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

Stress, Psychological Clinical Trial

— USOP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04549194
• Other study ID #: 2019PBMD06
• Secondary ID: 2020-A01658-31
• Status: Completed
• Phase: N/A
• Start date: September 9, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: November 2022
• Source: Direction Centrale du Service de Santé des Armées
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Stress, Psychological

Intervention

Biological:
• Blood collection
A blood sample will be collected before during and after the treatment.

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

Behavioral:
• 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

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

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

Locations

Country	Name	City	State
France	Institut de Recherche Biomédicale des Armées	Brétigny-sur-Orge

Sponsors (1)

Lead Sponsor	Collaborator
Direction Centrale du Service de Santé des Armées

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between the change in Burnout Assessment Tool (BAT) score following 1-month treatment in each arm	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.	After 1-month treatment
Secondary	Difference between the change in catecholamine level following 1-month treatment in each arm	Catecholamine level will be measured in blood before during and after 1-month treatment.	After 1-month treatment
Secondary	Difference between the change in aminoacid level following 1-month treatment in each arm	Aminoacid level will be measured in blood before during and after 1-month treatment.	After 1-month treatment
Secondary	Difference between the change in zonulin level following 1-month treatment in each arm	Zonulin level will be measured in blood before during and after 1-month treatment.	After 1-month treatment
Secondary	Difference between the change in Brain-Derived Neurotrophic Factor (BDNF) level following 1-month treatment in each arm	BDNF level will be measured in blood before during and after 1-month treatment.	After 1-month treatment
Secondary	Difference between the change in gamma-aminobutyric acid (GABA) level following 1-month treatment in each arm	GABA level will be measured in blood before during and after 1-month treatment.	After 1-month treatment
Secondary	Difference between the change in Tumor Necrosis Factor Alpha (TNFa) level following 1-month treatment in each arm	TNFa level will be measured in blood before during and after 1-month treatment.	After 1-month treatment
Secondary	Difference between the change in Interleukin-6 (IL6) level following 1-month treatment in each arm	IL6 level will be measured in blood before during and after 1-month treatment.	After 1-month treatment