Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2026-03-28 @ 2:31 PM
Study NCT ID:
NCT03022604
Status:
COMPLETED
Last Update Posted:
2017-01-24
First Post:
2017-01-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of a Pre-Workout Supplement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-20', 'studyFirstSubmitDate': '2017-01-12', 'studyFirstSubmitQcDate': '2017-01-12', 'lastUpdatePostDateStruct': {'date': '2017-01-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effects of a Pre-Workout Dietary Supplement on the Stroop Color and Word Test', 'timeFrame': 'Seven Days'}, {'measure': 'Effects of a Pre-Workout Dietary Supplement on the Word Recall Test', 'timeFrame': 'Seven Days'}, {'measure': 'Effects of a Pre-Workout Dietary Supplement on VAS Readiness to Perform', 'timeFrame': 'Seven Days'}, {'measure': 'Effects of a Pre-Workout Dietary Supplement on anaerobic sprint capacity on a bicycle ergometer', 'timeFrame': 'Seven Days'}, {'measure': 'Effects of a Pre-Workout Dietary Supplement on bench press power output', 'timeFrame': 'Seven Days'}, {'measure': 'Effects of a Pre-Workout Dietary Supplement on leg press power output', 'timeFrame': 'Seven Days'}, {'measure': 'Effects of a Pre-Workout Dietary Supplement on total work on the bench press', 'timeFrame': 'Seven Days'}, {'measure': 'Effects of a Pre-Workout Dietary Supplement on total work on the leg press', 'timeFrame': 'Seven Days'}], 'secondaryOutcomes': [{'measure': 'Effects of a Pre-Workout Dietary Supplement on energy expenditure', 'timeFrame': 'Seven Days'}, {'measure': 'Effects of a Pre-Workout Dietary Supplement on heart rate', 'timeFrame': 'Seven Days'}, {'measure': 'Effects of a Pre-Workout Dietary Supplement on blood pressure', 'timeFrame': 'Seven Days'}, {'measure': "Effects of a Pre-Workout Dietary Supplement on ECG's", 'timeFrame': 'Seven Days'}, {'measure': 'Effects of a Pre-Workout Dietary Supplement on blood lab results', 'timeFrame': 'Seven Days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Exercise Ergogenics']}, 'descriptionModule': {'briefSummary': 'This study is assessing the effects of a pre-workout dietary supplement.', 'detailedDescription': 'The purpose of this study is to examine the acute effects of a pre-workout dietary supplement at a standard dose and one that is delivered at 150% of the standard dose on energy metabolism, cardiovascular hemodynamics, blood metabolites and mental focus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must be apparently healthy males and/or females between the ages of 18 and 40\n* Participants must have at least 6 months immediate prior history of resistance training including the bench press and leg press/squat\n\nExclusion Criteria:\n\n* Participants who have a history of treatment for metabolic disease (i.e., diabetes), hypertension, hypotension, thyroid disease, arrhythmias and/or cardiovascular disease\n* Participants who currently use any prescription medication\n* Participants who are intolerant to caffeine and/or other natural stimulants\n* Participants who are pregnant or lactating women\n* Participants who have a history of smoking\n* Participants who drink excessively (12 drinks per week)'}, 'identificationModule': {'nctId': 'NCT03022604', 'acronym': 'NB6', 'briefTitle': 'Assessment of a Pre-Workout Supplement', 'organization': {'class': 'OTHER', 'fullName': 'Texas A&M University'}, 'officialTitle': 'Pharmacokinetic, Hemodynamic and Ergogenic Assessment of a Pre-Workout Dietary Supplement', 'orgStudyIdInfo': {'id': 'IRB2014-0795F'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'C4/Generation 4', 'description': '12 grams of C4/Generation 4 Extreme', 'interventionNames': ['Dietary Supplement: C4/Generation 4']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'C450X', 'description': '12 grams of C4X (150% of regular dose)', 'interventionNames': ['Dietary Supplement: C450X']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '12 grams of flavored dextrose', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'C4/Generation 4', 'type': 'DIETARY_SUPPLEMENT', 'description': '12 grams of C4/Generation 4', 'armGroupLabels': ['C4/Generation 4']}, {'name': 'C450X', 'type': 'DIETARY_SUPPLEMENT', 'description': '12 grams of C450X', 'armGroupLabels': ['C450X']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '12 grams of flavored dextrose', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Richard B Kreider, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Texas A&M University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Texas A&M University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nutrabolt', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}