- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04549194
Contribution of L-Tyrosine to Recovery From Operational Strain on Return From External Operation (USOP)
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
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Brétigny-sur-Orge, France, 91223
- Institut de Recherche Biomédicale des Armées
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tyrosine - External Operation
1-month L-Tyrosine treatment following 4-month external operation
|
A blood sample will be collected before during and after the treatment.
The participants will be administered 4 capsules of L-Tyrosine 500 mg per oral route daily over 1 month.
The participants will fill in several psychological questionnaires before, during and after treatment administration:
Photoplethysmography recording will be performed before during and after the treatment.
|
Experimental: Placebo - External Operation
1-month Placebo treatment following 4-month external operation
|
A blood sample will be collected before during and after the treatment.
The participants will fill in several psychological questionnaires before, during and after treatment administration:
Photoplethysmography recording will be performed before during and after the treatment.
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
|
A blood sample will be collected before during and after the treatment.
The participants will be administered 4 capsules of L-Tyrosine 500 mg per oral route daily over 1 month.
The participants will fill in several psychological questionnaires before, during and after treatment administration:
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
|
A blood sample will be collected before during and after the treatment.
The participants will fill in several psychological questionnaires before, during and after treatment administration:
Photoplethysmography recording will be performed before during and after the treatment.
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
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
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019PBMD06
- 2020-A01658-31 (Other Identifier: IDRCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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