Peripheral Artery DiseaseBEET PADNCT05624125
BEETroot Juice to Reverse Functional Impairment in PAD
A study testing Beetroot juice in people with Peripheral Artery Disease, run by Northwestern University at 4 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- Beetroot juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 4 sitesUnited States
- Study dates
- 25 Jan 2023to 1 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Above- or below-knee amputation
- Critical limb ischemia defined as an ABI <0.40 with symptoms of rest pain
- Wheelchair confinement or requiring a walker to ambulate
- Walking is limited by a symptom other than PAD
- Current foot ulcer on bottom of foot
- Failure to successfully complete the study run-in
Show all 23Show fewer
- Planned major surgery, coronary or leg revascularization during the next five months
- Major surgery, coronary or leg revascularization or major cardiovascular event in the previous three months
- 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.]
- Mini-Mental Status Examination (MMSE) score < 23
- Allergy to beetroot juice
- 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.
- 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.
- Non-English speaking
- 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.]
- Visual impairment that limits walking ability.
- 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.
- Baseline blood pressure <100/45.
- Participation in a supervised treadmill exercise program in previous three months.
- Using an antibacterial mouthwash (such as Cepacol) or a mouthwash containing chlorhexidine and unwilling to discontinue.
- An eGFR value <30 or potassium >5.0.
- History of kidney stones that requires minimized intake of oxalate. Potential participants who need to minimize oxalate intake will be excluded from the trial.
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 3 recruiting
- Active, not recruiting
University of Virginia
Charlottesville, Virginia, 22903
- Recruiting
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Kathryn Domanchuk, BS, 312-503-6438, k-domanchuk@northwestern.edu
Mary M McDermott, MD
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Tamar Polonsky, MD, 773-702-6153, tpolonsky@bsd.uchicago.edu
Tamar Polonsky, MD
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Diane Treat-Jacobson, PhD, 612-624-7613, treat001@umn.edu
Diane Treat-Jacobson, PhD
About this study
Official title: BEETroot Juice to Reverse Functional Impairment in PAD: The BEET PAD 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.
- Conditions
- Peripheral Artery Disease
- Being tested
- Beetroot juice, Placebo
- Keywords
- beetroot juice, mobility, intermittent claudication, peripheral artery disease
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beetroot juiceOther
Two 70 ml beetroot juice drinks daily for 4 months.
PlaceboOther
Two 70 ml placebo drinks daily for 4 months.
| Study group | Role | What they receive |
|---|---|---|
| Beetroot juice | Active comparator | 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. Receives: Other: Beetroot juice |
| Placebo | Placebo comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Four-month change in six-minute walk distance
Change in six-minute walk distance at four-month follow-up will be compared between those randomized to beetroot juice vs. those randomized to placebo
Measured: Baseline to four-month follow-up
Secondary outcomes (5)
2.5 hour change in six-minute walk distance (acute effect)
Change in six-minute walk distance 2.5 hours after drinking the first study beverage (acute effect) will be compared between those randomized to beetroot juice vs. those randomized to placebo
Measured: Baseline 2.5 hour follow-up
Four-month + 24 hour change in six-minute walk distance (chronic effect)
Change in six-minute walk distance at four-month follow-up, 24 hours after drinking study beverage (chronic effect) will be compared between those randomized to beetroot juice vs. those randomized to placebo
Measured: Baseline to four-month + 24 hour follow-up
Four-month change in calf muscle perfusion
Change in calf muscle perfusion will be compared between those randomized to beetroot juice vs. those randomized to placebo
Measured: Baseline to four-month follow-up
Four-month change in Walking Impairment Questionnaire (WIQ) distance score
Change in WIQ distance score will be compared between those randomized to beetroot juice vs. those randomized to placebo
Measured: Baseline to four-month follow-up
Four-month change in six-minute walk distance among participants randomized to beetroot juice
Among those randomized to beetroot juice, investigators will determine whether those who attain a higher immediate peak or a greater increase in plasma nitrate levels at 2.5 hours after the first dose of beetroot juice at baseline will have a greater six-minute walk improvement at 4-month follow-up, compared to those with a lower peak or a smaller increase in nitrite, respectively
Measured: 2.5 hour to four-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start25 Jan 2023
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Virginia, University of Chicago, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Mary McDermott, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05624125
- Sponsor's protocol ID
- STU00217101
- Other IDs
- R01AG073257
- Acronym
- BEET PAD
- Status last verified
- Apr 2026
- First submitted
- 13 Nov 2022
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McDermott MM, Cetlin MD, Domanchuk KJ, Xu S, Whipple MO, Polonsky T, Criqui MH, Guralnik JM, Tian L, Zhao L, Ho KJ, Greenland P, Treat-Jacobson D. Community-based recruitment with ankle brachial index testing to identify peripheral artery disease participants for randomized clinical trials. Am Heart J. 2026 Oct;300:107450. doi: 10.1016/j.ahj.2026.107450. Epub 2026 Apr 24.
PubMed 42035974
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BEETroot Juice to Reverse Functional Impairment in PAD: The BEET PAD Trial
- ClinicalTrials.gov ID
- NCT05624125
- Acronym / sponsor ID
- BEET PAD / STU00217101
- Conditions
- Peripheral Artery Disease
- Keywords
- beetroot juice, mobility, intermittent claudication, peripheral artery disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- University of Virginia, University of Chicago, National Institute on Aging (NIA)
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 21 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beetroot juice | Active comparator | Other: Beetroot juiceThe 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 | Placebo comparator | Other: PlaceboThe 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 50 and older
- Presence of peripheral artery disease, defined as:
Key exclusion criteria (23 listed)
- Above- or below-knee amputation
- Critical limb ischemia defined as an ABI <0.40 with symptoms of rest pain
- Wheelchair confinement or requiring a walker to ambulate
- Walking is limited by a symptom other than PAD
- Current foot ulcer on bottom of foot
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beetroot juiceTwo 70 ml beetroot juice drinks daily for 4 months. | Other | Beetroot juice |
| PlaceboTwo 70 ml placebo drinks daily for 4 months. | Other | Placebo |
Primary outcome
Four-month change in six-minute walk distance
Time frame: Baseline to four-month follow-up
Change in six-minute walk distance at four-month follow-up will be compared between those randomized to beetroot juice vs. those randomized to placebo
5 secondary outcomes
2.5 hour change in six-minute walk distance (acute effect)
Time frame: Baseline 2.5 hour follow-up
Four-month + 24 hour change in six-minute walk distance (chronic effect)
Time frame: Baseline to four-month + 24 hour follow-up
Four-month change in calf muscle perfusion
Time frame: Baseline to four-month follow-up
Four-month change in Walking Impairment Questionnaire (WIQ) distance score
Time frame: Baseline to four-month follow-up
Four-month change in six-minute walk distance among participants randomized to beetroot juice
Time frame: 2.5 hour to four-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Derived from this study: PubMed 42035974McDermott MM, Cetlin MD, Domanchuk KJ, Xu S, Whipple MO, Polonsky T, Criqui MH, Guralnik JM, Tian L, Zhao L, Ho KJ, Greenland P, Treat-Jacobson D. Community-based recruitment with ankle brachial index testing to identify peripheral artery disease participants for randomized clinical trials. Am Heart J. 2026 Oct;300:107450. doi: 10.1016/j.ahj.2026.107450. Epub 2026 Apr 24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beetroot juice in people with Peripheral Artery Disease, run by Northwestern University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary McDermott, MD (312-503-6419, mdm608@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Four-month change in six-minute walk distance (time frame: Baseline to four-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05624125, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.