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临床试验/NCT01615289
NCT01615289已完成不适用

Neural Effects of Green Tea Extract on Dorsolateral Prefrontal Cortex

University Hospital, Basel, Switzerland2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2010年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
12
试验地点
2
主要终点
Functional magnetic resonance imaging (fMRI) in healthy volunteers while they performed a working memory task

研究概览

简要总结

Green tea is being recognized as a beverage with potential benefits for human health and on cognitive function. In vitro and in vivo studies provide preliminary evidence that green tea intake may play a positive role in improving effects on cognitive functions. The investigators aim to examine the neural effects of green tea extract on brain activation in humans.

详细描述

As functional neuroimaging provides a means of examining how green tea extract acts on the brain, we used functional magnetic resonance imaging (fMRI) to study healthy volunteers while they performed a working memory task following intra-gastric administration of either 250 ml or 500 ml Rivella green® (RG), a milk whey based green tea extract containing soft drink, or Rivella blue® (RB), a milk whey based soft drink without green tea extract as sham condition in a double-blind, controlled design. Based on the literature on pharmacological and behavioural effects of green tea, we hypothesized - a priori - that green tea extract would subtly modulate the engagement of the dorsolateral prefrontal cortex (DLPFC), a brain region critically involved in many cognitive functions such as working memory processing.

A double-blind, controlled, within-subject study with counterbalanced order of substance administration using an established protocol (6-8) was conducted over 4 sessions (250 ml or 500 ml Rivella green® (including green tea extract; RG), 250 or 500 ml Rivella blue® (RB). Each participant was scanned four times with a one-week interval between scans. The order of substance administration across sessions was counterbalanced across subjects, such that equal numbers followed each substance sequence.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • right-handed healthy males, no drugs, non-smoking

排除标准

  • drug abuse, smoker, left-handed

结局指标

主要结局

Functional magnetic resonance imaging (fMRI) in healthy volunteers while they performed a working memory task

时间窗: 0 and 45 min

Whole brain analysis with a cluster-level threshold was followed by an a priori defined region of interest analysis of the dorsolateral prefrontal cortex including a cluster-level threshold and family-wise error adjustment for multiple comparisons.

次要结局

未报告次要终点

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Principal Investigator
主要研究者

Christoph Beglinger

Professor of Medicine

University Hospital, Basel, Switzerland

研究点 (2)

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