Overview

This trial has been completed.

Condition aging
Treatments niagen™, placebo
Phase phase 1/phase 2
Sponsor University of Colorado, Boulder
Collaborator ChromaDex, Inc.
Start date April 2015
End date October 2016
Trial size 30 participants
Trial identifier NCT02921659, 14-0475

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Placebo Comparator)
placebo, 500 mg, 2x/day for 6 weeks
placebo
silicified microcrystalline cellulose, vegetarian capsule
(Active Comparator)
Niagen™ (nicotinamide riboside chloride, ChromaDex, Inc.) 500mg, 2x/day for 6 weeks.
niagen™ Nicotinamide Riboside
nicotinamide riboside chloride, 250mg capsules

Primary Outcomes

Measure
Incidence of treatment emergent adverse events
time frame: 6 weeks

Secondary Outcomes

Measure
Endothelium Dependent Dilation
time frame: 6 weeks
Arterial Stiffness
time frame: 6 weeks
Cognitive Function
time frame: 6 weeks
Motor Function
time frame: 6 weeks
Systemic markers of oxidative stress and inflammation
time frame: 6 weeks

Eligibility Criteria

Male or female participants from 55 years up to 79 years old.

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).

Additional Information

Official title Safety & Efficacy of Nicotinamide Riboside Supplementation for Improving Physiological Function in Middle-Aged and Older Adults
Principal investigator Christopher R Martens, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by University of Colorado, Boulder.