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NCT03506646 · ClinicalTrials.gov registry record · NA
Dietary Nitrate Supplementation and Thermoregulation
A NA study of Peripheral Arterial Disease and Peripheral Artery Disease, sponsored by University of Nebraska.
- Completed
- Registry status
- NA
- Development phase
- 11
- Enrollment target
- 1
- Study location
NCT03506646 is a NA study of Peripheral Arterial Disease and Peripheral Artery Disease that has completed, run by University of Nebraska. The registered enrollment target is 11 participants, below the 4,206-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03506646, a NA study of Peripheral Arterial Disease and Peripheral Artery Disease, has completed, sponsored by University of Nebraska.
- COMPLETED
- Registry status
- NA
- Development phase
- 11 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT Beet root juice
Study Locations (1)
Nebraska
- University of Nebraska at Omaha - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2018-09-05 |
| Est. Completion | 2022-12-15 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03506646
The ClinicalTrials.gov registry entry for NCT03506646 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,206-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (100% lower). The listed sponsor is University of Nebraska, which has 407 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Peripheral Arterial Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03506646 reports 1 study location spanning 1 distinct geographic area - top geographies include Nebraska.
Frequently Asked Questions
What is clinical trial NCT03506646 about?
NCT03506646 is a clinical study titled "Dietary Nitrate Supplementation and Thermoregulation". 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 in...
What is the current status of trial NCT03506646?
This trial is currently completed. It is a NA study. The enrollment target is 11 participants. The study started on 2018-09-05. Estimated completion is 2022-12-15.
What conditions does trial NCT03506646 study?
This clinical trial studies the following conditions: Peripheral Arterial Disease, Peripheral Artery Disease.
What interventions are being tested in trial NCT03506646?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Beet root juice (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03506646?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03506646 being conducted?
This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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