Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2026-01-02 @ 6:27 AM
Study NCT ID:
NCT05503732
Status:
COMPLETED
Last Update Posted:
2024-11-15
First Post:
2022-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Energy Drinks on Sleep and Cardiovascular Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D061215', 'term': 'Energy Drinks'}], 'ancestors': [{'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-09-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-13', 'studyFirstSubmitDate': '2022-07-14', 'studyFirstSubmitQcDate': '2022-08-15', 'lastUpdatePostDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Changes in resting heart rate', 'timeFrame': 'Baseline and AM of day 2', 'description': 'Seated heart rate'}, {'measure': 'Changes in resting blood pressure', 'timeFrame': 'Baseline and AM of day 2', 'description': 'Seated systolic and diastolic blood pressure'}], 'primaryOutcomes': [{'measure': 'Changes in sleep efficiency', 'timeFrame': 'Throughout duration of sleep on both nights (night 1 and night 2)', 'description': 'Time asleep / time in bed'}, {'measure': 'Changes in sleep continuity', 'timeFrame': 'Throughout duration of sleep on both nights (night 1 and night 2)', 'description': 'Frequency of wakefulness after sleep initiation'}, {'measure': 'Changes in sleep architecture', 'timeFrame': 'Throughout duration of sleep on both nights (night 1 and night 2)', 'description': 'Time spent in each stage of sleep'}, {'measure': 'QT segment', 'timeFrame': 'Baseline, approximately 1 hour prior to energy drink consumption', 'description': 'QT duration'}, {'measure': 'QT segment', 'timeFrame': 'Throughout duration of sleep on both nights (night 1 and night 2)', 'description': 'QT duration'}, {'measure': 'Atrial arrhythmias', 'timeFrame': 'Baseline, approximately 1 hour prior to energy drink consumption', 'description': 'Frequency of ectopic atrial beats'}, {'measure': 'Atrial arrhythmias', 'timeFrame': 'Throughout duration of sleep on both nights (night 1 and night 2)', 'description': 'Frequency of ectopic atrial beats'}, {'measure': 'Ventricular arrhythmias', 'timeFrame': 'Baseline, approximately 1 hour prior to energy drink consumption', 'description': 'Frequency of ectopic ventricular beats'}, {'measure': 'Ventricular arrhythmias', 'timeFrame': 'Throughout duration of sleep on both nights (night 1 and night 2)', 'description': 'Frequency of ectopic ventricular beats'}], 'secondaryOutcomes': [{'measure': 'Sympathetic activation quantified by changes in plasma norepinephrine', 'timeFrame': 'Baseline and AM of day 2', 'description': 'Plasma norepinephrine while supine'}, {'measure': 'Sympathetic activation quantified by changes in plasma epinephrine', 'timeFrame': 'Baseline and AM of day 2', 'description': 'Plasma epinephrine while supine'}, {'measure': 'Sympathetic activation quantified by changes in plasma dopamine', 'timeFrame': 'Baseline and AM of day 2', 'description': 'Plasma dopamine while supine'}, {'measure': 'Sympathetic activation quantified by urine norepinephrine', 'timeFrame': 'Approximately 24 hours', 'description': 'Total urine norepinephrine secretion'}, {'measure': 'Sympathetic activation quantified by urine epinephrine', 'timeFrame': 'Approximately 24 hours', 'description': 'Total urine epinephrine secretion'}, {'measure': 'Sympathetic activation quantified by urine dopamine', 'timeFrame': 'Approximately 24 hours', 'description': 'Total urine dopamine secretion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Energy Drink'], 'conditions': ['Healthy', 'Caffeine']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn about the change in quality of sleep, structural organization of sleep, and cardiovascular responses after consuming an energy drink compared to a placebo drink with no caffeine or stimulants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults 18 years of age and older.\n* Healthy subjects without known cardiovascular disease and thyroid disease.\n* Subjects who are on no medications (except oral contraceptive pill).\n* Nonsmokers.\n* No prior history of caffeine sensitivity or allergy.\n\nExclusion Criteria:\n\n* Subjects with known cardiovascular or thyroid disease.\n* Subjects currently taking medications other than oral contraceptive pill.\n* Smokers.\n* Prior history of caffeine sensitivity or allergy.\n* Pregnancy.\n* Subjects who regularly consume energy drinks.\n* Subjects who typically go to sleep after midnight.\n* Subjects who traveled across 2 time zones in the last 7 days.\n* Shift workers.\n* Subjects who have or are suspected to have sleep apnea.\n* Subjects who have a body mass index \\> 35kg/m\\^2.'}, 'identificationModule': {'nctId': 'NCT05503732', 'briefTitle': 'Effects of Energy Drinks on Sleep and Cardiovascular Health', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Effects of Energy Drinks on Sleep and Cardiovascular Health in Healthy Young Adults A Double Blind Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '21-012902'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Energy drink first, then placebo drink', 'description': 'Subjects will consume two 16-oz energy drinks before sleep for the first study visit, then consume two 16-oz identical looking placebo drink before sleep at the second study visit.', 'interventionNames': ['Other: Energy Drink', 'Other: Placebo Drink']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo drink first, than energy drink', 'description': 'Subjects will consume two 16-oz identical looking placebo drink before sleep at the fist study visit, then consume two 16-oz energy drinks before sleep for the second study visit.', 'interventionNames': ['Other: Energy Drink', 'Other: Placebo Drink']}], 'interventions': [{'name': 'Energy Drink', 'type': 'OTHER', 'description': 'Two 16-oz energy drinks consumed orally to be finished approximately 4 hours prior to bed', 'armGroupLabels': ['Energy drink first, then placebo drink', 'Placebo drink first, than energy drink']}, {'name': 'Placebo Drink', 'type': 'OTHER', 'description': 'Two 16-oz identical looking placebo drink without caffeine consumed orally to be finished approximately 4 hours prior to bed', 'armGroupLabels': ['Energy drink first, then placebo drink', 'Placebo drink first, than energy drink']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Anna Svatikova, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Anna Svatikova', 'investigatorAffiliation': 'Mayo Clinic'}}}}