Response to Severe StressNCT01823276
Effect of Tyrosine on Behavioral, Physiological and Nutritional Status During Survive, Evade, Resist, Escape (SERE) School
A study testing Tyrosine-Containing Bar in people with Response to Severe Stress, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Response to Severe Stress
- What is being tested?
- Tyrosine-Containing Bar
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- Allergy to dairy products
- blood donation within 8 weeks of study start
Trial locations and contacts
1 site in 1 country.
United States1 site
US Army SERE School
Fort Bragg, North Carolina, 28307
About this study
Official title: Effect of Tyrosine on Behavioral, Physiological and Nutritional Status During Survive, Evade, Resist, Escape School
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.
Read more
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:
- 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.
- Supplemental tyrosine will reduce release of proinflammatory cytokines that may be increased by the stressful activities of SERE school.
- Conditions
- Response to Severe Stress
- Being tested
- Tyrosine-Containing Bar, Placebo Bar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tyrosine-Containing BarOther
Placebo BarOther
| Study group | Role | What they receive |
|---|---|---|
| Tyrosine-Containing Bar | Active comparator | 150 mg/kg dose of tyrosine per administration, administered twice Receives: Other: Tyrosine-Containing Bar |
| Placebo Bar | Placebo comparator | 0 mg/kg dose of tyrosine per administration, administered twice Receives: Other: Placebo Bar |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline cognitive function compared to cognitive function as measured following treatment administration
Measured: baseline and final week of training (approximately 2-3 weeks later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Response to Severe StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Army Research Institute of Environmental Medicine
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Harris R. Lieberman, United States Army Research Institute of Environmental Medicine
- Investigators
- Harris R Lieberman, PhD, Principal investigator, United States Army Research Institute of Environmental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01823276
- Sponsor's protocol ID
- 12-43 HC
- Status last verified
- May 2014
- First submitted
- 22 Mar 2013
- Last updated
- 21 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tyrosine on Behavioral, Physiological and Nutritional Status During Survive, Evade, Resist, Escape School
- ClinicalTrials.gov ID
- NCT01823276
- Acronym / sponsor ID
- 12-43 HC
- Conditions
- Response to Severe Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- United States Army Research Institute of Environmental MedicineUS federal agency
- Study start
- May 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 4 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Supplemental tyrosine will reduce release of proinflammatory cytokines that may be increased by the stressful activities of SERE school.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tyrosine-Containing Bar | Active comparator | Other: Tyrosine-Containing Bar150 mg/kg dose of tyrosine per administration, administered twice |
| Placebo Bar | Placebo comparator | Other: Placebo Bar0 mg/kg dose of tyrosine per administration, administered twice |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- Allergy to dairy products
- blood donation within 8 weeks of study start
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tyrosine-Containing Bar | Other | Tyrosine-Containing Bar |
| Placebo Bar | Other | Placebo Bar |
Primary outcome
change from baseline cognitive function compared to cognitive function as measured following treatment administration
Time frame: baseline and final week of training (approximately 2-3 weeks later)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harris R Lieberman, PhD principal investigator
United States Army Research Institute of Environmental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tyrosine-Containing Bar in people with Response to Severe Stress, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline cognitive function compared to cognitive function as measured following treatment administration (time frame: baseline and final week of training (approximately 2-3 weeks later)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2014.