Beetroot Juice for Peripheral Arterial Disease
(BEET PAD Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you must stop consuming beetroot juice, oral nitrate or nitrite, and beetroot supplements for 30 days before the trial and throughout its duration.
What data supports the effectiveness of the treatment Beetroot Juice for Peripheral Arterial Disease?
Is beetroot juice safe for human consumption?
How is beetroot juice treatment different from other treatments for peripheral arterial disease?
Beetroot juice is unique because it is rich in dietary nitrate, which the body converts to nitric oxide, a molecule that helps improve blood flow and oxygen delivery to muscles. This can enhance exercise tolerance and walking distance in patients with peripheral arterial disease, offering a natural alternative to traditional medications.12468
Eligibility Criteria
This trial is for people over 50 with peripheral artery disease (PAD), which means they have poor blood flow in their legs. They must have specific test results showing PAD and be able to walk a certain distance. People can't join if they've had major leg amputations, severe limb issues, need walkers or wheelchairs, have other conditions limiting walking, recent surgeries or heart events, mental impairment scores below a threshold, allergies to beetroot juice, don't speak English, are in another study recently or consume lots of beets.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive beetroot juice or placebo twice daily to assess its effects on six-minute walk distance and other health metrics
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of walking performance and muscle health
Treatment Details
Interventions
- Beetroot juice
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwestern University
Lead Sponsor
University of Virginia
Collaborator
University of Chicago
Collaborator
National Institute on Aging (NIA)
Collaborator