Theanine and Caffeine on Neurophysiology of Attention (NCT02770105) | Clinical Trial Compass
CompletedNot Applicable
Theanine and Caffeine on Neurophysiology of Attention
United States9 participantsStarted 2016-05
Plain-language summary
L-theanine and caffeine are nutritional compounds that are naturally found in tea. Our recent findings using an EEG paradigm are consistent with the findings of others, indicating that intake of L-theanine and caffeine reduce the time needed for a person to differentiate between two visual stimuli and react to only one stimulus. In order to understand how these compounds give rise to these improvements, the investigators need to study how these compounds are related to various areas of the brain. To achieve this, the investigators plan to scan the brains of nine participants after they take either 1) L-theanine alone, 2) caffeine alone 3) the combination of both L-theanine and caffeine as compared with a placebo (distilled water), to see which has the greatest impact on attention and on regions in the brain that bring about attention.
Who can participate
Age range
18 Years – 60 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy males\*
* Age 18-60 years
Exclusion Criteria:
* Gross impairment of vision or hearing that would prevent the participants from recognizing visual stimuli
* Physical, psychiatric or neurological impairment that could affect cognitive or motor functions
* Exposure to toxins or substances that are known to affect visual, auditory, cognitive or motor functions
* Regular intake of medication that could alter visual, auditory, cognitive or motor functions
* History of and / or current alcohol and / or drug abuse
* Disease or condition known to be precipitated or aggravated by tea or coffee
* Intake of drugs containing caffeine, other phosphodiesterase inhibitors or adenosine receptor blockers
* Intake of medications which are known to have pharmacological interactions with caffeine
* Participants with contra-indications to undergo fMRI scanning
* Unwilling or unable to discontinue the use of cell phones, smart phones or other electronic devices during the entire study visit.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Differences between fMRI blood oxygen level dependent (BOLD) responses of the brain recorded following administration of each substance and the placebo
Timeframe: Sixty minutes after administration of each of theanine, caffeine, theanine-caffeine combination and placebo