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The Effect of the Amino Acid L-Theanine on Alertness and Vigilance

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: NCT01851122
Recruitment Status : Completed
First Posted : May 10, 2013
Last Update Posted : December 13, 2023
Sponsor:
Information provided by (Responsible Party):
David Bauer, The University of Texas Health Science Center, Houston

Study Description
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Brief Summary:
The amino acid l-theanine (the active ingredient in green tea) is considered to have a calming effect without causing sleepiness. This study evaluates whether l-theanine affects blood pressure, heart rate, alertness, and sense of well-being.

Condition or disease Intervention/treatment Phase
Theanine, (L)-Isomer Dietary Supplement: L-theanine capsule Dietary Supplement: Placebo capsule Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of the Amino Acid L-Theanine on Alertness and Vigilance
Study Start Date : November 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Theanine

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo capsule Dietary Supplement: Placebo capsule
Experimental: L-theanine capsule Dietary Supplement: L-theanine capsule
L-theanine 250mg capsule


Outcome Measures
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Primary Outcome Measures :
  1. Alertness [ Time Frame: 48 hrs ]
    The average response time to identify a small rectangle shown on a computer screen.

  2. Alertness [ Time Frame: 48 hrs ]
    Degree of subjective alertness, measured on a visual analog scale

  3. Well-Being [ Time Frame: 48 hrs ]
    Sense of subjective well-being as measured on a visual analog scale


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • adult
  • able to swallow capsule

Exclusion Criteria:

  • none
Contacts and Locations
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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): NCT01851122


Locations
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United States, Texas
Physicians at Sugar Creek
Sugar Land, Texas, United States, 77478
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
More Information
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Responsible Party: David Bauer, Staff - Internal Medicine - Cardiology, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01851122    
Other Study ID Numbers: HSC-GEN-11-0299
First Posted: May 10, 2013    Key Record Dates
Last Update Posted: December 13, 2023
Last Verified: December 2023
Keywords provided by David Bauer, The University of Texas Health Science Center, Houston:
l-theanine
alertness
well-being