Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-28 @ 12:09 AM
Study NCT ID:
NCT04549194
Status:
COMPLETED
Last Update Posted:
2022-11-25
First Post:
2020-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contribution of L-Tyrosine to Recovery From Operational Strain on Return From External Operation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013315', 'term': 'Stress, Psychological'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D014443', 'term': 'Tyrosine'}, {'id': 'D017156', 'term': 'Photoplethysmography'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D010991', 'term': 'Plethysmography'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study is composed of 2 groups, each of which is composed of 2 arms:\n\n* External Operation group\n\n * L-Tyrosine arm\n * Placebo arm\n* Rear Base group\n\n * L-Tyrosine arm\n * Placebo arm'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-23', 'studyFirstSubmitDate': '2020-09-08', 'studyFirstSubmitQcDate': '2020-09-08', 'lastUpdatePostDateStruct': {'date': '2022-11-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference between the change in Burnout Assessment Tool (BAT) score following 1-month treatment in each arm', 'timeFrame': 'After 1-month treatment', '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.'}], 'secondaryOutcomes': [{'measure': 'Difference between the change in catecholamine level following 1-month treatment in each arm', 'timeFrame': 'After 1-month treatment', 'description': 'Catecholamine level will be measured in blood before during and after 1-month treatment.'}, {'measure': 'Difference between the change in aminoacid level following 1-month treatment in each arm', 'timeFrame': 'After 1-month treatment', 'description': 'Aminoacid level will be measured in blood before during and after 1-month treatment.'}, {'measure': 'Difference between the change in zonulin level following 1-month treatment in each arm', 'timeFrame': 'After 1-month treatment', 'description': 'Zonulin level will be measured in blood before during and after 1-month treatment.'}, {'measure': 'Difference between the change in Brain-Derived Neurotrophic Factor (BDNF) level following 1-month treatment in each arm', 'timeFrame': 'After 1-month treatment', 'description': 'BDNF level will be measured in blood before during and after 1-month treatment.'}, {'measure': 'Difference between the change in gamma-aminobutyric acid (GABA) level following 1-month treatment in each arm', 'timeFrame': 'After 1-month treatment', 'description': 'GABA level will be measured in blood before during and after 1-month treatment.'}, {'measure': 'Difference between the change in Tumor Necrosis Factor Alpha (TNFα) level following 1-month treatment in each arm', 'timeFrame': 'After 1-month treatment', 'description': 'TNFα level will be measured in blood before during and after 1-month treatment.'}, {'measure': 'Difference between the change in Interleukin-6 (IL6) level following 1-month treatment in each arm', 'timeFrame': 'After 1-month treatment', 'description': 'IL6 level will be measured in blood before during and after 1-month treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['L-tyrosine'], 'conditions': ['Stress, Psychological']}, 'descriptionModule': {'briefSummary': '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.\n\nThis may lead to a state of "operational strain" that refers to chronic stress and the allostatic load imposed by operational constraint.\n\nThe 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.).\n\nThis aging mechanism would be reversible after a sufficient period of resource restoration (sleep, physical activity, adapted diet, etc.).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* From 18 to 65 years of age\n\nExclusion Criteria:\n\n* Tyrosine intake within the previous 15 days\n* History of neurological or psychiatric disorder\n* History of nephrological or endocrine disorder or liver failure\n* Hereditary tyrosinemia'}, 'identificationModule': {'nctId': 'NCT04549194', 'acronym': 'USOP', 'briefTitle': 'Contribution of L-Tyrosine to Recovery From Operational Strain on Return From External Operation', 'organization': {'class': 'OTHER', 'fullName': 'Direction Centrale du Service de Santé des Armées'}, 'officialTitle': 'Contribution of L-Tyrosine to Recovery From Operational Strain on Return From External Operation', 'orgStudyIdInfo': {'id': '2019PBMD06'}, 'secondaryIdInfos': [{'id': '2020-A01658-31', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tyrosine - External Operation', 'description': '1-month L-Tyrosine treatment following 4-month external operation', 'interventionNames': ['Biological: Blood collection', 'Drug: L-Tyrosine 500 Mg', 'Behavioral: Psychological questionnaires', 'Device: Photoplethysmography']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo - External Operation', 'description': '1-month Placebo treatment following 4-month external operation', 'interventionNames': ['Biological: Blood collection', 'Behavioral: Psychological questionnaires', 'Device: Photoplethysmography', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Tyrosine - Rear Base', 'description': '1-month L-Tyrosine treatment following 4 months at rear base', 'interventionNames': ['Biological: Blood collection', 'Drug: L-Tyrosine 500 Mg', 'Behavioral: Psychological questionnaires', 'Device: Photoplethysmography']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo - Rear Base', 'description': '1-month Placebo treatment following 4 months at rear base', 'interventionNames': ['Biological: Blood collection', 'Behavioral: Psychological questionnaires', 'Device: Photoplethysmography', 'Drug: Placebo']}], 'interventions': [{'name': 'Blood collection', 'type': 'BIOLOGICAL', 'description': 'A blood sample will be collected before during and after the treatment.', 'armGroupLabels': ['Placebo - External Operation', 'Placebo - Rear Base', 'Tyrosine - External Operation', 'Tyrosine - Rear Base']}, {'name': 'L-Tyrosine 500 Mg', 'type': 'DRUG', 'description': 'The participants will be administered 4 capsules of L-Tyrosine 500 mg per oral route daily over 1 month.', 'armGroupLabels': ['Tyrosine - External Operation', 'Tyrosine - Rear Base']}, {'name': 'Psychological questionnaires', 'type': 'BEHAVIORAL', 'description': 'The participants will fill in several psychological questionnaires before, during and after treatment administration:\n\n* Life Event Checklist\n* Moral injury\n* Posttraumatic Checklist\n* Burnout Assessment Tool\n* State-Trait Anger Expression Inventory-2\n* Ruminative Response Scale - Reconsidered\n* Deployment Risk and Resilience Inventory-2\n* Questionnaire about tobacco use', 'armGroupLabels': ['Placebo - External Operation', 'Placebo - Rear Base', 'Tyrosine - External Operation', 'Tyrosine - Rear Base']}, {'name': 'Photoplethysmography', 'type': 'DEVICE', 'description': 'Photoplethysmography recording will be performed before during and after the treatment.', 'armGroupLabels': ['Placebo - External Operation', 'Placebo - Rear Base', 'Tyrosine - External Operation', 'Tyrosine - Rear Base']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'The participants will be administered 4 capsules of Lactose 500 mg (placebo) per oral route daily over 1 month.', 'armGroupLabels': ['Placebo - External Operation', 'Placebo - Rear Base']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91223', 'city': 'Brétigny-sur-Orge', 'country': 'France', 'facility': 'Institut de Recherche Biomédicale des Armées', 'geoPoint': {'lat': 48.61135, 'lon': 2.30593}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Direction Centrale du Service de Santé des Armées', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}