Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT04886869
Status:
UNKNOWN
Last Update Posted:
2021-05-14
First Post:
2021-04-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Caffeine and the Autonomic Nervous System
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-10', 'studyFirstSubmitDate': '2021-04-30', 'studyFirstSubmitQcDate': '2021-05-10', 'lastUpdatePostDateStruct': {'date': '2021-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart rate (HR)', 'timeFrame': '2 hours', 'description': 'ECG-based analysis of heart rate (beats per minute)'}], 'secondaryOutcomes': [{'measure': 'Periodic repolarization dynamics (PRD)', 'timeFrame': '2 hours', 'description': 'ECG-based analysis of repolarization instability (deg²)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Autonomic Nervous System Imbalance']}, 'referencesModule': {'references': [{'pmid': '35266046', 'type': 'DERIVED', 'citation': 'Schuttler D, Rudi WS, Bauer A, Hamm W, Brunner S. Impact of energy drink versus coffee consumption on periodic repolarization dynamics: an interventional study. Eur J Nutr. 2022 Aug;61(5):2847-2851. doi: 10.1007/s00394-022-02853-8. Epub 2022 Mar 10.'}]}, 'descriptionModule': {'briefSummary': 'Caffeine consumption has been linked to dysfunction of the autonomic nervous system. In this study the investigators analyze the effects of caffeine containing drinks (including energy drinks and coffee) on ECG based parameters of the autonomic nervous system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy individuals\n* \\> 18 years\n\nExclusion Criteria:\n\n* known cardiovascular disease\n* other diseases which may influence the autonomic nervous system\n* medication which may influence the autonomic nervous system\n* prior caffeine consumption (\\<24 hours)'}, 'identificationModule': {'nctId': 'NCT04886869', 'briefTitle': 'Caffeine and the Autonomic Nervous System', 'organization': {'class': 'OTHER', 'fullName': 'LMU Klinikum'}, 'officialTitle': 'Impact of Caffeine Consumption on Markers of the Autonomic Nervous System', 'orgStudyIdInfo': {'id': 'CaffeineLMU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Coffee', 'description': 'Oral consumption of 3 cups of coffee containing 240 mg caffeine', 'interventionNames': ['Dietary Supplement: caffeine']}, {'type': 'EXPERIMENTAL', 'label': 'Energy drink', 'description': 'Oral consumption of 750 mL of a commercial energy drink containing 240 mg caffeine', 'interventionNames': ['Dietary Supplement: caffeine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Oral consumption of 750 mL water', 'interventionNames': ['Dietary Supplement: caffeine']}], 'interventions': [{'name': 'caffeine', 'type': 'DIETARY_SUPPLEMENT', 'description': 'oral consumption', 'armGroupLabels': ['Coffee', 'Energy drink', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Munich', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Stefan Brunner, MD', 'role': 'CONTACT', 'email': 'Stefan.Brunner@med.uni-muenchen.de', 'phone': '+49 89 44000'}], 'facility': 'University Hospital Munich (LMU Klinikum)', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'centralContacts': [{'name': 'Stefan Brunner, MD', 'role': 'CONTACT', 'email': 'Stefan.Brunner@med.uni-muenchen.de', 'phone': '+49 89 4400 0'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LMU Klinikum', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'PD Dr. Stefan Brunner', 'investigatorAffiliation': 'LMU Klinikum'}}}}