Time Restricted Eating for Prevention of Age-related Vascular Cognitive Decline in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in neurovascular coupling using functional near infrared spectroscopy (fNIRS)
研究概览
简要总结
The central hypothesis of this study is that closer adherence to time restricted eating (TRE) will improve endothelial function, neurovascular (NVC) responses, resulting in improved cognitive performance, potentially through activation of SIRT1-dependent vasoprotective pathways.
详细描述
This hypothesis will be tested by assessing the effect of TRE (not more than 10hr eating window each day for 6 months) in healthy older adults (55-80 years of age).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥55 and ≤80 years of age
- •Adequate hearing and visual acuity to participate in the examinations
- •Ability to read and write in English
- •Competence to provide informed consent.
- •Mini Montreal Cognitive Assessment ≥12
- •Mini Nutritional Assessment ≥12
排除标准
- •Vision or hearing impairment that would impair the ability to complete study assessments
- •Active CNS disease including multiple sclerosis, uncontrolled seizures, active brain cancer
- •Cerebrovascular accident other than TIA within 60 days prior to Visit 0
- •Major psychiatric disease, including major depression not currently controlled on medications, alcohol or drug abuse
- •Diabetics prescribed sulfonylureas, meglitinides, and insulin
- •Any other medical condition which, in the opinion of investigator, would render the patient inappropriate or too unstable to complete the study protocol
研究组 & 干预措施
Time restricted eating
not more than 10 hrs. eating window daily goal for 6 months
干预措施: Time restricted eating (Other)
结局指标
主要结局
Change in neurovascular coupling using functional near infrared spectroscopy (fNIRS)
时间窗: baseline, up to 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 and deoxygenated hemoglobin measured over the cortical brain tissues. Neurovascular coupling will be evaluated as a change in oxy- and deoxy-hemoglobin between before and after completion of study.
Change in EEG spectra
时间窗: baseline, up to 6 months
EEG signal will be collected to generate spectral data. These data will be used for comparison of EEG activity between before and after treatment. Units of measure - power spectral density. Reported as a %change from baseline, before and after completion of study.
Change in neurovascular coupling using the dynamic retinal vessel analysis
时间窗: baseline, up to 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 completion of study.
次要结局
- Change in microvascular endothelial function(baseline, up to 6 months)
- Change in arterial stiffness(baseline, up to 6 months)
- Change in Attention(baseline, up to 6 months)
- Change in Executive Function(baseline, up to 6 months)
- Body composition(baseline, up to 6 months)
- Change in Glycocalyx - perfused boundary region(baseline, up to 6 months)
- Change in Working Memory(baseline, up to 6 months)
- Change in capillary density(baseline, up to 6 months)
- Change in red blood cell velocity(baseline, up to 6 months)
- Total daily energy expenditure(baseline, up to 6 months)
- Change in blood metabolic panel markers(baseline, up to 6 months)
- Change in BOLD signal(baseline, up to 6 months)
- Change in Processing Speed(baseline, up to 6 months)
- Dietary intakes(baseline, up to 6 months)
- Change in Language(baseline, up to 6 months)
- Change in Episodic Memory(baseline, up to 6 months)