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

Study Description

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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

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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

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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

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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

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Ages Eligible for Study:	55 Years to 79 Years (Adult, Senior)
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

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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

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Additional Information:

Description of Research Laboratory 

Responsible Party:	University of Colorado, Boulder
ClinicalTrials.gov Identifier:	NCT02921659 History of Changes
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; Niacin; Nicotinic Acids; Vitamin B Complex; Vitamins; Micronutrients; Growth Substances	Physiological Effects of Drugs; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Vasodilator Agents