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

November 23, 2022 updated by: Direction Centrale du Service de Santé des Armées

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.).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
116

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brétigny-sur-Orge, France, 91223
        • Institut de Recherche Biomédicale des Armées

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tyrosine - External Operation
1-month L-Tyrosine treatment following 4-month external operation
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.
Experimental: Placebo - External Operation
1-month Placebo treatment following 4-month external operation
Biological: Blood collection
A blood sample will be collected before during and after the treatment.
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.
Experimental: Tyrosine - Rear Base
1-month L-Tyrosine treatment following 4 months at rear base
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.
Experimental: Placebo - Rear Base
1-month Placebo treatment following 4 months at rear base
Biological: Blood collection
A blood sample will be collected before during and after the treatment.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
After 1-month treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
After 1-month treatment
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.
After 1-month treatment
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.
After 1-month treatment
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.
After 1-month treatment
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.
After 1-month treatment
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.
After 1-month treatment
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.
After 1-month treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Direction Centrale du Service de Santé des Armées

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 9, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 25, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019PBMD06
  • 2020-A01658-31 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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