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Inorganic Nitrate Supplement

Beetroot Juice for Peripheral Arterial Disease

Q: Do I satisfy the requirements for joining this research effort?

To be accepted into this medical trial, patients must have peripheral arterial disease and fall between the ages of 40 and 80. The total recruitment goal for this study is 28 participants.

Q: Is recruitment still underway for this trial?

The clinical trial is actively recruiting patients, as indicated on the official website. It was originally posted in February 2020 and last revised November 2022.

Q: How many participants may be included in this investigation?

Affirmative. Details on clinicaltrials.gov suggest that this medical trial is currently seeking applicants, having initially been posted in February 2020 and recently updated in November 2022. Specifically, 28 individuals are needed at a single research site.

Q: Has the FDA sanctioned dietary nitrate as a therapeutic solution?

Due to the limited clinical evidence regarding nitrate's safety and efficacy, our team at Power gave it a rating of 1 on a scale from 1-3.

Q: Are there age restrictions on participants of this experiment?

Those hoping to participate in this trial must be between the ages of 40 and 80.

Phase 1

Recruiting

Led By Jason D. Allen, PhD

Research Sponsored by University of Virginia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of stable intermittent claudication for 3 or more months, and an Ankle-brachial index test (ABI) <0.9 at rest

Symptomatic PAD (claudication or critical limb ischemia)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after a minimum of 3 days of supplementation with either placebo or nitrate rich beverage.

Awards & highlights

Study Summary

This trial is testing whether or not beetroot juice can help people with peripheral arterial disease by increasing blood flow and improving exercise performance.

Who is the study for?

This trial is for patients with Peripheral Arterial Disease (PAD) who experience leg pain during walking due to poor blood flow. They must have had stable symptoms for at least 3 months and an Ankle-brachial index test result of less than 0.9. Those with severe conditions affecting their limbs, recent major heart issues, extreme peripheral neuropathy, or uncontrolled diabetes cannot participate.Check my eligibility

What is being tested?

The study tests if drinking concentrated beetroot juice, which is high in dietary nitrate, improves blood flow and muscle function in PAD patients compared to a placebo drink without nitrates. Participants will be randomly assigned to receive either the real supplement or placebo in a double-blind manner.See study design

What are the potential side effects?

While not explicitly listed here, potential side effects may include changes in digestion due to beetroot juice consumption such as stomach upset or colored stools and possible interactions with existing medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had leg pain while walking for over 3 months and my ABI test result is less than 0.9.

Select...

I have pain in my legs due to poor blood flow.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after a minimum of 3 days of supplementation with either placebo or nitrate rich beverage.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after a minimum of 3 days of supplementation with either placebo or nitrate rich beverage.

This trial's timeline: 3 weeks for screening, Varies for treatment, and after a minimum of 3 days of supplementation with either placebo or nitrate rich beverage. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phosphocreatine kinetics after maximal exercise

Secondary outcome measures

Claudication Onset Time

Maximal hyperemia in different lower limb compartments

Peak exercise

+2 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Dietary nitrateActive Control1 Intervention

The active treatment, beetroot juice (BEET IT, James White Drinks, Ipswich, UK), contains 6.2mmol of inorganic nitrate. Participants will continue supplementation until they complete all testing visits.

Group II: concentrated beet root juice with depleted nitrate contentPlacebo Group1 Intervention

The placebo treatment is also beetroot juice provide by the same company (BEET IT, James White Drinks, Ipswich, UK), but it does not contain any inorganic nitrate. Participants will continue supplementation until they complete all testing visits.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor

754 Previous Clinical Trials

1,245,045 Total Patients Enrolled

8 Trials studying Peripheral Arterial Disease

482 Patients Enrolled for Peripheral Arterial Disease

Jason D. Allen, PhDPrincipal InvestigatorUniversity of Virginia

1 Previous Clinical Trials

35 Total Patients Enrolled

Media Library

BEET IT - Concentrate Beet root juice (Inorganic Nitrate Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05036213 — Phase 1

Peripheral Arterial Disease Research Study Groups: Dietary nitrate, concentrated beet root juice with depleted nitrate content

Peripheral Arterial Disease Clinical Trial 2023: BEET IT - Concentrate Beet root juice Highlights & Side Effects. Trial Name: NCT05036213 — Phase 1

BEET IT - Concentrate Beet root juice (Inorganic Nitrate Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05036213 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I satisfy the requirements for joining this research effort?

"To be accepted into this medical trial, patients must have peripheral arterial disease and fall between the ages of 40 and 80. The total recruitment goal for this study is 28 participants."

Answered by AI

Is recruitment still underway for this trial?

"The clinical trial is actively recruiting patients, as indicated on the official website. It was originally posted in February 2020 and last revised November 2022."

Answered by AI

How many participants may be included in this investigation?

"Affirmative. Details on clinicaltrials.gov suggest that this medical trial is currently seeking applicants, having initially been posted in February 2020 and recently updated in November 2022. Specifically, 28 individuals are needed at a single research site."

Answered by AI