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Nicotinamide riboside + resveratrol for Peripheral Arterial Disease (NICE Trial)

Phase 3

Waitlist Available

Led By Mary M McDermott, MD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 6-month follow-up

Awards & highlights

NICE Trial Summary

This trial will examine whether nicotinamide riboside (NR) improves walking performance in people with PAD and whether NR combined with resveratrol improves walking performance more than placebo.

Eligible Conditions

Peripheral Arterial Disease

NICE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 6-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 6-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6-month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Gastrocnemius Muscle Fiber Phenotype(NR/resveratrol or NR alone vs. placebo)

Maximal treadmill walking time (NR alone vs. placebo)

Maximal treadmill walking time (NR/resveratrol or NR alone vs. placebo)

+16 more

Other outcome measures

Gastrocnemius muscle satellite cell abundance (NR/resveratrol vs. placebo and NR vs. placebo)

Muscle fiber phenotype in gastrocnemius muscle (NR/Resveratrol vs. placebo and NR vs. placebo)

NAD+ abundance in gastrocnemius muscle (NR/Resveratrol vs. placebo and NR vs. placebo)

+8 more

NICE Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Nicotinamide riboside + resveratrolActive Control2 Interventions

Participants randomized to the NR + resveratrol arm of the study will receive 1,000 mg of NR and 125 mg of resveratrol daily for six months.

Group II: Nicotinamide riboside + placeboActive Control2 Interventions

Participants randomized to the NR + placebo arm of the study will receive 1,000 mg of NR and a placebo daily for six months.

Group III: Placebo + placeboPlacebo Group1 Intervention

Participants randomized to the placebo + placebo arm of study will receive placebo pills.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

American Heart AssociationOTHER

322 Previous Clinical Trials

4,933,458 Total Patients Enrolled

9 Trials studying Peripheral Arterial Disease

738 Patients Enrolled for Peripheral Arterial Disease

Northwestern UniversityLead Sponsor

1,585 Previous Clinical Trials

917,141 Total Patients Enrolled

24 Trials studying Peripheral Arterial Disease

4,332 Patients Enrolled for Peripheral Arterial Disease

Mary M McDermott, MDPrincipal InvestigatorNorthwestern University

4 Previous Clinical Trials

1,083 Total Patients Enrolled

4 Trials studying Peripheral Arterial Disease

1,083 Patients Enrolled for Peripheral Arterial Disease

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any patients enrolled in this clinical trial at the moment?

"That is correct. The information available on clinicaltrials.gov demonstrates that this trial is still looking for patients. This particular trial was first posted on October 1st, 2018 and was most recently updated on April 21st, 2022. There is a total of 90 participants that need to be enrolled, with one location currently hosting the trial."

Answered by AI

Are Nicotinamide riboside + resveratrol generally recognized as safe and effective by the FDA?

"Phase 3 trials have a moderate level of evidence supporting both safety and efficacy, so our team at Power has given it a score of 3."

Answered by AI

What other well-known research has looked at the effects of Nicotinamide riboside + resveratrol?

"There are a total of 20 clinical trials being conducted to test the efficacy of Nicotinamide riboside + resveratrol. 1 of those trials has progressed to Phase 3 testing. The majority of the Nicotinamide riboside + resveratrol studies are based out of Winston-Salem, North carolina; however, there are 24 total sites running these trials."

Answered by AI

What's the primary aim of this research?

"The purpose of this trial is to see if Six-minute walk distance improves for participants taking NR alone or NR+ resveratrol, compared to those taking a placebo. This will be measured over a Baseline to 6-month follow-up time frame. Additionally, the trial will also measure whether Muscle Fiber Phenotype, Physical Activity, and Walking Impairment Questionnaire (WIQ) distance score improve for participants taking NR alone or NR+ resveratrol, compared to those taking a placebo."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Nicotinamide Riboside With and Without Resveratrol to Improve Functioning in Peripheral Artery Disease

Mary McDermott 2018. "Nicotinamide Riboside With and Without Resveratrol to Improve Functioning in Peripheral Artery Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03743636.