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OpenTrials
Completed

NCT Number: NCT02921659

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.

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Key information

Conditions

Age range

55 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Clinical Translational Research Center

Boulder, Colorado, 80309, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Niagen™

Dietary Supplement

nicotinamide riboside chloride, 250mg capsules

Other names: Nicotinamide Riboside

Placebo

Dietary Supplement

silicified microcrystalline cellulose, vegetarian capsule

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Boulder

Other

Collaborators

  • ChromaDex, Inc.

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 3, 2016
Registry last updated
Dec 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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