Overview

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

Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
David N. Proctor
David N. Proctor, PhD
Collaborators:
Milton S. Hershey Medical Center
Wake Forest University Health Sciences
Criteria
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 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)