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临床试验/NCT01823276
NCT01823276已完成不适用

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

United States Army Research Institute of Environmental Medicine2 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2013年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
73
试验地点
2
主要终点
change from baseline cognitive function compared to cognitive function as measured following treatment administration

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 39 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 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)

排除标准

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

结局指标

主要结局

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

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

次要结局

未报告次要终点

研究者

发起方
United States Army Research Institute of Environmental Medicine
申办方类型
Fed
责任方
Principal Investigator
主要研究者

Harris R. Lieberman

Research Psychologist

United States Army Research Institute of Environmental Medicine

研究点 (2)

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