Clinical trial NCT01823276: Effect of Tyrosine on Behavioral, Physiological and Nutritional Status During Survive, Evade, Resist, Escape (SERE) School
Official title: Effect of Tyrosine on Behavioral, Physiological and Nutritional Status During Survive, Evade, Resist, Escape School
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Response to Severe Stress
Lead sponsor: United States Army Research Institute of Environmental Medicine
Sponsor class: FED
First posted: 2013-04-04
Enrollment: 73
Sex: MALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The objective of the proposed 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 will be conducted at the Army Survive, Evade, Resist, Escape (SERE) school at Fort Bragg, NC.

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 82 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 and blood samples, will be collected in a manner that does not interfere with ongoing training.

Hypotheses:

1. 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.
2. Supplemental tyrosine will reduce release of proinflammatory cytokines that may be increased by the stressful activities of SERE school.


Eligibility criteria: Inclusion Criteria:

* MUST BE ACTIVE DUTY ARMY SOLDIERS ENROLLED IN SPECIAL FORCES TRAINING AT US ARMY SERE SCHOOL
* Fluent in English (non-native English speakers can be enrolled)

Exclusion Criteria:

* Allergy to dairy products
* blood donation within 8 weeks of study start

Primary outcomes:
measure: change from baseline cognitive function compared to cognitive function as measured following treatment administration
timeFrame: baseline and final week of training (approximately 2-3 weeks later)
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Bragg
country: United States
facility: US Army SERE School
state: North Carolina
Study officials:
affiliation: United States Army Research Institute of Environmental Medicine
name: Harris R Lieberman, PhD
role: PRINCIPAL_INVESTIGATOR
References: