Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2026-02-20 @ 8:11 PM
Study NCT ID:
NCT02281851
Status:
COMPLETED
Last Update Posted:
2020-08-11
First Post:
2014-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Examining Endogenous Antioxidant Levels in Well Trained Cyclists
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'matthewsoden33@gmail.com', 'phone': '07800549318', 'title': 'Mathew Soden', 'organization': 'University of Birmingham'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'We underestimated the pool of cyclists who consumed antioxidants (\\>6 months) and would be willing to undertake a muscle core biopsy. In addition, the vitamin supplements consumed by the participants varied in concentration, compound and variety.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Supplemented', 'description': 'The group consists of well-trained cyclists who habitually consume vitamin/antioxidant supplements for a period longer than 6 months', 'otherNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Non-Supplemented', 'description': 'The group consists of well-trained cyclists who do not consume vitamin/antioxidant supplements', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Difference in Resting Levels of Endogenous Antioxidant Proteins in Skeletal Muscle - Superoxide Dismutase 2 (SOD-2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Supplemented', 'description': 'The group consists of well-trained cyclists who habitually consume vitamin/antioxidant supplements for a period longer than 6 months'}, {'id': 'OG001', 'title': 'Non-Supplemented', 'description': 'The group consists of well-trained cyclists who do not consume vitamin/antioxidant supplements'}], 'classes': [{'categories': [{'measurements': [{'value': '0.42', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.68', 'spread': '0.32', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Protein concentrations will be measured at baseline only', 'description': 'To examine the effects of habitual vitamin and antioxidant supplementation on endogenous antioxidant production, participants will have a muscle biopsy taken at rest to examine any differences in endogenous antioxidant protein concentrations', 'unitOfMeasure': 'Arbitrary Units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Supplemented', 'description': 'The group consists of well-trained cyclists who habitually consume vitamin/antioxidant supplements for a period longer than 6 months'}, {'id': 'FG001', 'title': 'Non-supplemented', 'description': 'The group consists of well-trained cyclists who do not consume vitamin/antioxidant supplements'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Supplemented', 'description': 'The group consists of well-trained cyclists who habitually consume vitamin/antioxidant supplements for a period longer than 6 months'}, {'id': 'BG001', 'title': 'Non-Supplemented', 'description': 'The group consists of well-trained cyclists who do not consume vitamin/antioxidant supplements'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-07', 'studyFirstSubmitDate': '2014-10-16', 'resultsFirstSubmitDate': '2020-01-15', 'studyFirstSubmitQcDate': '2014-10-30', 'lastUpdatePostDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-02', 'studyFirstPostDateStruct': {'date': '2014-11-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in Resting Levels of Endogenous Antioxidant Proteins in Skeletal Muscle - Superoxide Dismutase 2 (SOD-2)', 'timeFrame': 'Protein concentrations will be measured at baseline only', 'description': 'To examine the effects of habitual vitamin and antioxidant supplementation on endogenous antioxidant production, participants will have a muscle biopsy taken at rest to examine any differences in endogenous antioxidant protein concentrations'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Endogenous antioxidants', 'Antioxidant supplements', 'Vitamin Supplements', 'Exercise adaptations', 'Oxidative stress', 'Redox regulation', 'Cycling - exercise'], 'conditions': ['Oxidative Stress']}, 'descriptionModule': {'briefSummary': 'This study will investigate whether increased habitual intake of antioxidant supplements effects the concentration of endogenous antioxidants, the response of antioxidants to exercise, and differences in oxidative damage compared to a non-supplemented group.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cyclist from the local West Midlands (United Kingdom) area will be invited to take part in the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male,\n* BMI 18.8 29.9 kg/m2\n* cycle 3-7 times a week for durations longer than 60 minutes\n* cycled for a minimum of 3 years\n* accustomed to exhaustive cycling protocols\n* healthy (no known cardiovascular or metabolic disease)\n\nExclusion Criteria:\n\n* answering "NO" to any question on the general health questionnaire would result in exclusion from the study\n* current participation in another clinical study\n* current or recent smoker (last 30 days)\n* prescription or non-prescription of anti-inflammatory use \\>30 days prior to the experiment commencing or any other medications that in the opinion of the investigator may interfere with redox signalling'}, 'identificationModule': {'nctId': 'NCT02281851', 'briefTitle': 'Examining Endogenous Antioxidant Levels in Well Trained Cyclists', 'organization': {'class': 'OTHER', 'fullName': 'University of Birmingham'}, 'officialTitle': 'The Effects of Habitual Antioxidant Supplementation on Endogenous Antioxidants and Oxidative Damage in Well Trained Cyclists', 'orgStudyIdInfo': {'id': '125663'}, 'secondaryIdInfos': [{'id': '13/WM/0226', 'type': 'OTHER', 'domain': 'NRES Committee West Midlands - Solihull'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Supplemented', 'description': 'The group consists of well-trained cyclists who habitually consume vitamin/antioxidant supplements for a period longer than 6 months'}, {'label': 'Non-supplemented', 'description': 'The group consists of well-trained cyclists who do not consume vitamin/antioxidant supplements'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B15 2TT', 'city': 'Birmingham', 'state': 'West Midlands', 'country': 'United Kingdom', 'facility': 'School of Sport Exercise and Rehabilitation Sciences, University of Birmingham', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}], 'overallOfficials': [{'name': 'Sarah Aldred, MSc PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}