CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 11 enrolled
Drug / intervention
Placebo +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03506646
NCT03506646N/ACompleted

Dietary Nitrate Supplementation and Thermoregulation During Exercise

University of Nebraska·interventional·Posted Apr 24, 2018·Updated Nov 22, 2024

In Brief

A clinical study evaluating Placebo and Beet root juice for Peripheral Arterial Disease and Peripheral Artery Disease. Completed, enrolled 11 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedApr 24, 2018
Enrollment StartSep 5, 2018
Primary CompletionFeb 1, 2020
Study CompletionDec 15, 2022
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 8.2 years ago

Interventions

Placebodietary

Participants will be given a gelatin tablet to serve as the control condition. This will be a double-blinded, randomized, cross-over design to examine the effects of beetroot juice on endothelial function, leg function, and thermoregulation.

Beet root juicedietary

Beet root juice serves as a mode of dietary nitrate supplementation. This will be a double-blinded, randomized, cross-over design to examine the effects of beetroot juice on endothelial function, leg function, and thermoregulation.