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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Placebo + placebo | Placebo Comparator | Participants randomized to the placebo + placebo arm of study will receive placebo pills. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotinamide riboside | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline to 6-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 3-month follow-up |
| Six-minute Walk Distance (NR/Resveratrol vs. Placebo) |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrocnemius Muscle Satellite Cell Abundance (NR/Resveratrol vs. Placebo and NR vs. Placebo) | Investigators will perform calf muscle biopsies to determine whether among participants with PAD, those randomized to NR + resveratrol and NR alone have increased satellite cell abundance compared to the placebo group. Satellite cell abundance was measured via density (satellite cells/100 fibers) using antibodies against: Pax7, type 1 myosin, and laminin. |
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Mary M McDermott, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42035974 | Derived | 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 Apr 24;300:107450. doi: 10.1016/j.ahj.2026.107450. Online ahead of print. | |
| 36588397 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nicotinamide Riboside + Resveratrol | 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. Nicotinamide riboside: 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. Resveratrol: Participants randomized to the NR + resveratrol arm of the study will receive 125 mg of resveratrol daily for six months. |
| FG001 | Nicotinamide Riboside + Placebo | Participants randomized to the NR + placebo arm of the study will receive 1,000 mg of NR and a placebo daily for six months. Nicotinamide riboside: 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. Placebo: 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. |
| FG002 | Placebo + Placebo | Participants randomized to the placebo + placebo arm of study will receive placebo pills. Placebo: 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nicotinamide Riboside + Resveratrol | 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. Nicotinamide riboside: 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. Resveratrol: Participants randomized to the NR + resveratrol arm of the study will receive 125 mg of resveratrol daily for six months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Least Squares Mean | Standard Error | meters | Baseline to 6-month follow-up |
|
Adverse events data were collected monthly from baseline to 6-month follow-up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nicotinamide Riboside + Resveratrol | 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. Nicotinamide riboside: 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. Resveratrol: Participants randomized to the NR + resveratrol arm of the study will receive 125 mg of resveratrol daily for six months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lower extremity revascularization | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea or vomiting | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary M. McDermott, MD | Northwestern University | 312-503-6419 | mdm608@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 6, 2023 | Apr 8, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C018613 | nicotinamide-beta-riboside |
| D000077185 | Resveratrol |
| ID | Term |
|---|---|
| D000081225 | Stilbestrols |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
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|
| Resveratrol | Drug | Participants randomized to the NR + resveratrol arm of the study will receive 125 mg of resveratrol daily for six months. |
|
| Placebo | Other | 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. |
|
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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline to 6-month follow-up |
| Baseline to 6-month follow-up |
| NAD+ Abundance in Gastrocnemius Muscle (NR/Resveratrol vs. Placebo and NR vs. Placebo) | Investigators will perform calf muscle biopsies to determine whether among participants with PAD, those randomized to NR + resveratrol and NR alone have increased calf muscle NAD+ abundance, compared to the placebo group. 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. | Baseline to 6-month follow-up |
| Muscle Fiber Phenotype in Gastrocnemius Muscle (NR/Resveratrol vs. Placebo and NR vs. Placebo) | Investigators will perform calf muscle biopsies to determine whether among participants with PAD, those randomized to NR + resveratrol and NR alone have improved muscle fiber phenotype (Percent Type 1 myofibers (%)), compared to the placebo group. Measurements of fiber type % were determined on frozen muscle sections using antibodies against: Pax7, type 1 myosin, and laminin. | Baseline to 6-month follow-up |
| Walking Impairment Questionnaire (WIQ) Speed Score (NR Alone vs. Placebo) | Among participants with PAD, investigators will determine whether NR alone improves the Walking Impairment Questionnaire speed and stair climbing 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. | Baseline to 6-month follow-up |
| Short-Form Physical Functioning (SF-36) Score (NR Alone vs. Placebo) | Among participants with PAD, investigators will determine whether NR alone improves the Walking Impairment Questionnaire speed and stair climbing scores and the Short-Form Physical Functioning score at 6-month follow-up, compared to placebo. The SF-36 measures health status. The score range is 0-100, where 100 is best. | Baseline to 6-month follow-up |
| Walking Impairment Questionnaire (WIQ) Stair Climbing Score (NR/Resveratrol vs. Placebo) | Among participants with PAD, investigators will determine whether NR combined with resveratrol improves the Walking Impairment Questionnaire speed and stair climbing scores 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. | Baseline to 6-month follow-up |
| Short-Form Physical Functioning (SF-36) Score (NR/Resveratrol vs. Placebo) | Among participants with PAD, investigators will determine whether NR combined with resveratrol improves the Short-Form Physical Functioning score at 6-month follow-up, compared to placebo. The SF-36 measures health status. The score range is 0-100, where 100 is best. | Baseline to 6-month follow-up |
| Walking Impairment Questionnaire (WIQ) Speed Score (NR/Resveratrol vs. NR Alone) | Among participants with PAD, investigators will determine whether NR combined with resveratrol improves the Walking Impairment Questionnaire speed and stair climbing 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. | Baseline to 6-month follow-up |
| Short-Form Physical Functioning (SF-36) Score (NR/Resveratrol vs. NR Alone) | Among participants with PAD, investigators will determine whether NR combined with resveratrol improves the Walking Impairment Questionnaire speed and stair climbing scores and the Short-Form Physical Functioning score at 6-month follow-up, compared to NR alone. The SF-36 measures health status. The score range is 0-100, where 100 is best. | Baseline to 6-month follow-up |
| Walking Impairment Questionnaire (WIQ) Speed 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 the Walking Impairment Questionnaire (WIQ) speed and stair climbing 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. | Baseline to 6-month follow-up |
| Short-Form Physical Functioning (SF-36) 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 the Short-Form Physical Functioning score at 6-month follow-up, compared to placebo. The SF-36 measures health status. The score range is 0-100, where 100 is best. | Baseline to 6-month follow-up |
| Derived |
| Nayak 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. |
| BG001 | Nicotinamide Riboside + Placebo | Participants randomized to the NR + placebo arm of the study will receive 1,000 mg of NR and a placebo daily for six months. Nicotinamide riboside: 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. Placebo: 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. |
| BG002 | Placebo + Placebo | Participants randomized to the placebo + placebo arm of study will receive placebo pills. Placebo: 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ankle brachial index | The ABI test compares the blood pressures in the arms and legs to measure the blood flow to the legs. A lower ABI would indicate the narrowing or blockage of leg arteries. The Ankle Brachial Index is a ratio of Doppler recorded pressures in the lower and upper extremities. The normal range for ABI is 1.10-1.40. Peripheral artery disease is defined as an ABI < 0.90. ABI is calculated by dividing the average of the lower extremity arterial pressures (dorsalis pedis and posterior tibial pressures) by the average of the systolic brachial pressures. | Mean | Standard Deviation | ratio |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| 6-min walk distance | Mean | Standard Deviation | meters |
|
Participants randomized to the NR + placebo arm of the study will receive 1,000 mg of NR and a placebo daily for six months. Nicotinamide riboside: 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. Placebo: 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. |
| OG002 | Placebo + Placebo | Participants randomized to the placebo + placebo arm of study will receive placebo pills. Placebo: 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. |
|
|
|
| Primary | 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. | Posted | Least Squares Mean | Standard Error | meters | Baseline to 6-month follow-up |
|
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|
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| Secondary | 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. | Posted | Least Squares Mean | Standard Error | meters | Baseline to 3-month follow-up |
|
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| Secondary | 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. | Posted | Least Squares Mean | Standard Error | meters | Baseline to 3-month follow-up |
|
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| Secondary | 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. | Posted | Least Squares Mean | Standard Error | meters | Baseline to 3-month follow-up |
|
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|
| Secondary | 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. | Posted | Least Squares Mean | Standard Error | meters | Baseline to 6-month follow-up |
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| Secondary | 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. | Posted | Least Squares Mean | Standard Error | minutes | Baseline to 6-month follow-up |
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| Secondary | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline to 6-month follow-up |
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| Secondary | 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. | Posted | Least Squares Mean | Standard Error | Activity count per day | Baseline to 6-month follow-up |
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| Secondary | 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. | Posted | Least Squares Mean | Standard Error | minutes | Baseline to 6-month follow-up |
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| Secondary | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline to 6-month follow-up |
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| Secondary | 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. | Posted | Least Squares Mean | Standard Error | Activity count per day | Baseline to 6-month follow-up |
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| Secondary | 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. | Posted | Least Squares Mean | Standard Error | minutes | Baseline to 6-month follow-up |
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| Secondary | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline to 6-month follow-up |
|
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| Secondary | 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. | Posted | Least Squares Mean | Standard Error | Activity count per day | Baseline to 6-month follow-up |
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| Secondary | 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. | Posted | Least Squares Mean | Standard Error | meters | Baseline to 3-month follow-up |
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| Secondary | 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. | Posted | Least Squares Mean | Standard Error | meters | Baseline to 6-month follow-up |
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| Secondary | 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. | Posted | Least Squares Mean | Standard Error | minutes | Baseline to 6-month follow-up |
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| Secondary | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline to 6-month follow-up |
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| Secondary | 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. | Posted | Least Squares Mean | Standard Error | Activity count per day | Baseline to 6-month follow-up |
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| Secondary | 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. | Posted | Least Squares Mean | Standard Error | pmol/mg | Baseline to 6-month follow-up |
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| Secondary | 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. | Posted | Least Squares Mean | Standard Error | satellite cells/100 fibers | Baseline to 6-month follow-up |
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| Secondary | 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. | Posted | Least Squares Mean | Standard Error | percentage | Baseline to 6-month follow-up |
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| Other Pre-specified | Gastrocnemius Muscle Satellite Cell Abundance (NR/Resveratrol vs. Placebo and NR vs. Placebo) | Investigators will perform calf muscle biopsies to determine whether among participants with PAD, those randomized to NR + resveratrol and NR alone have increased satellite cell abundance compared to the placebo group. Satellite cell abundance was measured via density (satellite cells/100 fibers) using antibodies against: Pax7, type 1 myosin, and laminin. | Posted | Least Squares Mean | Standard Error | satellite cells/100 fibers | Baseline to 6-month follow-up |
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| Other Pre-specified | NAD+ Abundance in Gastrocnemius Muscle (NR/Resveratrol vs. Placebo and NR vs. Placebo) | Investigators will perform calf muscle biopsies to determine whether among participants with PAD, those randomized to NR + resveratrol and NR alone have increased calf muscle NAD+ abundance, compared to the placebo group. 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. | Posted | Least Squares Mean | Standard Error | pmol/mg | Baseline to 6-month follow-up |
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| Other Pre-specified | Muscle Fiber Phenotype in Gastrocnemius Muscle (NR/Resveratrol vs. Placebo and NR vs. Placebo) | Investigators will perform calf muscle biopsies to determine whether among participants with PAD, those randomized to NR + resveratrol and NR alone have improved muscle fiber phenotype (Percent Type 1 myofibers (%)), compared to the placebo group. Measurements of fiber type % were determined on frozen muscle sections using antibodies against: Pax7, type 1 myosin, and laminin. | Posted | Least Squares Mean | Standard Error | percentage | Baseline to 6-month follow-up |
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| Other Pre-specified | Walking Impairment Questionnaire (WIQ) Speed Score (NR Alone vs. Placebo) | Among participants with PAD, investigators will determine whether NR alone improves the Walking Impairment Questionnaire speed and stair climbing 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline to 6-month follow-up |
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| Other Pre-specified | Short-Form Physical Functioning (SF-36) Score (NR Alone vs. Placebo) | Among participants with PAD, investigators will determine whether NR alone improves the Walking Impairment Questionnaire speed and stair climbing scores and the Short-Form Physical Functioning score at 6-month follow-up, compared to placebo. The SF-36 measures health status. The score range is 0-100, where 100 is best. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline to 6-month follow-up |
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| Other Pre-specified | Walking Impairment Questionnaire (WIQ) Stair Climbing Score (NR/Resveratrol vs. Placebo) | Among participants with PAD, investigators will determine whether NR combined with resveratrol improves the Walking Impairment Questionnaire speed and stair climbing scores 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline to 6-month follow-up |
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| Other Pre-specified | Short-Form Physical Functioning (SF-36) Score (NR/Resveratrol vs. Placebo) | Among participants with PAD, investigators will determine whether NR combined with resveratrol improves the Short-Form Physical Functioning score at 6-month follow-up, compared to placebo. The SF-36 measures health status. The score range is 0-100, where 100 is best. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline to 6-month follow-up |
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| Other Pre-specified | Walking Impairment Questionnaire (WIQ) Speed Score (NR/Resveratrol vs. NR Alone) | Among participants with PAD, investigators will determine whether NR combined with resveratrol improves the Walking Impairment Questionnaire speed and stair climbing 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline to 6-month follow-up |
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| Other Pre-specified | Short-Form Physical Functioning (SF-36) Score (NR/Resveratrol vs. NR Alone) | Among participants with PAD, investigators will determine whether NR combined with resveratrol improves the Walking Impairment Questionnaire speed and stair climbing scores and the Short-Form Physical Functioning score at 6-month follow-up, compared to NR alone. The SF-36 measures health status. The score range is 0-100, where 100 is best. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline to 6-month follow-up |
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| Other Pre-specified | Walking Impairment Questionnaire (WIQ) Speed 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 the Walking Impairment Questionnaire (WIQ) speed and stair climbing 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline to 6-month follow-up |
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|
| Other Pre-specified | Short-Form Physical Functioning (SF-36) 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 the Short-Form Physical Functioning score at 6-month follow-up, compared to placebo. The SF-36 measures health status. The score range is 0-100, where 100 is best. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline to 6-month follow-up |
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|
|
|
| 0 |
| 33 |
| 9 |
| 33 |
| 24 |
| 33 |
| EG001 | Nicotinamide Riboside + Placebo | Participants randomized to the NR + placebo arm of the study will receive 1,000 mg of NR and a placebo daily for six months. Nicotinamide riboside: 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. Placebo: 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. | 0 | 28 | 6 | 28 | 18 | 28 |
| EG002 | Placebo + Placebo | Participants randomized to the placebo + placebo arm of study will receive placebo pills. Placebo: 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. | 0 | 29 | 6 | 29 | 21 | 29 |
| Bronchitis | General disorders | Systematic Assessment |
|
| Hypertension | General disorders | Systematic Assessment |
|
| Coronary revascularization | General disorders | Systematic Assessment |
|
| Carotid endarterectomy | General disorders | Systematic Assessment |
|
| Acute coronary syndrome | General disorders | Systematic Assessment |
|
| Stroke | General disorders | Systematic Assessment |
|
| Coronary ischemia | General disorders | Systematic Assessment |
|
| Syncope | General disorders | Systematic Assessment |
|
| Lightheadedness | General disorders | Systematic Assessment |
|
| Fall | General disorders | Systematic Assessment |
|
| Mass in groin region | General disorders | Systematic Assessment |
|
| Opioid withdrawal | General disorders | Systematic Assessment |
|
| COPD | General disorders | Systematic Assessment |
|
| Jaw pain | General disorders | Systematic Assessment |
|
| Angina | General disorders | Systematic Assessment |
|
| TIA | General disorders | Systematic Assessment |
|
| Pneumonia | General disorders | Systematic Assessment |
|
| Chest pain | General disorders | Systematic Assessment |
|
| Lung biopsy | General disorders | Systematic Assessment |
|
| Cancer | General disorders | Systematic Assessment |
|
| Diarrhea | General disorders | Systematic Assessment |
|
| Abdominal discomfort | General disorders | Systematic Assessment |
|
| Flushing | General disorders | Systematic Assessment |
|
Not provided
Not provided
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D059808 | Polyphenols |
| D010636 | Phenols |
Mixed model for repeated measures is applied to 3 groups comparisons. 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. |
| ANCOVA |
| 0.0602 |
| Mean Difference (Final Values) |
| 11.14 |
| 1-Sided |
| 90 |
| 2.16 |
| Superiority |
Mixed model for repeated measures is applied to 3 groups comparisons. 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. |
| ANCOVA |
| 0.8401 |
| Mean Difference (Final Values) |
| -35.13 |
| 1-Sided |
| 90 |
| -81.20 |
| Superiority |
Mixed model for repeated measures is applied to 3 groups comparisons. 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. |
| ANCOVA |
| 0.2378 |
| Mean Difference (Final Values) |
| 5.21 |
| 1-Sided |
| 90 |
| -4.47 |
| Superiority |