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Trial record 26 of 130 for:    Open Studies | NIA

Cocoa to Improve Walking Performance in Peripheral Artery Disease (COCOA-PAD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by Northwestern University
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Mary McDermott, Northwestern University
ClinicalTrials.gov Identifier:
NCT02876887
First received: May 16, 2016
Last updated: February 13, 2017
Last verified: February 2017
  Purpose
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.

Condition Intervention
Peripheral Artery Disease
Drug: Cocoa
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Cocoa to Improve Walking Performance in Peripheral Artery Disease

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Six-minute walk performance [ Time Frame: Change from baseline to six-month follow-up- There will be two measures: One 2-3 hours after the final Study Beverage dose- and one- 24 hours after the final dose. ]

Secondary Outcome Measures:
  • Maximal and pain-free treadmill walking time [ Time Frame: Change from baseline to six-month follow-up ]
  • Brachial artery flow-mediated dilation: change in brachial artery diameter [ Time Frame: Change from baseline to six-month follow-up- NOTE- there will be two measures: One 2-3 hours after the final Cocoa beverage dose and one 24 hours after the final cocoa beverage dose. ]
  • Accelerometer-measured physical activity [ Time Frame: Change from baseline to six-month follow-up ]
  • Calf skeletal muscle measures: change in calf skeletal muscle measures [ Time Frame: Change from baseline to six-month follow-up ]
  • MRI-measured calf skeletal muscle perfusion [ Time Frame: Change from baseline to six-month follow-up ]

Estimated Enrollment: 44
Actual Study Start Date: January 2017
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cocoa
Three servings per day of epicatechin-rich (75 mg daily) cocoa beverages for six months.
Drug: Cocoa
Placebo Comparator: Placebo
Three servings per day of placebo beverages for six months.
Drug: Placebo

Detailed Description:

Therapeutic properties that target pathophysiologic impairments in PAD. These therapeutic properties include improved skeletal muscle mitochondrial function, increased skeletal muscle capillary density, and favorable changes in skeletal muscle levels of myostatin and follistatin that increase muscle mass and strength. Cocoa also protects against ischemia-reperfusion injury, improves endothelial function, and reduces oxidative stress. In summary, epicatechin-rich cocoa targets and reverses several pathophysiologic processes that are common in PAD and that are associated with functional impairment and functional decline in PAD. However, the effect of chronic daily cocoa consumption on functional decline has not been studied in older people with PAD.

The COCOA-PAD trial is a pilot study of 44 PAD participants age 65 and older: a double-blind, randomized controlled pilot clinical trial to provide preliminary data to address the hypothesis that chronic daily epicatechin-rich cocoa improves lower extremity functioning in older people with PAD by improving mitochondrial oxidative metabolism, increasing calf muscle capillary density, promoting calf skeletal muscle mitochondrial biogenesis, and improving endothelial function.

In the primary aim, the investigators will determine whether PAD participants randomized to an epicatechin-rich cocoa beverage have greater increases or smaller declines in six-minute walk performance at 6-month follow-up, compared to those randomized to an identical appearing placebo drink with comparable caloric composition. In the secondary aims, the investigators will determine whether PAD participants randomized to cocoa have improved treadmill walking performance, improved brachial artery flow-mediated dilation, favorable changes in calf muscle biopsy measures of mitochondrial function, mitochondrial biogenesis, follistatin, myostatin, and capillary density, increased calf skeletal muscle regeneration and reduced oxidative stress, and increased MRI-measured calf muscle perfusion. Outcome measures will be carefully timed relative to the last intervention dose to distinguish between the acute vs. chronic effects of cocoa-epicatechin.

If the hypotheses are correct, results will be used to design a large, definitive randomized controlled trial of epicatechin-rich cocoa to improve lower extremity functioning and prevent mobility loss in the large and growing number of older people who are disabled by PAD.

  Eligibility

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. All participants will be age 65 and older.
  2. All participants will have PAD. PAD will be defined as follows. First, an ABI < 0.90 at baseline is an inclusion criterion for PAD. Second, potential participants with an ABI > 0.90 who have vascular lab evidence of PAD or angiographic evidence of PAD will be eligible.

Exclusion Criteria:

  1. Above- or below-knee amputation.
  2. Critical limb ischemia.
  3. Wheelchair-bound or requiring a cane or walker to ambulate.
  4. Walking is limited by a symptom other than PAD.
  5. Baseline six-minute walk value of <500 feet or >1,600 feet
  6. Lower extremity revascularization, major orthopedic surgery, cardiovascular event, or coronary revascularization in the previous three months.
  7. Planned revascularization or major surgery during the next six months.
  8. 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.]
  9. Mini-Mental Status Examination (MMSE) score < 23 or dementia.
  10. Unwilling to attend three visits in one week for final outcome measures.
  11. Allergy to chocolate.
  12. Unwilling or unable to consume products manufactured on the same equipment that processes peanuts, tree nuts, egg, wheat, soy, and milk.
  13. Use of cocoa-containing dietary supplements.
  14. Unwilling to give up major dietary sources of epicatechin during the study.
  15. > Class II NYHA heart failure or angina, increase in angina, angina at rest, or abnormal baseline treadmill stress test. Potential participants may become eligible following an abnormal baseline treadmill stress test if they have evidence of an absence of coronary ischemia based on testing with their own physician.
  16. 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.]
  17. Non-English speaking, a visual impairment that limits walking ability.
  18. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02876887

Contacts
Contact: Mary McDermott, MD 312-503-6419 mdm608@northwestern.edu
Contact: Kathryn Domanchuk, BS 312-503-6438 k-domanchuk@northwestern.edu

Locations
United States, Illinois
Northwestern University Feinberg School of Medicine Recruiting
Chicago, Illinois, United States, 60611
Contact: Kathryn Domanchuk, BS    312-503-6438    k-domanchuk@northwestern.edu   
Principal Investigator: Mary M McDermott, MD         
Sponsors and Collaborators
Northwestern University
National Institute on Aging (NIA)
Investigators
Principal Investigator: Mary McDermott, MD Northwestern University
  More Information

Responsible Party: Mary McDermott, Professor of Medicine at Northwestern University Feinberg School of Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT02876887     History of Changes
Other Study ID Numbers: STU00202741  R21AG050897 
Study First Received: May 16, 2016
Last Updated: February 13, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases

ClinicalTrials.gov processed this record on February 27, 2017