Phase IV Interventional Study: Effects of Dietary Interventions on Brain Functions in Healthy Elderly People
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Auditory verbal Learning Task
研究概览
简要总结
The researchers will investigate whether caloric restriction or dietary supplementation could provide positive effects on general brain functions in healthy elderly people.
详细描述
The age-related degradation of cognitive functions even to the point of neurodegenerative disorders such as Alzheimer's disease are a growing public-health concern with devastating effects.
Referring to animal data, empirical studies, and pilot human trials, a healthy diet rich in unsaturated fatty acids and low in calories should improve cognitive functions such as learning and memory. To test this hypothesis, the researchers study general brain functions in healthy elderly subjects (50-80 years old) during a short term diet.
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
- Single (Investigator)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy subjects
- •50-80 years old
- •moderate to heavy weight (BMI 25-30)
- •must be able to change diet/take supplements at home
排除标准
- •younger than 50 years
- •BMI < 25
- •psychiatric medication
- •severe disease
- •MMSE < 26
- •eating disorders
结局指标
主要结局
Auditory verbal Learning Task
时间窗: Baseline (timepoint 0), after 6 months (timepoint 6 months)
次要结局
- Functional/Structural brain changes(Baseline (timepoint 0), after 6 months (timepoint 6 months))
- Plasma biomarkers(Baseline (timepoint 0), after 6 months (timepoint 6 months)f intervention)
研究者
Agnes Floel
Prof. Dr. med. Agnes Flöel
University Hospital Muenster