BEETroot Juice to Reverse Functional Impairment in PAD: The BEET PAD Trial

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The BEET PAD Trial is a multi-centered double-blind randomized clinical trial designed to determine whether beetroot juice, compared to placebo, improves six-minute walk distance at four month follow-up in people with lower extremity peripheral artery disease (PAD). Investigators hypothesize that by simultaneously increasing lower extremity perfusion, gastrocnemius muscle mitochondrial activity, and myofiber health and regeneration, beetroot juice will significantly improve walking performance in people with PAD. The primary aim is to determine whether beetroot juice significantly improves six-minute walk distance at 4-month follow-up in people with PAD, compared to placebo. Preliminary evidence suggests that beetroot juice has both acute and chronic effects on walking performance in PAD. The primary outcome will measure the combined acute and chronic effect of beetroot juice (i.e. the maximal effect) on change in 6-minute walk at 4-month follow-up. In secondary aims, investigators will distinguish between acute and chronic effects of beetroot juice on six-minute walk and delineate biologic pathways by which beetroot juice improves walking performance in PAD, by measuring change in gastrocnemius muscle perfusion (MRI arterial spin labeling) and gastrocnemius muscle health. The trial will assess the durability of beetroot juice effects on six-minute walk. Nitrate in beetroot juice is metabolized to nitrite and subsequently to NO, attaining peak nitrite levels 2.5 hours after ingestion. The trial will determine whether a higher peak or a greater increase in plasma nitrite at 2.5 hours after beetroot juice consumption at baseline has a greater effect on six-minute walk at 4-month follow-up, compared to a lower peak or a smaller increase, respectively.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• Age 50 and older

• Presence of peripheral artery disease, defined as:

‣ An ankle brachial index (ABI) \<= 0.90 at baseline

⁃ Vascular lab evidence of PAD (such as a toe brachial pressure \<= 0.70 or an ankle brachial index \<=0.90), or angiographic evidence of PAD defined as at least 70% stenosis of an artery supplying the lower extremities.

⁃ An ABI of \>0.90 and \<=1.00 who experience a 20% or greater drop in ABI in either leg after the heel-rise test.

Locations
United States
Illinois
Northwestern University Feinberg School of Medicine
RECRUITING
Chicago
University of Chicago
RECRUITING
Chicago
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Virginia
University of Virginia
NOT_YET_RECRUITING
Charlottesville
Contact Information
Primary
Mary McDermott, MD
mdm608@northwestern.edu
312-503-6419
Backup
Kathryn Domanchuk, BS
k-domanchuk@northwestern.edu
312-503-6438
Time Frame
Start Date: 2023-01-25
Estimated Completion Date: 2028-10-01
Participants
Target number of participants: 210
Treatments
Active_comparator: Beetroot juice
The beetroot juice intervention comes in a single 70 ml drink and is manufactured by James White Drinks. Each drink contains beetroot juice and 2% lemon juice, made from concentrates. Each serving of 70 mL of beetroot juice contains 400 mgs (6.45 millimoles) of nitrate and will be taken twice daily for a total daily dose of 800 mgs (12.90 millimoles) of nitrate.
Placebo_comparator: Placebo
The placebo comes in a single 70 ml drink and is manufactured by James White Drinks. The placebo contains beetroot juice and 2% lemon juice, made from concentrates, and is filtered to remove nitrate.
Sponsors
Collaborators: National Institute on Aging (NIA), University of Virginia, University of Chicago
Leads: Northwestern University

This content was sourced from clinicaltrials.gov

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