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

Primary Purpose

Stress, Psychological

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood collection
L-Tyrosine 500 Mg
Psychological questionnaires
Photoplethysmography
Placebo
Sponsored by
Direction Centrale du Service de Santé des Armées
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stress, Psychological focused on measuring L-tyrosine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Institut de Recherche Biomédicale des Armées

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Tyrosine - External Operation

Placebo - External Operation

Tyrosine - Rear Base

Placebo - Rear Base

Arm Description

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

1-month Placebo treatment following 4-month external operation

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

1-month Placebo treatment following 4 months at rear base

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
Difference between the change in Tumor Necrosis Factor Alpha (TNFα) level following 1-month treatment in each arm
TNFα level will be measured in blood before during and after 1-month treatment.
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.

Full Information

First Posted
September 8, 2020
Last Updated
November 23, 2022
Sponsor
Direction Centrale du Service de Santé des Armées
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1. Study Identification

Unique Protocol Identification Number
NCT04549194
Brief Title
Contribution of L-Tyrosine to Recovery From Operational Strain on Return From External Operation
Acronym
USOP
Official Title
Contribution of L-Tyrosine to Recovery From Operational Strain on Return From External Operation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
September 9, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Direction Centrale du Service de Santé des Armées

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological
Keywords
L-tyrosine

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tyrosine - External Operation
Arm Type
Experimental
Arm Description
1-month L-Tyrosine treatment following 4-month external operation
Arm Title
Placebo - External Operation
Arm Type
Experimental
Arm Description
1-month Placebo treatment following 4-month external operation
Arm Title
Tyrosine - Rear Base
Arm Type
Experimental
Arm Description
1-month L-Tyrosine treatment following 4 months at rear base
Arm Title
Placebo - Rear Base
Arm Type
Experimental
Arm Description
1-month Placebo treatment following 4 months at rear base
Intervention Type
Biological
Intervention Name(s)
Blood collection
Intervention Description
A blood sample will be collected before during and after the treatment.
Intervention Type
Drug
Intervention Name(s)
L-Tyrosine 500 Mg
Intervention Description
The participants will be administered 4 capsules of L-Tyrosine 500 mg per oral route daily over 1 month.
Intervention Type
Behavioral
Intervention Name(s)
Psychological questionnaires
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Photoplethysmography
Intervention Description
Photoplethysmography recording will be performed before during and after the treatment.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The participants will be administered 4 capsules of Lactose 500 mg (placebo) per oral route daily over 1 month.
Primary Outcome Measure Information:
Title
Difference between the change in Burnout Assessment Tool (BAT) score following 1-month treatment in each arm
Description
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.
Time Frame
After 1-month treatment
Secondary Outcome Measure Information:
Title
Difference between the change in catecholamine level following 1-month treatment in each arm
Description
Catecholamine level will be measured in blood before during and after 1-month treatment.
Time Frame
After 1-month treatment
Title
Difference between the change in aminoacid level following 1-month treatment in each arm
Description
Aminoacid level will be measured in blood before during and after 1-month treatment.
Time Frame
After 1-month treatment
Title
Difference between the change in zonulin level following 1-month treatment in each arm
Description
Zonulin level will be measured in blood before during and after 1-month treatment.
Time Frame
After 1-month treatment
Title
Difference between the change in Brain-Derived Neurotrophic Factor (BDNF) level following 1-month treatment in each arm
Description
BDNF level will be measured in blood before during and after 1-month treatment.
Time Frame
After 1-month treatment
Title
Difference between the change in gamma-aminobutyric acid (GABA) level following 1-month treatment in each arm
Description
GABA level will be measured in blood before during and after 1-month treatment.
Time Frame
After 1-month treatment
Title
Difference between the change in Tumor Necrosis Factor Alpha (TNFα) level following 1-month treatment in each arm
Description
TNFα level will be measured in blood before during and after 1-month treatment.
Time Frame
After 1-month treatment
Title
Difference between the change in Interleukin-6 (IL6) level following 1-month treatment in each arm
Description
IL6 level will be measured in blood before during and after 1-month treatment.
Time Frame
After 1-month treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Institut de Recherche Biomédicale des Armées
City
Brétigny-sur-Orge
ZIP/Postal Code
91223
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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