Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2025-12-30 @ 1:40 PM
Study NCT ID:
NCT01141504
Status:
COMPLETED
Last Update Posted:
2012-01-10
First Post:
2010-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Oral Adenosine-triphosphate (ATP) on Human Muscle Performance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-09', 'studyFirstSubmitDate': '2010-06-09', 'studyFirstSubmitQcDate': '2010-06-09', 'lastUpdatePostDateStruct': {'date': '2012-01-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Work Performed', 'timeFrame': 'Measured after 15 days of intervention', 'description': 'The work and total work performed in 3 exercise fatigue tests given after 15 days of nutritional intervention.'}], 'secondaryOutcomes': [{'measure': 'Decrease in work performed in each successive test', 'timeFrame': 'Measured after 15 days of intervention', 'description': 'The decrease in total work performed in each of 3 successive fatigue tests will be measured and used as a measure of muscle fatigability after 15 days of nutritional intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Supplemental ATP', 'Muscle Work Performed', 'Muscle Fatigue'], 'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'Adenosine-triphosphate (ATP) serves as the sole energy source for muscle contraction. Therefore human performance of brief maximal exercise is limited, in part, by the availability of ATP to the contracting muscle. Because muscle ATP storage is small (enough to sustain maximal exercise for less than 1 second), factors that enhance either storage or resynthesis of ATP may have a positive impact on repeated muscle contractions. The current study will test the hypothesis that increasing ATP availability to muscle via oral supplementation will improve performance of repeated high intensity exercise as measured by a) work performed in each of the three 50 contraction fatigue tests, b) sum of total work performed, and c) percentage decrement in total work from the first to third third 50 contraction test.', 'detailedDescription': 'To date we have studied 10 subjects who have followed through with all 3 of the original interventions (Placebo, 250 mg PeakATP/d and 400 mg PeakATP/d). Currently we have received approval and are expanding the study with 5 additional subjects who will receive the Placebo, 400 mg PeakATP/d and the 400 mg PealATP/d plus proprietary blend interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No major medical conditions;\n* Able to perform fatigue testing procedures;\n* Not currently taking prescription medications;\n* Not currently taking dietary supplements (a daily multi-vitamin not exceeding RDA is permitted)\n\nExclusion Criteria:\n\n* Major medical condition affecting metabolism or general function;\n* Not able to perform fatigue testing;\n* Taking prescription medications;\n* Taking a dietary supplement other than a multi-vitamin not exceeding RDA'}, 'identificationModule': {'nctId': 'NCT01141504', 'briefTitle': 'Effect of Oral Adenosine-triphosphate (ATP) on Human Muscle Performance', 'organization': {'class': 'INDUSTRY', 'fullName': 'Metabolic Technologies Inc.'}, 'officialTitle': 'Effect of Oral ATP on Human Muscle Performance', 'orgStudyIdInfo': {'id': 'MTI2010-CS01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Oral placebo capsules similar in color and size to the intervention', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PeakATP 250', 'description': 'Oral supplement capsules containing 250 mg/day of PeakATP', 'interventionNames': ['Dietary Supplement: PeakATP 250']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PeakATP 400', 'description': 'Oral supplement capsules containing 400 mg/day of PeakATP', 'interventionNames': ['Dietary Supplement: PeakATP 400']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PeakATP 400 plus proprietary blend', 'description': 'Oral supplement capsules containing 400 mg/day of PeakATP plus a proprietary blend', 'interventionNames': ['Dietary Supplement: PeakATP 400 plus proprietary blend']}], 'interventions': [{'name': 'PeakATP 250', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The nutritional intervention provides for oral ingestion of 250 mg PeakATP per day', 'armGroupLabels': ['PeakATP 250']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo capsules that are comparable in size and color to the active comparator for blinding purposes', 'armGroupLabels': ['Placebo']}, {'name': 'PeakATP 400', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The nutritional intervention provides for oral ingestion of 400 mg PeakATP per day', 'armGroupLabels': ['PeakATP 400']}, {'name': 'PeakATP 400 plus proprietary blend', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The nutritional intervention provides for oral ingestion of 400 mg PeakATP per day plus a proprietary blend of additional nutrients', 'armGroupLabels': ['PeakATP 400 plus proprietary blend']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50010', 'city': 'Ames', 'state': 'Iowa', 'country': 'United States', 'facility': 'Iowa State University', 'geoPoint': {'lat': 42.03471, 'lon': -93.61994}}], 'overallOfficials': [{'name': 'John A Rathmacher, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Metabolic Technologies Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Metabolic Technologies Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Iowa State University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}