- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00981955
The Effects of Caffeine and L-theanine Both Alone and in Combination on Cerebral Blood Flow, Cognition and Mood
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Tyne & Wear
-
Newcastle upon Tyne, Tyne & Wear, United Kingdom, NE1 8ST
- Northumbria University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
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:
|
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:
|
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:
|
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
Sponsor
Investigators
- Principal Investigator: Crystal Haskell, PhD, Northumbria University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25AA1
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.
Clinical Trials on Cognitive Function
-
University School of Physical Education in WroclawActive, not recruitingCognitive Function | Executive FunctionPoland
-
Maastricht UniversityWageningen University and Research; Top Institute Food and Nutrition; Netherlands...TerminatedCognitive Function | Ageing | Physical Function | Mitochondrial FunctionNetherlands
-
University Hospital, GenevaCompletedCognitive Function | Falls | Physical FunctionSwitzerland
-
University of FloridaNational Institutes of Health (NIH); National Institute on Aging (NIA)CompletedCognitive Function | Older Adults | Physical FunctionUnited States
-
Columbia UniversityNational Institute on Aging (NIA)Terminated
-
Örebro University, SwedenNot yet recruiting
-
Radicle ScienceActive, not recruitingCognitive FunctionUnited States
-
Vanderbilt University Medical CenterCompletedCognitive Function
-
Maastricht University Medical CenterBioActor B.V.Completed
-
University of OstravaCompletedCognitive FunctionCzechia
Clinical Trials on Caffeine and L-theanine
-
Sha'ar Menashe Mental Health CenterStanley Medical Research Institute; Beersheva Mental Health CenterCompleted
-
Texas Tech UniversityTexas Tech University Health Sciences CenterCompletedAttention Deficit Hyperactivity DisorderUnited States
-
Butler HospitalCompletedPsychiatric Disorder | Cortical ExcitabilityUnited States
-
The University of Texas Health Science Center,...CompletedTheanine, (L)-IsomerUnited States
-
Ethical Naturals, Inc.KGK Science Inc.Active, not recruiting
-
University of British ColumbiaCompleted
-
Texas Tech UniversityCompleted
-
Icahn School of Medicine at Mount SinaiTerminatedCognitive PerformanceUnited States
-
Sha'ar Menashe Mental Health CenterTirat Carmel Mental Health CenterUnknownSchizophrenia | Schizoaffective Disorder
-
University of FloridaRecruitingMotor Activity | Cognitive Symptom | Stress Response | Mental Stress | Physiological Stress | Multitasking BehaviorUnited States