Effect of Polyamine-enriched Dietary Supplementation on Cognitive Function in Healthy Older Adults With Subjective Cognitive Decline
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Cognitive Function (from neuropsychological test battery)
研究概览
简要总结
The overall objective of this study is to examine the effect of polyamine supplementation on cognitive performance of individuals with subjective cognitive decline.
详细描述
Memory abilities are known to decline during aging, a process that is accelerated in pathological conditions like subjective, mild cognitive impairment (MCI) and Alzheimer's disease (AD), all of which are a growing public-health concern with devastating effects. Polyamines supplementation and corresponding up-regulation of autophagy (i.e., cellular protein degradation pathways) may be a key target of intervention against age-related memory decline. The study will investigate whether a polyamine-enriched dietary supplementation (through capsule intake) could provide positive effects on the cognitive function of elderly individuals (60-80 years old) with subjective cognitive decline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cognitive healthy subjects with subjective memory decline and self-reported concerns
- •60-80 years old
- •No manifest dementia (DSM-IV criteria)
- •No limitations in activities of daily living
- •Capacity for consent
排除标准
- •Gluten, histamine or wheat seedling intolerance
- •Severe neurological, internal or psychological diseases
- •Advanced heart or respiratory diseases, severe arteriosclerosis, untreated thyroid disease or diabetes
- •Malignant tumors, current or past history
- •Brain tumors, stroke
- •Disorders that impair attention
- •Coagulation disorder, Marcumar or ASS therapy
- •Drug abuse or alcohol dependency
- •Current polyamine substitution
研究组 & 干预措施
Polyamine supplementation
750 mg polyamine-rich plant extract per day
干预措施: Polyamine supplementation (Dietary Supplement)
Placebo
750 mg potato starch per day
干预措施: Placebo supplementation (Dietary Supplement)
结局指标
主要结局
Change in Cognitive Function (from neuropsychological test battery)
时间窗: Prior to intervention (baseline) and after 3 months of intervention
Comparing changes in cognitive function in subjects with polyamine intake and placebo treatment (pre vs. post intervention)
次要结局
- Vascular parameters(Prior to intervention (baseline) and after 3 months of intervention)
- Laboratory parameters(Prior to intervention (baseline) and after 3 months of intervention)
研究者
Claudia Schwarz
Postdoctoral Researcher
Charite University, Berlin, Germany