Contribution of L-Tyrosine to Recovery From Operational Strain on Return From External Operation
NCT ID: NCT04549194
Last Updated: 2022-11-25
Study Results
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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COMPLETED
NA
116 participants
INTERVENTIONAL
2020-09-09
2021-06-30
Brief Summary
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This may lead to a state of "operational strain" that refers to chronic stress and the allostatic load imposed by operational constraint.
The investigators believe that operational strain could manifest itself by a kind of accelerated aging of the organism due to the increased allostatic load without sufficient resource restoration (neurotransmitter precursors, partial and repeated sleep deprivation, etc.).
This aging mechanism would be reversible after a sufficient period of resource restoration (sleep, physical activity, adapted diet, etc.).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
* External Operation group
* L-Tyrosine arm
* Placebo arm
* Rear Base group
* L-Tyrosine arm
* Placebo arm
PREVENTION
TRIPLE
Study Groups
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Tyrosine - External Operation
1-month L-Tyrosine treatment following 4-month external operation
Blood collection
A blood sample will be collected before during and after the treatment.
L-Tyrosine 500 Mg
The participants will be administered 4 capsules of L-Tyrosine 500 mg per oral route daily over 1 month.
Psychological questionnaires
The participants will fill in several psychological questionnaires before, during and after treatment administration:
* Life Event Checklist
* Moral injury
* Posttraumatic Checklist
* Burnout Assessment Tool
* State-Trait Anger Expression Inventory-2
* Ruminative Response Scale - Reconsidered
* Deployment Risk and Resilience Inventory-2
* Questionnaire about tobacco use
Photoplethysmography
Photoplethysmography recording will be performed before during and after the treatment.
Placebo - External Operation
1-month Placebo treatment following 4-month external operation
Blood collection
A blood sample will be collected before during and after the treatment.
Psychological questionnaires
The participants will fill in several psychological questionnaires before, during and after treatment administration:
* Life Event Checklist
* Moral injury
* Posttraumatic Checklist
* Burnout Assessment Tool
* State-Trait Anger Expression Inventory-2
* Ruminative Response Scale - Reconsidered
* Deployment Risk and Resilience Inventory-2
* Questionnaire about tobacco use
Photoplethysmography
Photoplethysmography recording will be performed before during and after the treatment.
Placebo
The participants will be administered 4 capsules of Lactose 500 mg (placebo) per oral route daily over 1 month.
Tyrosine - Rear Base
1-month L-Tyrosine treatment following 4 months at rear base
Blood collection
A blood sample will be collected before during and after the treatment.
L-Tyrosine 500 Mg
The participants will be administered 4 capsules of L-Tyrosine 500 mg per oral route daily over 1 month.
Psychological questionnaires
The participants will fill in several psychological questionnaires before, during and after treatment administration:
* Life Event Checklist
* Moral injury
* Posttraumatic Checklist
* Burnout Assessment Tool
* State-Trait Anger Expression Inventory-2
* Ruminative Response Scale - Reconsidered
* Deployment Risk and Resilience Inventory-2
* Questionnaire about tobacco use
Photoplethysmography
Photoplethysmography recording will be performed before during and after the treatment.
Placebo - Rear Base
1-month Placebo treatment following 4 months at rear base
Blood collection
A blood sample will be collected before during and after the treatment.
Psychological questionnaires
The participants will fill in several psychological questionnaires before, during and after treatment administration:
* Life Event Checklist
* Moral injury
* Posttraumatic Checklist
* Burnout Assessment Tool
* State-Trait Anger Expression Inventory-2
* Ruminative Response Scale - Reconsidered
* Deployment Risk and Resilience Inventory-2
* Questionnaire about tobacco use
Photoplethysmography
Photoplethysmography recording will be performed before during and after the treatment.
Placebo
The participants will be administered 4 capsules of Lactose 500 mg (placebo) per oral route daily over 1 month.
Interventions
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Blood collection
A blood sample will be collected before during and after the treatment.
L-Tyrosine 500 Mg
The participants will be administered 4 capsules of L-Tyrosine 500 mg per oral route daily over 1 month.
Psychological questionnaires
The participants will fill in several psychological questionnaires before, during and after treatment administration:
* Life Event Checklist
* Moral injury
* Posttraumatic Checklist
* Burnout Assessment Tool
* State-Trait Anger Expression Inventory-2
* Ruminative Response Scale - Reconsidered
* Deployment Risk and Resilience Inventory-2
* Questionnaire about tobacco use
Photoplethysmography
Photoplethysmography recording will be performed before during and after the treatment.
Placebo
The participants will be administered 4 capsules of Lactose 500 mg (placebo) per oral route daily over 1 month.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* History of neurological or psychiatric disorder
* History of nephrological or endocrine disorder or liver failure
* Hereditary tyrosinemia
18 Years
65 Years
ALL
Yes
Sponsors
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Direction Centrale du Service de Santé des Armées
OTHER
Responsible Party
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Locations
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Institut de Recherche Biomédicale des Armées
Brétigny-sur-Orge, , France
Countries
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Other Identifiers
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2020-A01658-31
Identifier Type: OTHER
Identifier Source: secondary_id
2019PBMD06
Identifier Type: -
Identifier Source: org_study_id
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