Impact of Resveratrol on Brain Function and Structure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from baseline Verbal Learning Task Scores at 6 months
研究概览
简要总结
The study will investigate whether resveratrol could provide positive effects on memory and brain structures and functions in healthy elderly participants.
详细描述
Cell and animal studies postulated various beneficial effects of resveratrol, ranging from a reduction of inflammatory processes and the treatment of cancer to the prevention of cardiovascular diseases and stroke. With regard to cognitive decline, rodent models for Alzheimer's disease (AD) showed improved learning and decelerated hippocampal neurodegeneration after intake of resveratrol.
Animal and first human studies provided evidence that resveratrol might serve as an easy, cost-effective option to develop novel prevention and treatment strategies against age-associated cognitive decline. To test this hypothesis, the researchers study general brain structure and function on healthy older individuals (> 60years old).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •subjects who are healthy or with subjective memory complaints
- •older than 60 years old
- •normal to overweight participants (BMI: 22-40 kg/sqm)
排除标准
- •Psychiatric diseases
- •severe untreated internal diseases
- •younger than 60 years
- •BMI < 22 or >40
研究组 & 干预措施
resveratrol supplementation
Dietary Supplement: Resveratrol
干预措施: resveratrol supplementation (Dietary Supplement)
placebo supplementation
Dietary Supplement: Placebo
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change from baseline Verbal Learning Task Scores at 6 months
时间窗: Baseline (timepoint 0), after 6 months (timepoint 6 months)
次要结局
- Change from baseline Verbal Learning Task Scores at 12 months(after 12 months (timepoint 12 months))
- Mini Mental State Examination(Baseline (timepoint 0), after 6 months (timepoint 6 months) and after 12 months (timepoint 12 months))
- Structural changes on the brain MRI images(Baseline (timepoint 0), after 6 months (timepoint 6 months) and after 12 months (timepoint 12 months))
- Functional changes on the brain MRI images(Baseline (timepoint 0), after 6 months (timepoint 6 months) and after 12 months (timepoint 12 months))
- Plasma biomarkers(Baseline (timepoint 0), after 6 months (timepoint 6 months) and after 12 months (timepoint 12 months))