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NCT05624125 · ClinicalTrials.gov registry record · NA
BEETroot Juice to Reverse Functional Impairment in PAD
A NA study of Peripheral Artery Disease, sponsored by Northwestern University.
- Recruiting
- Registry status
- NA
- Development phase
- 210
- Enrollment target
- 4
- Study locations
NCT05624125: Recruiting NA study of Peripheral Artery Disease, sponsored by Northwestern University.
NCT05624125 is a NA study of Peripheral Artery Disease that is actively recruiting participants, run by Northwestern University. The registered enrollment target is 210 participants, above the 123-participant average among 50 other Peripheral Artery Disease trials with a reported enrollment target (71% higher). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05624125, a NA study of Peripheral Artery Disease, is actively recruiting participants, sponsored by Northwestern University.
- RECRUITING
- Registry status
- NA
- Development phase
- 210 participants
- Enrollment target
- 4
- Study locations
Study Summary
The BEET PAD Trial is a multi-centered double-blind randomized clinical trial designed to determine whether beetroot juice, compared to placebo, improves six-minute walk distance at four month follow-up in people with lower extremity peripheral artery disease (PAD). Investigators hypothesize that by simultaneously increasing lower extremity perfusion, gastrocnemius muscle mitochondrial activity, and myofiber health and regeneration, beetroot juice will significantly improve walking performance in people with PAD. The primary aim is to determine whether beetroot juice significantly improves six-minute walk distance at 4-month follow-up in people with PAD, compared to placebo. Preliminary evidence suggests that beetroot juice has both acute and chronic effects on walking performance in PAD. The primary outcome will measure the combined acute and chronic effect of beetroot juice (i.e. the maximal effect) on change in 6-minute walk at 4-month follow-up. In secondary aims, investigators will distinguish between acute and chronic effects of beetroot juice on six-minute walk and delineate biologic pathways by which beetroot juice improves walking performance in PAD, by measuring change in gastrocnemius muscle perfusion (MRI arterial spin labeling) and gastrocnemius muscle health. The trial will assess the durability of beetroot juice effects on six-minute walk. Nitrate in beetroot juice is metabolized to nitrite and subsequently to NO, attaining peak nitrite levels 2.5 hours after ingestion. The trial will determine whether a higher peak or a greater increase in plasma nitrite at 2.5 hours after beetroot juice consumption at baseline has a greater effect on six-minute walk at 4-month follow-up, compared to a lower peak or a smaller increase, respectively.
Primary Outcome
Change in six-minute walk distance at four-month follow-up will be compared between those randomized to beetroot juice vs. those randomized to placebo
Conditions Studied
Interventions
- OTHER Placebo
- OTHER Beetroot juice
Study Locations (4)
Illinois
- Northwestern University Feinberg School of Medicine - Chicago
- University of Chicago - Chicago
Minnesota
- University of Minnesota - Minneapolis
Virginia
- University of Virginia - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2023-01-25 |
| Est. Completion | 2028-10-01 |
| Phase | NA |
What NCT05624125 shows while recruiting
NCT05624125 is an interventional study that assigns participants to a tested intervention. The registered 210 participants enrollment target is mid-sized for trials with a published cap, above the 123-participant average among 50 other Peripheral Artery Disease trials with a reported enrollment target (71% higher).
The record links to 1 condition, with Peripheral Artery Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05624125 reports a single indexed study location in Illinois, Minnesota, Virginia.
Frequently Asked Questions
What is clinical trial NCT05624125 about?
NCT05624125 is a clinical study titled "BEETroot Juice to Reverse Functional Impairment in PAD". The BEET PAD Trial is a multi-centered double-blind randomized clinical trial designed to determine whether beetroot juice, compared to placebo, improves six-minute walk distance at four month follow-up in people with lower extremity peripheral artery disease (PAD). Investigators hypothesize that by...
What is the current status of trial NCT05624125?
This trial is currently recruiting. It is a NA study. The enrollment target is 210 participants. The study started on 2023-01-25. Estimated completion is 2028-10-01.
What conditions does trial NCT05624125 study?
This clinical trial studies the following conditions: Peripheral Artery Disease.
What interventions are being tested in trial NCT05624125?
The interventions under investigation include: Placebo (OTHER), Beetroot juice (OTHER).
Who is sponsoring clinical trial NCT05624125?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05624125 being conducted?
This trial has 4 study locations across Illinois, Minnesota, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05624125's enrollment target sits among peer trials
210 12th of 50 higher than 39 of 50 other Peripheral Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Peripheral Artery Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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