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The Effects of Oral Inorganic Nitrate Supplementation on Lower Limb Perfusion During Exercise in Patients With PAD

NCT05036213 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2023-11-29

No results posted yet for this study

Summary

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.

Conditions

  • Peripheral Arterial Disease
  • Peripheral Vascular Diseases

Interventions

DRUG

BEET IT - Concentrate Beet root juice

Each bottle contains 75ml of concentrated beetroot juice with approximately 6.2mmol of inorganic nitrate. The product is provided by BEET IT, James White Drinks, Ipswich, UK.

DRUG

BEET IT - Concentrate Beet root juice (nitrate depleted)

Each bottle contains 75ml of concentrated beetroot juice with depleted nitrate, thus, no inorganic nitrate is found in thisbeverage. The product is also provided by BEET IT, James White Drinks, Ipswich, UK.

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Principal Investigators

  • Jason D. Allen, PhD · University of Virginia

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-01
Primary Completion
2024-12-31
Completion
2024-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05036213 on ClinicalTrials.gov