Effect of Tyrosine on Behavioral, Physiological and Nutritional Status During Survive, Evade, Resist, Escape (SERE) School

NCT01823276 | Completed

• 1 other identifier: 12-43 HC
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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

Conditions

Response to Severe Stress

Outcome Measures

Primary Outcomes (1)

• change from baseline cognitive function compared to cognitive function as measured following treatment administration

  baseline and final week of training (approximately 2-3 weeks later)

Study Arms (2)

Tyrosine-Containing Bar

ACTIVE COMPARATOR

150 mg/kg dose of tyrosine per administration, administered twice

Other: Tyrosine-Containing Bar

Placebo Bar

PLACEBO COMPARATOR

0 mg/kg dose of tyrosine per administration, administered twice

Other: Placebo Bar

Interventions

Tyrosine-Containing Bar OTHER

Tyrosine-Containing Bar

Placebo Bar OTHER

Placebo Bar

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• United States Army Research Institute of Environmental Medicine: lead

Study Sites (1)

US Army SERE School

Fort Bragg, North Carolina, 28307, United States

Location

Study Officials

• Harris R Lieberman, PhD

  United States Army Research Institute of Environmental Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Psychologist

Study Record Dates

• First Submitted: March 22, 2013
• First Posted: April 4, 2013
• Study Start: May 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: May 21, 2014

Record last verified: 2014-05

Locations

US (1)