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临床试验/NCT01594086
NCT01594086已完成不适用

Effects of Green Tea Consumption on Homocysteine Metabolism and Cognitive Dysfunction in Elderly: An Exploratory Clinical Study

University of Shizuoka2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2012年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
Changes in the serum homocysteine levels

研究概览

简要总结

Green tea contains catechins and theanine as major ingredients and has been reported to have various beneficial influences on human health. It is reported that the drinking green tea is inversely associated with serum homocysteine level in elderly. However the effect of green tea consumption on cognitive dysfunction is not clinically clarified. The purpose of this study is to investigate the effects of green tea consumption on homocysteine metabolism and cognitive dysfunction in elderly with impaired cognitive function.

详细描述

Elderly people with impaired cognitive function go on increasing year by year with the coming aged society. Among them, the Alzheimer disease is a major cause of the illness, which is progressively worse, has no fundamental curable therapy, and induces the burdens of caregivers as well as the health insurance and national budget. Recently, homocysteine metabolism is reported to be related to atherosclerosis in aging, and draw attention as the etiology of cognitive dysfunction in elderly.

Green tea contains catechins and theanine as main ingredients. These components are reported to have anti-atherogenic action and effect on improving cognitive dysfunction. However, clinical evidence for homocysteine metabolism and cognitive dysfunction has not been clarified. Therefore, in this study, the investigators attempted to investigate the effects of green tea consumption on homocysteine metabolism and cognitive dysfunction in elderly with impaired cognitive function.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Obtained written informed consent before participation
  • Possible to consume green tea powder
  • Possessing cognitive dysfunction; MMSE score less than 30
  • Possible not to take any supplement possessing anti-oxidizing effect; i.e., vitamin A, C, E, β-carotene

排除标准

  • Possessing allergy to green tea
  • Possessing severe cardiac, respiratory, renal, or hepatic dysfunction
  • Possessing severe anemia
  • Diagnosed as inadequate to participate in the study by doctor

结局指标

主要结局

Changes in the serum homocysteine levels

时间窗: between baseline and 3 months after

Changes in the serum homocysteine levels before and after the intervention

次要结局

  • Changes in serum lipid levels(between baseline and 3 months after)
  • Changes in serum folic acid levels(between baseline and 3 months after)
  • Changes in mini mental state examination (MMSE) scores(between baseline and 3 months after)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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