Effects of beetroot juice on leg blood flow during exercise in patients with PAD
The Effects of Oral Inorganic Nitrate Supplementation on Lower Limb Perfusion and Metabolism During Exercise in Patients With Peripheral Arterial Disease (PAD)
PHASE1 · University of Virginia · NCT05036213
This study is testing if drinking concentrated beetroot juice for a few days can help improve blood flow in the legs during exercise for people with Peripheral Arterial Disease.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | University of Virginia (other) |
| Locations | 1 site (Charlottesville, Virginia) |
| Trial ID | NCT05036213 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of oral inorganic nitrate supplementation, specifically through concentrated beetroot juice, on lower limb perfusion during exercise in patients with Peripheral Arterial Disease (PAD) who experience intermittent claudication. The study aims to determine whether 3-6 days of dietary nitrate consumption can enhance tissue perfusion, oxygen delivery, and muscle metabolism compared to a placebo. By measuring changes in exercise performance, the trial seeks to provide insights into improving the quality of life for patients suffering from this condition.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with stable intermittent claudication and an ankle-brachial index (ABI) of less than 0.9.
Not a fit: Patients with limb-threatening ischemia, severe peripheral neuropathy, or other conditions that limit walking may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved exercise performance and quality of life for patients with PAD.
How similar studies have performed: Previous studies have shown promising results with nitrate supplementation in enhancing exercise performance in patients with PAD, suggesting a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * - History of stable intermittent claudication for 3 or more months, and an Ankle-brachial index test (ABI) \<0.9 at rest. * Symptomatic PAD (claudication or critical limb ischemia) Exclusion Criteria: * - Limb threatening ischemia, including rest pain and/or gangrene; impending limb loss or chronic osteomyelitis. * Lower extremity vascular surgery, angioplasty or lumbar sympathectomy within 3 months of enrollment; * severe peripheral neuropathy or any condition other than PAD that limits walking such as unstable angina; * history of significant left main or three vessel coronary artery disease (\>70% stenosis, unprotected by grafts) or recent myocardial infarction (6 weeks); * chest pain during treadmill exercise which appears before the onset of claudication, * chronic renal failure with an eGRF\<30; Type 1diabetes mellitus, a BMI\>40, and a HbA1c\>8.5%. Refusal to give or inability to give informed consent. Pregnancy (Self-reported).
Where this trial is running
Charlottesville, Virginia
- University of Virginia — Charlottesville, Virginia, United States (RECRUITING)
Study contacts
- Principal investigator: Jason D. Allen, PhD — University of Virginia
- Study coordinator: Casey C Derella, PhD
- Email: bxg7vn@virginia.edu
- Phone: 434-243-8677
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Peripheral Arterial Disease, Peripheral Vascular Diseases, PAD, nitrate, nitric oxide