Nicotinamide Riboside With and Without Resveratrol to Improve Functioning in Peripheral Artery Disease
Status:
Recruiting
Trial end date:
2022-04-01
Target enrollment:
Participant gender:
Summary
NICE is a randomized clinical trial that will examine the effects of nicotinamide riboside
(NR) both with and without resveratrol to test whether, among people with PAD, NR
significantly improves walking performance more than placebo and whether NR combined with
resveratrol significantly improves walking performance more than placebo. If our findings
support our hypotheses, results will be used to design a large, definitive randomized
clinical.
We will randomize 90 participants with PAD to one of the following three groups: NR +
resveratrol, NR + placebo, or placebo + placebo. Our primary outcome is change in six-minute
walk distance between baseline and 6-month follow-up. Secondary outcomes are change in
maximal treadmill walking time, patient-reported walking ability (measured by the Walking
Impairment Questionnaire (WIQ)), quality of life (measured by the Short Form-36 Physical
Functioning (SF-36 PF) score), and physical activity (measured by accelerometer). Calf
skeletal muscle biopsy specimens collected in participants in the NICE Trial will be analyzed
for NAD+ abundance, stem cell (satellite cell) abundance and muscle fiber phenotype.