Effects of Peanut Intake on Task-related Brain Activation and Cognitive Functions in Older Adults With Memory Complaints: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- changes from baseline in Brian activation
研究概览
简要总结
The study will test the effects of Peanuts on task-related brain activation and cognitive functions in older adults with memory complaints.
详细描述
The purpose of the study is to determine the effects of peanuts on cognitive performance and task-related brain activation on functional magnetic resonance imaging (fMRI) in older adults. The specific aim of the study is to explore the neuroprotective effects of a peanut-enriched diet (2-3 oz of peanuts to replace 20% of the total energy of the habitual diet) for 12 weeks compared to a peanut-excluded habitual diet in elderly men and women with increased risk for CVD and self-reported memory complaints. The study population is older adults 60-80 years in age.
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 (Care Provider, Outcomes Assessor)
盲法说明
The participants will be aware if they received the intervention or not, however, the cognitive testers and FMRI techs would not be aware of the participant randomization group and neither will the data analyst.
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-demented elderly between 60-80 years of age
- •Self-reported memory complaints
- •Two cardiovascular risk factors
- •Stable weight for at least 6 months prior to recruitment
排除标准
- •Peanut allergy
- •Endocrine, metabolic and neuropsychological disorders
- •Ineligible to get an MRI
- •Consuming more than 3 servings/week of nuts including peanuts
研究组 & 干预措施
Peanut Group
Peanuts: 2-3 ounces per day to replace 20% of daily energy intake
干预措施: Peanuts (Dietary Supplement)
Control Group
Habitual diet abstain from eating peanuts
干预措施: Habitual Diet (Other)
结局指标
主要结局
changes from baseline in Brian activation
时间窗: baseline to 12 weeks
Changes will be assessed by Functional MRI (fMRI) on participants. there is no units of measure
changes from baseline serum markers of inflammation
时间窗: baseline to 12 weeks
changes in serum inflammation markers which includes hs-CRP, IL-6, TNF-α, ICAM/VCAM, eSelectin, F2-isoprostanes, 8-hydroxy-deoxyguanosine (8-OH-dG) will all be assessed using ELISA
次要结局
- changes from baseline in global cognitive composite score(baseline to 12 weeks)
- Change in serum brain-derived neurotrophic factor (pg/mL)(baseline to 12 weeks)