Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2025-12-24 @ 3:00 PM
Study NCT ID:
NCT02921659
Status:
COMPLETED
Last Update Posted:
2016-12-01
First Post:
2016-09-29
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety & Efficacy of Nicotinamide Riboside Supplementation for Improving Physiological Function in Middle-Aged and Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C018613', 'term': 'nicotinamide-beta-riboside'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-29', 'studyFirstSubmitDate': '2016-09-29', 'studyFirstSubmitQcDate': '2016-09-30', 'lastUpdatePostDateStruct': {'date': '2016-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of treatment emergent adverse events', 'timeFrame': '6 weeks', 'description': 'self reported side effects, vital signs, hematology, liver enzymes, markers of kidney function and blood chemistry'}], 'secondaryOutcomes': [{'measure': 'Endothelium Dependent Dilation', 'timeFrame': '6 weeks', 'description': 'Brachial Artery Flow-Mediated Dilation (FMD)'}, {'measure': 'Arterial Stiffness', 'timeFrame': '6 weeks', 'description': 'Aortic Pulse Wave Velocity (PWV)'}, {'measure': 'Cognitive Function', 'timeFrame': '6 weeks', 'description': 'NIH Toolbox Cognitive Function Battery'}, {'measure': 'Motor Function', 'timeFrame': '6 weeks', 'description': 'NIH Toolbox Motor Function Battery'}, {'measure': 'Systemic markers of oxidative stress and inflammation', 'timeFrame': '6 weeks', 'description': 'Assessment of plasma C-reactive protein (CRP) and circulating and mononuclear cell-derived cytokine and antioxidant expression.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['nicotinamide riboside', 'aging', 'arterial stiffness', 'endothelial dysfunction'], 'conditions': ['Aging']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.colorado.edu/intphys/research/cardiovascular.html', 'label': 'Description of Research Laboratory'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy of supplementation with the Nicotinamide Adenine Dinucleotide (NAD+) precursor compound, Nicotinamide Riboside (NR), for improving physiological function (vascular, motor, and cognitive) in healthy middle-aged and older adults.', 'detailedDescription': 'Overall, the proposed research project has the long-term potential to influence clinical practice by establishing novel therapies for treating multiple domains of age-associated physiological dysfunction and thereby reducing the risk of clinical disease and disability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Ability to provide informed consent\n* Baseline brachial flow-mediated dilation (FMD) \\< 6%Δ (rationale: non-invasive screening to ensure exclusion of subjects with exceptionally high baseline endothelial function.\n* Ability to perform motor and cognitive tests (e.g., can rise from a chair, walk for 2 min, climb 10 stairs)\n* Women will be confirmed as postmenopausal (either natural or surgical) based on cessation of menses for \\>1 year.\n\nExclusion Criteria:\n\n* ages \\<55 years or ≥80 years\n* body mass index (BMI) \\>40 kg/m2 (rationale: vascular function and blood pressure measurements can be inaccurate in severely obese subjects and these subjects may differ in many ways from normal weight, overweight or less obese subjects)\n* not weight stable in the prior 3 months (\\>2 kg weight change) or unwilling to remain weight stable throughout study (rationale: recent weight change or weight loss can influence vascular function)\n* having unstable angina, acute myocardial infarction, coronary angioplasty, or aorto-coronary bypass surgery as defined by the occurrence of an event, symptom, surgery, or change in medication and/or dosage within 3 months prior to enrollment\n* having thyroid disease that is not controlled by medications or \\<3 month's use of a particular medication and/or dosage (rationale: uncontrolled thyroid diseases are associated with alterations in vascular function)\n* having past or present alcohol dependence or abuse, as defined by the American Psychiatry Association, Diagnostic and Statistical Manual of Mental Disorders\n* abnormal blood chemistries for renal and liver function (\\>1 standard deviation outside the normal range)\n* Moderate or severe peripheral artery disease (ankle-brachial index \\<0.7).\n* Insufficient health to participate in a VO2max test based on a physical examination and/or graded exercise test (this will be determined in accordance with stated contraindications for exercise testing provided by the American Heart Association)."}, 'identificationModule': {'nctId': 'NCT02921659', 'briefTitle': 'Safety & Efficacy of Nicotinamide Riboside Supplementation for Improving Physiological Function in Middle-Aged and Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Boulder'}, 'officialTitle': 'Safety & Efficacy of Nicotinamide Riboside Supplementation for Improving Physiological Function in Middle-Aged and Older Adults', 'orgStudyIdInfo': {'id': '14-0475'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'placebo, 500 mg, 2x/day for 6 weeks', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Niagen™', 'description': 'Niagen™ (nicotinamide riboside chloride, ChromaDex, Inc.) 500mg, 2x/day for 6 weeks.', 'interventionNames': ['Dietary Supplement: Niagen™']}], 'interventions': [{'name': 'Niagen™', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Nicotinamide Riboside'], 'description': 'nicotinamide riboside chloride, 250mg capsules', 'armGroupLabels': ['Niagen™']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'silicified microcrystalline cellulose, vegetarian capsule', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80309', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'Clinical Translational Research Center', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}], 'overallOfficials': [{'name': 'Christopher R Martens, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Boulder'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Boulder', 'class': 'OTHER'}, 'collaborators': [{'name': 'ChromaDex, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}