Cocoa to Improve Walking Performance in Peripheral Artery Disease (COCOA-PAD)
|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|
- 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. ]
- 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 ]
|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)|
Active Comparator: Cocoa
Three servings per day of epicatechin-rich (75 mg daily) cocoa beverages for six months.
Placebo Comparator: Placebo
Three servings per day of placebo beverages for six months.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02876887
|Contact: Mary McDermott, MDfirstname.lastname@example.org|
|Contact: Kathryn Domanchuk, BSemail@example.com|
|United States, Illinois|
|Northwestern University Feinberg School of Medicine||Recruiting|
|Chicago, Illinois, United States, 60611|
|Contact: Kathryn Domanchuk, BS 312-503-6438 firstname.lastname@example.org|
|Principal Investigator: Mary M McDermott, MD|
|Principal Investigator:||Mary McDermott, MD||Northwestern University|