Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2026-04-13 @ 2:25 AM
Study NCT ID:
NCT03449992
Status:
COMPLETED
Last Update Posted:
2018-03-01
First Post:
2018-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Nitrate Supplementation on Elite Runners
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Twelve participants were randomly assigned to either an intervention group or a placebo group, and a 4 digits code based on their Spanish ID card were used to code their names.\n\nThen, an independent researcher prepared individual bags with either a 15-days worth of placebo drinks or beetroot drinks, and gave it to the athletes. Then, this person was withdrawn for the research procedures.\n\nFinally, another group of researchers, without knowing what athlete was on each group (intervention or placebo), conducted the performance tests pre and post 15 days of supplementation, and another group analyzed the data once collected.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Twelve elite distance runners were randomly assigned to either an intervention group or a placebo group. Participants in each group consumed beetroot juice or a placebo drink for 15 consecutive days.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2017-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-22', 'studyFirstSubmitDate': '2018-02-19', 'studyFirstSubmitQcDate': '2018-02-22', 'lastUpdatePostDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Running economy', 'timeFrame': 'Changes from baseline at 15 days', 'description': 'The cost of running (oxygen consumption) at different speeds'}], 'secondaryOutcomes': [{'measure': 'Time to exhaustion', 'timeFrame': 'Changes from baseline at 15 days', 'description': 'Time that the athlete endured running until voluntarily ending the exercise'}, {'measure': 'Muscle power', 'timeFrame': 'Changes from baseline at 15 days', 'description': 'Ability to produce muscle power in a jump test'}, {'measure': 'Muscle oxygenation', 'timeFrame': 'Changes from baseline at 15 days', 'description': 'Saturation of O2 in the vastus lateralis during exercise'}, {'measure': 'RPE', 'timeFrame': 'Changes from baseline at 15 days', 'description': 'Rate of perceived exertion during the exercise'}, {'measure': 'Running mechanics', 'timeFrame': 'Changes from baseline at 15 days', 'description': 'Contact and flight time of each step during the exercise'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nutrition', 'Physical Performance', 'Sport Physiology', 'Nitrates', 'Elite Athletes']}, 'referencesModule': {'availIpds': [{'url': 'https://doi.org/10.6084/m9.figshare.5873190.v1', 'type': 'Individual Participant Data Set'}]}, 'descriptionModule': {'briefSummary': 'This study analyzed the effects of 15 days of beetroot juice supplementation on different performance measures in elite Spanish distance runners', 'detailedDescription': 'This study analyzed the effects of 15 days beetroot juice supplementation on the VO2max, running economy, exercise perceived exertion, muscle power and locomotion mechanics in a group of 12 elite Spanish middle and long distance runners'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Competing in national and international events\n* Personal best in urban 10k: 33 minutes 0 seconds\n\nExclusion Criteria:\n\n* Injury'}, 'identificationModule': {'nctId': 'NCT03449992', 'briefTitle': 'The Effects of Nitrate Supplementation on Elite Runners', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Autonoma de Madrid'}, 'officialTitle': 'The Effects of Beet-root Juice Supplementation on Exercise Economy, Rating of Perceived Exertion and Running Mechanics in Elite Distance Runners', 'orgStudyIdInfo': {'id': 'BEETRUN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Participants in this group ingested nitrate-rich beetroot juice for 15 days', 'interventionNames': ['Dietary Supplement: nitrate-rich beetroot juice']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Participants in this group ingested a placebo drink for 15 days', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'nitrate-rich beetroot juice', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Beetroot juice'], 'description': 'Nitrate-rich beetroot juice supplementation was administered for 15 consecutive days to participants in this arm', 'armGroupLabels': ['Intervention group']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo drink', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Carlos Balsalobre-Fernández, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Autonoma de Madrid'}]}, 'ipdSharingStatementModule': {'url': 'https://doi.org/10.6084/m9.figshare.5873190.v1', 'infoTypes': ['ANALYTIC_CODE'], 'timeFrame': 'Indefinitely available', 'ipdSharing': 'YES', 'description': 'Coded database with data of the pre-post measures will be made available', 'accessCriteria': 'Open access'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Autonoma de Madrid', 'class': 'OTHER'}, 'collaborators': [{'name': 'Camilo Jose Cela University', 'class': 'OTHER'}, {'name': 'Universidad Politecnica de Madrid', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Carlos Balsalobre-Fernández', 'investigatorAffiliation': 'Universidad Autonoma de Madrid'}}}}