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OpenTrials
Completed

NCT Number: NCT01615289

Neural Effects of Green Tea Extract on Dorsolateral Prefrontal Cortex

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.

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Key information

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Basel, CH-4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • drug abuse, smoker, left-handed

Treatment and study plan

Single intragastric instillation of 250 ml green tea extract

Dietary Supplement

Intragastric instillation by feeding tube

Single intragastric instillation of 500 ml green tea extract

Dietary Supplement

Intragastric instillation by feeding tube

Single intragastric instillation of 250 ml control solution

Dietary Supplement

Intragastric instillation by feeding tube

Single intragastric instillation of 500 ml control solution

Dietary Supplement

Intragastric instillation by feeding tube

Primary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Jun 8, 2012
Registry last updated
Jun 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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