Safety & Efficacy of Nicotinamide Riboside Supplementation for Improving Physiological Function in Middle-Aged and Older Adults
- Conditions
- Aging
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: Niagen™
- Registration Number
- NCT02921659
- Lead Sponsor
- University of Colorado, Boulder
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Placebo placebo, 500 mg, 2x/day for 6 weeks Niagen™ Niagen™ Niagen™ (nicotinamide riboside chloride, ChromaDex, Inc.) 500mg, 2x/day for 6 weeks.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Endothelium Dependent Dilation 6 weeks Brachial Artery Flow-Mediated Dilation (FMD)
Cognitive Function 6 weeks NIH Toolbox Cognitive Function Battery
Arterial Stiffness 6 weeks Aortic Pulse Wave Velocity (PWV)
Trial Locations
- Locations (1)
Clinical Translational Research Center
🇺🇸Boulder, Colorado, United States