title: Effect of Resveratrol on Walking Performance in Older People With Peripheral Artery Disease: The RESTORE Randomized Clinical Trial.
abstract: Research shows that resveratrol, a sirtuin activator in red wine, improves exercise endurance and skeletal-muscle oxidative metabolism in animals and may enhance vascular function in humans. Resveratrol supplement sales exceed $30 million annually in the United States, but few data are available regarding its efficacy in humans.
  
  
  
  To determine whether resveratrol, 125 mg/d or 500 mg/d, improves the 6-minute walk performance in patients with peripheral artery disease (PAD).
  
  
  
  This parallel-design, double-blind, randomized clinical trial, called Resveratrol to Improve Outcomes in Older People With PAD (RESTORE), was conducted at Northwestern University. Sixty-six participants 65 years or older with PAD were randomized to receive a daily capsule of resveratrol, 125 mg or 500 mg, or placebo for 6 months. Participants were randomized using a randomly permuted block method stratified by baseline 6-minute walk test performance. This trial was conducted between January 1, 2015, and August 5, 2016, and data analyses were performed according to the intention-to-treat concept.
  
  
  
  Administration of resveratrol, 125 or 500 mg/d, or placebo once daily.
  
  
  
  The primary outcome measure was the change in 6-minute walk distance at the 6-month follow-up. One of the secondary outcomes was change in maximal treadmill walking time. Because of the preliminary nature of the trial, the a priori power calculation used a 1-sided test with a significance level of P < .10.
  
  
  
  The 66 participants were predominantly men (45 [68%]), had a mean (SD) age of 74.4 (6.6) years, and had a mean (SD) ankle brachial index of 0.67 (0.18). Sixty-four (97%) completed follow-up. Six-month mean (SE) changes in 6-minute walk distance were 4.6 (8.1) m for the 125-mg resveratrol group, -12.8 (7.5) m for the 500-mg resveratrol group, and -12.3 (7.9) m for the placebo group (P = .07 for the 125-mg resveratrol group vs placebo; P = .96 for the 500-mg resveratrol group vs placebo). Six-month mean (SE) changes in maximal treadmill walking time were 0.5 (2.3) minutes for the 125-mg resveratrol group, -0.6 (2.1) minutes for the 500-mg resveratrol group, and 0.4 (2.1) minutes for the placebo group (P = .18 for the 125-mg resveratrol group vs placebo; P = .12 for the 500-mg resveratrol group vs placebo).
  
  
  
  The RESTORE trial found no consistent evidence that resveratrol improves walking performance in patients 65 years or older with PAD.
  
  
  
  clinicaltrials.gov Identifier: NCT02246660.
authors.affiliation: Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois.|Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois.|Senior Editor.
authors.forename: Mary M
authors.initials: MM
authors.lastname: McDermott
authors.affiliation: Department of Aging and Geriatric Research, University of Florida, Gainesville.
authors.forename: Christiaan
authors.initials: C
authors.lastname: Leeuwenburgh
authors.affiliation: Department of Epidemiology, University of Maryland, Baltimore.
authors.forename: Jack M
authors.initials: JM
authors.lastname: Guralnik
authors.affiliation: Department of Health Research and Policy, Stanford University, Stanford, California.
authors.forename: Lu
authors.initials: L
authors.lastname: Tian
authors.affiliation: Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
authors.forename: Robert
authors.initials: R
authors.lastname: Sufit
authors.affiliation: Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
authors.forename: Lihui
authors.initials: L
authors.lastname: Zhao
authors.affiliation: Department of Family Medicine and Public Health, University of California at San Diego, San Diego.
authors.forename: Michael H
authors.initials: MH
authors.lastname: Criqui
authors.affiliation: Department of Surgery, University of North Carolina, Chapel Hill.|Editor.
authors.forename: Melina R
authors.initials: MR
authors.lastname: Kibbe
authors.affiliation: Department of Medicine, University of Wisconsin, Madison.
authors.forename: James H
authors.initials: JH
authors.lastname: Stein
authors.affiliation: Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
authors.forename: Donald
authors.initials: D
authors.lastname: Lloyd-Jones
authors.affiliation: Department of Aging and Geriatric Research, University of Florida, Gainesville.
authors.forename: Stephen D
authors.initials: SD
authors.lastname: Anton
authors.affiliation: Department of Medicine, University of Chicago, Chicago, Illinois.
authors.forename: Tamar S
authors.initials: TS
authors.lastname: Polonsky
authors.affiliation: Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
authors.forename: Ying
authors.initials: Y
authors.lastname: Gao
authors.affiliation: Division of Intramural Research, National Institute on Aging, Bethesda, Maryland.
authors.forename: Rafael
authors.initials: R
authors.lastname: de Cabo
authors.affiliation: Division of Intramural Research, National Institute on Aging, Bethesda, Maryland.
authors.forename: Luigi
authors.initials: L
authors.lastname: Ferrucci
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000975:Antioxidants / Q000008:administration & dosage* / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D058729:Peripheral Arterial Disease / Q000503:physiopathology*; D010807:Physical Endurance; D010865:Pilot Projects; D000077185:Resveratrol / Q000008:administration & dosage* / Q000627:therapeutic use; D000070857:Walk Test
chemical_list: D000975:Antioxidants; D000077185:Resveratrol