AvoCog - The Effect of Daily Avocado Intake on Cognitive Function in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in brain activity
研究概览
简要总结
The goal of this clinical trial is to determine if adding avocados to the diet of impacts cognition in 70 older adults, age 65-85, without dementia. We will test for change in functional MRI, cognitive performance, and brain blood flow. Intervention group participants will be asked to consume 1 avocado per day for 12 weeks. Participants in the control group will be asked to continue their normal intake for 12 weeks. Throughout the study, participants will be asked to perform cognitive tests, MRI, blood tests, and questionnaires.
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 (Investigator, Outcomes Assessor)
盲法说明
Participants cannot be blinded to their allocation in order to follow the study protocol. Investigator and Outcomes Assessor will be blinded.
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females aged 65-85 years
- •Good general health with no concomitant disease
- •BMI 18.5 - 35 kg/m2
- •Mini Mental State Exam ≥26
- •Reports consuming ≤2 medium avocados per month
- •Reports consuming ≤3 servings of carotenoid-rich foods per week and ≤3 servings of fruits and vegetables per day
- •Skin carotenoid content <400
排除标准
- •Unwilling or unable to consume avocado
- •Latex allergy
- •Consistently taking lutein + zeaxanthin supplements
- •Skin carotenoid content ≥400
- •Central neurological disease such as Alzheimer's disease, Parkinson's disease, multiple sclerosis, stroke, brain tumor, etc.
- •Serious medical risk: cancer requiring chemotherapy or radiation within the past 5 years, recent cardiac event (i.e. heart attack, etc.)
- •Diabetes mellitus or uncontrolled hypertension
- •Use of psychoactive or investigational medications
- •Consumption of ≥3 alcoholic drinks per day or substance abuse
- •Unable to undergo MRI
研究组 & 干预措施
Avocado Group
Participants will consume 1 avocado per day and receive education to maintain usual caloric intake for 12 weeks and participate in 4 study visits.
干预措施: Avocado Group (Other)
No Diet Modification Group
Participants will continue their normal dietary pattern for 12 weeks and participate in 4 study visits.
结局指标
主要结局
Change in brain activity
时间窗: Baseline and 12 weeks
MRI will be used to measure changes in brain activity during resting state, a working memory task, and executive function task.
次要结局
- Changes in memory and executive function(Baseline and 12 weeks)
- Changes in cerebral blood flow(Baseline and 12 weeks)
研究者
Matthew Taylor
Dr. Matthew K Taylor, PhD, RD
University of Kansas Medical Center