The Effects of Caffeine and L-theanine Both Alone and in Combination on Cerebral Blood Flow, Cognition and Mood

July 22, 2010 updated by: Northumbria University

A Randomised, Double Blind, Placebo-controlled Study to Evaluate the Effects of Caffeine and L-theanine Both Alone and in Combination on Cerebral Blood Flow, Cognition and Mood.

Although the beneficial effects of caffeine on cognition and mood have been reported in a number of studies, relatively few studies have looked at the effects of caffeine in combination with other phytonutrients despite the fact that caffeine is seldom consumed in isolation. L-theanine is a naturally occurring amino-acid found in tea, and has been used historically as a relaxing agent (Haskell et al., 2008). Few have assessed the impact of l-theanine on cognition, but of those that have, the most interesting results were obtained when l-theanine was assessed in combination with caffeine (Haskell et al., 2008). It remains unclear what is underlying the reported effects.

Near Infrared Spectroscopy (NIRS) is an emerging neuroimaging technology that is capable of determining changes in cerebral blood flow (CBF) by measuring the optical properties of oxygenated and deoxygenated blood (Bunce et al., 2006). No study to date has used NIRS to assess cerebral blood flow following treatment with either caffeine, l-theanine or a combination of both. It is anticipated that the proposed study will provide some insight into the mechanism of the previously observed effects both alone and in combination.

A randomised, double-blind, placebo controlled, balanced crossover design study will assess the effects of 75mg caffeine, 50mg l-theanine and a 75mg caffeine/50mg l-theanine combination in 24 young healthy adults (18-35). Cognitive and mood assessments will take place at baseline and at 30 minutes following treatment whilst cerebral haemodynamics are measured via the technique of NIRS.

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Tyne & Wear
      • Newcastle upon Tyne, Tyne & Wear, United Kingdom, NE1 8ST
        • Northumbria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 33 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy
  • Aged 18-35
  • Either caffeine consumers (consume more than 150mg caffeine per day) or non-consumers (less than 44mg caffeine per day).

Exclusion Criteria:

  • Smoke or consume any tobacco products
  • Not proficient in English language
  • Pregnant (or seeking to become pregnant)
  • Taking recreational, over the counter/prescription medication (including the contraceptive pill), and/or dietary/herbal supplements
  • Have food allergies or sensitivities
  • Have history of/current head trauma, learning difficulties , ADHD, migraines or any gastric problems

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 75mg caffeine
Acute oral administration of 75mg of caffeine, 50mg l-theanine, 75mg caffeine and 50mg l-theanine in combination or placebo. One dosage administered on each of four separate study days.
Other Names:
  • Sun-theanine (l-theanine)
Active Comparator: 50mg l-theanine
Acute oral administration of 75mg of caffeine, 50mg l-theanine, 75mg caffeine and 50mg l-theanine in combination or placebo. One dosage administered on each of four separate study days.
Other Names:
  • Sun-theanine (l-theanine)
Active Comparator: 75mg caffeine and 50mg l-theanine
Acute oral administration of 75mg of caffeine, 50mg l-theanine, 75mg caffeine and 50mg l-theanine in combination or placebo. One dosage administered on each of four separate study days.
Other Names:
  • Sun-theanine (l-theanine)
Placebo Comparator: 0mg caffeine/l-theanine
Acute oral administration of 75mg of caffeine, 50mg l-theanine, 75mg caffeine and 50mg l-theanine in combination or placebo. One dosage administered on each of four separate study days.
Other Names:
  • Sun-theanine (l-theanine)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cerebral blood flow
Time Frame: 0-80 minutes post dose
0-80 minutes post dose
Cognitive function
Time Frame: 0-70 minutes post-dose
0-70 minutes post-dose
Mood
Time Frame: 85 minutes post dose
85 minutes post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Crystal Haskell, PhD, Northumbria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

September 21, 2009

First Submitted That Met QC Criteria

September 21, 2009

First Posted (Estimate)

September 22, 2009

Study Record Updates

Last Update Posted (Estimate)

July 23, 2010

Last Update Submitted That Met QC Criteria

July 22, 2010

Last Verified

July 1, 2010

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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