Safety & Efficacy of Nicotinamide Riboside Supplementation for Improving Physiological Function in Middle-Aged and Older Adults
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ClinicalTrials.gov Identifier: NCT02921659 |
Recruitment Status :
Completed
First Posted : October 3, 2016
Last Update Posted : December 1, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Aging | Dietary Supplement: Niagen™ Dietary Supplement: Placebo | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Safety & Efficacy of Nicotinamide Riboside Supplementation for Improving Physiological Function in Middle-Aged and Older Adults |
Study Start Date : | April 2015 |
Actual Primary Completion Date : | October 2016 |
Actual Study Completion Date : | October 2016 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
placebo, 500 mg, 2x/day for 6 weeks
|
Dietary Supplement: Placebo
silicified microcrystalline cellulose, vegetarian capsule |
Active Comparator: Niagen™
Niagen™ (nicotinamide riboside chloride, ChromaDex, Inc.) 500mg, 2x/day for 6 weeks.
|
Dietary Supplement: Niagen™
nicotinamide riboside chloride, 250mg capsules
Other Name: Nicotinamide Riboside |
- Incidence of treatment emergent adverse events [ Time Frame: 6 weeks ]self reported side effects, vital signs, hematology, liver enzymes, markers of kidney function and blood chemistry
- Endothelium Dependent Dilation [ Time Frame: 6 weeks ]Brachial Artery Flow-Mediated Dilation (FMD)
- Arterial Stiffness [ Time Frame: 6 weeks ]Aortic Pulse Wave Velocity (PWV)
- Cognitive Function [ Time Frame: 6 weeks ]NIH Toolbox Cognitive Function Battery
- Motor Function [ Time Frame: 6 weeks ]NIH Toolbox Motor Function Battery
- Systemic markers of oxidative stress and inflammation [ Time Frame: 6 weeks ]Assessment of plasma C-reactive protein (CRP) and circulating and mononuclear cell-derived cytokine and antioxidant expression.

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Ages Eligible for Study: | 55 Years to 79 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02921659
United States, Colorado | |
Clinical Translational Research Center | |
Boulder, Colorado, United States, 80309 |
Principal Investigator: | Christopher R Martens, Ph.D. | University of Colorado, Boulder |
Responsible Party: | University of Colorado, Boulder |
ClinicalTrials.gov Identifier: | NCT02921659 |
Other Study ID Numbers: |
14-0475 |
First Posted: | October 3, 2016 Key Record Dates |
Last Update Posted: | December 1, 2016 |
Last Verified: | November 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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