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

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

Tracking Information

• First Submitted Date: July 30, 2013
• First Posted Date: August 1, 2013
• Last Update Posted Date: November 3, 2020
• Study Start Date: July 2009
• Actual Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Other
• Condition: Reaction to Severe Stress, Unspecified

Intervention

• Other: Tyrosine-Containing Food Bar
• Other: Placebo Bar

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 30, 2013): 80
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: October 2009
• Actual Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)

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.]

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 39 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01913925
• Other Study ID Numbers: H08-05
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: United States Army Research Institute of Environmental Medicine
• Original Responsible Party: Same as current
• Current Study Sponsor: United States Army Research Institute of Environmental Medicine
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• 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