Effect of Tyrosine Supplementation on Cognitive Performance and Mood During Military Stress
Primary Purpose
Reaction to Severe Stress, Unspecified
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tyrosine-Containing Food Bar
Placebo Bar
Sponsored by
About this trial
This is an interventional other trial for Reaction to Severe Stress, Unspecified
Eligibility Criteria
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.]
Sites / Locations
- US Navy SERE School
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Tyrosine-Containing Food Bar
Placebo bar
Arm Description
150 mg/kg dose of tyrosine per administration, administered twice
0 mg/kg dose of tyrosine per administration, administered twice
Outcomes
Primary Outcome Measures
change from baseline cognitive function compared to cognitive function as measured following treatment administration
Secondary Outcome Measures
Full Information
NCT ID
NCT01913925
First Posted
July 30, 2013
Last Updated
November 2, 2020
Sponsor
United States Army Research Institute of Environmental Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01913925
Brief Title
Effect of Tyrosine Supplementation on Cognitive Performance and Mood During Military Stress
Official Title
Effect of Tyrosine Supplementation on Cognitive Performance and Mood During Military Stress
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United States Army Research Institute of Environmental Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
Exposure to the stressors of SERE school will adversely impact cognitive performance and mood of volunteers.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reaction to Severe Stress, Unspecified
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tyrosine-Containing Food Bar
Arm Type
Active Comparator
Arm Description
150 mg/kg dose of tyrosine per administration, administered twice
Arm Title
Placebo bar
Arm Type
Placebo Comparator
Arm Description
0 mg/kg dose of tyrosine per administration, administered twice
Intervention Type
Other
Intervention Name(s)
Tyrosine-Containing Food Bar
Intervention Type
Other
Intervention Name(s)
Placebo Bar
Primary Outcome Measure Information:
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.]
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harris R. Lieberman, PhD
Organizational Affiliation
United States Army Research Institute of Environmental Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
US Navy SERE School
City
Brunswick
State/Province
Maine
ZIP/Postal Code
04011
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Tyrosine Supplementation on Cognitive Performance and Mood During Military Stress
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