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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maine
      • Brunswick, Maine, United States, 04011
        • US Navy SERE School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.]

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Tyrosine-Containing Food Bar
150 mg/kg dose of tyrosine per administration, administered twice
PLACEBO_COMPARATOR: Placebo bar
0 mg/kg dose of tyrosine per administration, administered twice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
baseline and final week of training (approximately 1 week later)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Harris R. Lieberman, PhD, United States Army Research Institute of Environmental Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (ACTUAL)

October 1, 2009

Study Completion (ACTUAL)

October 1, 2009

Study Registration Dates

First Submitted

July 30, 2013

First Submitted That Met QC Criteria

July 30, 2013

First Posted (ESTIMATE)

August 1, 2013

Study Record Updates

Last Update Posted (ACTUAL)

November 3, 2020

Last Update Submitted That Met QC Criteria

November 2, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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