Beetroot Juice for Peripheral Arterial Disease

Recruiting in Palo Alto (17 mi)

Overseen byJason D. Allen, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: University of Virginia

Trial Summary

What is the purpose of this trial?

Peripheral arterial disease (PAD) is a highly prevalent and costly condition. Intermittent claudication (IC), defined as ischemic leg pain that occurs with walking, results in functional impairment, reduced daily physical activity, and a lower quality of life. Although the mechanisms contributing to functional impairment are not fully delineated, current evidence suggests that the uncoupling of skeletal muscle cellular metabolism from tissue perfusion may be responsible for exercise intolerance. We have previously shown increases in plasma inorganic nitrite, via oral nitrate, produced clinically significant increases exercise performance in patients with PAD+IC. The hypothesis of this proposal is in patients with PAD+IC, 3-6 days of oral dietary nitrate consumption (in the form of concentrated beetroot juice) will produce a greater tissue perfusion, oxygen delivery, and enhanced muscle metabolism in comparison to placebo. This will translate into an increase in physical performance in both muscle specific plantar flexion exercise and treadmill measures of pain free ambulation. In order to test this hypothesis, we will recruit 10 patients PAD+IC in a randomized, double-blind, placebo controlled, cross over design.

Eligibility Criteria

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.

Inclusion Criteria

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

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

Exclusion Criteria

I am unable or unwilling to give consent for treatment.

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

I experience chest pain when exercising before feeling leg pain.

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Treatment Details

Interventions

BEET IT - Concentrate Beet root juice (Inorganic Nitrate Supplement)
BEET IT - Concentrate Beet root juice (nitrate depleted) (Placebo)

Trial OverviewThe 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.

Participant Groups

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.