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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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

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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, 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
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Information from the National Library of Medicine

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


Locations
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United States, Colorado
Clinical Translational Research Center
Boulder, Colorado, United States, 80309
Sponsors and Collaborators
University of Colorado, Boulder
ChromaDex, Inc.
Investigators
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Principal Investigator: Christopher R Martens, Ph.D. University of Colorado, Boulder
More Information
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Additional Information:

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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
Keywords provided by University of Colorado, Boulder:
nicotinamide riboside
aging
arterial stiffness
endothelial dysfunction
Additional relevant MeSH terms:
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Niacinamide
Vitamin B Complex
Vitamins
Micronutrients
 Nutrients
Growth Substances
Physiological Effects of Drugs