Actively Recruiting

Phase Not Applicable
Age: 50Years +
All Genders
ID05624125

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

Led by Northwestern University · Updated on 2026-04-15

210

Participants Needed

4

Research Sites

26 weeks

Total Duration

On this page

Sponsors

N

Northwestern University

Lead Sponsor

U

University of Virginia

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of beetroot juice on walking ability in people aged 50 and older with peripheral artery disease (PAD), a condition that affects blood flow to the legs. This multi-center, double-blind, randomized clinical trial aims to see if beetroot juice can improve the distance participants can walk in six minutes after four months compared to a placebo. The study also explores how beetroot juice affects muscle blood flow, muscle health, and regeneration, as well as the relationship between nitrate metabolism and walking performance. Participants receive either two 70 ml drinks daily for four months containing beetroot juice with nitrate or a placebo drink that looks similar but has the nitrate removed. Each active drink provides 400 mg of nitrate, totaling 800 mg daily. The study measures both the immediate effect of beetroot juice 2.5 hours after consumption and the longer-term effects after four months. The placebo group receives a nitrate-free beetroot juice drink to compare results. During the trial, participants undergo tests including a six-minute walk test at baseline, 2.5 hours, and four months to measure walking distance changes. Additional assessments measure calf muscle blood flow using MRI, muscle health, and questionnaire scores related to walking ability. Researchers will monitor nitrate levels in the blood to understand their impact. Participants are followed for at least four months, with strict eligibility criteria and health monitoring to ensure safety and study integrity.

CONDITIONS

Brief Title

BEETroot Juice to Reverse Functional Impairment in PAD

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 50 years or older
  • Diagnosis of peripheral artery disease confirmed by ankle brachial index (ABI) ≤ 0.90, vascular lab evidence (such as toe brachial pressure ≤ 0.70), angiographic evidence with at least 70% artery narrowing, or ABI >0.90 to ≤1.00 with a 20% or greater drop after heel-rise test
  • Ability to walk without a wheelchair or walker
  • Willingness to avoid beetroot juice, oral nitrate or nitrite supplements, or beetroot supplements for 30 days before baseline and during the trial
  • Ability to speak English
Not Eligible

You will not qualify if you...

  • Above- or below-knee amputation
  • Critical limb ischemia with ABI <0.40 and rest pain
  • Wheelchair confinement or need for a walker to walk
  • Walking limited by causes other than PAD
  • Current foot ulcer on bottom of foot
  • Failure to complete study run-in phase
  • Planned major surgery or vascular procedures in next five months
  • Major surgery, vascular procedures, or major cardiovascular event in past three months
  • Major medical illnesses like lung disease requiring oxygen, Parkinson's disease, life expectancy under six months, or recent cancer treatment
  • Mini-Mental Status Exam score below 23
  • Allergy to beetroot juice
  • Current consumption of beetroot juice or related supplements unwilling to stop
  • Daily beet consumption of one cup or more unwilling to stop
  • Non-English speaking
  • Participation in other clinical trials within past three months
  • Visual impairment limiting walking ability
  • Six-minute walk distance less than 500 feet or greater than 1600 feet (with investigator discretion)
  • Baseline blood pressure below 100/45
  • Participation in supervised treadmill exercise in past three months
  • Use of antibacterial or chlorhexidine-containing mouthwash unwilling to stop
  • Kidney function with eGFR below 30 or potassium above 5.0
  • History of kidney stones requiring low oxalate intake
  • Investigator discretion if trial is unsafe or unsuitable for participant

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 4 months

Participants receive two 70 ml drinks daily of either beetroot juice or placebo for 4 months to evaluate effects on functional impairment in PAD.

Baseline visit and follow-up visits during treatment

Trial Site Locations

Total: 4 locations

1

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States, 60611

Actively Recruiting

2

University of Chicago

Chicago, Illinois, United States, 60637

Actively Recruiting

3

University of Minnesota

Minneapolis, Minnesota, United States, 55455

Actively Recruiting

4

University of Virginia

Charlottesville, Virginia, United States, 22903

Active, Not Recruiting

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Research Team

M

Mary McDermott, MD

K

Kathryn Domanchuk, BS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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