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Effect of Tyrosine Supplementation on Cognitive Performance and Mood During Military Stress

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: NCT01913925
Recruitment Status : Completed
First Posted : August 1, 2013
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
United States Army Research Institute of Environmental Medicine

Tracking Information
First Submitted Date  ICMJE July 30, 2013
First Posted Date  ICMJE August 1, 2013
Last Update Posted Date November 3, 2020
Study Start Date  ICMJE July 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2013)
change from baseline cognitive function compared to cognitive function as measured following treatment administration [ Time Frame: baseline and final week of training (approximately 1 week later) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Tyrosine Supplementation on Cognitive Performance and Mood During Military Stress
Official Title  ICMJE Effect of Tyrosine Supplementation on Cognitive Performance and Mood During Military Stress
Brief Summary

The objective of this research is to determine if tyrosine, an amino acid found in protein-containing foods, will mitigate the cognitive deficits and adverse effects on behavior and mood produced by exposure to military stress. This study was conducted at the US Navy Survive, Evade, Resist, Escape (SERE) school at Brunswick, Maine (ME).

Tyrosine is the dietary precursor of the catecholamine norepinephrine, a key brain neurotransmitter that is critical for the central nervous system (CNS) response to various types of acute stress. Psychological stress increases catecholamine turnover in the brain, increasing the requirement for tyrosine to support synthesis of norepinephrine. Animal and human studies have shown that tyrosine supplementation can produce beneficial effects on cognitive and physiological functions during exposure to a variety of acute stressors.

This project will determine if volunteers treated with supplemental tyrosine during stressful phases of SERE training experience less degradation in cognitive performance and mood than volunteers treated with placebo. Tyrosine or placebo will be administered in a specially developed food bar provided to volunteers. The bar is part of a prototype of ration-component designed for use during assault operations. A between-subjects, double blind experimental design will be employed. Tyrosine, an amino acid found in most protein-containing foods, has been tested in hundreds of volunteers without adverse effects.

Approximately 100 volunteers will be recruited from several SERE classes to ensure up to 80 volunteers complete the study. They will be tested during several portions of SERE. A comprehensive but brief battery of cognitive tests, as well as saliva samples, and heart rate data will be collected in a manner that does not interfere with ongoing training.

Hypotheses:

  1. Exposure to the stressors of SERE school will adversely impact cognitive performance and mood of volunteers.
  2. The adverse effects of psychological stress on cognitive performance and mood during SERE school will be reduced when volunteers are given supplemental tyrosine compared to placebo treatment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Condition  ICMJE Reaction to Severe Stress, Unspecified
Intervention  ICMJE
  • Other: Tyrosine-Containing Food Bar
  • Other: Placebo Bar
Study Arms  ICMJE
  • Active Comparator: Tyrosine-Containing Food Bar
    150 mg/kg dose of tyrosine per administration, administered twice
    Intervention: Other: Tyrosine-Containing Food Bar
  • Placebo Comparator: Placebo bar
    0 mg/kg dose of tyrosine per administration, administered twice
    Intervention: Other: Placebo Bar
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 30, 2013)
80
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Active duty military enrolled in the US Navy SERE School, Brunswick, ME.
  • Fluent in English (non-native English speakers can be enrolled).

Exclusion Criteria:

  • None.

[All volunteers enrolled in SERE school require a medical clearance. No additional inclusion or exclusion criteria are necessary.]

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 39 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01913925
Other Study ID Numbers  ICMJE H08-05
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party United States Army Research Institute of Environmental Medicine
Original Responsible Party Same as current
Current Study Sponsor  ICMJE United States Army Research Institute of Environmental Medicine
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Harris R. Lieberman, PhD United States Army Research Institute of Environmental Medicine
PRS Account United States Army Research Institute of Environmental Medicine
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP