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Inorganic Nitrate Supplement

Beetroot Juice for Peripheral Arterial Disease

Phase 1

Recruiting

Led By Jason D. Allen, PhD

Research Sponsored by University of Virginia

Eligibility Criteria Checklist

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

Must have

History of stable intermittent claudication for 3 or more months, and an Ankle-brachial index test (ABI) <0.9 at rest

Symptomatic PAD (claudication or critical limb ischemia)

Must not have

Refusal to give or inability to give informed consent

Chest pain during treadmill exercise which appears before the onset of claudication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after a minimum of 3 days of supplementation with either placebo or nitrate rich beverage.

Summary

This trial is testing whether or not beetroot juice can help people with peripheral arterial disease by increasing blood flow and improving exercise performance.

Who is the study for?

This trial is for patients with Peripheral Arterial Disease (PAD) who experience leg pain during walking due to poor blood flow. They must have had stable symptoms for at least 3 months and an Ankle-brachial index test result of less than 0.9. Those with severe conditions affecting their limbs, recent major heart issues, extreme peripheral neuropathy, or uncontrolled diabetes cannot participate.

What is being tested?

The study tests if drinking concentrated beetroot juice, which is high in dietary nitrate, improves blood flow and muscle function in PAD patients compared to a placebo drink without nitrates. Participants will be randomly assigned to receive either the real supplement or placebo in a double-blind manner.

What are the potential side effects?

While not explicitly listed here, potential side effects may include changes in digestion due to beetroot juice consumption such as stomach upset or colored stools and possible interactions with existing medications.

Eligibility Criteria

Inclusion Criteria

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

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I have had leg pain while walking for over 3 months and my ABI test result is less than 0.9.

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I have pain in my legs due to poor blood flow.

Exclusion Criteria

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

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I am unable or unwilling to give consent for treatment.

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I experience chest pain when exercising before feeling leg pain.

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I have had major heart artery blockage or a recent heart attack.

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I have type 1 diabetes, a BMI over 40, and my HbA1c level is above 8.5%.

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I do not have severe nerve pain or conditions that limit my walking.

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My kidney function is severely reduced.

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I am experiencing severe limb pain or risk of losing a limb due to poor blood flow.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after a minimum of 3 days of supplementation with either placebo or nitrate rich beverage.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after a minimum of 3 days of supplementation with either placebo or nitrate rich beverage.

This trial's timeline: 3 weeks for screening, Varies for treatment, and after a minimum of 3 days of supplementation with either placebo or nitrate rich beverage. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Phosphocreatine kinetics after maximal exercise

Secondary study objectives

Claudication Onset Time

Maximal hyperemia in different lower limb compartments

Peak exercise

+2 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Dietary nitrateActive Control1 Intervention

The active treatment, beetroot juice (BEET IT, James White Drinks, Ipswich, UK), contains 6.2mmol of inorganic nitrate. Participants will continue supplementation until they complete all testing visits.

Group II: concentrated beet root juice with depleted nitrate contentPlacebo Group1 Intervention

The placebo treatment is also beetroot juice provide by the same company (BEET IT, James White Drinks, Ipswich, UK), but it does not contain any inorganic nitrate. Participants will continue supplementation until they complete all testing visits.

0 / 9Eligibility criteria met