Ignite Creation Date:
2025-12-24 @ 11:58 AM
Ignite Modification Date:
2026-01-06 @ 7:19 PM
Study NCT ID:
NCT01710761
Status:
UNKNOWN
Last Update Posted:
2013-01-23
First Post:
2012-10-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Neo40(TM) With Caffeine on Cycling Time Trial Performance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2013-09-17', 'releaseDate': '2013-07-05'}], 'estimatedResultsFirstSubmitDate': '2013-07-05'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D002110', 'term': 'Caffeine'}], 'ancestors': [{'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2013-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-01-22', 'studyFirstSubmitDate': '2012-10-17', 'studyFirstSubmitQcDate': '2012-10-17', 'lastUpdatePostDateStruct': {'date': '2013-01-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improved Time Trial Performance', 'timeFrame': 'After 20 min steady-state cycling', 'description': 'Participants will cycle 20 min at increasing intensity: 8 min at 55% VO2max, 6 min at 65% VO2max, 6 min at 75% VO2max. The 20 km time trial consists of rolling hills.'}], 'secondaryOutcomes': [{'measure': 'Improved work efficiency', 'timeFrame': 'During 20 min steady-state cycling', 'description': 'Expired gases will be collected and compared to expected VO2. Blood will be collected prior to treatment, prior to exercise and during each cycling intensity to analyze lactate accumulation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['nitric oxide', 'cycling performance', 'lactate', 'VO2'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Acute supplementation of Neo40(TM), a nitrate lozenge, will improve cycling performance'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Regular commuter cyclist or spin class participant\n* Male (VO2max \\< 50) or Female (VO2max \\< 45)\n* Healthy\n* Blood pressure below 140/90\n* Non-smoker\n\nExclusion Criteria:\n\n* Does not cycle 2-3 times/week\n* Regular consumption of performance-enhancing substances\n* Type I or Type II diabetes\n* Renal, hepatic or cardiac disease\n* Current infectious disease'}, 'identificationModule': {'nctId': 'NCT01710761', 'briefTitle': 'Effects of Neo40(TM) With Caffeine on Cycling Time Trial Performance', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas at Austin'}, 'officialTitle': 'Effects of Neo40(TM) With Caffeine on Cycling Time Trial Performance', 'orgStudyIdInfo': {'id': '2012-05-0033'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Nitrate supplement with caffeine', 'interventionNames': ['Dietary Supplement: Nitrate supplement with caffeine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Same form factor and flavor as test lozenge but contains no active ingredients', 'armGroupLabels': ['Placebo']}, {'name': 'Nitrate supplement with caffeine', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Lozenge consisting of beetroot and 75 mg caffeine', 'armGroupLabels': ['Nitrate supplement with caffeine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78712', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas at Austin', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Lynne Kammer-Kerwick, MSE, MA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas at Austin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas at Austin', 'class': 'OTHER'}, 'collaborators': [{'name': 'Neogenis Laboratories', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2013-07-05', 'type': 'RELEASE'}, {'date': '2013-09-17', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Lynne Kammer, , University of Texas at Austin'}}}}