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NCT Number: NCT00981955

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.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Northumbria University

Newcastle upon Tyne, Tyne & Wear, Ne1 8ST, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Caffeine and L-theanine

Dietary Supplement

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)

Primary outcomes

  1. Cerebral blood flow

    Time frame: 0-80 minutes post dose

  2. Cognitive function

    Time frame: 0-70 minutes post-dose

  3. Mood

    Time frame: 85 minutes post dose

Sponsors and collaborators

Lead sponsor

Northumbria University

Other

Registry information

Official study title

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.

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 22, 2009
Registry last updated
Jul 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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