Neural Effects of Green Tea Extract on Dorsolateral Prefrontal Cortex

NCT01615289 | Completed

• 1 other identifier: EKBB 32/09
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Exploratory Behavior

Outcome Measures

Primary Outcomes (1)

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

  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.

  0 and 45 min

Study Arms (4)

Green tea extract, 250 ml

ACTIVE COMPARATOR

Single intragastric instillation of 250 ml green tea extract

Dietary Supplement: Single intragastric instillation of 250 ml green tea extract

Green tea extract, 500 ml

ACTIVE COMPARATOR

Intragastric instillation of 500 ml green tea extract solution

Dietary Supplement: Single intragastric instillation of 500 ml green tea extract

Control solution, 250 ml

PLACEBO COMPARATOR

Intragastric instillation of 250 ml control solution

Dietary Supplement: Single intragastric instillation of 250 ml control solution

Control solution, 500 ml

PLACEBO COMPARATOR

Single intragastric instillation of 500 ml control solution

Dietary Supplement: Single intragastric instillation of 500 ml control solution

Interventions

Single intragastric instillation of 250 ml green tea extract DIETARY_SUPPLEMENT

Intragastric instillation by feeding tube

Green tea extract, 250 ml

Single intragastric instillation of 500 ml green tea extract DIETARY_SUPPLEMENT

Intragastric instillation by feeding tube

Green tea extract, 500 ml

Single intragastric instillation of 250 ml control solution DIETARY_SUPPLEMENT

Intragastric instillation by feeding tube

Control solution, 250 ml

Single intragastric instillation of 500 ml control solution DIETARY_SUPPLEMENT

Intragastric instillation by feeding tube

Control solution, 500 ml

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• drug abuse, smoker, left-handed

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital

Basel, CH-4031, Switzerland

Location

MeSH Terms

Conditions

Exploratory Behavior

Interventions

Tea

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Christoph Beglinger, MD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: June 5, 2012
• First Posted: June 8, 2012
• Study Start: July 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2012
• Last Updated: June 8, 2012

Record last verified: 2012-06

Locations

CH (1)