Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-02-22 @ 7:05 AM
Study NCT ID:
NCT03324256
Status:
COMPLETED
Last Update Posted:
2019-05-20
First Post:
2017-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Energy Drinks and Vascular Function
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': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-05-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-16', 'studyFirstSubmitDate': '2017-10-20', 'studyFirstSubmitQcDate': '2017-10-24', 'lastUpdatePostDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in endothelial function', 'timeFrame': 'Before and 1 and 2 hrs following consumption of drink and gum', 'description': 'Brachial artery flow-mediated dilation'}], 'secondaryOutcomes': [{'measure': 'Change in arterial stiffness', 'timeFrame': 'Before and 1 and 2 hrs following consumption of drink and gum', 'description': 'Carotid to femoral pulse wave velocity'}, {'measure': 'Change in wave reflection', 'timeFrame': 'Before and 1 and 2 hrs following consumption of drink and gum', 'description': 'Augmentation index'}, {'measure': 'Change in peripheral and central blood pressures', 'timeFrame': 'Before and 1 and 2 hrs following consumption of drink and gum', 'description': 'Brachial and aortic blood pressures'}, {'measure': 'Change in thrombosis and platelet function', 'timeFrame': 'Before and 1 and 2 hrs following consumption of drink and gum', 'description': 'Thromboelastograph and platelet aggregation tests'}, {'measure': 'Change in circulating factors related to vascular function', 'timeFrame': 'Before and 1 and 2 hrs following consumption of drink and gum', 'description': 'Circulating levels of Trimethylamine N-oxide (TMAO) and markers of oxidative stress and inflammation'}, {'measure': 'Change in heart rhythm', 'timeFrame': 'Before and 1 and 2 hrs following consumption of drink and gum', 'description': 'Electrocardiogram'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Energy drink consumption'], 'conditions': ['Vascular Function']}, 'descriptionModule': {'briefSummary': 'The purpose of this study will be to examine the acute effect of commercially available energy products on endothelial function, arterial stiffness and thrombosis in healthy young males.', 'detailedDescription': 'The use of energy products has significantly increased in the last few years and is especially high among young men. The present study will compare the acute effect of a commercially available energy drink, energy gum, coffee and control beverage on endothelial function, arterial stiffness and circulating markers of thrombosis, inflammation and oxidative stress.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being Male\n* 18-30 years of age\n* No indication of major clinical disease (e.g. diabetes, hypertension, significant arrhythmias, syncope and cardiovascular disease)\n* BMI ≤ 30 kg/m\\^2 and blood pressure ≤ 140/90 mmHg\n* Consumption of \\<400mg of caffeine/day\n* Prior history of consumption of energy drinks\n\nExclusion criteria:\n\n* Being female\n* Age \\<18 or \\>30 years\n* BMI\\> 30 kg/m\\^2 and blood pressure \\> 140/90 mmHg\n* Use of medication that may affect vascular measures\n* Use of tobacco products including smoking\n* Vegan or vegetarian diet\n* Being energy drink or caffeine naïve or consumption of \\>400 mg of caffeine/day\n* Consumption of \\>1 energy drinks per month\n* Being a shift worker'}, 'identificationModule': {'nctId': 'NCT03324256', 'briefTitle': 'Energy Drinks and Vascular Function', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Acute Effect of Energy Drinks on Vascular Function', 'orgStudyIdInfo': {'id': 'IRB201700678'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Energy drink and placebo gum', 'description': 'Commercially-available energy drink (16oz) + 2 pieces of placebo gum', 'interventionNames': ['Other: energy drink', 'Other: placebo gum']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Caffeinated drink and placebo gum', 'description': 'Commercially-available caffeinated drink (16oz) + 2 pieces of placebo gum', 'interventionNames': ['Other: caffeinated drink', 'Other: placebo gum']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control drink and energy gum', 'description': 'Control drink (16oz) + 2 pieces of energy gum', 'interventionNames': ['Other: Energy gum', 'Other: Control drink']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control drink and placebo gum', 'description': 'Control drink (16oz) + 2 pieces of placebo gum', 'interventionNames': ['Other: placebo gum', 'Other: Control drink']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Energy drink and total sleep deprivation', 'description': 'Commercially-available energy drink (16oz) + 2 pieces of placebo gum following total sleep deprivation', 'interventionNames': ['Other: energy drink', 'Other: placebo gum', 'Other: Total sleep deprivation']}], 'interventions': [{'name': 'energy drink', 'type': 'OTHER', 'description': '16 oz cold commercially-available energy drink', 'armGroupLabels': ['Energy drink and placebo gum', 'Energy drink and total sleep deprivation']}, {'name': 'caffeinated drink', 'type': 'OTHER', 'description': '16oz cold commercially-available caffeinated drink', 'armGroupLabels': ['Caffeinated drink and placebo gum']}, {'name': 'Energy gum', 'type': 'OTHER', 'description': '2 pieces of commercially-available energy gum', 'armGroupLabels': ['Control drink and energy gum']}, {'name': 'placebo gum', 'type': 'OTHER', 'description': '2 pieces of commercially-available placebo gum', 'armGroupLabels': ['Caffeinated drink and placebo gum', 'Control drink and placebo gum', 'Energy drink and placebo gum', 'Energy drink and total sleep deprivation']}, {'name': 'Control drink', 'type': 'OTHER', 'description': '16oz cold control drink', 'armGroupLabels': ['Control drink and energy gum', 'Control drink and placebo gum']}, {'name': 'Total sleep deprivation', 'type': 'OTHER', 'description': '24-hour total sleep deprivation prior to consumption of energy drink and placebo gum', 'armGroupLabels': ['Energy drink and total sleep deprivation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32611', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Demetra Christou, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}