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Trial record 9 of 9 for:    Caffeine Anhydrous

Theanine and Caffeine on Neurophysiology of Attention (THECNA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02770105
Recruitment Status : Completed
First Posted : May 12, 2016
Last Update Posted : September 2, 2016
Sponsor:
Information provided by (Responsible Party):
Texas Tech University

Brief 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.

Condition or disease Intervention/treatment Phase
L-theanine Other: Theanine Other: Caffeine Other: Theanine-Caffeine Combination Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Official Title: Neurophysiological Correlates of L-theanine, Caffeine and Their Combination on Improving Selective Attention in a Visual Reaction Time Task: A Functional Magnetic Resonance Imaging (fMRI) Study
Study Start Date : May 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine
Drug Information available for: Theanine


Intervention Details:
  • Other: Theanine
    Oral administration of 200mg of L-theanine powder dissolved in 200ml of distilled water
  • Other: Caffeine
    Oral administration of 160mg of anhydrous caffeine powder dissolved in 200ml of distilled water
  • Other: Theanine-Caffeine Combination
    Oral administration of 200mg of L-theanine and 160mg of anhydrous caffeine powder, dissolved in 200ml of distilled water
  • Other: Placebo
    Oral administration of 200ml of distilled water


Primary Outcome Measures :
  1. Differences between fMRI blood oxygen level dependent (BOLD) responses of the brain recorded following administration of each substance and the placebo [ Time Frame: Sixty minutes after administration of each of theanine, caffeine, theanine-caffeine combination and placebo ]
    Theanine, caffeine, theanine-caffeine combination and distilled water (placebo) will be administered on 4 separate days (at least 5 days apart) in a random order. Functional MRI scans will be performed 60 minutes after each administration. Primary outcome measure will be the difference in fMRI BOLD responses obtained for each substance and the placebo.


Secondary Outcome Measures :
  1. Differences between mean recognition visual reaction times recorded following administration of each substance and the placebo [ Time Frame: Sixty minutes after administration of each of theanine, caffeine, theanine-caffeine combination and placebo ]
    Theanine, caffeine, theanine-caffeine combination and distilled water (placebo) will be administered on 4 separate days (at least 5 days apart) in a random order. Functional MRI scans will be performed 60 minutes after each administration. A secondary outcome measure will be the difference in mean recognition visual reaction time task obtained for each substance and the placebo, when the subjects perform the task in the fMRI scanner.

  2. Differences between proportion of errors caused while performing the recognition visual reaction time task following administration of each substance and the placebo [ Time Frame: Sixty minutes after administration of each of theanine, caffeine, theanine-caffeine combination and placebo ]
    Theanine, caffeine, theanine-caffeine combination and distilled water (placebo) will be administered on 4 separate days (at least 5 days apart) in a random order. Functional MRI scans will be performed 60 minutes after each administration. A secondary outcome measure will be the difference in proportion of errors caused while performing the recognition visual reaction time task in the fMRI scanner after each substance and the placebo.

  3. Differences between proportion of omissions caused while performing the recognition visual reaction time task following administration of each substance and the placebo [ Time Frame: Sixty minutes after administration of each of theanine, caffeine, theanine-caffeine combination and placebo ]
    Theanine, caffeine, theanine-caffeine combination and distilled water (placebo) will be administered on 4 separate days (at least 5 days apart) in a random order. Functional MRI scans will be performed 60 minutes after each administration. A secondary outcome measure will be the difference in proportion of omissions caused while performing the recognition visual reaction time task in the fMRI scanner after each substance and the placebo.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02770105


Locations
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United States, Texas
Texas Tech University - Department of Nutritional Sciences
Lubbock, Texas, United States, 79409
Sponsors and Collaborators
Texas Tech University
Investigators
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Principal Investigator: Martin Binks, PhD Texas Tech University - Department of Nutritional Sciences
Publications:
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Responsible Party: Texas Tech University
ClinicalTrials.gov Identifier: NCT02770105    
Other Study ID Numbers: TTUIRB505445
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: September 2, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Texas Tech University:
L-theanine
caffeine
selective attention
fMRI
RVRT
Additional relevant MeSH terms:
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Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents