跳至主要内容
临床试验/NCT02023645
NCT02023645Unknown不适用

The Effects of a Lutein + Zeaxanthin Intervention on Cognitive Function and Neural Efficiency

University of Georgia1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2012年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
120
试验地点
1
主要终点
macular pigment optical density

研究概览

简要总结

Past research suggests that retinal lutein levels are related to cognitive function as measured via behavioral tests. The goal of the present study is to investigate the relationship between lutein and cognitive function in a wider variety of the population (young, healthy adults and older adults), using a wider variety of methods (behavioral testing and neuroimaging).

详细描述

Past research suggests that retinal lutein levels are related to cognitive function as measured via behavioral tests. The goal of the present study is to investigate the relationship between lutein and cognitive function in a wider variety of the population (young, healthy adults and older adults), using a wider variety of methods (behavioral testing and neuroimaging).

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •visual acuity correctable to 20:40 or better, Snellen notation
  • •able to swallow a dietary supplement
  • •free of dementia, characterized by a score of less than 1.5 on the Clinical Dementia Rating Scale

排除标准

  • •GI conditions that interfere with lipid absorption
  • •presence of or past diagnosis of age-related macular degeneration
  • •visual acuity poorer than 20:40, Snellen notation
  • •has taken lutein, omega-3 fatty acid or fish oil supplements within the last 6 months
  • •presence of dementia, characterized by a score of 1.5 or greater on the Clinical Dementia Rating Scale

研究组 & 干预措施

Active supplement

Experimental

10 mg lutein + 2 mg zeaxanthin

干预措施: active supplement (Dietary Supplement)

inert placebo

Placebo Comparator

placebo for comparison

干预措施: placebo (Other)

结局指标

主要结局

macular pigment optical density

时间窗: 12 months

optical density of macular pigment layer in central retina, defined in log units of optical density

次要结局

  • reaction time(12-months)
  • serum carotenoid levels(12 months)
  • executive function(12-months)
  • short-term memory(12-months)
  • visual attention(12-months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Billy R. Hammond

Professor and Principal Investigator

University of Georgia

研究点 (1)

Loading locations...

相似试验