Ignite Creation Date:
2025-12-24 @ 1:27 PM
Ignite Modification Date:
2025-12-26 @ 12:05 AM
Study NCT ID:
NCT05575895
Status:
COMPLETED
Last Update Posted:
2022-10-14
First Post:
2022-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Systemic Microvascular Reactivity After Ingestion of an Energy Drink in Young Male Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-11', 'studyFirstSubmitDate': '2022-10-05', 'studyFirstSubmitQcDate': '2022-10-10', 'lastUpdatePostDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endothelium-dependent skin microvascular reactivity', 'timeFrame': 'Microvascular reactivity will be evaluated after a 20-minute rest in the supine position in a temperature-controlled room.', 'description': 'Cutaneous microvascular flow measured with laser speckle contrast imaging'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endothelial Function']}, 'descriptionModule': {'briefSummary': 'Purpose: Energy drinks (EDs) are nonalcoholic beverages whose main ingredients are sugar, taurine, and caffeine. Their consumption is rising worldwide, with only few conflicting studies examining their vascular effects in young adults. We evaluated microvascular reactivity (MR) before and after ED in young healthy male volunteers.\n\nMethods: Systemic MR was evaluated in the skin of the forearm using laser speckle contrast imaging with acetylcholine (ACh) iontophoresis before, 90 and 180 minutes after the consumption of one can of ED or the same volume of water (control), followed by postocclusive reactive hyperemia (PORH).', 'detailedDescription': 'Energy drinks (EDs) are nonalcoholic beverages whose main ingredients are sugar, taurine, and caffeine. These products are marketed as boosters of mental and physical performance and are increasingly used in Western societies. Case reports of adverse effects related to ED consumption have been described in healthy young individuals, including coronary artery vasospasm, and myocardial infarction. These data suggest that endothelial dysfunction (EDysf) plays a role in ED cardiovascular effects and have prompted studies with conflicting results. The present study evaluated the microvascular reactivity (MR) after ingestion of one can of ED compared to a control, in young healthy male volunteers.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'healthy male volunteers with no relevant findings in the medical history', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy male volunteers with no relevant findings in the medical history\n\nExclusion Criteria:\n\n* being a competitive athlete;\n* being on regular medication;\n* using illicit drugs;\n* being allergic to coffee, taurine or any of the components of the selected energy drink; - -\n* having a body mass index ≥ 30 kg/m2.'}, 'identificationModule': {'nctId': 'NCT05575895', 'briefTitle': 'Evaluation of Systemic Microvascular Reactivity After Ingestion of an Energy Drink in Young Male Volunteers', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Institute of Cardiology, Laranjeiras, Brazil'}, 'officialTitle': 'Evaluation of Systemic Microvascular Reactivity After Ingestion of an Energy Drink in Young Male Volunteers', 'orgStudyIdInfo': {'id': 'CAAE 13135219.0.0000.5272'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Energy Drink', 'description': 'Ingestion of 250 ml of the energy drink (Red Bull®)\n\n\\- Evaluation of systemic skin microvascular endothelial function Laser-based method for evaluating non-invasive, operator-independent systemic microvascular function that detects microvascular flow in the skin for the evaluation of systemic vascular endothelial function.', 'interventionNames': ['Dietary Supplement: Ingestion of the energy drink (Red Bull®)']}, {'label': 'Control', 'description': 'Ingestion of 250 ml of mineral water (Minalba®)\n\n\\- Evaluation of systemic skin microvascular endothelial function Laser-based method for evaluating non-invasive, operator-independent systemic microvascular function that detects microvascular flow in the skin for the evaluation of systemic vascular endothelial function.', 'interventionNames': ['Dietary Supplement: Ingestion of mineral water']}], 'interventions': [{'name': 'Ingestion of the energy drink (Red Bull®)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Ingestion of 250 ml of the energy drink (Red Bull®)', 'armGroupLabels': ['Energy Drink']}, {'name': 'Ingestion of mineral water', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Ingestion of 250 ml of mineral water (Minalba®)', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22240-006', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'National Institute of Cardiology, Ministry of Health, Brazil', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '22240006', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Eduardo Tibiriçá', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Cardiology, Laranjeiras, Brazil', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior researcher', 'investigatorFullName': 'Eduardo Tibirica, MD, PhD', 'investigatorAffiliation': 'National Institute of Cardiology, Laranjeiras, Brazil'}}}}