Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-26 @ 1:41 AM
Study NCT ID:
NCT03501433
Status:
COMPLETED
Last Update Posted:
2020-09-25
First Post:
2018-04-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Nicotinamide Riboside on Metabolism and Vascular Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}], 'ancestors': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C018613', 'term': 'nicotinamide-beta-riboside'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'I single investigator will be responsible for blinding. All researchers involved in collection and evaluation of data will remain blinded to treatments.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized, cross-over'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-23', 'studyFirstSubmitDate': '2018-04-10', 'studyFirstSubmitQcDate': '2018-04-10', 'lastUpdatePostDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NAD+', 'timeFrame': '7 days', 'description': 'Blood and peripheral blood mononuclear cell (PBMC) levels'}], 'secondaryOutcomes': [{'measure': 'Vasodilatory responsiveness', 'timeFrame': '7 days', 'description': 'Post-Occlusion Reactive Hyperemia (PORH)'}, {'measure': 'Lipdemia', 'timeFrame': '7 days', 'description': 'Fasting and postprandial'}, {'measure': 'Oxidative stress and inflammation', 'timeFrame': '7 days', 'description': 'Plasma markers and expression in circulating PBMCs'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['postpandial', 'lipemia', 'microvascular'], 'conditions': ['Aging', 'Lipemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effects of Nicotinamide Riboside (NR) supplementation on metabolism and vascular function following high-fat meal. Differences between young (18-35) and older (60-75) adults will be determined.', 'detailedDescription': 'The purpose of this study is to determine the effects of 7 days of Nicotinamide Riboside (NR) or placebo supplementation on metabolism and vascular function following high-fat meal. Differences between young (18-35) and older (60-75) adults will be determined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 to 35 (young) and 60 to 75 (older)\n* Normo- or pre-hypertensive (blood pressure \\<140/90 mmHg)\n* Non-smokers\n* Able to give informed consent and participate in all laboratory visits\n\nExclusion Criteria:\n\n* Currently taking any medications that could interfere with cardiovascular or metabolic outcomes will be excluded from the study (e.g., beta-blockers)\n* Known metabolic (e.g. Type I or Type II diabetes, cardiovascular disease, etc.) or immunologic (e.g. HIV, cancer, autoimmune, etc.) diseases\n* Food allergies to egg, milk, soy or wheat\n* Women who are pregnant or planning to become pregnant during the course of the study,\n* Pacemaker or other implanted device\n* Unwilling to participate in the experimental protocol or blood draws will be excluded'}, 'identificationModule': {'nctId': 'NCT03501433', 'briefTitle': 'Effects of Nicotinamide Riboside on Metabolism and Vascular Function', 'organization': {'class': 'OTHER', 'fullName': 'Iowa State University'}, 'officialTitle': 'Effects of Nicotinamide Riboside on Metabolism and Vascular Function', 'orgStudyIdInfo': {'id': '17-603'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nicotinamide Riboside Chloride (Niagen)', 'description': '7 days of nicotinamide riboside supplementation (250 mg/d x 2/day).', 'interventionNames': ['Dietary Supplement: Nicotinamide riboside chloride (Niagen)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '7 days of placebo supplementation (2/day)', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Nicotinamide riboside chloride (Niagen)', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Nicotinamide Riboside, Niagen'], 'description': '250 mg capsules 2x/day for 7 days', 'armGroupLabels': ['Nicotinamide Riboside Chloride (Niagen)']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '2x/day for 7 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50011', 'city': 'Ames', 'state': 'Iowa', 'country': 'United States', 'facility': 'Iowa State University', 'geoPoint': {'lat': 42.03471, 'lon': -93.61994}}], 'overallOfficials': [{'name': 'Rudy Valentine, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Iowa State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Iowa State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Rudy Valentine', 'investigatorAffiliation': 'Iowa State University'}}}}