Extra-virgin Olive Oil Prevents Mild Cognitive Impairment Conversion to Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Effect of olive oil on the BBB intactness
研究概览
简要总结
Until now there is no medical treatment and/or intervention that can slow, stop or reverse the underlying neurodegenerative of Alzheimer's disease (AD). The goal of this study is to demonstrate "Oleocanthal rich-extra-virgin olive oil (EVOO) consumption stops or delay mild cognitive impairment conversion to AD by restoring the blood-brain barrier (BBB) function in humans".
Specific Aims:
- Evaluate effect of EVOO on the brain function by functional MRI (fMRI) imaging, and BBB function by dynamic contrast-enhanced MRI (DCE-MRI).
- Evaluate effect of EVOO on cognitive function and on selected biomarkers
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, experiencing mild cognitive impairment with:
- •Mini-Mental State Exam (MMSE) scores between 18-30 (based on education level
- •memory complaint, have objective memory loss measured by education adjusted scores on Wechsler Memory Scale Logical Memory VI
- •Clinical Dementia Rating (CDR) score 0.5.
排除标准
- •Subjects with contradictions for MRI include: the presence of metal or electronic devices such as metallic joint prostheses, artificial heart valves, an implantable heart defibrillator, a pacemaker, metal clips, cochlear implants, a bullet, shrapnel or any other type of metal fragment; breathing problems or disorders, claustrophobia, inner ear disorders, vertigo or dizziness, tattoos or permanent makeup that contains metal, and body piercing jewelry that cannot be removed.
- •Subjects will be excluded if they are smokers
- •Subjects who have have clinically important medical or neuropsychiatric comorbidity.
- •Subjects who have renal problems or are allergic to the MRI contrast agent.
研究组 & 干预措施
EVOO-phenol high
Extra-virgin olive oil rich with oleocanthal and other phenolic compounds that will be added to daily diet
干预措施: EVOO (Other)
OO-phenol low
Olive oil with low phenolic content that will be added to daily diet
干预措施: OO (Other)
结局指标
主要结局
Effect of olive oil on the BBB intactness
时间窗: 6 months
Will be evaluated by DCE-MRI
Effect of olive oil on the brain activity
时间窗: 6 months
Will be evaluated by fMRI
次要结局
- Cognitive function(6 months)