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

This study is currently recruiting participants.
Verified June 2017 by Mary McDermott, Northwestern University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02876887
First Posted: August 24, 2016
Last Update Posted: June 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Mary McDermott, Northwestern University
May 16, 2016
August 24, 2016
June 20, 2017
January 2017
June 2019   (Final data collection date for primary outcome measure)
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. ]
Six-minute walk performance [ Time Frame: Change from baseline to six-month follow-up ]
Complete list of historical versions of study NCT02876887 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Maximal and pain-free treadmill walking time [ Time Frame: Change from baseline to six-month follow-up ]
  • Brachial artery flow-mediated dilation: change in absolute change in brachial artery diameter 60 seconds after cuff release [ Time Frame: Change from baseline to six-month follow-up ]
  • Brachial artery flow-mediated dilation: change in the absolute change in brachial artery diameter 90 seconds after cuff release [ Time Frame: Change from baseline to six-month follow-up ]
  • Brachial artery flow-mediated dilation: change in the percent brachial artery diameter 60 seconds after cuff release [ Time Frame: Change from baseline to six-month follow-up ]
  • Brachial artery flow-mediated dilation: change in the percent brachial artery diameter 90 seconds after cuff release [ Time Frame: Change from baseline to six-month follow-up ]
  • Accelerometer-measured physical activity [ Time Frame: Change from baseline to six-month follow-up ]
  • Calf skeletal muscle measures: change in mitochondrial function, mitochondrial biogenesis, follistatin, myostatin, and capillary density [ Time Frame: Change from baseline to six-month follow-up ]
Not Provided
Not Provided
 
Cocoa to Improve Walking Performance in Peripheral Artery Disease
Cocoa to Improve Walking Performance in Peripheral Artery Disease
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.

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 60 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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Peripheral Artery Disease
  • Drug: Cocoa
  • Drug: Placebo
  • Active Comparator: Cocoa
    Three servings per day of epicatechin-rich (75 mg daily) cocoa beverages for six months.
    Intervention: Drug: Cocoa
  • Placebo Comparator: Placebo
    Three servings per day of placebo beverages for six months.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
44
June 2019
June 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. All participants will be age 60 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. 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).
  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.
Sexes Eligible for Study: All
60 Years and older   (Adult, Senior)
No
Contact: Mary McDermott, MD 312-503-6419 mdm608@northwestern.edu
Contact: Kathryn Domanchuk, BS 312-503-6438 k-domanchuk@northwestern.edu
United States
 
 
NCT02876887
STU00202741
R21AG050897 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Plan to Share IPD: Undecided
Mary McDermott, Northwestern University
Northwestern University
National Institute on Aging (NIA)
Principal Investigator: Mary McDermott, MD Northwestern University
Northwestern University
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP