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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A01658-31 | Other Identifier | IDRCB |
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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.).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tyrosine - External Operation | Experimental | 1-month L-Tyrosine treatment following 4-month external operation |
|
| Placebo - External Operation | Experimental | 1-month Placebo treatment following 4-month external operation |
|
| Tyrosine - Rear Base | Experimental | 1-month L-Tyrosine treatment following 4 months at rear base |
|
| Placebo - Rear Base | Experimental | 1-month Placebo treatment following 4 months at rear base |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood collection | Biological | A blood sample will be collected before during and after the treatment. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Difference between the change in aminoacid level following 1-month treatment in each arm |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Recherche Biomédicale des Armées | Brétigny-sur-Orge | 91223 | France |
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| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D014443 | Tyrosine |
| D017156 | Photoplethysmography |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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The study is composed of 2 groups, each of which is composed of 2 arms:
External Operation group
Rear Base group
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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.
| L-Tyrosine 500 Mg | Drug | The participants will be administered 4 capsules of L-Tyrosine 500 mg per oral route daily over 1 month. |
|
| Psychological questionnaires | Behavioral | The participants will fill in several psychological questionnaires before, during and after treatment administration:
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| Photoplethysmography | Device | Photoplethysmography recording will be performed before during and after the treatment. |
|
| Placebo | Drug | The participants will be administered 4 capsules of Lactose 500 mg (placebo) per oral route daily over 1 month. |
|
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 | 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 | 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 | 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 | 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 | IL6 level will be measured in blood before during and after 1-month treatment. | After 1-month treatment |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D010991 | Plethysmography |
| D003935 | Diagnostic Techniques, Cardiovascular |