Safety & Efficacy of Nicotinamide Riboside Supplementation for Improving Physiological Function in Middle-Aged and Older Adults

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.

Study Overview

• Status: Completed
• Conditions: Aging
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Niagen™

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Boulder, Colorado, United States, 80309
      • Clinical Translational Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 79 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Nicotinamide Riboside

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment emergent adverse events	self reported side effects, vital signs, hematology, liver enzymes, markers of kidney function and blood chemistry	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endothelium Dependent Dilation	Brachial Artery Flow-Mediated Dilation (FMD)	6 weeks
Arterial Stiffness	Aortic Pulse Wave Velocity (PWV)	6 weeks
Cognitive Function	NIH Toolbox Cognitive Function Battery	6 weeks
Motor Function	NIH Toolbox Motor Function Battery	6 weeks
Systemic markers of oxidative stress and inflammation	Assessment of plasma C-reactive protein (CRP) and circulating and mononuclear cell-derived cytokine and antioxidant expression.	6 weeks

Collaborators and Investigators

• Sponsor: University of Colorado, Boulder
• Collaborators: ChromaDex, Inc.

Publications and helpful links

Helpful Links

• Description of Research Laboratory

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (ACTUAL): October 1, 2016
• Study Completion (ACTUAL): October 1, 2016

Study Registration Dates

• First Submitted: September 29, 2016
• First Submitted That Met QC Criteria: September 30, 2016
• First Posted (ESTIMATE): October 3, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): December 1, 2016
• Last Update Submitted That Met QC Criteria: November 29, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: endothelial dysfunction; aging; arterial stiffness; nicotinamide riboside
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin B Complex; Niacinamide
• Other Study ID Numbers: 14-0475

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO