Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-31 @ 7:40 AM
Study NCT ID:
NCT04963556
Status:
COMPLETED
Last Update Posted:
2021-07-15
First Post:
2020-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Red Bull® on the Effects of Training and Haemodynamic Parameters
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Blinded to verum or placebo drink'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2018-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-05', 'studyFirstSubmitDate': '2020-11-13', 'studyFirstSubmitQcDate': '2021-07-05', 'lastUpdatePostDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect on blood pressure', 'timeFrame': '24 hours', 'description': 'Effect on systolic and diastolic blood pressure'}], 'secondaryOutcomes': [{'measure': 'Pulse wave velocity', 'timeFrame': '24 hours', 'description': 'central pulse wave velocity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Effects of; Food, Allergic']}, 'descriptionModule': {'briefSummary': 'Background:\n\nThe consumption of Energy Drinks (EDs) can acutely lead to negative side effects, such as raised blood pressure and impaired endothelial function. Nevertheless, they are sold worldwide and are often consumed before physical activity (PA). In contrast to the blood pressure elevating effect of EDs, PA leads to a reduction of blood pressure. The effect of ED consumption on blood pressure response during and after endurance training is currently unresolved.\n\nMethods:\n\nA total of 23 participants (eleven men, twelve women) were evaluated in the intervention study with a blinded Cross-Over Design. They consumed on two different days either 355 ml Red Bull (RB) or 355 ml Placebo (Pla) in randomised order. The peripheral (PBP) and central blood pressure (CBP) were measured before, during and after a 30-minute aerobic endurance training, by the Schiller BR-102 plus PWA device.', 'detailedDescription': 'Background:\n\nThe consumption of Energy Drinks (EDs) can acutely lead to negative side effects, such as raised blood pressure and impaired endothelial function. Nevertheless, they are sold worldwide and are often consumed before physical activity (PA). In contrast to the blood pressure elevating effect of EDs, PA leads to a reduction of blood pressure. The effect of ED consumption on blood pressure response during and after endurance training is currently unresolved.\n\nMethods:\n\nA total of 23 participants (eleven men, twelve women) were evaluated in the intervention study with a blinded Cross-Over Design. They consumed on two different days either 355 ml Red Bull (RB) or 355 ml Placebo (Pla) in randomised order. The peripheral (PBP) and central blood pressure (CBP) were measured before, during and after a 30-minute aerobic endurance training, by the Schiller BR-102 plus PWA device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No known cardiovascular diseases such as arterial hypertension and diabetes mellitus.\n* No ophthalmological diseases such as glaucoma or macular degeneration.\n* No regular medication\n* No vasodilator abuse for 24 h before the respective intervention (e.g. smoking, use of stimulants, β-blockers).\n* No pregnancy (anamnestic)'}, 'identificationModule': {'nctId': 'NCT04963556', 'briefTitle': 'Effects of Red Bull® on the Effects of Training and Haemodynamic Parameters', 'organization': {'class': 'OTHER', 'fullName': 'University of Basel'}, 'officialTitle': 'Effects of Red Bull® on the Effects of Moderate Endurance Training Measured by Haemodynamic Parameters', 'orgStudyIdInfo': {'id': '2017-01079'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Red Bull', 'description': 'Drinking of 355 ml Red Bull', 'interventionNames': ['Dietary Supplement: Red Bull']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Drinking of 355 ml sweetened water', 'interventionNames': ['Dietary Supplement: Red Bull']}], 'interventions': [{'name': 'Red Bull', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Placebo'], 'description': 'Drinking of Red Bull before exercise', 'armGroupLabels': ['Placebo', 'Red Bull']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4052', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'University of Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Arno Schmidt-Trucksäss, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Basel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Basel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med.', 'investigatorFullName': 'Arno Schmidt-Trucksäss', 'investigatorAffiliation': 'University of Basel'}}}}