Aging
Conditions
Keywords
nicotinamide riboside, aging, arterial stiffness, endothelial dysfunction
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTNiagen™
nicotinamide riboside chloride, 250mg capsules
DIETARY_SUPPLEMENTPlacebo
silicified microcrystalline cellulose, vegetarian capsule
Sponsors
ChromaDex, Inc.
University of Colorado, Boulder
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
55 Years to 79 Years
Healthy volunteers
Yes
Inclusion criteria
* Ability to provide informed consent * Baseline brachial flow-mediated dilation (FMD) \< 6%Δ (rationale: non-invasive screening to ensure exclusion of subjects with exceptionally high baseline endothelial function. * Ability to perform motor and cognitive tests (e.g., can rise from a chair, walk for 2 min, climb 10 stairs) * Women will be confirmed as postmenopausal (either natural or surgical) based on cessation of menses for \>1 year.
Exclusion criteria
* ages \<55 years or ≥80 years * 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) * 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) * 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 * 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) * having past or present alcohol dependence or abuse, as defined by the American Psychiatry Association, Diagnostic and Statistical Manual of Mental Disorders * abnormal blood chemistries for renal and liver function (\>1 standard deviation outside the normal range) * Moderate or severe peripheral artery disease (ankle-brachial index \<0.7). * 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment emergent adverse events | 6 weeks | self reported side effects, vital signs, hematology, liver enzymes, markers of kidney function and blood chemistry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endothelium Dependent Dilation | 6 weeks | Brachial Artery Flow-Mediated Dilation (FMD) |
| Arterial Stiffness | 6 weeks | Aortic Pulse Wave Velocity (PWV) |
| Cognitive Function | 6 weeks | NIH Toolbox Cognitive Function Battery |
| Motor Function | 6 weeks | NIH Toolbox Motor Function Battery |
| Systemic markers of oxidative stress and inflammation | 6 weeks | Assessment of plasma C-reactive protein (CRP) and circulating and mononuclear cell-derived cytokine and antioxidant expression. |
Countries
United States
Outcome results
None listed