Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-02-28 @ 4:57 AM
Study NCT ID:
NCT02647567
Status:
COMPLETED
Last Update Posted:
2016-01-06
First Post:
2015-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Caffeine Intake and Additive Effects on Cognition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002110', 'term': 'Caffeine'}], 'ancestors': [{'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-04', 'studyFirstSubmitDate': '2015-12-05', 'studyFirstSubmitQcDate': '2016-01-04', 'lastUpdatePostDateStruct': {'date': '2016-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Simple Reaction Time', 'timeFrame': 'Acute Change from Baseline Psychomotor test to 1 min after aerobic exercise, and after 30 min'}, {'measure': 'Rey Auditory Verbal Learning Test', 'timeFrame': 'Acute Change from Baseline Cognitive test to 1 min after aerobic exercise, and after 30 min'}, {'measure': 'Sustained Attention Test', 'timeFrame': 'Acute Change from Baseline Cognitive test to 1 min after aerobic exercise, and after 30 min'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cognitive', 'Aerobic Exercise', 'Performance'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Caffeine is a methylxanthine commonly consumed by the population for their psychostimulant properties, and their intake when in moderate doses seem to produce positive effects on stress, mood and memory. So, understanding that a positive effect of aerobic exercise can be displayed also on cognition, as caffeine, when in proper proportions, the investigators do not know if the joining of the two strategies into a single activity would be able to promote additional effects enhancing cognitive processes related to memory, attention, and motor reaction time.', 'detailedDescription': 'Determine if 500 mg of caffeine can generate additional effects to 30 minutes of aerobic exercise enhancing cognitive memory tasks (Rey Auditory Verbal Learning Test - RAVLT), attention (sustained attention span; working speed; Percentual of errors by confusion) and simple reaction time (SRT).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fighting men\n* Low levels of consumption of caffeine daily\n\nExclusion Criteria:\n\n* Use more than 400 mg caffeine day\n* Mental diseases\n* Cognitive deficits'}, 'identificationModule': {'nctId': 'NCT02647567', 'acronym': 'Caffeine', 'briefTitle': 'Caffeine Intake and Additive Effects on Cognition', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal do Rio de Janeiro'}, 'officialTitle': 'Can Caffeine Intake Combined With Aerobic Exercise Leads to Cognitive Improvement and Psychomotor Performance in Trained Individuals?', 'orgStudyIdInfo': {'id': 'UNIVERSO-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Caffeine Intake', 'description': 'The experimental group ingest 500 mg of caffeine before (60 min) aerobic exercise (procedure double blind), and perform a battery of neuropsychological and psychomotor tests. 1 min and 30 min after the exercise the subjects perform a new battery of neuropsychological and psychomotor tests.', 'interventionNames': ['Other: Caffeine Intake']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Intake', 'description': 'The control group ingest 500 mg of placebo before (60 min) aerobic exercise (procedure double blind), and perform a battery of neuropsychological and psychomotor tests. 1 min and 30 min after the exercise the subjects perform a new battery of neuropsychological and psychomotor tests.', 'interventionNames': ['Other: Placebo Intake']}], 'interventions': [{'name': 'Caffeine Intake', 'type': 'OTHER', 'otherNames': ['Caffeine'], 'description': 'The experimental group ingest 500 mg of caffeine before (60 min) aerobic exercise (procedure double blind), and perform a battery of neuropsychological and psychomotor tests. 1 min and 30 min after the exercise the subjects perform a new battery of neuropsychological and psychomotor tests.', 'armGroupLabels': ['Caffeine Intake']}, {'name': 'Placebo Intake', 'type': 'OTHER', 'otherNames': ['Placebo'], 'description': 'The control group ingest 500 mg of placebo before (60 min) aerobic exercise (procedure double blind), and perform a battery of neuropsychological and psychomotor tests. 1 min and 30 min after the exercise the subjects perform a new battery of neuropsychological and psychomotor tests.', 'armGroupLabels': ['Placebo Intake']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Sérgio Machado, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Salgado de Oliveira University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal do Rio de Janeiro', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctorade in Mental Health', 'investigatorFullName': 'Alberto Souza de Sá Filho', 'investigatorAffiliation': 'Universidade Federal do Rio de Janeiro'}}}}