Early Intervention in Cognitive Aging
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Insulin resistance
研究概览
简要总结
Nutritional intervention in overweight middle aged individuals with subjective memory complaints.
详细描述
Late-onset AD develops over many years during a preclinical period in which neuropathological changes accumulate before dementia is evident. Deposition of amyloid-beta (Aβ) in the brain is the earliest recognized biomarker of AD pathology, and, demographically, Aβ accumulation begins to accelerate at age 50, a period when the incidence of metabolic disturbance increases as well. Hyperinsulinemia associated with insulin receptor resistance has been associated with AD pathololgy, and metabolic disturbance in mid-life increases risk for subsequent dementia. There are indications that subjective memory complaints can be an early indicator of developing neuropathology and may be the first manifestation of future dementia. This research involves intervention studies in different samples of individuals from this population to investigate the extent to which berry fruit supplementation and ketone metabolism might improve cognitive performance in association with enhancement of metabolic function and related factors. The ultimate goal of this research is to develop interventional approaches that might be applied with at-risk individuals in the preclinical period of dementia to forestall or prevent progression of neurocognitive decline.
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 (Participant, Investigator)
盲法说明
There is no blind in the dietary intervention given that participants are aware of the nature of the foods they consume. However, each dietary approach is described as healthy. In the berry supplementation studies, there is double blinding using berry fruit and placebo powders that are packaged with a code.
入排标准
- 年龄范围
- 50 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •overweight; subjective memory complaints
排除标准
- •diabetes; liver or kidney disease; age-related memory disorder; neurologic or psychiatric condition; substance abuse
结局指标
主要结局
Insulin resistance
时间窗: Eight or 12 weeks after enrollment
HOMA-IR will be derived from fasting glucose and insulin
Cognitive function
时间窗: Eight or 12 weeks after enrollment
Performances on examiner-adminstered instruments assessing memory function
次要结局
- Long term glucose concentration(Eight or 12 weeks after enrollment)
研究者
Robert Krikorian
Professor
University of Cincinnati
