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

• ClinicalTrials.gov Identifier: NCT02921659
• Recruitment Status: Completed
• First Posted: October 3, 2016
• Last Update Posted: December 1, 2016
• Sponsor: University of Colorado, Boulder
• Collaborator: ChromaDex, Inc.
• Information provided by (Responsible Party): University of Colorado, Boulder

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Aging	Dietary Supplement: Niagen™; Dietary Supplement: Placebo	Phase 1; Phase 2

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 Design

• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. Endothelium Dependent Dilation [ Time Frame: 6 weeks ]
   Brachial Artery Flow-Mediated Dilation (FMD)
2. Arterial Stiffness [ Time Frame: 6 weeks ]
   Aortic Pulse Wave Velocity (PWV)
3. Cognitive Function [ Time Frame: 6 weeks ]
   NIH Toolbox Cognitive Function Battery
4. Motor Function [ Time Frame: 6 weeks ]
   NIH Toolbox Motor Function Battery
5. 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.

Eligibility Criteria

• Ages Eligible for Study: 55 Years to 79 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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).

Contacts and Locations

Locations

United States, Colorado

Clinical Translational Research Center

Boulder, Colorado, United States, 80309

Sponsors and Collaborators

University of Colorado, Boulder

ChromaDex, Inc.

Investigators

• Principal Investigator: Christopher R Martens, Ph.D.; University of Colorado, Boulder

More Information

Additional Information:

Description of Research Laboratory 

• Responsible Party: University of Colorado, Boulder
• ClinicalTrials.gov Identifier: NCT02921659
• Other Study ID Numbers: 14-0475
• First Posted: October 3, 2016
• Last Update Posted: December 1, 2016
• Last Verified: November 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by University of Colorado, Boulder:

nicotinamide riboside; aging; arterial stiffness; endothelial dysfunction

Additional relevant MeSH terms:

Niacinamide; Vitamin B Complex; Vitamins; Micronutrients; Physiological Effects of Drugs