Using beetroot juice to improve walking in patients with peripheral artery disease

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

This study is testing if drinking beetroot juice can help people with peripheral artery disease walk better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 210 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Northwestern University (Academic / other)
• Locations: 4 sites (Chicago, Illinois and 3 other locations)
• Trial ID: NCT05624125 on ClinicalTrials.gov

What this trial studies

The BEET PAD Trial is a multi-centered, double-blind, randomized clinical trial aimed at assessing the effectiveness of beetroot juice in enhancing walking performance in individuals with lower extremity peripheral artery disease (PAD). Participants will be given either beetroot juice or a placebo, and their six-minute walk distance will be measured at a four-month follow-up. The study hypothesizes that beetroot juice will improve lower extremity blood flow and muscle health, leading to better walking outcomes. This trial builds on preliminary evidence suggesting that beetroot juice may have beneficial effects on mobility in PAD patients.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 50 and older who have been diagnosed with peripheral artery disease.

Not a fit: Patients with critical limb ischemia, amputations, or those whose walking limitations are due to conditions other than PAD may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a simple dietary intervention that significantly improves mobility and quality of life for patients with peripheral artery disease.

How similar studies have performed: Preliminary evidence suggests that similar approaches using beetroot juice have shown positive effects on walking performance in patients with PAD.

Eligibility criteria

Inclusion Criteria:

1. Age 50 and older
2. Presence of peripheral artery disease, defined as:

   1. An ankle brachial index (ABI) \<= 0.90 at baseline
   2. 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.
   3. 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.

Exclusion Criteria:

1. Above- or below-knee amputation
2. Critical limb ischemia defined as an ABI \<0.40 with symptoms of rest pain
3. Wheelchair confinement or requiring a walker to ambulate
4. Walking is limited by a symptom other than PAD
5. Current foot ulcer on bottom of foot
6. Failure to successfully complete the study run-in
7. Planned major surgery, coronary or leg revascularization during the next five months
8. Major surgery, coronary or leg revascularization or major cardiovascular event in the previous three months
9. Major medical illness including 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. \[NOTE: potential participants may still qualify if they have had treatment for an early stage cancer in the past two years and the prognosis is excellent. Participants who require oxygen only at night may still qualify.\]
10. Mini-Mental Status Examination (MMSE) score \< 23
11. Allergy to beetroot juice
12. Currently consuming beetroot juice, oral nitrate or nitrite, or a beetroot supplement and/or unwilling to avoid beetroot juice during the study. Participants will be asked to discontinue these items for 30 days before baseline testing and throughout the clinical trial. If the potential participant is unwilling to refrain from taking these items, they will not be eligible for the clinical trial.
13. Currently consuming one cup or more of beets daily. Participants will be asked to discontinue beet ingestion of one cup or more of beets for 30 days before baseline testing and throughout the clinical trial. If the potential participant is unwilling to refrain from daily beet consumption of one cup or more for 30 days before the trial and during the trial, they will not be eligible for the clinical trial.
14. Non-English speaking
15. Participation in or completion of a clinical trial in the previous three months. \[NOTE: after completing a stem cell or gene therapy intervention, participants will become eligible after the final study follow-up visit of the stem cell or gene therapy study so long as at least six months have passed since the final intervention administration. After completing a supplement or drug therapy (other than stem cell or gene therapy), participants will be eligible after the final study follow-up visit as long as at least three months have passed since the final intervention of the trial.\]
16. Visual impairment that limits walking ability.
17. Six-minute walk distance of \<500 feet or \>1600 feet. Investigator discretion will be used to decide whether participants who walk greater than 1600 feet are eligible.
18. Baseline blood pressure \<100/45.
19. Participation in a supervised treadmill exercise program in previous three months.
20. Using an antibacterial mouthwash (such as Cepacol) or a mouthwash containing chlorhexidine and unwilling to discontinue.
21. An eGFR value \<30 or potassium \>5.0.
22. History of kidney stones that requires minimized intake of oxalate. Potential participants who need to minimize oxalate intake will be excluded from the trial.
23. 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.

Where this trial is running

Chicago, Illinois and 3 other locations

• Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States (Recruiting)
• University of Chicago — Chicago, Illinois, United States (Recruiting)
• University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
• University of Virginia — Charlottesville, Virginia, United States (Active_not_recruiting)

Study contacts

• Study coordinator: Mary McDermott, MD

Conditions Peripheral Artery Disease; beetroot juice, mobility, intermittent claudication, peripheral artery disease