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

NCT04549194 | Completed

• 2 other identifiers: 2019PBMD062020-A01658-31
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.).

Conditions

Stress, Psychological

Keywords

L-tyrosine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

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

  After 1-month treatment

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

  After 1-month treatment

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

  After 1-month treatment

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

  After 1-month treatment

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

  After 1-month treatment

Study Arms (4)

Tyrosine - External Operation

EXPERIMENTAL

1-month L-Tyrosine treatment following 4-month external operation

Biological: Blood collection; Drug: L-Tyrosine 500 Mg; Behavioral: Psychological questionnaires; Device: Photoplethysmography

Placebo - External Operation

EXPERIMENTAL

1-month Placebo treatment following 4-month external operation

Biological: Blood collection; Behavioral: Psychological questionnaires; Device: Photoplethysmography; Drug: Placebo

Tyrosine - Rear Base

EXPERIMENTAL

1-month L-Tyrosine treatment following 4 months at rear base

Biological: Blood collection; Drug: L-Tyrosine 500 Mg; Behavioral: Psychological questionnaires; Device: Photoplethysmography

Placebo - Rear Base

EXPERIMENTAL

1-month Placebo treatment following 4 months at rear base

Biological: Blood collection; Behavioral: Psychological questionnaires; Device: Photoplethysmography; Drug: Placebo

Interventions

Blood collection BIOLOGICAL

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

Placebo - External Operation; Placebo - Rear Base; Tyrosine - External Operation; Tyrosine - Rear Base

L-Tyrosine 500 Mg DRUG

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

Tyrosine - External Operation; Tyrosine - Rear Base

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

Placebo - External Operation; Placebo - Rear Base; Tyrosine - External Operation; Tyrosine - Rear Base

Photoplethysmography DEVICE

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

Placebo - External Operation; Placebo - Rear Base; Tyrosine - External Operation; Tyrosine - Rear Base

Placebo DRUG

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

Placebo - External Operation; Placebo - Rear Base

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• From 18 to 65 years of age

You may not qualify if:

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

Sponsors & Collaborators

• Direction Centrale du Service de Santé des Armées: lead

Study Sites (1)

Institut de Recherche Biomédicale des Armées

Brétigny-sur-Orge, 91223, France

Location

MeSH Terms

Conditions

Stress, Psychological

Interventions

Blood Specimen Collection; Tyrosine; Photoplethysmography

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Plethysmography; Diagnostic Techniques, Cardiovascular

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 16, 2020
• Study Start: September 9, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: November 25, 2022

Record last verified: 2022-11

Locations

FR (1)