Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-01-01 @ 12:19 PM
Study NCT ID:
NCT04050358
Status:
WITHDRAWN
Last Update Posted:
2023-02-15
First Post:
2019-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Basis™ and High Intensity Interval Training (HIIT) on Muscle Metabolism and Exercise Performance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Lack of Funds', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-13', 'studyFirstSubmitDate': '2019-08-06', 'studyFirstSubmitQcDate': '2019-08-06', 'lastUpdatePostDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mitochondrial function', 'timeFrame': '3 weeks', 'description': 'Measured via high-resolution respirometry using the Oroboros Oxygraph'}], 'secondaryOutcomes': [{'measure': 'Exercise Capacity', 'timeFrame': '3 weeks', 'description': 'To measure maximal endurance capacity measured via VO2max'}, {'measure': 'Muscle strength', 'timeFrame': '3 weeks', 'description': 'To measure maximal voluntary contraction using a force transducer strength chair'}, {'measure': 'Muscle power', 'timeFrame': '3 weeks', 'description': 'Determine the effects of HIIT with and without NRPT supplementation on muscle power producing capabilities measured by the 30 second Wingate test'}, {'measure': 'Mitochondrial proteins', 'timeFrame': '3 weeks', 'description': 'To determine whether HIIT with NRPT supplementation improves mitochondrial function more so than HIIT alone, using Western blotting'}, {'measure': 'Body Mass', 'timeFrame': '3 weeks', 'description': 'To determine the effects of HIIT with and without NRPT supplementation on body composition by measuring body mass using a bioelectrical impedance analysis scale'}, {'measure': 'Percent Body Fat', 'timeFrame': '3 weeks', 'description': 'To determine the effects of HIIT with and without NRPT supplementation on body composition by measuring percent body fat using a bioelectrical impedance analysis scale'}, {'measure': 'Recovery via POMS', 'timeFrame': '3 weeks', 'description': 'To determine the effects of HIIT with and without NRPT supplementation on recovery via profile of mood states (POMS)'}, {'measure': 'Recovery via RESTQ', 'timeFrame': '3 weeks', 'description': 'To determine the effects of HIIT with and without NRPT supplementation on recovery via recovery stress (RESTQ) questionnaire'}, {'measure': 'Physical activity levels using FitBit', 'timeFrame': '3 weeks', 'description': "To characterize volunteer's habitual physical activity levels."}, {'measure': 'Height', 'timeFrame': '3 weeks', 'description': 'Measure height using a stadiometer, to characterize demographics of recruited volunteers the recruited volunteers'}, {'measure': 'Blood pressure', 'timeFrame': '3 weeks', 'description': 'Measure blood pressure using Dinamap Pro monitor to characterize demographics of recruited volunteers the recruited volunteers'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This is a single-center, randomized, placebo-controlled pilot study to evaluate the effects of high intensity interval training (HIIT) and daily administration of BasisTM for 3 weeks, in 18-35 year old males.\n\nThe study will consist of a screening visit, baseline visit, followed by treatment and HIIT phase (3 weeks) and a post-supplementation, follow-up visit (this will occur 48 h (or more) after the final HIIT session). Following the screening phase, subjects who meet entry criteria will be randomly assigned to 1 of 2 treatment groups: recommended dose of BasisTM (250 mg Nicotinamide Riboside and 50 mg Pterostilbene) per day or matching-placebo in a 1:1 ratio.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 35 year old males\n* Body mass index between 18.5-30 kg.m-2\n* Ability to give informed consent\n* Recreationally active (defined in the present study as exercising once a week or more).\n\nExclusion Criteria:\n\n* Those regularly conducting HIIT or highly trained in endurance events (e.g. triathlete)\n* Currently taking supplements known to affect metabolism (e.g. ibuprofen, stimulants, vitamins, NR)\n* Taking prescribed medication\n* Consuming a vegan diet\n* Consuming a high fat, low carbohydrate diet\n* Habitual consumption of protein and/or dairy supplements (e.g. whey protein)\n* Smokers'}, 'identificationModule': {'nctId': 'NCT04050358', 'briefTitle': 'Effect of Basis™ and High Intensity Interval Training (HIIT) on Muscle Metabolism and Exercise Performance', 'organization': {'class': 'INDUSTRY', 'fullName': 'Elysium Health'}, 'officialTitle': 'The Effect of Basis™ and High Intensity Interval Training (HIIT) on Muscle Metabolism and Exercise Performance in Healthy 18 - 35 Year Olds', 'orgStudyIdInfo': {'id': 'Basis-HIIT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1X dose of NRPT', 'interventionNames': ['Dietary Supplement: NRPT']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Dietary Supplement: Placebo oral capsule']}], 'interventions': [{'name': 'NRPT', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['BasisTM'], 'description': 'Subjects randomly assigned to the active group will receive Nicotinamide Riboside and Pterostilbene (each capsule contains 125 mg NR and 25 mg PT, total daily dose is 2 capsules) for 3 weeks', 'armGroupLabels': ['1X dose of NRPT']}, {'name': 'Placebo oral capsule', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Subjects randomly assigned to the Placebo group will receive placebo oral capsules for 3 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EX1 2LU', 'city': 'Exeter', 'country': 'United Kingdom', 'facility': 'University of Exeter', 'geoPoint': {'lat': 50.7236, 'lon': -3.52751}}], 'overallOfficials': [{'name': 'Timothy Etheridge, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Exeter'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elysium Health', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Exeter', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}