Peripheral Artery DiseasePhase 3NICENCT03743636
Nicotinamide Riboside With and Without Resveratrol to Improve Functioning in Peripheral Artery Disease
A Phase 3 study testing Nicotinamide riboside and Resveratrol in people with Peripheral Artery Disease, run by Northwestern University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- Nicotinamide riboside and Resveratrol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 23 May 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All participants will have PAD. PAD will be defined as the following: 1) An ankle-brachial index (ABI) <=0.90 at the baseline study visit or 2) Vascular laboratory evidence or angiographic evidence of PAD. Inclusion based on prior vascular laboratory evidence will be determined by the study principal investigator and includes, for example, a toe brachial index (TBI) < 0.70, Duplex measure showing 70% stenosis or great, a post heel-rise or post-exercise ABI drop of 20% or greater, or ABI values <= 0.90. Angiographic evidence of PAD consists of a stenosis of 70% or greater in a lower extremity artery.
Who cannot join
- Above- or below-knee amputation.
- Critical limb ischemia.
- Wheelchair-bound or requiring a walker to ambulate.
- Walking is limited by a symptom other than PAD.
- Current foot ulcer on bottom of foot.
- End stage renal disease defined as a GFR less than 20 ml/min/1.73 M2.
Show all 22Show fewer
- Significant liver impairment defined as two or more hepatic function enzymes >3.0 times the upper limit of normal. [NOTE: participants who meet this criterion may undergo a re-test of hepatic function tests to determine whether initially elevated hepatic enzymes represented a transient or spurious phenomenon.]
- Failure to successfully complete the 2-week study run-in.
- Planned lower extremity revascularization, orthopedic surgery, or other major surgery during the next six months.
- Lower extremity revascularization, orthopedic surgery, cardiovascular event, coronary revascularization, or other major surgery in the previous three months.
- Participation in supervised treadmill exercise during the previous three months.
- Major medical illness including renal disease requiring dialysis, lung disease requiring oxygen, Parkinson's disease, a life-threatening illness with life expectancy less than six months, or cancer requiring treatment in the previous two years. [NOTE: potential participants may still qualify if they have had treatment for an early stage cancer in the past two years and the prognosis is excellent. Participants who only use oxygen at night may still qualify.]
- Mini-Mental Status Examination (MMSE) score <23 or dementia.
- Participation in or completion of a clinical trial in the previous three months. [NOTE: after completing a stem cell or gene therapy intervention, participants will become eligible after the final study follow-up visit of the stem cell or gene therapy study so long as at least six months have passed since the final intervention administration. After completing a supplement or drug therapy (other than stem cell or gene therapy), participants will be eligible after the final study follow-up visit as long as at least three months have passed since the final intervention of the trial.]
- Currently taking a dose of 250 mg or more of nicotinamide riboside, vitamin B3, niacin. Currently taking a slow-release form of niacin. Currently taking resveratrol or has taken any these drug(s) in past six months. Participants taking a multi-vitamin will not be excluded if the dose of vitamin B3 is less than 250 mgs.
- Increase in angina or angina at rest
- Non-English speaking.
- Visual impairment that limits walking ability.
- Women who are pregnant or who are pre-menopausal will not be eligible.
- In addition to the above criteria, investigator discretion will be used to determine if the trial is unsafe or not a good fit for the potential participant.
- Potentially eligible participants will be advised that Medicare coverage for 12 weeks of supervised treadmill exercise is now available. Potential participants who have not participated in supervised treadmill exercise covered by Medicare and who desire to participate will be referred back to their physician for follow-up. These individuals may become eligible six months after they complete supervised treadmill exercise.
- Vulnerable populations (fetuses, pregnant women, children, prisoners, and institutionalized persons) and adults unable to consent will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nicotinamide Riboside With and Without Resveratrol to Improve Functioning in Peripheral Artery Disease: The NICE Trial
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 findings support the hypotheses, results will be used to design a large, definitive randomized clinical.
The study will randomize 90 participants with PAD to one of the following three groups: NR + resveratrol, NR + placebo, or placebo + placebo.
- Conditions
- Peripheral Artery Disease
- Being tested
- Nicotinamide riboside, Resveratrol, Placebo
- Keywords
- Peripheral Artery Disease, PAD, Resveratrol, Nicotinamide riboside (NR), Six-minute walk, Functional performance
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotinamide ribosideDrug
Also called NR, Niagen
Participants randomized to the NR + resveratrol arm or the NR + placebo arm of the study will receive 1,000 mg of NR daily for six months.
ResveratrolDrug
Participants randomized to the NR + resveratrol arm of the study will receive 125 mg of resveratrol daily for six months.
PlaceboOther
Participants randomized to the NR + placebo arm of the study will receiving placebo pills that are identical in appearance to resveratrol. Participants randomized to the placebo + placebo arm of the study will receive pills that are identical in appearance to NR and resveratrol. Participants will receive placebo pills daily for six months.
| Study group | Role | What they receive |
|---|---|---|
| Nicotinamide riboside + resveratrol | Active comparator | 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. Receives: Drug: Nicotinamide riboside; Drug: Resveratrol |
| Nicotinamide riboside + placebo | Active comparator | Participants randomized to the NR + placebo arm of the study will receive 1,000 mg of NR and a placebo daily for six months. Receives: Drug: Nicotinamide riboside; Other: Placebo |
| Placebo + placebo | Placebo comparator | Participants randomized to the placebo + placebo arm of study will receive placebo pills. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-minute Walk Distance (NR Alone vs. Placebo)
Among participants with PAD, investigators will determine whether NR alone improves six-minute walk distance at 6-month follow-up, compared to placebo.
Measured: Baseline to 6-month follow-up
Six-minute Walk Distance (NR/Resveratrol vs. Placebo)
Among participants with PAD, investigators will determine whether NR combined with resveratrol improves six-minute walk performance at 6-month follow-up, compared to placebo.
Measured: Baseline to 6-month follow-up
Secondary outcomes (21)
Six-minute Walk Distance (NR Alone vs. Placebo)
Among participants with PAD, investigators will determine whether NR alone improves six-minute walk performance at 3-month follow-up, compared to placebo.
Measured: Baseline to 3-month follow-up
Six-minute Walk Distance (NR/Resveratrol vs. Placebo)
Among participants with PAD, investigators will determine whether NR combined with resveratrol improves six-minute walk performance at 3-month follow-up, compared to placebo.
Measured: Baseline to 3-month follow-up
Six-minute Walk Distance (NR/Resveratrol vs. NR Alone)
Among participants with PAD, investigators will determine whether NR combined with resveratrol improves six-minute walk performance at 3-month follow-up, compared to NR alone.
Measured: Baseline to 3-month follow-up
Six-minute Walk Distance (NR/Resveratrol vs. NR Alone)
Among participants with PAD, investigators will determine whether NR combined with resveratrol improves six-minute walk performance at 6-month follow-up, compared to NR alone.
Measured: Baseline to 6-month follow-up
Maximal Treadmill Walking Time (NR Alone vs. Placebo)
Among participants with PAD, investigators will determine whether NR alone improves maximal treadmill walking time at 6-month follow-up, compared to placebo.
Measured: Baseline to 6-month follow-up
Walking Impairment Questionnaire (WIQ) Distance Score (NR Alone vs. Placebo)
Among participants with PAD, investigators will determine whether NR alone improves the Walking Impairment Questionnaire (WIQ) distance score at 6-month follow-up, compared to placebo.
The WIQ is a well validated questionnaire that measures patient-reported walking limitations in distance and speed and stair-climbing. They are scored on a 0-100 scale and that 100 indicates the best possible score.
Measured: Baseline to 6-month follow-up
Physical Activity (NR Alone vs. Placebo)
Among participants with PAD, investigators will determine whether NR alone improves physical activity at 6-month follow-up, compared to placebo.
The physical activity outcome was measured with the ActiGraph, in Activity Units. Higher scores indicate greater activity. The lowest possible score is zero, indicating sedentary time.
Measured: Baseline to 6-month follow-up
Maximal Treadmill Walking Time (NR/Resveratrol vs. Placebo)
Among participants with PAD, investigators will determine whether NR combined with resveratrol improves maximal treadmill walking time at 6-month follow-up, compared to placebo.
Measured: Baseline to 6-month follow-up
Walking Impairment Questionnaire (WIQ) Distance Score (NR/Resveratrol vs. Placebo)
Among participants with PAD, investigators will determine whether NR combined with resveratrol improves the Walking Impairment Questionnaire distance score at 6-month follow-up, compared to placebo.
The WIQ is a well validated questionnaire that measures patient-reported walking limitations in distance and speed and stair-climbing. They are scored on a 0-100 scale and that 100 indicates the best possible score.
Measured: Baseline to 6-month follow-up
Physical Activity (NR/Resveratrol vs. Placebo)
Among participants with PAD, investigators will determine whether NR combined with resveratrol improves physical activity at 6-month follow-up, compared to placebo.
The physical activity outcome was measured with the ActiGraph, in Activity Units. Higher scores indicate greater activity. The lowest possible score is zero, indicating sedentary time.
Measured: Baseline to 6-month follow-up
Maximal Treadmill Walking Time (NR/Resveratrol vs. NR Alone)
Among participants with PAD, investigators will determine whether NR combined with resveratrol improves maximal treadmill walking time at 6-month follow-up, compared to NR alone.
Measured: Baseline to 6-month follow-up
Walking Impairment Questionnaire (WIQ) Distance Score (NR/Resveratrol vs. NR Alone)
Among participants with PAD, investigators will determine whether NR combined with resveratrol improves the Walking Impairment Questionnaire (WIQ) distance score at 6-month follow-up, compared to NR alone.
The WIQ is a well validated questionnaire that measures patient-reported walking limitations in distance and speed and stair-climbing. They are scored on a 0-100 scale and that 100 indicates the best possible score.
Measured: Baseline to 6-month follow-up
Physical Activity (NR/Resveratrol vs. NR Alone)
Among participants with PAD, investigators will determine whether NR combined with resveratrol improves physical activity at 6-month follow-up, compared to NR alone..
The physical activity outcome was measured with the ActiGraph, in Activity Units. Higher scores indicate greater activity. The lowest possible score is zero, indicating sedentary time.
Measured: Baseline to 6-month follow-up
Six-minute Walk Distance (NR/Resveratrol or NR Alone vs. Placebo)
Participants with PAD who received NR alone and those who received NR + resveratrol will be combined into one group and compared to the group receiving placebo, to determine whether NR alone or NR+ resveratrol (combined group)have greater improvement in six-minute walk distance, compared to those randomized to placebo.
Mixed model for repeated measures is applied to Placebo vs. 2 NR groups combined. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.
Measured: Baseline to 3-month follow-up
Six-minute Walk Distance (NR/Resveratrol or NR Alone vs. Placebo)
Participants with PAD who received NR alone and those who received NR + resveratrol will be combined into one group and compared to the group receiving placebo, to determine whether NR alone or NR+ resveratrol (combined group)have greater improvement in six-minute walk distance, compared to those randomized to placebo.
Mixed model for repeated measures is applied to Placebo vs. 2 NR groups combined. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.
Measured: Baseline to 6-month follow-up
Maximal Treadmill Walking Time (NR/Resveratrol or NR Alone vs. Placebo)
Participants with PAD who received NR alone and those who received NR + resveratrol will be combined into one group and compared to the group receiving placebo, to determine whether NR alone or NR+ resveratrol (combined group)have greater improvement in maximal treadmill walking time, compared to those randomized to placebo.
Measured: Baseline to 6-month follow-up
Walking Impairment Questionnaire (WIQ) Distance Score (NR/Resveratrol or NR Alone vs. Placebo)
Participants with PAD who received NR alone and those who received NR + resveratrol will be combined into one group and compared to the group receiving placebo, to determine whether NR alone or NR+ resveratrol (combined group)have greater improvement in Walking Impairment Questionnaire distance score, compared to those randomized to placebo.
The WIQ is a well validated questionnaire that measures patient-reported walking limitations in distance and speed and stair-climbing. They are scored on a 0-100 scale and that 100 indicates the best possible score.
Measured: Baseline to 6-month follow-up
Physical Activity (NR/Resveratrol or NR Alone vs. Placebo)
Participants with PAD who received NR alone and those who received NR + resveratrol will be combined into one group and compared to the group receiving placebo, to determine whether NR alone or NR+ resveratrol (combined group)have greater improvement in physical activity, compared to those randomized to placebo.
The physical activity outcome was measured with the ActiGraph, in Activity Units. Higher scores indicate greater activity. The lowest possible score is zero, indicating sedentary time.
Mixed model for repeated measures is applied to Placebo vs. 2 NR groups combined. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.
Measured: Baseline to 6-month follow-up
NAD+ Abundance in Gastrocnemius Muscle (NR/Resveratrol or NR Alone vs. Placebo)
The outcome measure is the comparison of 6-month change in gastrocnemius muscle biopsy measures of NAD+ abundance between NR and placebo and between NR + resveratrol and placebo. Participants with PAD who received NR alone and those who received NR + resveratrol will be combined into one group and compared to the group receiving placebo, to determine whether NR alone or NR+ resveratrol (combined group) have greater improvement in NAD+ abundance, compared to those randomized to placebo. Measurements of NAD+ abundance were completed using High Performance Liquid Chromatography (HPLC) with a Shimadzu LC-20A pump and UV-VIS detector using a Supelco LC-18-Tcolumn, normalized to muscle weight.
Measured: Baseline to 6-month follow-up
Satellite Cell Abundance in Gastrocnemius Muscle (NR/Resveratrol or NR Alone vs. Placebo)
The outcome measure is the comparison of 6-month changes in gastrocnemius muscle biopsy measures of satellite cell abundance between NR and placebo and between NR + resveratrol and placebo. Participants with PAD who received NR alone and those who received NR + resveratrol will be combined into one group and compared to the group receiving placebo, to determine whether NR alone or NR+ resveratrol (combined group) have greater improvement in satellite cell abundance, compared to those randomized to placebo. Satellite cell abundance was measured via density (satellite cells/100 fibers) using antibodies against: Pax7, type 1 myosin, and laminin.
Measured: Baseline to 6-month follow-up
Gastrocnemius Muscle Fiber Phenotype(NR/Resveratrol or NR Alone vs. Placebo)
The outcome measure is the comparison of 6-month changes in gastrocnemius muscle biopsy measures of Percent Type 1 myofibers (%) between NR and placebo and between NR + resveratrol and placebo. Participants with PAD who received NR alone and those who received NR + resveratrol will be combined into one group and compared to the group receiving placebo, to determine whether NR alone or NR+ resveratrol (combined group) have greater improvement in muscle fiber phenotype, compared to those randomized to placebo. Measurements of fiber type % were determined on frozen muscle sections using antibodies against: Pax7, type 1 myosin, and laminin.
Mixed model for repeated measures is applied to Placebo vs. 2 NR groups combined. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.
Measured: Baseline to 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start1 Oct 2018
- Primary completion23 May 2023
- Study completion23 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Mary McDermott, Northwestern University
- Investigators
- Mary M McDermott, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03743636
- Sponsor's protocol ID
- STU00206660
- Acronym
- NICE
- Status last verified
- Jan 2025
- First submitted
- 20 May 2018
- Last updated
- 14 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McDermott MM, Cetlin MD, Domanchuk KJ, Xu S, Whipple MO, Polonsky T, Criqui MH, Guralnik JM, Tian L, Zhao L, Ho KJ, Greenland P, Treat-Jacobson D. Community-based recruitment with ankle brachial index testing to identify peripheral artery disease participants for randomized clinical trials. Am Heart J. 2026 Oct;300:107450. doi: 10.1016/j.ahj.2026.107450. Epub 2026 Apr 24.
PubMed 42035974Nayak P, Polonsky T, Tian L, Greenland P, Xu S, Zhang D, Zhao L, Criqui MH, Kibbe MR, Gladders B, Goodney P, Ho K, Guralnik JM, McDermott MM. Medical therapies, comorbid conditions, and functional performance in people with peripheral artery disease enrolled in clinical trials between 2004 and 2021. Vasc Med. 2023 Apr;28(2):144-146. doi: 10.1177/1358863X221145533. Epub 2023 Jan 1.
PubMed 36588397
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicotinamide Riboside With and Without Resveratrol to Improve Functioning in Peripheral Artery Disease: The NICE Trial
- ClinicalTrials.gov ID
- NCT03743636
- Acronym / sponsor ID
- NICE / STU00206660
- Conditions
- Peripheral Artery Disease
- Keywords
- Peripheral Artery Disease, PAD, Resveratrol, Nicotinamide riboside (NR), Six-minute walk, Functional performance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 23 May 2023 (actual)
- Study completion
- 23 May 2023 (actual)
- First posted
- 16 Nov 2018 (actual)
- Results
- Posted 14 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 findings support the hypotheses, results will be used to design a large, definitive randomized clinical.
The study will randomize 90 participants with PAD to one of the following three groups: NR + resveratrol, NR + placebo, or placebo + placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nicotinamide riboside + resveratrol | Active comparator | Drug: Nicotinamide riboside, Drug: ResveratrolParticipants 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. |
| Nicotinamide riboside + placebo | Active comparator | Drug: Nicotinamide riboside, Other: PlaceboParticipants randomized to the NR + placebo arm of the study will receive 1,000 mg of NR and a placebo daily for six months. |
| Placebo + placebo | Placebo comparator | Other: PlaceboParticipants randomized to the placebo + placebo arm of study will receive placebo pills. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All participants will have PAD. PAD will be defined as the following: 1) An ankle-brachial index (ABI) <=0.90 at the baseline study visit or 2) Vascular laboratory evidence or angiographic evidence of PAD. Inclusion based on prior vascular laboratory evidence will be determined by the study principal investigator and includes, for example, a toe brachial index (TBI) < 0.70, Duplex measure showing 70% stenosis or great, a post heel-rise or post-exercise ABI drop of 20% or greater, or ABI values <= 0.90. Angiographic evidence of PAD consists of a stenosis of 70% or greater in a lower extremity artery.
Key exclusion criteria (22 listed)
- Above- or below-knee amputation.
- Critical limb ischemia.
- Wheelchair-bound or requiring a walker to ambulate.
- Walking is limited by a symptom other than PAD.
- Current foot ulcer on bottom of foot.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotinamide ribosideAlso: NR, NiagenParticipants randomized to the NR + resveratrol arm or the NR + placebo arm of the study will receive 1,000 mg of NR daily for six months. | Drug | Nicotinamide riboside + placebo, Nicotinamide riboside + resveratrol |
| ResveratrolParticipants randomized to the NR + resveratrol arm of the study will receive 125 mg of resveratrol daily for six months. | Drug | Nicotinamide riboside + resveratrol |
| PlaceboParticipants randomized to the NR + placebo arm of the study will receiving placebo pills that are identical in appearance to resveratrol. Participants randomized to the placebo + placebo arm of the study will receive pills that are identical in appearance to NR and resveratrol. Participants will receive placebo pills daily for six months. | Other | Nicotinamide riboside + placebo, Placebo + placebo |
Primary outcome
Six-minute Walk Distance (NR Alone vs. Placebo)
Time frame: Baseline to 6-month follow-up
Among participants with PAD, investigators will determine whether NR alone improves six-minute walk distance at 6-month follow-up, compared to placebo.
Six-minute Walk Distance (NR/Resveratrol vs. Placebo)
Time frame: Baseline to 6-month follow-up
Among participants with PAD, investigators will determine whether NR combined with resveratrol improves six-minute walk performance at 6-month follow-up, compared to placebo.
21 secondary outcomes
Six-minute Walk Distance (NR Alone vs. Placebo)
Time frame: Baseline to 3-month follow-up
Six-minute Walk Distance (NR/Resveratrol vs. Placebo)
Time frame: Baseline to 3-month follow-up
Six-minute Walk Distance (NR/Resveratrol vs. NR Alone)
Time frame: Baseline to 3-month follow-up
Six-minute Walk Distance (NR/Resveratrol vs. NR Alone)
Time frame: Baseline to 6-month follow-up
Maximal Treadmill Walking Time (NR Alone vs. Placebo)
Time frame: Baseline to 6-month follow-up
Walking Impairment Questionnaire (WIQ) Distance Score (NR Alone vs. Placebo)
Time frame: Baseline to 6-month follow-up
Physical Activity (NR Alone vs. Placebo)
Time frame: Baseline to 6-month follow-up
Maximal Treadmill Walking Time (NR/Resveratrol vs. Placebo)
Time frame: Baseline to 6-month follow-up
Walking Impairment Questionnaire (WIQ) Distance Score (NR/Resveratrol vs. Placebo)
Time frame: Baseline to 6-month follow-up
Physical Activity (NR/Resveratrol vs. Placebo)
Time frame: Baseline to 6-month follow-up
Maximal Treadmill Walking Time (NR/Resveratrol vs. NR Alone)
Time frame: Baseline to 6-month follow-up
Walking Impairment Questionnaire (WIQ) Distance Score (NR/Resveratrol vs. NR Alone)
Time frame: Baseline to 6-month follow-up
Physical Activity (NR/Resveratrol vs. NR Alone)
Time frame: Baseline to 6-month follow-up
Six-minute Walk Distance (NR/Resveratrol or NR Alone vs. Placebo)
Time frame: Baseline to 3-month follow-up
Six-minute Walk Distance (NR/Resveratrol or NR Alone vs. Placebo)
Time frame: Baseline to 6-month follow-up
Maximal Treadmill Walking Time (NR/Resveratrol or NR Alone vs. Placebo)
Time frame: Baseline to 6-month follow-up
Walking Impairment Questionnaire (WIQ) Distance Score (NR/Resveratrol or NR Alone vs. Placebo)
Time frame: Baseline to 6-month follow-up
Physical Activity (NR/Resveratrol or NR Alone vs. Placebo)
Time frame: Baseline to 6-month follow-up
NAD+ Abundance in Gastrocnemius Muscle (NR/Resveratrol or NR Alone vs. Placebo)
Time frame: Baseline to 6-month follow-up
Satellite Cell Abundance in Gastrocnemius Muscle (NR/Resveratrol or NR Alone vs. Placebo)
Time frame: Baseline to 6-month follow-up
Gastrocnemius Muscle Fiber Phenotype(NR/Resveratrol or NR Alone vs. Placebo)
Time frame: Baseline to 6-month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42035974McDermott MM, Cetlin MD, Domanchuk KJ, Xu S, Whipple MO, Polonsky T, Criqui MH, Guralnik JM, Tian L, Zhao L, Ho KJ, Greenland P, Treat-Jacobson D. Community-based recruitment with ankle brachial index testing to identify peripheral artery disease participants for randomized clinical trials. Am Heart J. 2026 Oct;300:107450. doi: 10.1016/j.ahj.2026.107450. Epub 2026 Apr 24.
- Derived from this study: PubMed 36588397Nayak P, Polonsky T, Tian L, Greenland P, Xu S, Zhang D, Zhao L, Criqui MH, Kibbe MR, Gladders B, Goodney P, Ho K, Guralnik JM, McDermott MM. Medical therapies, comorbid conditions, and functional performance in people with peripheral artery disease enrolled in clinical trials between 2004 and 2021. Vasc Med. 2023 Apr;28(2):144-146. doi: 10.1177/1358863X221145533. Epub 2023 Jan 1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary M McDermott, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nicotinamide riboside and Resveratrol in people with Peripheral Artery Disease, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six-minute Walk Distance (NR Alone vs. Placebo) (time frame: Baseline to 6-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03743636, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.