Cocoa to Improve Walking Performance in Peripheral Artery Disease

NCT02876887 | Completed Results DMC

• 2 other identifiers: STU00202741R21AG050897
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The COCOA-PAD trial will determine whether epicatechin-rich cocoa daily for six months improves walking performance in individuals with peripheral artery disease compared to placebo.

Conditions

Peripheral Artery Disease

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Six-minute Walk Distance

  Following a standardized protocol, participants walked up and down a 100-ft hallway for 6 minutes after instruction to cover as much distance as possible.

  Change from baseline to six-month follow-up. Note - There will be two measures: One 2-3 hours after the final study beverage dose and one 24 hours after the final dose.

Secondary Outcomes (6)

• Change From Baseline in Maximal and Pain-free Treadmill Walking Time

  Change from baseline to six-month follow-up

• Change in Baseline From Brachial Artery Flow-mediated Dilation: Change in Brachial Artery Diameter

  Change from baseline to six-month follow-up. Note - there will be two measures: One 2-3 hours after the final study beverage dose and one 24 hours after the final study beverage dose.

• Change From Baseline Accelerometer-measured Physical Activity

  Change from baseline to six-month follow-up

• Change in Baseline Calf Skeletal Muscle Measures: Abundance of PGC1α, Myostatin and Follistatin

  Change from baseline to six-month follow-up

• Change in Baseline MRI-Measured Calf Skeletal Muscle Perfusion

  Change from baseline to six-month follow-up

Study Arms (2)

Cocoa

ACTIVE COMPARATOR

Three servings per day of epicatechin-rich (75 mg daily) cocoa beverages for six months.

Drug: Cocoa

Placebo

PLACEBO COMPARATOR

Three servings per day of placebo beverages for six months.

Drug: Placebo

Interventions

Cocoa DRUG

Cocoa

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All participants will be age 60 and older.

You may not qualify if:

• Above- or below-knee amputation.
• Critical limb ischemia.
• Wheelchair-bound or requiring a cane or walker to ambulate.
• Walking is limited by a symptom other than PAD.
• Baseline six-minute walk value of \<500 feet or \>1,600 feet
• Lower extremity revascularization, major orthopedic surgery, cardiovascular event, or coronary revascularization in the previous three months.
• Planned revascularization or major surgery during the next six 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. \[NOTE: potential participants may still qualify if they have had treatment for an early stage cancer in the past two years and the prognosis is excellent. Participants who require oxygen only at night may still qualify.\]
• Mini-Mental Status Examination (MMSE) score \< 23 or dementia.
• Unwilling to attend three visits in one week for final outcome measures.
• Allergy to chocolate.
• Unwilling or unable to consume products manufactured on the same equipment that processes peanuts, tree nuts, egg, wheat, soy, and milk.
• Use of cocoa-containing dietary supplements.
• Unwilling to give up major dietary sources of epicatechin during the study.
• Symptoms of heart failure or angina that limit walking activity more than ischemic leg symptoms, increase in angina, or angia at rest (i.e. unstable angina).

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 (1)

• McDermott MM, Criqui MH, Domanchuk K, Ferrucci L, Guralnik JM, Kibbe MR, Kosmac K, Kramer CM, Leeuwenburgh C, Li L, Lloyd-Jones D, Peterson CA, Polonsky TS, Stein JH, Sufit R, Van Horn L, Villarreal F, Zhang D, Zhao L, Tian L. Cocoa to Improve Walking Performance in Older People With Peripheral Artery Disease: The COCOA-PAD Pilot Randomized Clinical Trial. Circ Res. 2020 Feb 28;126(5):589-599. doi: 10.1161/CIRCRESAHA.119.315600. Epub 2020 Feb 14.

  PMID: 32078436 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Chocolate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Mary McDermott, MD, Jeremiah Stamler Professor
• Organization: Northwestern University

mdm608@northwester.edu

1 312 503 6419

Study Officials

• Mary 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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine at Northwestern University Feinberg School of Medicine

Study Record Dates

• First Submitted: May 16, 2016
• First Posted: August 24, 2016
• Study Start: January 1, 2017
• Primary Completion: October 15, 2019
• Study Completion: October 15, 2019
• Last Updated: August 6, 2020
• Results First Posted: August 6, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)