Bioavailability
Conditions
Keywords
Healthy participants, Dietary supplement, Bioavailability, Niagen™, Nicotinamide riboside, N-methylnicotinamide
Brief summary
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.
Interventions
OTHERPlacebo
DIETARY_SUPPLEMENTNiagen™ 100
DIETARY_SUPPLEMENTNiagen™ 300
DIETARY_SUPPLEMENTNiagen™ 1000
Sponsors
ChromaDex, Inc.
KGK Science Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI 25-30kg/m² * 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) * Double-barrier method * 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
Exclusion criteria
* 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 * Bleeding disorder * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urinary Methylnicotinamide | 8 weeks: from baseline to end of study | Change in levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Nicotinamide Riboside Metabolites | 8 weeks: from baseline to end of study | Change in levels |
| Urinary Nicotinamide Riboside Metabolites | 8 weeks: from baseline to end of study | Change in levels |
| Muscle Nicotinamide Riboside Metabolites | 8 weeks: from baseline to end of study | Change in Levels of Metabolites Assessed from Muscle Tissue collected with Micro-Needle Biopsy |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Abnormal Laboratory Values | 8 weeks: baseline to end of study | Assessment of hematology and clinical chemistry parameters: CBC, electrolytes (Na, K, CL), AST, ALT, GGT, BUN, HDL, LDL, triglycerides and total cholesterol |
| Resting Metabolic Rate | 8 weeks: from baseline to end of study | Change in Levels (kcal/day) Assessed by the ReeVue Indirect Calorimeter |
| Incidence of Adverse Events | 8 weeks: baseline to end of study | Review of adverse events |
| Expression profile: Branched Amino Acids | 8 weeks: from baseline to end of study | — |
| Expression profile: high sensitivity C-reactive protein | 8 weeks: from baseline to end of study | — |
| Incidence of Abnormal Vital Signs | 8 weeks: from baseline to end of study | Resting blood pressure |
Countries
Canada
Outcome results
None listed