A Study Investigating the Effects of Niagen™ in Healthy Adults. (15NRHC)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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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.
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Ages Eligible for Study:
40 Years to 60 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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:
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)
Non-hormonal intrauterine devices
Vasectomy of partner
Healthy as determined by laboratory results, medical history, and physical exam
Agrees to comply with study procedure
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).
Agrees to refrain from consuming caffeine (i.e. coffee) on the days of study visits 3 to 7 (prior to the visit)
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
Has given voluntary, written, informed consent to participate in the study
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
Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
Alcohol use >2 standard alcoholic drinks per day
History of alcohol or drug abuse within the past year
Medicinal use of marijuana
Diabetes (Type I or Type II)
Subjects taking lipid lowering drugs
History of renal and/or liver disease
History of pellagra or niacin deficiency
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
Subjects with or who had recently experienced a traumatic injury, inflammation, infections or had undergone surgery
Use of natural health products containing NR within 14 days prior to randomization and during the course of the study
Unstable medical conditions as determined by the Qualified Investigator
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
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
Participation in a clinical research trial within 30 days prior to randomization
Allergy or sensitivity to study supplement ingredients
Allergy or sensitivity to lidocaine
Serum creatinine ≥ 130µmol/L for males and ≥ 125µmol/L for female
Individuals who are cognitively impaired and/or who are unable to give informed consent
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