Neural Effects of Green Tea Extract on Dorsolateral Prefrontal Cortex

NCT ID: NCT01615289

Last Updated: 2012-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Exploratory Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Green tea extract, 250 ml

Single intragastric instillation of 250 ml green tea extract

Group Type ACTIVE_COMPARATOR

Single intragastric instillation of 250 ml green tea extract

Intervention Type DIETARY_SUPPLEMENT

Intragastric instillation by feeding tube

Green tea extract, 500 ml

Intragastric instillation of 500 ml green tea extract solution

Group Type ACTIVE_COMPARATOR

Single intragastric instillation of 500 ml green tea extract

Intervention Type DIETARY_SUPPLEMENT

Intragastric instillation by feeding tube

Control solution, 250 ml

Intragastric instillation of 250 ml control solution

Group Type PLACEBO_COMPARATOR

Single intragastric instillation of 250 ml control solution

Intervention Type DIETARY_SUPPLEMENT

Intragastric instillation by feeding tube

Control solution, 500 ml

Single intragastric instillation of 500 ml control solution

Group Type PLACEBO_COMPARATOR

Single intragastric instillation of 500 ml control solution

Intervention Type DIETARY_SUPPLEMENT

Intragastric instillation by feeding tube

Interventions

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Single intragastric instillation of 250 ml green tea extract

Intragastric instillation by feeding tube

Intervention Type DIETARY_SUPPLEMENT

Single intragastric instillation of 500 ml green tea extract

Intragastric instillation by feeding tube

Intervention Type DIETARY_SUPPLEMENT

Single intragastric instillation of 250 ml control solution

Intragastric instillation by feeding tube

Intervention Type DIETARY_SUPPLEMENT

Single intragastric instillation of 500 ml control solution

Intragastric instillation by feeding tube

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* drug abuse, smoker, left-handed
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Christoph Beglinger

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christoph Beglinger, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

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University Hospital

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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EKBB 32/09

Identifier Type: -

Identifier Source: org_study_id

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