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

NCT ID: NCT01823276

Last Updated: 2014-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Response to Severe Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Tyrosine-Containing Bar

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

Group Type ACTIVE_COMPARATOR

Tyrosine-Containing Bar

Intervention Type OTHER

Placebo Bar

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

Group Type PLACEBO_COMPARATOR

Placebo Bar

Intervention Type OTHER

Interventions

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Tyrosine-Containing Bar

Intervention Type OTHER

Placebo Bar

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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United States Army Research Institute of Environmental Medicine

FED

Sponsor Role lead

Responsible Party

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Harris R. Lieberman

Research Psychologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Harris R Lieberman, PhD

Role: PRINCIPAL_INVESTIGATOR

United States Army Research Institute of Environmental Medicine

Locations

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US Army SERE School

Fort Bragg, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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12-43 HC

Identifier Type: -

Identifier Source: org_study_id

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