Beetroot Juice for Peripheral Arterial Disease

(BEET PAD Trial)

Recruiting at 3 trial locations

Overseen By Mary McDermott, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Must not be taking: Oral nitrates, Nitrites

Disqualifiers: Amputation, Critical limb ischemia, Wheelchair, Major surgery, others

Compensation: Varies

Number of Visits: 2

Duration: 16 weeks

210 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether beetroot juice can help people with peripheral artery disease (PAD) walk longer distances. Researchers aim to determine if beetroot juice can improve blood flow and muscle health in the legs, enhancing walking performance over four months. Participants will drink either beetroot juice or a placebo (a look-alike drink without the active ingredient) to compare results. This trial may suit individuals with diagnosed PAD who struggle with walking distances due to the condition and do not regularly consume beetroot juice or eat beets. As an unphased trial, it offers an opportunity to contribute to understanding potential new benefits of beetroot juice for PAD.

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.

Is there any evidence suggesting that beetroot juice is likely to be safe for humans?

Research shows that beetroot juice is usually safe for consumption. Studies have found that it can improve brain function and may serve as a non-invasive option for individuals with Peripheral Artery Disease (PAD). In smaller studies, short-term use of beetroot juice improved certain health indicators without causing serious issues.

These findings suggest that beetroot juice might be safe for those considering it as a treatment. However, consulting a healthcare provider before starting any new treatment is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for Peripheral Arterial Disease (PAD), which often involve medications to improve blood flow like cilostazol or pentoxifylline, beetroot juice offers a natural alternative. This treatment is unique because it harnesses the power of dietary nitrates found in beetroot juice, which can help widen blood vessels and improve circulation. Researchers are excited about this because it provides a simple, non-invasive option that could complement or even reduce the need for pharmaceutical interventions. Plus, the delivery method as a juice is user-friendly and easy to incorporate into daily life.

What evidence suggests that beetroot juice might be an effective treatment for PAD?

Research suggests that beetroot juice, which participants in this trial may receive, might help people with Peripheral Artery Disease (PAD) walk more easily. Some studies have found it can increase walking time before pain by 18% and total walking time by 17%. Beetroot juice may improve blood flow and muscle function, enhance blood vessel performance, and lower blood pressure. However, not all studies showed improvements, so results can vary. Overall, beetroot juice seems promising but isn't guaranteed to help everyone. Participants in this trial will be assigned to either the beetroot juice group or a placebo group to evaluate its effectiveness. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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

I am 50 years old or older.

I have been diagnosed with PAD based on vascular tests or angiography.

My ABI is between 0.90 and 1.00, and it drops by 20% or more after a physical test.

Exclusion Criteria

I have severe leg pain at rest due to poor blood flow.

I have a current foot ulcer on the bottom of my foot.

I haven't been in a clinical trial for at least 3 months, or 6 months if it was for stem cell/gene therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive beetroot juice or placebo twice daily to assess its effects on six-minute walk distance and other health metrics

16 weeks

Regular visits for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of walking performance and muscle health

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Beetroot juice
• Placebo

Trial Overview

The BEET PAD Trial is testing whether drinking beetroot juice improves walking ability after four months compared to a placebo drink. The idea is that the natural compounds in beetroot juice might help increase blood flow and muscle health in the legs of those with PAD.

How Is the Trial Designed?

Group I: Beetroot juice Active Control 1 Intervention

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.

Group II: Placebo Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

University of Virginia

Collaborator

Trials

802

Recruited

1,342,000+

University of Chicago

Collaborator

Trials

1,086

Recruited

844,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

Ingesting beetroot juice rich in nitrate (NO3-) significantly increases plasma levels of both nitrate and nitrite (NO2-), which can positively affect cardiovascular measures like mean arterial pressure (MAP).

While both NO3- and NO2- have the potential to lower MAP, the expected reduction in systolic and diastolic blood pressure was not observed, suggesting that the role of NO2- in blood pressure regulation alongside NO3- needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of Nitrate and Nitrite Following Beetroot Juice Drink Consumption. Jakubcik, EM., Rutherfurd-Markwick, K., Chabert, M., et al.[2021]

Dietary supplementation with beetroot juice significantly increased plasma nitrite levels, which are linked to improved nitric oxide production, and led to longer walking times before experiencing claudication pain in patients with peripheral arterial disease (PAD).

The study, involving 8 subjects in a randomized crossover design, demonstrated that beetroot juice not only enhanced exercise tolerance but also reduced oxygen extraction in the gastrocnemius muscle during exercise, indicating better oxygen delivery to tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary nitrate supplementation enhances exercise performance in peripheral arterial disease. Kenjale, AA., Ham, KL., Stabler, T., et al.[2021]

In a study involving 15 COPD patients, acute ingestion of beetroot juice significantly improved exercise capacity, allowing patients to exercise longer at a submaximal workload compared to a placebo.

Beetroot juice also led to notable reductions in both resting and exercise-induced blood pressure, indicating potential cardiovascular benefits alongside improved exercise performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary nitrate supplementation improves exercise performance and decreases blood pressure in COPD patients. Berry, MJ., Justus, NW., Hauser, JI., et al.[2018]

This study will evaluate the effects of beetroot juice, rich in nitrates, on cardiovascular performance in 25 postmenopausal women with systemic arterial hypertension, using both acute (800 mg) and daily doses (400 mg) over a week.

The research aims to provide insights into how beetroot juice can improve cardiovascular health during exercise, potentially leading to specific nutritional recommendations for women with hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nitrate-rich beet juice intake on cardiovascular performance in response to exercise in postmenopausal women with arterial hypertension: study protocol for a randomized controlled trial. Benjamim, CJR., Sousa, YBA., Porto, AA., et al.[2023]

In a study involving 18 patients with peripheral arterial disease, both nitrate-rich vegetables and beetroot juice significantly increased plasma nitrate and nitrite levels, with beetroot juice showing the highest increase.

Despite the increase in plasma nitrate and nitrite, there were no improvements in exercise tolerance, muscle oxygenation, or cardiovascular function, indicating that higher nitrate levels do not necessarily enhance physical performance in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute Effects of Dietary Nitrate on Exercise Tolerance, Muscle Oxygenation, and Cardiovascular Function in Patients With Peripheral Arterial Disease. van der Avoort, CMT., van Loon, LJC., Verdijk, LB., et al.[2022]

Acute dietary nitrate supplementation from beetroot juice significantly increased plasma nitrate and nitrite levels and reduced resting arterial pulse wave velocity, indicating a biological effect on vascular function.

However, despite these systemic changes, the supplementation did not enhance blood flow or brachial artery dilation during graded handgrip exercise in healthy young men, suggesting that its benefits may not extend to improving exercise-induced blood flow.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute dietary nitrate supplementation does not augment submaximal forearm exercise hyperemia in healthy young men. Kim, JK., Moore, DJ., Maurer, DG., et al.[2018]

A moderate dose of dietary nitrate from beetroot juice significantly improved skeletal muscle microvascular function and increased the 6-minute walking distance in patients with peripheral artery disease (PAD), based on a study involving 10 participants.

The improvements in microvascular function were positively correlated with better walking distances, suggesting that dietary nitrate may enhance blood flow and exercise recovery in PAD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moderate dose of dietary nitrate improves skeletal muscle microvascular function in patients with peripheral artery disease. Pekas, EJ., Anderson, CP., Park, SY.[2023]

In a study involving 17 chronic kidney disease (CKD) patients, supplementation with beetroot juice, which is high in dietary nitrate, significantly reduced blood pressure and renal resistive index (RRI), suggesting potential cardiovascular benefits.

The reduction in blood pressure and RRI after beetroot juice consumption may be attributed to the release of nitric oxide (NO), a vasodilator, indicating that dietary nitrate could be a useful adjunct therapy for managing hypertension in CKD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary nitrate load lowers blood pressure and renal resistive index in patients with chronic kidney disease: A pilot study. Kemmner, S., Lorenz, G., Wobst, J., et al.[2018]

Citations

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pmc.ncbi.nlm.nih.gov

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Efficacy of Beetroot Juice in Patients With Peripheral Artery ...

Two studies demonstrated significant differences in COT and PWT, while others reported either no significant changes or improvements in both ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT05624125

BEETroot Juice to Reverse Functional Impairment in PAD

Preliminary evidence suggests that beetroot juice has both acute and chronic effects on walking performance in PAD. The primary outcome will measure the ...

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frontiersin.org

frontiersin.org/journals/nutrition/articles/10.3389/fnut.2024.1398108/full

Effects of short-term dietary nitrate supplementation on ...

In this small study of PAD patients, short-term nitrate supplementation with beetroot juice did not improve leg exercise tolerance, but robustly increased ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S1089860325000266

Exploring the therapeutic potential of beetroot juice in ...

Beetroot juice enhances exercise performance and microvascular function in PAD. Beetroot juice improves endothelial function and lowers blood pressure.

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adanews.ada.org

adanews.ada.org/huddles/beetroot-juice-shows-early-potential-in-treating-peripheral-artery-disease/

Beetroot juice shows early potential in treating peripheral ...

Two trials reported significant gains: one found an 18% increase in claudication onset time and a 17% improvement in peak walking time. Other trials, however, ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11257697/

Effects of short-term dietary nitrate supplementation on ...

In this small study of PAD patients, short-term nitrate supplementation with beetroot juice did not improve leg exercise tolerance, but robustly ...