Safety & Efficacy of Nicotinamide Riboside Supplementation for Improving Physiological Function in Middle-Aged and Older Adults
NCT ID: NCT02921659
Last Updated: 2016-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2015-04-30
2016-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Placebo
placebo, 500 mg, 2x/day for 6 weeks
Placebo
silicified microcrystalline cellulose, vegetarian capsule
Niagen™
Niagen™ (nicotinamide riboside chloride, ChromaDex, Inc.) 500mg, 2x/day for 6 weeks.
Niagen™
nicotinamide riboside chloride, 250mg capsules
Interventions
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Niagen™
nicotinamide riboside chloride, 250mg capsules
Placebo
silicified microcrystalline cellulose, vegetarian capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
55 Years
79 Years
ALL
Yes
Sponsors
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ChromaDex, Inc.
INDUSTRY
University of Colorado, Boulder
OTHER
Responsible Party
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Principal Investigators
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Christopher R Martens, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Boulder
Locations
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Clinical Translational Research Center
Boulder, Colorado, United States
Countries
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Related Links
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Description of Research Laboratory
Other Identifiers
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14-0475
Identifier Type: -
Identifier Source: org_study_id