Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-05 @ 1:44 PM
Study NCT ID:
NCT02134756
Status:
COMPLETED
Last Update Posted:
2020-12-07
First Post:
2014-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Impact of Nutritional Supplementation on Aerobic Performance and Fatigue
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mkilpatrick@usf.edu', 'phone': '(813) 362-6696', 'title': 'Marcus Kilpatrick', 'organization': 'University of South Florida'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'NutraStem Active', 'description': 'Daily supplementation with NutraStem Active; 2 capsules per day for 28 days', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Daily supplementation with placebo; 2 capsules per day for 28 days', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Perceived Exertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NutraStem Active', 'description': 'Daily supplementation with NutraStem Active; 2 capsules per day for 28 days\n\nNutraStem Active'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Daily supplementation with placebo; 2 capsules per day for 28 days\n\nNutraStem Active'}], 'classes': [{'categories': [{'measurements': [{'value': '6.7', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '7.4', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': 'Ratings of perceived exertion (RPE) as measured on a self-report scale. The scale is a single-item measure ranging from 0 (no exertion) to 10 (max exertion).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Perceived Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NutraStem Active', 'description': 'Daily supplementation with NutraStem Active; 2 capsules per day for 28 days\n\nNutraStem Active'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Daily supplementation with placebo; 2 capsules per day for 28 days\n\nNutraStem Active'}], 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': 'Ratings of perceived fatigue as measured on a self-report scale. The scale is a single-item measure ranging from 1 (not at all) to 5 (extremely).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Perceived Energy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NutraStem Active', 'description': 'Daily supplementation with NutraStem Active; 2 capsules per day for 28 days\n\nNutraStem Active'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Daily supplementation with placebo; 2 capsules per day for 28 days\n\nNutraStem Active'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': 'Ratings of perceived energy as measured on a self-report scale. The scale is a single-item measure ranging from 1 (not at all) to 5 (extremely).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NutraStem Active', 'description': '2 capsules per day for 28 days'}, {'id': 'FG001', 'title': 'Placebo', 'description': '2 capsules per day for 28 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'NutraStem Active', 'description': 'Daily supplementation with NutraStem Active; 2 capsules per day for 28 days\n\nNutraStem Active'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Daily supplementation with placebo; 2 capsules per day for 28 days\n\nNutraStem Active'}, {'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': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', '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': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '23', 'spread': '6', 'groupId': 'BG000'}, {'value': '26', 'spread': '7', 'groupId': 'BG001'}, {'value': '25', 'spread': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Perceived Exertion', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Perceived Exertion', 'classes': [{'categories': [{'measurements': [{'value': '7.5', 'spread': '1.7', 'groupId': 'BG000'}, {'value': '7.5', 'spread': '1.8', 'groupId': 'BG001'}, {'value': '7.5', 'spread': '1.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-12', 'studyFirstSubmitDate': '2014-04-11', 'resultsFirstSubmitDate': '2019-07-16', 'studyFirstSubmitQcDate': '2014-05-08', 'lastUpdatePostDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-12', 'studyFirstPostDateStruct': {'date': '2014-05-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perceived Exertion', 'timeFrame': '28 days', 'description': 'Ratings of perceived exertion (RPE) as measured on a self-report scale. The scale is a single-item measure ranging from 0 (no exertion) to 10 (max exertion).'}], 'secondaryOutcomes': [{'measure': 'Perceived Fatigue', 'timeFrame': '28 days', 'description': 'Ratings of perceived fatigue as measured on a self-report scale. The scale is a single-item measure ranging from 1 (not at all) to 5 (extremely).'}, {'measure': 'Perceived Energy', 'timeFrame': '28 days', 'description': 'Ratings of perceived energy as measured on a self-report scale. The scale is a single-item measure ranging from 1 (not at all) to 5 (extremely).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Supplement impact', 'Performance', 'Fatigue'], 'conditions': ['Performance', 'Fatigue']}, 'descriptionModule': {'briefSummary': 'Compare an over-the-counter dietary supplement (NutraStem Active®) and placebo over a 30-day intervention on aerobic exercise performance and fatigue.\n\nThe hypothesis is that supplementation with NutraStem Active® improve aerobic performance and reduce subjective measures of fatigue.', 'detailedDescription': 'Compare an over-the-counter dietary supplement (NutraStem Active®) and placebo over a 30-day intervention on aerobic exercise performance and fatigue.\n\nThe hypothesis is that supplementation with NutraStem Active® improve aerobic performance and reduce subjective measures of fatigue.\n\nThe basic protocol includes baseline assessment of fitness and participation in a vigorous session of exercise immediately before and 30 days after consumption of the experimental supplement or placebo.\n\nThe exercise task is intended to be fatiguing and demanding but is not expected to create failure.\n\nThe supplement makes claims related to boosting exercise performance and reducing fatigue.\n\nThe study design will determine if these outcomes are in fact present in a group of healthy, young, and active adults.\n\nThe primary dependent measures are perceived exertion during exercise and levels of fatigue measured on multiple non-exercise days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy\n* physically active\n* non-smoker\n\nExclusion Criteria:\n\n* known cardiovascular, pulmonary, or metabolic disease\n* body mass index greater than 35'}, 'identificationModule': {'nctId': 'NCT02134756', 'briefTitle': 'Impact of Nutritional Supplementation on Aerobic Performance and Fatigue', 'organization': {'class': 'OTHER', 'fullName': 'University of South Florida'}, 'officialTitle': 'Impact of Nutritional Supplementation on Aerobic Performance and Fatigue', 'orgStudyIdInfo': {'id': 'USF-NS.Active-2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NutraStem Active', 'description': 'Daily supplementation with NutraStem Active; 2 capsules per day for 28 days', 'interventionNames': ['Drug: NutraStem Active']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Daily supplementation with placebo; 2 capsules per day for 28 days', 'interventionNames': ['Drug: NutraStem Placebo']}], 'interventions': [{'name': 'NutraStem Active', 'type': 'DRUG', 'armGroupLabels': ['NutraStem Active']}, {'name': 'NutraStem Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33620', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Health and Exercise Science Laboratory', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'overallOfficials': [{'name': 'Marcus W Kilpatrick, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of South Florida'}, {'name': 'Danielle Williams', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of South Florida'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}