RESveratrol To Improve Outcomes in oldeR pEople With PAD (the RESTORE Trial)

NCT02246660 | Completed Results DMC

• 2 other identifiers: 1R21AG047510-01R21AG047510
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The RESTORE trial will determine whether resveratrol supplementation can improve walking performance in older people with lower extremity peripheral arterial disease (PAD). Resveratrol, a polyphenol and natural supplement, specifically targets several impairments associated with walking difficulty and mobility loss in people with PAD.

Conditions

Peripheral Arterial Disease

Keywords

Peripheral Artery Disease; Peripheral Arterial Disease; PAD

Outcome Measures

Primary Outcomes (1)

• 6-Minute Walk Distance, Meters

  Six month changes in 6-Minute Walk Distance (meters) in response to resveratrol therapy in patients with Peripheral Artery Disease were measured.

  Baseline and 6 month follow-up

Study Arms (3)

Resveratrol - 500 mg/day

ACTIVE COMPARATOR

The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.

Drug: Resveratrol

Resveratrol - 125 mg/day

ACTIVE COMPARATOR

The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.

Drug: Resveratrol

Placebo

PLACEBO COMPARATOR

Placebo will be taken orally for 6 months.

Drug: Placebo

Interventions

Resveratrol DRUG

The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative. OR The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.

Also known as: Polygonum cuspidatum

Resveratrol - 125 mg/day; Resveratrol - 500 mg/day

Placebo DRUG

Placebo will be taken orally for 6 months.

Also known as: No active study medication

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Ankle-brachial index (ABI) \< 0.90 at baseline screening (at visit), or, medical evidence of prior lower extremity revascularization if ABI ≥ 0.90.
• or older

You may not qualify if:

• Above/below-knee amputation, critical limb ischemia, wheelchair-bound, or require the use of a walker or cane
• Other symptom(s) limiting walking ability, other than PAD
• Underwent/experienced lower extremity revascularization, a cardiovascular event, or coronary artery bypass surgery within 3 months of screening. Underwent major orthopedic surgery within 6 months of screening. Planning to have revascularization or major elective surgery within the next 6 months.
• Major medical illness including renal disease that requires dialysis or lung disease that requires oxygen
• Score of \< 23 on Mini-Mental Status Examination at screening or major psychiatric illness
• Currently participating in a separate clinical trial
• Significant renal or liver dysfunction at baseline
• Does not successfully complete the study run-in period
• Has an extreme baseline 6 minute walk value (\< 500 ft or \> 1,600 feet )
• Treated for cancer during the last 2 years (unless prognosis is excellent)
• Severe hearing impairment or other communication difficulties (e.g. non-English speaking) or legally blind
• Diagnosis of Parkinson's disease
• Unable to return to medical center at required visit frequency
• Otherwise poorly suited to intervention (at the discretion of the PI)

Sponsors & Collaborators

• Northwestern University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Related Publications (3)

• Gonzalez-Freire M, Moore AZ, Peterson CA, Kosmac K, McDermott MM, Sufit RL, Guralnik JM, Polonsky T, Tian L, Kibbe MR, Criqui MH, Li L, Leeuwenburgh C, Ferrucci L. Associations of Peripheral Artery Disease With Calf Skeletal Muscle Mitochondrial DNA Heteroplasmy. J Am Heart Assoc. 2020 Apr 7;9(7):e015197. doi: 10.1161/JAHA.119.015197. Epub 2020 Mar 21.

  PMID: 32200714 DERIVED

• McDermott MM, Peterson CA, Sufit R, Ferrucci L, Guralnik JM, Kibbe MR, Polonsky TS, Tian L, Criqui MH, Zhao L, Stein JH, Li L, Leeuwenburgh C. Peripheral artery disease, calf skeletal muscle mitochondrial DNA copy number, and functional performance. Vasc Med. 2018 Aug;23(4):340-348. doi: 10.1177/1358863X18765667. Epub 2018 May 8.

  PMID: 29734865 DERIVED

• McDermott MM, Leeuwenburgh C, Guralnik JM, Tian L, Sufit R, Zhao L, Criqui MH, Kibbe MR, Stein JH, Lloyd-Jones D, Anton SD, Polonsky TS, Gao Y, de Cabo R, Ferrucci L. Effect of Resveratrol on Walking Performance in Older People With Peripheral Artery Disease: The RESTORE Randomized Clinical Trial. JAMA Cardiol. 2017 Aug 1;2(8):902-907. doi: 10.1001/jamacardio.2017.0538.

  PMID: 28403379 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

Results Point of Contact

• Title: Dr. Mary McDermott
• Organization: Northwestern University

mdm608@northwestern.edu

312-503-6419

Study Officials

• Mary M McDermott, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: September 18, 2014
• First Posted: September 23, 2014
• Study Start: January 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: September 1, 2016
• Last Updated: April 30, 2018
• Results First Posted: April 30, 2018

Record last verified: 2017-11

Locations

US (1)