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Vasodilator
Beetroot Juice for Peripheral Arterial Disease (HeartBeet Trial)
Phase 2
Waitlist Available
Led By Urs A Leuenberger, MD
Research Sponsored by David N. Proctor, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with peripheral arterial disease (PAD)
Fontaine stage II or less - no pain while resting
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 days after initiating daily ingestion of beetroot juice
Awards & highlights
HeartBeet Trial Summary
This trial will test whether short-term consumption of inorganic nitrate can improve blood flow responses, large artery hemodynamics, and leg oxygenation/exercise tolerance in patients with peripheral arterial disease.
Who is the study for?
This trial is for adults aged 21-85 with Peripheral Arterial Disease (PAD) who can consent and walk on a treadmill. They should have an ankle-brachial index below 0.9, no pain at rest, and be in good health otherwise. Excluded are those on certain heart or ED medications, pregnant women, children, those with severe liver or lung disease, recent heart attacks or uncontrolled hypertension/diabetes.Check my eligibility
What is being tested?
The study tests if drinking concentrated beetroot juice improves blood flow in the heart and legs of PAD patients compared to a placebo drink. It aims to see if this can help increase exercise tolerance without triggering leg pain or high blood pressure that PAD patients often experience during physical activity.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects from consuming beetroot juice may include changes in urine color (pink), digestive discomforts like stomach upset or cramps, and possible allergic reactions for those sensitive to its components.
HeartBeet Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with peripheral arterial disease.
Select...
I don't have pain in my legs while resting.
Select...
I have been diagnosed with peripheral artery disease (PAD).
HeartBeet Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 days after initiating daily ingestion of beetroot juice
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 days after initiating daily ingestion of beetroot juice
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Exercise performance
Secondary outcome measures
Coronary vascular function
Leg vascular function
Other outcome measures
Blood measures of nitrate absorption and conversion
HeartBeet Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Beetroot juice (Beet-It Organic Shot)Active Control1 Intervention
Subjects will consume 70 ml of beetroot juice (Beet-It Organic Shot) twice per day (morning, afternoon) for 5 to 7 days to assess the short term effects of this nitrate supplement on graded treadmill walking responses (day 4) and vasodilator/vasoconstrictor responses in the coronary and lower leg circulations (day 5 or 6 or 7). On both study visits, subjects will consume their morning dose 1 hour 45 min before experiments begin.
Group II: Beetroot juice placebo (Beet-It Organic Placebo)Placebo Group1 Intervention
Subjects will consume 70 ml of beetroot juice placebo (Beet-It Organic Placebo) twice per day (morning, afternoon) for 5 to 7 days to assess the short term effects of this nitrate supplement on graded treadmill walking responses (day 4) and vasodilator/vasoconstrictor responses in the coronary and lower leg circulations (day 5 or 6 or 7). On both study visits, subjects will consume their morning dose 1 hour 45 min before experiments begin.
Find a Location
Who is running the clinical trial?
Milton S. Hershey Medical CenterOTHER
492 Previous Clinical Trials
2,798,810 Total Patients Enrolled
5 Trials studying Peripheral Arterial Disease
321 Patients Enrolled for Peripheral Arterial Disease
Wake Forest University Health SciencesOTHER
1,239 Previous Clinical Trials
1,004,171 Total Patients Enrolled
1 Trials studying Peripheral Arterial Disease
20 Patients Enrolled for Peripheral Arterial Disease
David N. Proctor, PhDLead Sponsor
1 Previous Clinical Trials
37 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with peripheral arterial disease.I understand the study and can agree to participate.You are allergic to beetroot juice or lemon juice.Your blood tests show a problem with your hemoglobin or hematocrit levels.I am currently taking medication like sildenafil or tadalafil.My high blood pressure is not under control.My diabetes is not under control.I have had a heart attack or unstable chest pain in the last 6 months.I frequently use an inhaler or need extra oxygen.My kidney function is not normal.I have been diagnosed with Barrett's esophagus.I cannot walk on a treadmill at 2.0 miles/hour.Your heart is not pumping blood effectively (ejection fraction < 40%).I don't have pain in my legs while resting.I am between 21 and 85 years old.I have been diagnosed with peripheral artery disease (PAD).I am a child.I am currently taking nitroglycerine or nitrate medications.I am currently taking medication for stomach acid.My liver isn't working properly.
Research Study Groups:
This trial has the following groups:- Group 1: Beetroot juice (Beet-It Organic Shot)
- Group 2: Beetroot juice placebo (Beet-It Organic 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 individuals aged 35 years or over being accepted as participants in this research?
"Patients aged 21 to 85 are eligible for this medical trial. In contrast, those younger than 18 can partake in 11 different studies while individuals aged over 65 have access to 210 alternate trials."
Answered by AI
Has Beet-It Organic Shot been given a stamp of approval from the FDA?
"With no proof of efficacy and some evidence of safety, our team at Power rated Beetroot juice (Beet-It Organic Shot) a 2 on the risk scale."
Answered by AI
Are there any current opportunities to participate in this research?
"Clinicaltrials.gov confirms that this medical trial, which was initially posted in December 2015 and updated most recently on February 2022, is not actively seeking participants at present. However, there are 217 other clinical trials currently recruiting patients for their study protocols."
Answered by AI
Who is the target demographic for this research investigation?
"To be eligible for this medical trial, candidates should have peripheral arterial disease and must be between 21 and 85 years of age. Approximately 12 individuals will ultimately join the study."
Answered by AI
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