Effect of Bilberry (European Blueberries) and Grape Polyphenols on Cognition and Blood Parameters in Normal, Aged Men With Subjective Memory Decline
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- neuropsychological test scores and whole blood gene regulation
研究概览
简要总结
The purpose of this study is to determine whether dietary intervention with blueberry and grape juice extracts in elderly men with subjective memory problems would raise performance on neuropsychological memory tests and change biomarker of muscle damage and whole blood gene expression profiles.
详细描述
A number of studies have shown that increased dietary intake of fruits and vegetable extracts high in antioxidants (e.g., blueberries, strawberries and spinach) can retard and even reverse age-related decline in brain function and in cognitive and motor performance in rats. This is the first placebo-controlled human study to evaluate the effect of dietary intake of fruit polyphenols on neuropsychological test scores and whole blood gene regulation
Sixty-two non-demented, non-depressed men (age 67-77 years) with subjective memory decline, were randomly assigned to a blueberry/grape juice- and placebo-group in a 9 week double blind intervention study. Pre- and post treatment assessment were measured with a computerised neuropsychological test battery (CANTAB), including tests for motor speed, visual reaction time, and spatial memory. Dietary habits were registered before intervention and several clinical biomarkers were measured in plasma/serum before and after the intervention. Pre- and post intervention-samples for measurement of gene regulation were also collected
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 67 Years 至 77 Years（Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •age 67-77 years
- •gradual subjective memory decline
- •response to advertisement
排除标准
- •head trauma with loss of consciousness and lasting symptoms
- •brain stroke within last 3 years
- •dementia, clinically diagnosed
- •signs of brain-degenerative disease
- •Mini Mental Status Examination score less than 26
- •depression (MADRS; Montgomery Asberg Depression Rating Scale score above 20)
- •ongoing treatment for cancer (cytostatica)/diabetes
- •reported or observed serious mental illness
- •reported or observed use of narcotics (any, present or past)
- •reported or observed abuse of alcohol
- •visual, auditory, or motor handicaps of relevance for performance
结局指标
主要结局
neuropsychological test scores and whole blood gene regulation
时间窗: December 2006 - july 2007
whole blood gene regulation; parameters in blood
时间窗: 2006 and 2007
neuropsychological test scores; whole blood gene regulation; parameters in blood
时间窗: 2006 and 2007
次要结局
- gene expression of stress, repair and maintenance processes measured by whole genome microarray analysis in blood(2007 and 2009)