Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-26 @ 6:27 PM
Study NCT ID:
NCT01795534
Status:
COMPLETED
Last Update Posted:
2017-07-19
First Post:
2013-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Beetroot Juice as a Potential Ergogenic Aid During Exercise in Hypoxia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'j.h.macdonald@bangor.ac.uk', 'phone': '+441248383272', 'title': 'Dr Jamie Macdonald', 'organization': 'Bangor University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'During three study periods only (1st intervention, wash out period, second intervention)', 'eventGroups': [{'id': 'EG000', 'title': 'Beetroot Shot', 'description': 'Data is for all participants following consumption of 1x70ml concentrated NO-3 shot of rich beetroot juice (\\~7mmol nitrate) (Beet It, James White Drinks Ltd, Ipswich, UK).', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Shot', 'description': 'Data is for all participants following consumption of 1x70ml nitrate-depleted beetroot shot (\\~0.003mmol of nitrate)(Beet It, James White Drinks Ltd, Ipswich, UK).', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Complete a 10 km Run', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Beetroot Shot', 'description': 'Includes groups randomized to receive beetroot first and placebo first.\n\nData is for all participants following consumption of 1x70ml concentrated NO-3 shot of rich beetroot juice (\\~7mmol nitrate) (Beet It, James White Drinks Ltd, Ipswich, UK).'}, {'id': 'OG001', 'title': 'Placebo Shot', 'description': 'Includes groups randomized to receive beetroot first and placebo first.\n\nData is for all participants following consumption of 1x70ml nitrate-depleted beetroot shot (\\~0.003mmol of nitrate)(Beet It, James White Drinks Ltd, Ipswich, UK).'}], 'classes': [{'categories': [{'measurements': [{'value': '2862', 'spread': '233', 'groupId': 'OG000'}, {'value': '2874', 'spread': '265', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Period 1 (on day of 1st intervention) and period 2 (on day of 2nd intervention)', 'description': 'Time taken following consumption of beetroot shot or consumption of placebo shot', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Beetroot Shot Then Placebo Shot', 'description': 'Intervention: Participants will first consume a Beetroot shot: 1x70ml concentrated NO-3 shot of rich Beetroot juice (\\~7mmol nitrate) (Beet It, James White Drinks Ltd, Ipswich, UK).\n\nFollowing a four day wash out, participants will then consume a Nitrate-depleted beetroot shot: 1x70ml nitrate-depleted beetroot Placebo shot (\\~0.003mmol of nitrate)(Beet It, James White Drinks Ltd, Ipswich, UK)'}, {'id': 'FG001', 'title': 'Placebo Shot Then Beetroot Shot', 'description': 'Intervention: participants will first consume a Nitrate-depleted beetroot shot: 1x70ml nitrate-depleted beetroot Placebo shot (\\~0.003mmol of nitrate)(Beet It, James White Drinks Ltd, Ipswich, UK)\n\nFollowing a four day wash out, participants will then consume a Beetroot shot: 1x70ml concentrated NO-3 shot of rich Beetroot juice (\\~7mmol nitrate) (Beet It, James White Drinks Ltd, Ipswich, UK).'}], 'periods': [{'title': 'First Intervention (First Shot)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Wash Out Period (4 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention (Second Shot)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'Includes groups randomized to receive beetroot shot first and placebo first.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37', 'spread': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Includes groups randomized to receive beetroot shot first and placebo first.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-20', 'studyFirstSubmitDate': '2013-02-18', 'resultsFirstSubmitDate': '2014-06-16', 'studyFirstSubmitQcDate': '2013-02-19', 'lastUpdatePostDateStruct': {'date': '2017-07-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-03-25', 'studyFirstPostDateStruct': {'date': '2013-02-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-04-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Complete a 10 km Run', 'timeFrame': 'Period 1 (on day of 1st intervention) and period 2 (on day of 2nd intervention)', 'description': 'Time taken following consumption of beetroot shot or consumption of placebo shot'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypoxia']}, 'descriptionModule': {'briefSummary': 'The study will aim to describe and evaluate the effect of beetroot juice supplementation upon whole body running exercise at altitude. It is hypothesised that beetroot supplementation will decrease time to complete a 10 km time trial.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Trained athletes with personal best performances for a 10km run of sub 40 minutes\n\nExclusion Criteria:\n\n\\- Unable to give informed consent Unstable medical condition.'}, 'identificationModule': {'nctId': 'NCT01795534', 'briefTitle': 'Beetroot Juice as a Potential Ergogenic Aid During Exercise in Hypoxia', 'organization': {'class': 'OTHER', 'fullName': 'Bangor University'}, 'officialTitle': 'Beetroot Juice as a Potential Ergogenic Aid During Exercise in Hypoxia', 'orgStudyIdInfo': {'id': 'Jan 13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Beetroot shot then placebo shot', 'description': 'Intervention: Participants will first consume a Beetroot shot: 1x70ml concentrated NO-3 shot of rich Beetroot juice (\\~7mmol nitrate) (Beet It, James White Drinks Ltd, Ipswich, UK).\n\nFollowing a four day wash out, participants will then consume a Nitrate-depleted beetroot shot: 1x70ml nitrate-depleted beetroot Placebo shot (\\~0.003mmol of nitrate)(Beet It, James White Drinks Ltd, Ipswich, UK)', 'interventionNames': ['Dietary Supplement: Beetroot shot then placebo shot']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo shot then beetroot shot', 'description': 'Intervention: Participants will first consume a Nitrate-depleted beetroot shot: 1x70ml nitrate-depleted beetroot Placebo shot (\\~0.003mmol of nitrate)(Beet It, James White Drinks Ltd, Ipswich, UK).\n\nFollowing a four day wash out, participants will then consume a Beetroot shot: 1x70ml concentrated NO-3 shot of rich Beetroot juice (\\~7mmol nitrate) (Beet It, James White Drinks Ltd, Ipswich, UK).', 'interventionNames': ['Dietary Supplement: Placebo shot then beetroot shot']}], 'interventions': [{'name': 'Beetroot shot then placebo shot', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Beetroot shot, four day wash out, then placebo shot', 'armGroupLabels': ['Beetroot shot then placebo shot']}, {'name': 'Placebo shot then beetroot shot', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo shot, four day wash out, then beetroot shot', 'armGroupLabels': ['Placebo shot then beetroot shot']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LL57 2PZ', 'city': 'Bangor', 'state': 'Gwynedd', 'country': 'United Kingdom', 'facility': 'Bangor University', 'geoPoint': {'lat': 54.66079, 'lon': -5.66802}}], 'overallOfficials': [{'name': 'Jamie H Macdonald, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bangor University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bangor University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}