Neural Effects of Green Tea Extract on Dorsolateral Prefrontal Cortex

Sponsor
University Hospital, Basel, Switzerland (Other)
Overall Status
Completed
CT.gov ID
NCT01615289
Collaborator
(none)
12
1
4
18
0.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Single intragastric instillation of 250 ml green tea extract
  • Dietary Supplement: Single intragastric instillation of 500 ml green tea extract
  • Dietary Supplement: Single intragastric instillation of 250 ml control solution
  • Dietary Supplement: Single intragastric instillation of 500 ml control solution
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Study Start Date :
Jul 1, 2010
Actual Primary Completion Date :
Jan 1, 2011
Actual Study Completion Date :
Jan 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Green tea extract, 250 ml

Single intragastric instillation of 250 ml green tea extract

Dietary Supplement: Single intragastric instillation of 250 ml green tea extract
Intragastric instillation by feeding tube

Active Comparator: Green tea extract, 500 ml

Intragastric instillation of 500 ml green tea extract solution

Dietary Supplement: Single intragastric instillation of 500 ml green tea extract
Intragastric instillation by feeding tube

Placebo Comparator: Control solution, 250 ml

Intragastric instillation of 250 ml control solution

Dietary Supplement: Single intragastric instillation of 250 ml control solution
Intragastric instillation by feeding tube

Placebo Comparator: Control solution, 500 ml

Single intragastric instillation of 500 ml control solution

Dietary Supplement: Single intragastric instillation of 500 ml control solution
Intragastric instillation by feeding tube

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • right-handed healthy males, no drugs, non-smoking
Exclusion Criteria:
  • drug abuse, smoker, left-handed

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Basel Switzerland CH-4031

Sponsors and Collaborators

  • University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Christoph Beglinger, MD, University Hospital, Basel, Switzerland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Christoph Beglinger, Professor of Medicine, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01615289
Other Study ID Numbers:
  • EKBB 32/09
First Posted:
Jun 8, 2012
Last Update Posted:
Jun 8, 2012
Last Verified:
Jun 1, 2012
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 8, 2012