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Completed

NCT Number: NCT04549194

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

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.).

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Key information

Conditions

Stress, Psychological Behavior Behavioral Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Recherche Biomédicale des Armées

Brétigny-sur-Orge, 91223, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood collection

Biological

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

L-Tyrosine 500 Mg

Drug

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

Psychological questionnaires

Behavioral

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

Device

Photoplethysmography recording will be performed before during and after the treatment.

Placebo

Drug

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

Primary outcomes

  1. Difference between the change in Burnout Assessment Tool (BAT) score following 1-month treatment in each arm

    Time frame: After 1-month treatment

    The 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 outcomes

  1. Difference between the change in catecholamine level following 1-month treatment in each arm

    Time frame: After 1-month treatment

    Catecholamine level will be measured in blood before during and after 1-month treatment.

  2. Difference between the change in aminoacid level following 1-month treatment in each arm

    Time frame: After 1-month treatment

    Aminoacid level will be measured in blood before during and after 1-month treatment.

  3. Difference between the change in zonulin level following 1-month treatment in each arm

    Time frame: After 1-month treatment

    Zonulin level will be measured in blood before during and after 1-month treatment.

  4. Difference between the change in Brain-Derived Neurotrophic Factor (BDNF) level following 1-month treatment in each arm

    Time frame: After 1-month treatment

    BDNF level will be measured in blood before during and after 1-month treatment.

  5. Difference between the change in gamma-aminobutyric acid (GABA) level following 1-month treatment in each arm

    Time frame: After 1-month treatment

    GABA level will be measured in blood before during and after 1-month treatment.

  6. Difference between the change in Tumor Necrosis Factor Alpha (TNFα) level following 1-month treatment in each arm

    Time frame: After 1-month treatment

    TNFα level will be measured in blood before during and after 1-month treatment.

  7. Difference between the change in Interleukin-6 (IL6) level following 1-month treatment in each arm

    Time frame: After 1-month treatment

    IL6 level will be measured in blood before during and after 1-month treatment.

Sponsors and collaborators

Lead sponsor

Direction Centrale du Service de Santé des Armées

Other

Registry information

Acronym: USOP

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 16, 2020
Registry last updated
Nov 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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