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Beetroot Juice for Peripheral Arterial Disease (BEET PAD Trial)

N/A

Recruiting

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

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

Must have

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.

Must not have

Walking is limited by a symptom other than PAD

Critical limb ischemia defined as an ABI <0.40 with symptoms of rest pain

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to four-month follow-up

Summary

This trial investigates whether beetroot juice can improve walking performance in people with PAD. It tests the acute & chronic effects on 6-minute walk and looks at biological pathways.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed here, potential side effects from consuming beetroot juice could include changes in urine color (pink or red), stomach upset or discomfort due to its detoxifying properties. Allergic reactions may occur but are considered rare.

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 PAD based on vascular tests or angiography.

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

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I am 50 years old or older.

Exclusion Criteria

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

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My walking is limited by a condition that is not related to leg artery disease.

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

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

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I am not willing to stop consuming beetroot products for the study duration.

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My vision problems make it hard for me to walk.

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I have had an amputation above or below the knee.

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I use a wheelchair or walker to move around.

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I use a specific mouthwash and don't want to stop.

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I do not speak English.

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I haven't had major surgery or significant heart issues in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to four-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to four-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to four-month follow-up for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Four-month change in six-minute walk distance

Secondary study objectives

2.5 hour change in six-minute walk distance (acute effect)

Four-month + 24 hour change in six-minute walk distance (chronic effect)

Four-month change in Walking Impairment Questionnaire (WIQ) distance score

+2 more

Other study objectives

Durability of effect on six-minute walk distance

Four-month change in Short-Form 36 Physical Function questionnaire score

Four-month change in Walking Impairment Questionnaire (WIQ) speed and stair climbing scores

+3 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Beetroot juiceActive Control1 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: PlaceboPlacebo Group1 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.

0 / 13Eligibility criteria met