Clinical trial NCT04549194: Contribution of L-Tyrosine to Recovery From Operational Strain on Return From External Operation
Official title: Contribution of L-Tyrosine to Recovery From Operational Strain on Return From External Operation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Keywords: L-tyrosine
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: PREVENTION

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.).


Eligibility criteria: 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

Primary outcomes:
measure: Difference between the change in Burnout Assessment Tool (BAT) score following 1-month treatment in each arm
timeFrame: After 1-month treatment
Secondary outcomes:
measure: Difference between the change in catecholamine level following 1-month treatment in each arm
timeFrame: After 1-month treatment
measure: Difference between the change in aminoacid level following 1-month treatment in each arm
timeFrame: After 1-month treatment
measure: Difference between the change in zonulin level following 1-month treatment in each arm
timeFrame: After 1-month treatment
measure: Difference between the change in Brain-Derived Neurotrophic Factor (BDNF) level following 1-month treatment in each arm
timeFrame: After 1-month treatment
measure: Difference between the change in gamma-aminobutyric acid (GABA) level following 1-month treatment in each arm
timeFrame: After 1-month treatment
measure: Difference between the change in Tumor Necrosis Factor Alpha (TNFα) level following 1-month treatment in each arm
timeFrame: After 1-month treatment
measure: Difference between the change in Interleukin-6 (IL6) level following 1-month treatment in each arm
timeFrame: After 1-month treatment
Other outcomes:
Locations:
city: Brétigny-sur-Orge
country: France
facility: Institut de Recherche Biomédicale des Armées
Study officials:
References: