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Contribution of L-Tyrosine to Recovery From Operational Strain on Return From External Operation

Contribution of L-Tyrosine to Recovery From Operational Strain on Return From External Operation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04549194
Acronym
USOP
Enrollment
116
Registered
2020-09-16
Start date
2020-09-09
Completion date
2021-06-30
Last updated
2022-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress, Psychological

Keywords

L-tyrosine

Brief summary

Operational conditions amplify soldier's constraints and stress factors, upsetting individual and collective adaptive landmarks. The soldier's resistance is strained by the high intensity of stressors, by the long duration of exposure and by their cumulative effect. 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.).

Interventions

BIOLOGICALBlood collection

A blood sample will be collected before during and after the treatment.

The participants will be administered 4 capsules of L-Tyrosine 500 mg per oral route daily over 1 month.

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 recording will be performed before during and after the treatment.

DRUGPlacebo

The participants will be administered 4 capsules of Lactose 500 mg (placebo) per oral route daily over 1 month.

Sponsors

Direction Centrale du Service de Santé des Armées
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

The pharmacist, carrying out the packaging and labelling of the treatment units, will ensure the blinding. Neither the participant nor the investigator will know what treatment is being administered.

Intervention model description

The study is composed of 2 groups, each of which is composed of 2 arms: * External Operation group * L-Tyrosine arm * Placebo arm * Rear Base group * L-Tyrosine arm * Placebo arm

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* From 18 to 65 years of age

Exclusion criteria

* Tyrosine intake within the previous 15 days * History of neurological or psychiatric disorder * History of nephrological or endocrine disorder or liver failure * Hereditary tyrosinemia

Design outcomes

Primary

MeasureTime frameDescription
Difference between the change in Burnout Assessment Tool (BAT) score following 1-month treatment in each armAfter 1-month treatmentThe Burnout Assessment Tool (BAT) is used to assess burn-out risk. The score ranges from 1 to 5, with higher scores indicating a higher risk of burn-out.

Secondary

MeasureTime frameDescription
Difference between the change in aminoacid level following 1-month treatment in each armAfter 1-month treatmentAminoacid level will be measured in blood before during and after 1-month treatment.
Difference between the change in zonulin level following 1-month treatment in each armAfter 1-month treatmentZonulin level will be measured in blood before during and after 1-month treatment.
Difference between the change in Brain-Derived Neurotrophic Factor (BDNF) level following 1-month treatment in each armAfter 1-month treatmentBDNF level will be measured in blood before during and after 1-month treatment.
Difference between the change in catecholamine level following 1-month treatment in each armAfter 1-month treatmentCatecholamine level will be measured in blood before during and after 1-month treatment.
Difference between the change in Tumor Necrosis Factor Alpha (TNFα) level following 1-month treatment in each armAfter 1-month treatmentTNFα level will be measured in blood before during and after 1-month treatment.
Difference between the change in Interleukin-6 (IL6) level following 1-month treatment in each armAfter 1-month treatmentIL6 level will be measured in blood before during and after 1-month treatment.
Difference between the change in gamma-aminobutyric acid (GABA) level following 1-month treatment in each armAfter 1-month treatmentGABA level will be measured in blood before during and after 1-month treatment.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026