Ignite Creation Date:
2025-12-24 @ 12:46 PM
Ignite Modification Date:
2026-02-24 @ 2:29 PM
Study NCT ID:
NCT02264561
Status:
COMPLETED
Last Update Posted:
2015-04-08
First Post:
2014-09-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Caffeine's Effect on Attention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D002110', 'term': 'Caffeine'}], 'ancestors': [{'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-07', 'studyFirstSubmitDate': '2014-09-24', 'studyFirstSubmitQcDate': '2014-10-09', 'lastUpdatePostDateStruct': {'date': '2015-04-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Attention test: milliseconds and index of stimulus sensitivity', 'timeFrame': 'duration 10 days from screening to last visit (V2)'}], 'secondaryOutcomes': [{'measure': 'Central Nervous System :response time.', 'timeFrame': 'duration: 10 days from screening to last visit (V2)'}, {'measure': 'Mood measures: Visual Analog scale.', 'timeFrame': 'duration 10 days from screening to last visit V2'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Attention']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether caffeine improves attention.', 'detailedDescription': 'Single centre single dose cross-over, placebo-controlled, double blind, randomized trial with two treatment conditions : caffeine and placebo'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Healthy male and female Aged 40-60 years'}, 'identificationModule': {'nctId': 'NCT02264561', 'briefTitle': "Caffeine's Effect on Attention", 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'The Effect of Caffeine on Attention', 'orgStudyIdInfo': {'id': '14.12.NRC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Mannitol administered at visit 1 and at visit 2', 'interventionNames': ['Other: Food']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'caffeine', 'description': 'caffeine administered at visit 1 and at visit 2', 'interventionNames': ['Other: Food']}], 'interventions': [{'name': 'Food', 'type': 'OTHER', 'otherNames': ['Caffeine'], 'description': 'Active group', 'armGroupLabels': ['Placebo', 'caffeine']}, {'name': 'Food', 'type': 'OTHER', 'otherNames': ['Placebo'], 'description': 'Control group', 'armGroupLabels': ['Placebo', 'caffeine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2333', 'city': 'Leiden', 'state': 'CL', 'country': 'Netherlands', 'facility': 'Center for Human Drug Research', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}