Neural Effects of Green Tea Extract on Dorsolateral Prefrontal Cortex

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christoph Beglinger, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01615289
First received: June 5, 2012
Last updated: June 7, 2012
Last verified: June 2012
  Purpose

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 Intervention
Exploratory Behavior
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Functional magnetic resonance imaging (fMRI) in healthy volunteers while they performed a working memory task [ Time Frame: 0 and 45 min ] [ Designated as safety issue: No ]
    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.


Enrollment: 12
Study Start Date: July 2010
Study Completion Date: January 2012
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • drug abuse, smoker, left-handed
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01615289

Locations
Switzerland
University Hospital
Basel, Switzerland, CH-4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Christoph Beglinger, MD University Hospital, Basel, Switzerland
  More Information

No publications provided

Responsible Party: Christoph Beglinger, Professor of Medicine, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01615289     History of Changes
Other Study ID Numbers: EKBB 32/09
Study First Received: June 5, 2012
Last Updated: June 7, 2012
Health Authority: Switzerland: Ethikkommission

ClinicalTrials.gov processed this record on July 09, 2014