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Beetroot Juice for Peripheral Arterial Disease (BEET PAD Trial)
N/A
Recruiting
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Vascular lab evidence of PAD (such as a toe brachial pressure <= 0.70 or an ankle brachial index <=0.90), or angiographic evidence of PAD defined as at least 70% stenosis of an artery supplying the lower extremities.
An ABI of >0.90 and <=1.00 who experience a 20% or greater drop in ABI in either leg after the heel-rise test.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to four-month follow-up
Awards & highlights
BEET PAD Trial Summary
This trial investigates whether beetroot juice can improve walking performance in people with PAD. It tests the acute & chronic effects on 6-minute walk and looks at biological pathways.
Who is the study for?
This trial is for people over 50 with peripheral artery disease (PAD), which means they have poor blood flow in their legs. They must have specific test results showing PAD and be able to walk a certain distance. People can't join if they've had major leg amputations, severe limb issues, need walkers or wheelchairs, have other conditions limiting walking, recent surgeries or heart events, mental impairment scores below a threshold, allergies to beetroot juice, don't speak English, are in another study recently or consume lots of beets.Check my eligibility
What is being tested?
The BEET PAD Trial is testing whether drinking beetroot juice improves walking ability after four months compared to a placebo drink. The idea is that the natural compounds in beetroot juice might help increase blood flow and muscle health in the legs of those with PAD.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects from consuming beetroot juice could include changes in urine color (pink or red), stomach upset or discomfort due to its detoxifying properties. Allergic reactions may occur but are considered rare.
BEET PAD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with PAD based on vascular tests or angiography.
Select...
My ABI is between 0.90 and 1.00, and it drops by 20% or more after a physical test.
Select...
I am 50 years old or older.
BEET PAD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to four-month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to four-month follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Four-month change in six-minute walk distance
Secondary outcome measures
2.5 hour change in six-minute walk distance (acute effect)
Four-month + 24 hour change in six-minute walk distance (chronic effect)
Four-month change in Walking Impairment Questionnaire (WIQ) distance score
+2 moreOther outcome measures
Durability of effect on six-minute walk distance
Four-month change in Short-Form 36 Physical Function questionnaire score
Four-month change in Walking Impairment Questionnaire (WIQ) speed and stair climbing scores
+3 moreBEET PAD Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Beetroot juiceActive Control1 Intervention
The beetroot juice intervention comes in a single 70 ml drink and is manufactured by James White Drinks. Each drink contains beetroot juice and 2% lemon juice, made from concentrates. Each serving of 70 mL of beetroot juice contains 400 mgs (6.45 millimoles) of nitrate and will be taken twice daily for a total daily dose of 800 mgs (12.90 millimoles) of nitrate.
Group II: PlaceboPlacebo Group1 Intervention
The placebo comes in a single 70 ml drink and is manufactured by James White Drinks. The placebo contains beetroot juice and 2% lemon juice, made from concentrates, and is filtered to remove nitrate.
Find a Location
Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
917,021 Total Patients Enrolled
24 Trials studying Peripheral Arterial Disease
4,212 Patients Enrolled for Peripheral Arterial Disease
University of VirginiaOTHER
753 Previous Clinical Trials
1,244,821 Total Patients Enrolled
8 Trials studying Peripheral Arterial Disease
300 Patients Enrolled for Peripheral Arterial Disease
University of ChicagoOTHER
1,003 Previous Clinical Trials
819,539 Total Patients Enrolled
3 Trials studying Peripheral Arterial Disease
1,726 Patients Enrolled for Peripheral Arterial Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe leg pain at rest due to poor blood flow.I have a current foot ulcer on the bottom of my foot.I haven't been in a clinical trial for at least 3 months, or 6 months if it was for stem cell/gene therapy.I am not willing to stop consuming beetroot products for the study duration.My vision problems make it hard for me to walk.I am 50 years old or older.You have been in a supervised treadmill exercise program in the last three months.I have had an amputation above or below the knee.I use a wheelchair or walker to move around.My walking is limited by a condition that is not related to leg artery disease.I have been diagnosed with PAD based on vascular tests or angiography.My ABI is between 0.90 and 1.00, and it drops by 20% or more after a physical test.You didn't complete the initial study requirements.I do not have a severe illness or cancer needing treatment in the last 2 years, except for early-stage cancer with a good prognosis.I can walk less than 500 feet or more than 1600 feet in six minutes.I am scheduled for major surgery or heart/leg artery treatment in the next 5 months.I use a specific mouthwash and don't want to stop.I am willing to stop eating one cup or more of beets daily for 30 days before and during the trial.I do not speak English.Your ankle brachial index (ABI) is less than or equal to 0.90.I have been diagnosed with peripheral artery disease.Your blood pressure is lower than 100 over 45.I haven't had major surgery or significant heart issues in the last 3 months.Your Mini-Mental Status Examination (MMSE) score is less than 23.You are allergic to beetroot juice.
Research Study Groups:
This trial has the following groups:- Group 1: Beetroot juice
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still available positions for participants in this research?
"According to clinicaltrials.gov, this trial is looking for volunteers and was first advertised on December 1st 2022; the posting has been updated as recently as November 13th 2022."
Answered by AI
How many individuals are actively engaged in this experiment?
"Affirmative. According to clinicaltrials.gov, the trial is actively recruiting patients since it was first advertised on December 1st 2022 and last edited November 13th 2022. The research necessitates 210 participants from 3 separate sites."
Answered by AI
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