Dietary Nitrate Supplementation and Thermoregulation

Completed · Not applicable · Has a placebo group

Conditions studied: Peripheral Arterial Disease, Peripheral Artery Disease

In brief

This is a double-blinded, randomized, crossover design study to assess the effects of dietary nitrate supplementation (beetroot juice) on peripheral artery disease (PAD) patients (ages 50-85) diagnosed with Fontaine stage I or II PAD (as determined by vascular surgeon at UNMC). Exclusion criteria include: 1) experience severe claudication (leg pain) at rest or tissue loss due to PAD (Fontaine stage III and IV), 2) have limited walking capacity due to conditions other than PAD, 3) are already supplementing with a form of dietary nitrate, or 4) have an allergy to beetroot juice. Subjects will be required to visit the lab 3 times and will be randomized to receive either the supplement or the placebo for the 2nd and 3rd visits. There will be a washout period of 14 days between the 2nd and 3rd visits. Visit 1 will take approximately 2 hours and the 2nd/3rd visits will take approximately 1.5 hours. Total experimentation period will last approximately 15 days. Visit 1 will consist of non-invasive baseline testing including assessment of endothelial function (flow-mediated dilation by ultrasound imaging), maximal walking capacity (Gardner treadmill protocol), leg function (near-infrared spectroscopy, time to onset claudication, blood flow to lower extremities), and body core temperature (rectal thermometer). Visits 2 and 3 will require consumption of either the supplement or placebo. The same tests from the baseline measurements will be performed for visits 2 and 3. There will be a recommended fourth visit, albeit not required, to review study results.

Key facts

Study ID

NCT03506646

Run by

University of Nebraska

People needed

11

Starts

2018-09-05

Expected to finish

2022-12-15

Last updated by the study team

2024-11-22

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• be able to give written, informed consent
• demonstrate positive history of chronic claudication
• have a history of exercise-limiting claudication
• have an ankle/brachial index < 0.90 at rest
• have a stable blood pressure regimen, stable lipid regimen, stable diabetes regimen and risk factor control for 6 weeks.
• be between 50-85 years old

You may not qualify if…

• pain at rest (severe claudication) and/or tissue loss due to PAD (Fontaine stage III and IV)
• acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma
• limited walking capacity due to other conditions other than PAD
• a form of nitrate supplementation already included in their diet/regimen
• an allergy to beetroot juice

Where it is running

• University of Nebraska at Omaha — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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