Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-02-25 @ 7:23 PM
Study NCT ID:
NCT02712593
Status:
COMPLETED
Last Update Posted:
2018-04-11
First Post:
2016-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Investigating the Effects of Niagen™ in Healthy Adults.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-10', 'studyFirstSubmitDate': '2016-03-01', 'studyFirstSubmitQcDate': '2016-03-14', 'lastUpdatePostDateStruct': {'date': '2018-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Resting Metabolic Rate', 'timeFrame': '8 weeks: from baseline to end of study', 'description': 'Change in Levels (kcal/day) Assessed by the ReeVue Indirect Calorimeter'}, {'measure': 'Expression profile: Branched Amino Acids', 'timeFrame': '8 weeks: from baseline to end of study'}, {'measure': 'Expression profile: high sensitivity C-reactive protein', 'timeFrame': '8 weeks: from baseline to end of study'}, {'measure': 'Incidence of Abnormal Vital Signs', 'timeFrame': '8 weeks: from baseline to end of study', 'description': 'Resting blood pressure'}, {'measure': 'Incidence of Abnormal Laboratory Values', 'timeFrame': '8 weeks: baseline to end of study', 'description': 'Assessment of hematology and clinical chemistry parameters: CBC, electrolytes (Na, K, CL), AST, ALT, GGT, BUN, HDL, LDL, triglycerides and total cholesterol'}, {'measure': 'Incidence of Adverse Events', 'timeFrame': '8 weeks: baseline to end of study', 'description': 'Review of adverse events'}], 'primaryOutcomes': [{'measure': 'Urinary Methylnicotinamide', 'timeFrame': '8 weeks: from baseline to end of study', 'description': 'Change in levels'}], 'secondaryOutcomes': [{'measure': 'Blood Nicotinamide Riboside Metabolites', 'timeFrame': '8 weeks: from baseline to end of study', 'description': 'Change in levels'}, {'measure': 'Urinary Nicotinamide Riboside Metabolites', 'timeFrame': '8 weeks: from baseline to end of study', 'description': 'Change in levels'}, {'measure': 'Muscle Nicotinamide Riboside Metabolites', 'timeFrame': '8 weeks: from baseline to end of study', 'description': 'Change in Levels of Metabolites Assessed from Muscle Tissue collected with Micro-Needle Biopsy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Healthy participants', 'Dietary supplement', 'Bioavailability', 'Niagen™', 'Nicotinamide riboside', 'N-methylnicotinamide'], 'conditions': ['Bioavailability']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the effect of repeated doses of Niagen™ on Niagen™ metabolite concentrations in blood, urine and muscle. There will be 3 doses of Niagen™ compared to a placebo. One quarter of subjects will receive the low dose of Niagen™, one quarter will receive the moderate dose of Niagen™, one quarter will receive the higher dose of Niagen™ and one quarter will reveive the placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* BMI 25-30kg/m²\n* If female, subject is not of child bearing potential, which is defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with \\> 1 year since last menstruation) OR Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include:\n\n * Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)\n * Double-barrier method\n * Non-hormonal intrauterine devices\n * Vasectomy of partner\n* Healthy as determined by laboratory results, medical history, and physical exam\n* Agrees to comply with study procedure\n* Agrees to maintain current level of physical activity throughout the study and avoid exercising on the day of study visits 3 to 7 (prior to the visit).\n* Agrees to refrain from consuming caffeine (i.e. coffee) on the days of study visits 3 to 7 (prior to the visit)\n* Agrees to avoid taking Vitamin B3 (niacin, nicotinic acid,niacinamide) supplements or multivitamins 14 days prior to randomization and for the duration of the study period\n* Has given voluntary, written, informed consent to participate in the study\n* Agrees to avoid foods that contain high amounts of tryptophan and niacin and limit their ingestion of foods containing moderate amounts of tryptophan and niacin\n\nExclusion Criteria:\n\n* Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial\n* Alcohol use \\>2 standard alcoholic drinks per day\n* History of alcohol or drug abuse within the past year\n* Medicinal use of marijuana\n* Diabetes (Type I or Type II)\n* Subjects taking lipid lowering drugs\n* History of renal and/or liver disease\n* History of pellagra or niacin deficiency\n* Significant or untreated medical disorders including recent myocardial ischemia or infarction, unstable angina, uncontrolled hypertension, AIDS, malignancy, and neurological disorders including epilepsy, and recent cerebrovascular disease\n* Subjects with or who had recently experienced a traumatic injury, inflammation, infections or had undergone surgery\n* Use of natural health products containing NR within 14 days prior to randomization and during the course of the study\n* Unstable medical conditions as determined by the Qualified Investigator\n* Clinically significant abnormal lab results at screening (e.g. AST and/or ALT \\> 2 x ULN, and/or bilirubin \\> 2 x ULN) will be assessed by the Medical Investigator\n* History of or current diagnosis of any cancer (except for successfully treated basal cell carcinoma) diagnosed less than 5 years prior to screening. Subjects with cancer in full remission more than 5 years after diagnosis are acceptable\n* Participation in a clinical research trial within 30 days prior to randomization\n* Allergy or sensitivity to study supplement ingredients\n* Allergy or sensitivity to lidocaine\n* Bleeding disorder\n* Serum creatinine ≥ 130µmol/L for males and ≥ 125µmol/L for female\n* Individuals who are cognitively impaired and/or who are unable to give informed consent\n* Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or which may pose significant risk to the subjects"}, 'identificationModule': {'nctId': 'NCT02712593', 'acronym': '15NRHC', 'briefTitle': 'A Study Investigating the Effects of Niagen™ in Healthy Adults.', 'organization': {'class': 'INDUSTRY', 'fullName': 'KGK Science Inc.'}, 'officialTitle': 'A Randomized, Double-blind, Placebo Controlled Parallel Study Investigating the Effects of Niagen™ (Nicotinamide Riboside) on Niagen™ Metabolites in Healthy Adults.', 'orgStudyIdInfo': {'id': '15NRHC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Niagen™ 100', 'interventionNames': ['Dietary Supplement: Niagen™ 100']}, {'type': 'EXPERIMENTAL', 'label': 'Niagen™ 300', 'interventionNames': ['Dietary Supplement: Niagen™ 300']}, {'type': 'EXPERIMENTAL', 'label': 'Niagen™ 1000', 'interventionNames': ['Dietary Supplement: Niagen™ 1000']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Niagen™ 100', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Niagen™ 100']}, {'name': 'Niagen™ 300', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Niagen™ 300']}, {'name': 'Niagen™ 1000', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Niagen™ 1000']}, {'name': 'Placebo', 'type': 'OTHER', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A 5R8', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'KGK Synergize Inc.', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'Gordon Schacter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KGK Science Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KGK Science Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'ChromaDex, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}