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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: mdm608@northwestern.edu
• Phone: 312-503-6419

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Antiplatelet-Only versus Antiplatelet plus Low-Dose Rivaroxaban after Heart Events

  In adults 65 or older with prior heart events and certain arterial diseases, this study tests whether continuing clopidogrel alone is no worse than adding low-dose rivaroxaban to aspirin-based therapy.

  Recruiting Phase 4 Seoul National University Bundang Hospital · Seongnam-si, Gyeonggi-do · NCT07796217

• Home-based Pedal Exerise Therapy for Moderate-to-Severe PAD

  This pilot study tests whether a 12-week home-based pedal exerciser program, guided remotely, can help adults with moderate-to-severe PAD improve walking and function.

  Recruiting Laval University · Lévis, Quebec · NCT07655206

• Super-resolution ultrasound imaging for peripheral artery disease

  This project will test whether super-resolution contrast ultrasound can reveal small-vessel problems in adults with or without peripheral artery disease.

  Recruiting Peking University First Hospital · Beijing, Beijing Municipality · NCT07374601

• Obstructive sleep apnea prevalence in people with peripheral artery disease

  This project will test how common obstructive sleep apnea is in adults with peripheral artery disease by using sleep polygraphy during routine care.

  Recruiting Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer · Toulon, Var · NCT07283289

• Using wearable activity trackers and a mobile app to help people with peripheral artery disease walk better

  This project will test whether a personalized home walking program guided by wearable activity trackers and automatic feedback can help people with peripheral artery disease walk as well as supervised exercise sessions.

  Recruiting at 2 sites Chinese University of Hong Kong · Hong Kong, Hong Kong and 1 other locations · NCT07012070

• Evaluating a Paclitaxel Coated Balloon for Treating Atherosclerosis in Leg Arteries

  This study is testing a special balloon treatment to see if it can safely improve blood flow and reduce symptoms in people with blocked leg arteries due to peripheral artery disease.

  Recruiting at 2 sites Balton Sp.zo.o. · Chrzanów, Malopolska and 2 other locations · NCT06734221

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.