Effect of Beetroot Juice on Coronary Blood Flow and Walking Performance in PAD

Last updated: April 5, 2023
Sponsor: David N. Proctor, PhD
Overall Status: Active - Not Recruiting

Phase

2

Condition

Claudication

Peripheral Arterial Occlusive Disease

Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT02553733
00003242
  • Ages 21-85
  • All Genders

Study Summary

In this study the investigators will test the hypothesis that short-term consumption of inorganic nitrate (supplied in concentrated beetroot juice) enhances coronary blood flow responses, large artery hemodynamics, and leg oxygenation/exercise tolerance in patients with peripheral arterial disease (PAD). Understanding and improving blood flow regulation in the heart and skeletal muscles of patients with PAD is important because exercise triggers symptoms of leg pain and substantially raises blood pressure and myocardial demand in these patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients with peripheral arterial disease (PAD)
  2. Capable of giving informed consent
  3. Men and women age 21- 85 years
  4. Diagnosed with PAD (i.e., ankle-brachial index below 0.9)
  5. Fontaine stage II or less - no pain while resting
  6. Satisfactory history and physical exam

Exclusion

Exclusion Criteria:

  1. Children
  2. Pregnant or nursing women
  3. Patients taking nitroglycerine or nitrate preparations
  4. Patients taking phosphodiesterase inhibitors such as sildenafil or tadalafil
  5. Patients taking proton pump inhibitors
  6. Ejection fraction < 40%
  7. Uncontrolled hypertension
  8. Uncontrolled diabetes
  9. Myocardial infarction within past 6 months or unstable angina
  10. Severe lung disease (i.e., on supplemental oxygen or frequently use rescue inhalers)
  11. Abnormality in hemoglobin or hematocrit or methemoglobin
  12. Impaired renal function
  13. Impaired liver function
  14. History or diagnosis of Barrett's esophagus
  15. Known allergy to beetroot juice or lemon juice
  16. Inability to walk on a treadmill at a moderate pace (2.0 miles/hour)

Study Design

Total Participants: 12
Study Start date:
December 01, 2015
Estimated Completion Date:
December 31, 2024

Study Description

Peripheral arterial disease (PAD) is a strong predictor of cardiovascular mortality and negatively affects functional capacity and quality of life for as many as 14 million patients in the U.S. alone. One open-label study showed that acute consumption of beetroot juice improved 6 min walk performance, reduced blood pressure, and enhanced leg muscle oxygenation in PAD patients. However, no studies have rigorously confirmed these findings in a double-blind manner, nor have the effects of this supplement been investigated (acutely or short-term) in the coronary circulation of PAD patients.

In addition to studying its effects on graded treadmill walking performance and consequent large artery vasodilation, the present study will examine the effects of short-term beetroot juice consumption (twice/day) on both coronary and leg vasodilator (graded calf flexion) and vasoconstrictor (isometric handgrip, voluntary apnea) responses in patients with PAD. Participants will randomly consume either nitrate-rich or nitrate-depleted beetroot juice with a 7 to 14 day wash-out period between. Effects of beetroot juice consumption on plasma nitrate, nitrite and methemoglobin will also be assessed.

Connect with a study center

  • Milton S. Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

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