Enhancing Memory Functions in Patients With Mild Cognitive Impairment by Dietary Interventions and in Combination With Exercise and Cognitive Training - Proof of Concept and Mechanisms
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Alzheimer's Disease Assessment Scale - cognitive subscale
研究概览
简要总结
The study will investigate whether dietary modification could provide positive effects on brain functions in elderly people with mild cognitive impairment.
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, dietary modification (caloric restriction, omega-3 fatty acids and resveratrol) should improve cognitive functions such as learning and memory. To test this hypothesis, the researchers study general brain functions in elderly subjects (50-80 years old) with mild cognitive impairment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •subjects with mild cognitive impairment
- •50-80 years old
- •moderate to heavy weight (BMI 25-35)
排除标准
- •severe disease
- •younger than 50 years
- •BMI < 25
研究组 & 干预措施
Caloric restriction
干预措施: caloric restriction (Behavioral)
resveratrol supplementation
干预措施: resveratrol supplementation (Behavioral)
placebo
干预措施: Placebo (Behavioral)
2nd step: intervention + physical /cognitive training
most effective dietary intervention plus physical and cognitive training
干预措施: 2nd step: intervention + physical / cognitive training (Behavioral)
2nd step: most effective dietary intervention plus control
most effective dietary intervention plus control
干预措施: 2nd step: intervention + control (Behavioral)
omega-3 supplementation
干预措施: omega-3 supplementation (Behavioral)
结局指标
主要结局
Alzheimer's Disease Assessment Scale - cognitive subscale
时间窗: Prior to intervention and after 6 months of intervention
次要结局
- Functional/Structural brain changes(Prior to intervention and after 6 months of intervention)
- Plasma biomarkers(Prior to intervention and after 6 months of intervention)
研究者
Agnes Flöel
Prof. Dr. med. Agnes Flöel, Neurologie
Charite University, Berlin, Germany