Stress, PsychologicalUSOPNCT04549194
Contribution of L-Tyrosine to Recovery From Operational Strain on Return From External Operation
A study testing Blood collection, L-Tyrosine 500 Mg and Psychological questionnaires in people with Stress, Psychological, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- Blood collection, L-Tyrosine 500 Mg and Psychological questionnaires
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteFrance
- Study dates
- 9 Sep 2020to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- From 18 to 65 years of age
Who cannot join
- Tyrosine intake within the previous 15 days
- History of neurological or psychiatric disorder
- History of nephrological or endocrine disorder or liver failure
- Hereditary tyrosinemia
Trial locations and contacts
1 site in 1 country.
France1 site
Institut de Recherche Biomédicale des Armées
Brétigny-sur-Orge, 91223
About this study
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.
Read more
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.).
- Conditions
- Stress, Psychological
- Being tested
- Blood collection, L-Tyrosine 500 Mg, Psychological questionnaires, Photoplethysmography, Placebo
- Keywords
- L-tyrosine
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collectionBiological
A blood sample will be collected before during and after the treatment.
L-Tyrosine 500 MgDrug
The participants will be administered 4 capsules of L-Tyrosine 500 mg per oral route daily over 1 month.
Psychological questionnairesBehavioural
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
PhotoplethysmographyDevice
Photoplethysmography recording will be performed before during and after the treatment.
PlaceboDrug
The participants will be administered 4 capsules of Lactose 500 mg (placebo) per oral route daily over 1 month.
| Study group | Role | What they receive |
|---|---|---|
| Tyrosine - External Operation | Experimental | 1-month L-Tyrosine treatment following 4-month external operation Receives: Biological: Blood collection; Drug: L-Tyrosine 500 Mg; Behavioral: Psychological questionnaires; Device: Photoplethysmography |
| Placebo - External Operation | Experimental | 1-month Placebo treatment following 4-month external operation Receives: Biological: Blood collection; Behavioral: Psychological questionnaires; Device: Photoplethysmography; Drug: Placebo |
| Tyrosine - Rear Base | Experimental | 1-month L-Tyrosine treatment following 4 months at rear base Receives: Biological: Blood collection; Drug: L-Tyrosine 500 Mg; Behavioral: Psychological questionnaires; Device: Photoplethysmography |
| Placebo - Rear Base | Experimental | 1-month Placebo treatment following 4 months at rear base Receives: Biological: Blood collection; Behavioral: Psychological questionnaires; Device: Photoplethysmography; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After 1-month treatment
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After 1-month treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start9 Sep 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04549194
- Sponsor's protocol ID
- 2019PBMD06
- Other IDs
- 2020-A01658-31
- Acronym
- USOP
- Status last verified
- Nov 2022
- First submitted
- 8 Sep 2020
- Last updated
- 25 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of L-Tyrosine to Recovery From Operational Strain on Return From External Operation
- ClinicalTrials.gov ID
- NCT04549194
- Acronym / sponsor ID
- USOP / 2019PBMD06
- Conditions
- Stress, Psychological
- Keywords
- L-tyrosine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- 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
| Arm | Type | Receives |
|---|---|---|
| Tyrosine - External Operation | Experimental | Biological: Blood collection, Drug: L-Tyrosine 500 Mg, Behavioral: Psychological questionnaires, Device: Photoplethysmography1-month L-Tyrosine treatment following 4-month external operation |
| Placebo - External Operation | Experimental | Biological: Blood collection, Behavioral: Psychological questionnaires, Device: Photoplethysmography, Drug: Placebo1-month Placebo treatment following 4-month external operation |
| Tyrosine - Rear Base | Experimental | Biological: Blood collection, Drug: L-Tyrosine 500 Mg, Behavioral: Psychological questionnaires, Device: Photoplethysmography1-month L-Tyrosine treatment following 4 months at rear base |
| Placebo - Rear Base | Experimental | Biological: Blood collection, Behavioral: Psychological questionnaires, Device: Photoplethysmography, Drug: Placebo1-month Placebo treatment following 4 months at rear base |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- From 18 to 65 years of age
Key exclusion criteria (4 listed)
- Tyrosine intake within the previous 15 days
- History of neurological or psychiatric disorder
- History of nephrological or endocrine disorder or liver failure
- Hereditary tyrosinemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood collectionA blood sample will be collected before during and after the treatment. | Biological | Placebo - External Operation, Placebo - Rear Base, Tyrosine - External Operation, Tyrosine - Rear Base |
| L-Tyrosine 500 MgThe participants will be administered 4 capsules of L-Tyrosine 500 mg per oral route daily over 1 month. | Drug | Tyrosine - External Operation, Tyrosine - Rear Base |
| Psychological questionnairesThe 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 | Behavioural | Placebo - External Operation, Placebo - Rear Base, Tyrosine - External Operation, Tyrosine - Rear Base |
| PhotoplethysmographyPhotoplethysmography recording will be performed before during and after the treatment. | Device | Placebo - External Operation, Placebo - Rear Base, Tyrosine - External Operation, Tyrosine - Rear Base |
| PlaceboThe participants will be administered 4 capsules of Lactose 500 mg (placebo) per oral route daily over 1 month. | Drug | Placebo - External Operation, Placebo - Rear Base |
Primary outcome
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.
7 secondary outcomes
Difference between the change in catecholamine level following 1-month treatment in each arm
Time frame: After 1-month treatment
Difference between the change in aminoacid level following 1-month treatment in each arm
Time frame: After 1-month treatment
Difference between the change in zonulin level following 1-month treatment in each arm
Time frame: 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
Difference between the change in gamma-aminobutyric acid (GABA) level following 1-month treatment in each arm
Time frame: 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
Difference between the change in Interleukin-6 (IL6) level following 1-month treatment in each arm
Time frame: After 1-month treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood collection, L-Tyrosine 500 Mg and Psychological questionnaires in people with Stress, Psychological, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between the change in Burnout Assessment Tool (BAT) score following 1-month treatment in each arm (time frame: After 1-month treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2022.