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Vasodilator

Beetroot Juice for Peripheral Arterial Disease (HeartBeet Trial)

Phase 2

Waitlist Available

Led By Urs A Leuenberger, MD

Research Sponsored by David N. Proctor, PhD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with peripheral arterial disease (PAD)

Fontaine stage II or less - no pain while resting

Must not have

Patients taking phosphodiesterase inhibitors such as sildenafil or tadalafil

Uncontrolled hypertension

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 days after initiating daily ingestion of beetroot juice

Summary

This trial will test whether short-term consumption of inorganic nitrate can improve blood flow responses, large artery hemodynamics, and leg oxygenation/exercise tolerance in patients with peripheral arterial disease.

Who is the study for?

This trial is for adults aged 21-85 with Peripheral Arterial Disease (PAD) who can consent and walk on a treadmill. They should have an ankle-brachial index below 0.9, no pain at rest, and be in good health otherwise. Excluded are those on certain heart or ED medications, pregnant women, children, those with severe liver or lung disease, recent heart attacks or uncontrolled hypertension/diabetes.

What is being tested?

The study tests if drinking concentrated beetroot juice improves blood flow in the heart and legs of PAD patients compared to a placebo drink. It aims to see if this can help increase exercise tolerance without triggering leg pain or high blood pressure that PAD patients often experience during physical activity.

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects from consuming beetroot juice may include changes in urine color (pink), digestive discomforts like stomach upset or cramps, and possible allergic reactions for those sensitive to its components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with peripheral arterial disease.

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I don't have pain in my legs while resting.

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I have been diagnosed with peripheral artery disease (PAD).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking medication like sildenafil or tadalafil.

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My high blood pressure is not under control.

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My diabetes is not under control.

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I have had a heart attack or unstable chest pain in the last 6 months.

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I frequently use an inhaler or need extra oxygen.

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My kidney function is not normal.

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I have been diagnosed with Barrett's esophagus.

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I cannot walk on a treadmill at 2.0 miles/hour.

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I am currently taking nitroglycerine or nitrate medications.

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I am currently taking medication for stomach acid.

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My liver isn't working properly.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 days after initiating daily ingestion of beetroot juice

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 days after initiating daily ingestion of beetroot juice

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 days after initiating daily ingestion of beetroot juice for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Exercise performance

Secondary study objectives

Coronary vascular function

Leg vascular function

Other study objectives

Blood measures of nitrate absorption and conversion

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Beetroot juice (Beet-It Organic Shot)Active Control1 Intervention

Subjects will consume 70 ml of beetroot juice (Beet-It Organic Shot) twice per day (morning, afternoon) for 5 to 7 days to assess the short term effects of this nitrate supplement on graded treadmill walking responses (day 4) and vasodilator/vasoconstrictor responses in the coronary and lower leg circulations (day 5 or 6 or 7). On both study visits, subjects will consume their morning dose 1 hour 45 min before experiments begin.

Group II: Beetroot juice placebo (Beet-It Organic Placebo)Placebo Group1 Intervention

Subjects will consume 70 ml of beetroot juice placebo (Beet-It Organic Placebo) twice per day (morning, afternoon) for 5 to 7 days to assess the short term effects of this nitrate supplement on graded treadmill walking responses (day 4) and vasodilator/vasoconstrictor responses in the coronary and lower leg circulations (day 5 or 6 or 7). On both study visits, subjects will consume their morning dose 1 hour 45 min before experiments begin.

0 / 14Eligibility criteria met