling Using the Dynamic Retinal Vessel Analysis
大体时间:Baseline, 6 months
|
Flicker light-induced dilation of the retinal vessels (percentage increase over baseline diameter) will be measured in the right or left eye of each study participant using the Dynamic Vessel Analyzer (DVA, IMEDOS Systems, Jena, Germany).
The change in retinal vessel diameters is tracked and reported as a %change from baseline, before and after treatment.
|
Baseline, 6 months
|
|
Neurovascular Coupling Using Transcranial Doppler
大体时间:Baseline, 6 months
|
Transcranial Doppler sonography will be used to measure the change in the blood flow velocities during the cognitive n-back task between before and after treatment.
|
Baseline, 6 months
|
|
Microvascular Endothelial Function
大体时间:Baseline, 6 months
|
Changes in microvascular endothelial function will be assessed using laser speckle contrast imaging (LSCI) in the hand using the flow mediated dilation approach.
The change in skin perfusion is calculated and reported as a fold change from baseline.
|
Baseline, 6 months
|
|
Macrovascular Endothelial Function
大体时间:Baseline, 6 months
|
Changes in macrovascular endothelial function will be assessed using sonography during flow mediated dilation approach.
The change in brachial artery diameter is calculated and reported as a %change from baseline.
|
Baseline, 6 months
|
|
Deep Tissue Oxygen Saturation
大体时间:Baseline, 6 months
|
Transcutaneous deep tissue oxygen saturation will be measured using the inSpectra near infrared device.
The data are calculated and reported as a %change from baseline.
|
Baseline, 6 months
|
|
Arterial Stiffness
大体时间:Baseline, 6 months
|
The arterial stiffness will be measured using the pulse wave analysis approach (SphygmoCor, Atcor medical, Itasca IL, or similar).
Analysis generated the augmentation index which will be used for comparison before and after treatment.
|
Baseline, 6 months
|
|
ECG
大体时间:Baseline, 6 months
|
ECG will be recorded for heart rate variability analysis.
The values of high frequency domain, low frequency domain, their ratio, as well as total power will be calculated and used for comparison before and after treatment.
|
Baseline, 6 months
|
|
Glycocalyx - Perfused Boundary Region
大体时间:Baseline, 6 months
|
Video recordings of the sublingual vasculature will be performed using the high definition video camera GlycoCheck (Microvascular health solutions).
Data collected will include perfused boundary region (um), and will be used for comparison before and after treatment.
|
Baseline, 6 months
|
|
Capillary Density
大体时间:Baseline, 6 months
|
Video recordings of the sublingual vasculature will be performed using the high definition video camera GlycoCheck (Microvascular health solutions).
Data collected will include capillary density (mm/mm^2), and will be used for comparison before and after treatment.
|
Baseline, 6 months
|
|
Red Blood Cell Velocity
大体时间:Baseline, 6 months
|
Video recordings of the sublingual vasculature will be performed using the high definition video camera GlycoCheck (Microvascular health solutions).
Data collected will include red blood cell velocity (um/sec), and will be used for comparison before and after treatment.
|
Baseline, 6 months
|
|
Inhibitory Control and Attention
大体时间:Baseline, 6 months
|
Flanker Inhibitory Control and Attention Test was used to assess inhibitory control and attention.
The participant is asked to focus on a particular stimulus while inhibiting attention to the stimuli flanking it.
Scores are fully adjusted to nationally representative normative sample of NIH toolbox test takers, accounting for age, sex, race, and education (mean = 50; SD = 10).
Higher scores represent better outcomes.
|
Baseline, 6 months
|
|
Episodic Memory
大体时间:Baseline, 6 months
|
Picture Sequence Memory Test was used to assess episodic memory.
Participants are shown a number of activities, and then asked to reproduce the sequence of pictures as it was presented to them.
Scores are fully adjusted to nationally representative normative sample of NIH toolbox test takers, accounting for age, sex, race, and education (mean = 50; SD = 10).
Higher scores represent better outcomes.
|
Baseline, 6 months
|
|
Working Memory
大体时间:Baseline, 6 months
|
List Sorting Working Memory Test was used to assess working memory.
The participant is asked to recall and sequence different stimuli that are presented visually and via audio.
Scores are fully adjusted to nationally representative normative sample of NIH toolbox test takers, accounting for age, sex, race, and education (mean = 50; SD = 10).
Higher scores represent better outcomes.
|
Baseline, 6 months
|
|
Language
大体时间:Baseline, 6 months
|
Picture Vocabulary Test measures receptive vocabulary administered in a computer-adaptive test (CAT) format.
Respondents select the picture that most closely matches the meaning of the word.
Scores are fully adjusted to nationally representative normative sample of NIH toolbox test takers, accounting for age, sex, race, and education (mean = 50; SD = 10).
Higher scores represent better outcomes.
|
Baseline, 6 months
|
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Executive Function
大体时间:Baseline, 6 months
|
Dimensional Change Card Sort Test was used to assess cognitive flexibility and attention.
The participant is asked to match a series of picture pairs to a target picture.
Scores are fully adjusted to nationally representative normative sample of NIH toolbox test takers, accounting for age, sex, race, and education (mean = 50; SD = 10).
Higher scores represent better outcomes.
|
Baseline, 6 months
|
|
Processing Speed
大体时间:Baseline, 6 months
|
Pattern Comparison Processing Speed Test was used to assess processing speed.
Participants are asked to quickly determine whether two stimuli are the same or not the same.
Scores are fully adjusted to nationally representative normative sample of NIH toolbox test takers, accounting for age, sex, race, and education (mean = 50; SD = 10).
Higher scores represent better outcomes.
|
Baseline, 6 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Stefano Tarantini, PhD、University of Oklahoma
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2022年11月17日
初级完成 (实际的)
2024年1月10日
研究完成 (实际的)
2024年1月10日
研究注册日期
首次提交
2022年7月22日
首先提交符合 QC 标准的
2022年8月2日
首次发布 (实际的)
2022年8月4日
研究记录更新
最后更新发布 (实际的)
2026年8月17日
上次提交的符合 QC 标准的更新
2026年6月25日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.