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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
Sponsor:
Collaborator:
ChromaDex, Inc.
Information provided by (Responsible Party):
University of Colorado, Boulder

September 29, 2016
October 3, 2016
December 1, 2016
April 2015
October 2016   (Final data collection date for primary outcome measure)
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
Safety & Tolerability [ Time Frame: 6 weeks ]
Assessment of side effects, vital signs, hematology, liver enzymes, markers of kidney function and blood chemistry
Complete list of historical versions of study NCT02921659 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Safety & Efficacy of Nicotinamide Riboside Supplementation for Improving Physiological Function in Middle-Aged and Older Adults
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.
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.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Aging
  • Dietary Supplement: Niagen™
    nicotinamide riboside chloride, 250mg capsules
    Other Name: Nicotinamide Riboside
  • Dietary Supplement: Placebo
    silicified microcrystalline cellulose, vegetarian capsule
  • Placebo Comparator: Placebo
    placebo, 500 mg, 2x/day for 6 weeks
    Intervention: Dietary Supplement: Placebo
  • Active Comparator: Niagen™
    Niagen™ (nicotinamide riboside chloride, ChromaDex, Inc.) 500mg, 2x/day for 6 weeks.
    Intervention: Dietary Supplement: Niagen™
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
Same as current
October 2016
October 2016   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
55 Years to 79 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02921659
14-0475
Yes
Not Provided
Plan to Share IPD: No
University of Colorado, Boulder
University of Colorado, Boulder
ChromaDex, Inc.
Principal Investigator: Christopher R Martens, Ph.D. University of Colorado, Boulder
University of Colorado, Boulder
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP