Among people with peripheral artery disease (PAD) age 50 and older, the investigators will test the hypothesis that PAD participants randomized to nicotinamide riboside (NR) will have greater improvement or less decline in six-minute walk distance at six-month follow-up, compared to those randomized to placebo. The study will randomize 250 participants with PAD age 50 and older to one of two groups for six months: nicotinamide riboside vs placebo. Our primary outcome is change in six-minute walk distance at six-month follow-up. Secondary outcomes are Walking Impairment Questionnaire (WIQ) distance score, PROMIS Mobility score, calf muscle perfusion (measured by magnetic resonance arterial spin labeling (MRI ASL)), oxidative stress (measured by plasma oxidized LDL), NAD+ abundance in whole blood, 6-minute walk improvement by baseline whole blood NAD+ levels, and 6-minute walk distance at 4 weeks after intervention completion. To achieve the specific aims, the study will randomize 250 participants age 50 and older with PAD to one of two groups: nicotinamide riboside vs placebo. Participants will be followed for six months, with an additional four-week follow-up period after completion of the study intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
250
The nicotinamide riboside intervention is manufactured by ChromaDex. Participants randomized to nicotinamide riboside will take two capsules twice daily. Each capsule contains 250 mg of nicotinamide riboside, for a total of 1000 mg of nicotinamide riboside per day.
The placebo is manufactured by ChromaDex and is visually identical to the nicotinamide riboside capsules. Participants randomized to placebo will take two capsules twice daily. The placebo will not contain any nicotinamide riboside.
Six-minute walk distance
Change in six-minute walk distance between baseline and 6-month follow-up.
Time frame: Baseline to 6-months
Walking Impairment Questionnaire (WIQ) distance score
Patient reported outcome measuring assessing participant perceived ability to walk distances. Scored on a 0-100 scale, 100-best.
Time frame: Baseline to 6-month follow-up
PROMIS Mobility score.
Patient reported outcome measure of mobility.
Time frame: Baseline to 6-month follow-up
Calf muscle perfusion
Calf muscle perfusion measured by magnetic resonance imaging (MRI) arterial spin labeling.
Time frame: Baseline to 6-month follow-up
Oxidative stress
Measured by plasma oxidized LDL.
Time frame: Baseline to 6-month follow-up
NAD+
NAD+ will be measured in whole blood
Time frame: Baseline to 6-month follow-up
6-minute walk
Distance walked in 6- minutes
Time frame: Baseline to four weeks after primary outcome measurement (i.e. 7-month follow-up)
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