NCT02770105

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 12, 2016

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

September 2, 2016

Status Verified

May 1, 2016

Enrollment Period

1 month

First QC Date

May 6, 2016

Last Update Submit

August 31, 2016

Conditions

Keywords

L-theaninecaffeineselective attentionfMRIRVRT

Outcome Measures

Primary Outcomes (1)

  • Differences between fMRI blood oxygen level dependent (BOLD) responses of the brain recorded following administration of each substance and the 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.

    Sixty minutes after administration of each of theanine, caffeine, theanine-caffeine combination and placebo

Secondary Outcomes (3)

  • Differences between mean recognition visual reaction times recorded following administration of each substance and the placebo

    Sixty minutes after administration of each of theanine, caffeine, theanine-caffeine combination and placebo

  • Differences between proportion of errors caused while performing the recognition visual reaction time task following administration of each substance and the placebo

    Sixty minutes after administration of each of theanine, caffeine, theanine-caffeine combination and placebo

  • Differences between proportion of omissions caused while performing the recognition visual reaction time task following administration of each substance and the placebo

    Sixty minutes after administration of each of theanine, caffeine, theanine-caffeine combination and placebo

Interventions

Oral administration of 200mg of L-theanine powder dissolved in 200ml of distilled water

Oral administration of 160mg of anhydrous caffeine powder dissolved in 200ml of distilled water

Oral administration of 200mg of L-theanine and 160mg of anhydrous caffeine powder, dissolved in 200ml of distilled water

PlaceboOTHER

Oral administration of 200ml of distilled water

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy males\*
  • Age 18-60 years

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Tech University - Department of Nutritional Sciences

Lubbock, Texas, 79409, United States

Location

Related Publications (3)

  • Kahathuduwa CN, Dassanayake TL, Amarakoon AMT, Weerasinghe VS. Acute effects of theanine, caffeine and theanine-caffeine combination on attention. Nutr Neurosci. 2017 Jul;20(6):369-377. doi: 10.1080/1028415X.2016.1144845. Epub 2016 Feb 12.

    PMID: 26869148BACKGROUND
  • Weerasinghe V, Kahathuduwa C, Amarakoon T, Dassanayake T. Synergistic Effect of Theanine and Caffeine on Visual Reaction Time, Evoked Potentials and Cognitive Event Related Potentials. Journal of Clinical Neurophysiology. 2015; 32(4): S396.

    BACKGROUND
  • Camfield DA, Stough C, Farrimond J, Scholey AB. Acute effects of tea constituents L-theanine, caffeine, and epigallocatechin gallate on cognitive function and mood: a systematic review and meta-analysis. Nutr Rev. 2014 Aug;72(8):507-22. doi: 10.1111/nure.12120. Epub 2014 Jun 19.

    PMID: 24946991BACKGROUND

MeSH Terms

Interventions

theanineCaffeine

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Martin Binks, PhD

    Texas Tech University - Department of Nutritional Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2016

First Posted

May 12, 2016

Study Start

May 1, 2016

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

September 2, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations