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

Launched by UNIVERSITY OF VIRGINIA · Sep 1, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how taking a supplement made from concentrated beetroot juice, which is high in dietary nitrate, may help improve blood flow and exercise performance in patients with Peripheral Arterial Disease (PAD) who experience leg pain while walking, known as intermittent claudication. The researchers believe that by increasing blood flow and oxygen delivery to the muscles, patients may be able to walk longer distances without pain. To test this idea, they will recruit 10 patients who have had stable claudication for at least three months and have a specific test result indicating limited blood flow in their legs.

Participants in the trial can expect to take either the beetroot juice supplement or a placebo (a non-active substitute) for a few days before switching to the other treatment. This study is open to adults of all genders aged between 18 and 80 who meet certain health criteria, such as having a history of intermittent claudication but not having severe complications from PAD. It's important to know that individuals with certain serious health issues or recent surgeries may not be eligible to participate. Overall, the trial aims to see if this natural supplement can help improve the quality of life for those suffering from this condition.

Gender

ALL

Eligibility 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).