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

NCT ID: NCT04549194

Last Updated: 2022-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-09

Study Completion Date

2021-06-30

Brief Summary

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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.).

Detailed Description

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Conditions

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Stress, Psychological

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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.

Study Groups

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Tyrosine - External Operation

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

Group Type EXPERIMENTAL

Blood collection

Intervention Type BIOLOGICAL

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

L-Tyrosine 500 Mg

Intervention Type DRUG

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

Psychological questionnaires

Intervention Type 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

Photoplethysmography

Intervention Type DEVICE

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

Placebo - External Operation

1-month Placebo treatment following 4-month external operation

Group Type EXPERIMENTAL

Blood collection

Intervention Type BIOLOGICAL

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

Psychological questionnaires

Intervention Type 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

Photoplethysmography

Intervention Type DEVICE

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

Placebo

Intervention Type DRUG

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

Tyrosine - Rear Base

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

Group Type EXPERIMENTAL

Blood collection

Intervention Type BIOLOGICAL

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

L-Tyrosine 500 Mg

Intervention Type DRUG

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

Psychological questionnaires

Intervention Type 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

Photoplethysmography

Intervention Type DEVICE

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

Placebo - Rear Base

1-month Placebo treatment following 4 months at rear base

Group Type EXPERIMENTAL

Blood collection

Intervention Type BIOLOGICAL

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

Psychological questionnaires

Intervention Type 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

Photoplethysmography

Intervention Type DEVICE

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

Placebo

Intervention Type DRUG

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

Interventions

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Blood collection

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

Intervention Type BIOLOGICAL

L-Tyrosine 500 Mg

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

Intervention Type DRUG

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

Intervention Type BEHAVIORAL

Photoplethysmography

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

Intervention Type DEVICE

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Direction Centrale du Service de Santé des Armées

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institut de Recherche Biomédicale des Armées

Brétigny-sur-Orge, , France

Site Status

Countries

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France

Other Identifiers

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2020-A01658-31

Identifier Type: OTHER

Identifier Source: secondary_id

2019PBMD06

Identifier Type: -

Identifier Source: org_study_id

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