Dietary Supplementation With EVOO Phenolics Prevents MCI Progression to Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Cerebrovascular function
研究概览
简要总结
The goal of this clinical trial is to determine whether the extra-virgin olive oil (EVOO) phenolic dietary supplement can improve memory function and modulate biomarkers among individuals with mild cognitive impairment (MCI). The main questions it aims to answer are:
- Does dietary supplementation with EVOO phenolics improve cognitive function?
- What would be the effect of the EVOO dietary supplement on other MCI-related biomarkers, including vascular function and biological pathways?
Researchers will compare the EVOO dietary supplements with a placebo (a look-alike substance that contains no EVOO phenolics)
Participants will:
- Take EVOO dietary supplements or a placebo daily for 6 months
- Visit the study site during the 6-month study for screening and testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CDR (Clinical Dementia Rating) score of 0.5 OR MoCA (Montreal Cognitive Assessment) score of 18-25.
排除标准
- •History or presence of vascular disease that may affect cognitive function
- •History or presence of stroke within the past 1 year
- •Recent transient ischemic attack (TIA) within the past 180 days
- •History of severe, clinically significant CNS trauma
- •History of intracranial tumor
- •History or presence of kidney disease (eGFR <60 mL/min/1.73m2)
- •Presence of a pacemaker
- •Presence of metal in the body
- •Allergic to the MRI contrast agent "Multihance"
- •Pregnancy
结局指标
主要结局
Cerebrovascular function
时间窗: At baseline and end of treatment (6 months)
To assess the effect of extra virgin olive oil (EVOO) phenolic dietary supplements on blood barin barrier function using Dynamic Contrast-Enhanced MRI (DCE-MRI)
Cerebrovascular blood flow
时间窗: At baseline and end of treament (6 months)
To assess the effect of extra virgin olive oil (EVOO) phenolic dietary supplements on cerebrovascular blood flow using Near Infrared Spectroscopy.
Cognitive function
时间窗: At baseline and end of treament (6 months)
To assess the effect of extra virgin olive oil (EVOO) phenolic dietary supplements on cognitive function, the Clinical Dementia Rating (CDR) and the National Institutes of Health (NIH) Toolbox Cognition Battery will be used. CDR and NIH Toolbox cognitive tests will be combined to report the overall effect of the intervention on changes in cognitive function. A CDR score of 0.5 indicates mild cognitive impairment, and a score of 3 indicates dementia. Those with a CDR score of 0 indicate normal cognitive function. For the NIH Toolbox tests, the Total Cognition Composite score is used, with 70 or lower indicating impaired cognition and 130 and above indicating superior cognitive ability.
次要结局
- Blood biomarkers(At baseline and end of treatmnet (6 months))
- Proteomics(At baseline and end of treatmnet (6 months))
- Metabolomics(At baseline and end of treatment (6 months))