Clinical trial NCT00981955: The Effects of Caffeine and L-theanine Both Alone and in Combination on Cerebral Blood Flow, Cognition and Mood
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cognitive Function
Mood
Keywords: Caffeine
Ltheanine
Near Infrared Spectroscopy
Cerebral Blood Flow
Cognitive Function
Mood
Lead sponsor: Northumbria University
Sponsor class: OTHER
First posted: 2009-09-22
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Cerebral blood flow
timeFrame: 0-80 minutes post dose
measure: Cognitive function
timeFrame: 0-70 minutes post-dose
measure: Mood
timeFrame: 85 minutes post dose
Secondary outcomes:
Other outcomes:
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: Northumbria University
state: Tyne & Wear
Study officials:
affiliation: Northumbria University
name: Crystal Haskell, PhD
role: PRINCIPAL_INVESTIGATOR
References: