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Dietary Supplement

Dietary Nitrates for Heart Failure

Phase 1 & 2

Waitlist Available

Led By Linda R Peterson, MD

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

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

Must have

Men and women with a history of heart failure (and/or pulmonary hypertension for PA catheter substudy) aged 18 or older

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after brj or placebo ingestion

Awards & highlights

Study Summary

This trial is testing whether beetroot juice can improve exercise tolerance and power in heart failure patients, as well as other measures.

Who is the study for?

This trial is for adults with heart failure or pulmonary hypertension. It's also open to healthy adults of the same age range as a control group. People can't join if they're under 18, or if they take certain medications like proton pump inhibitors, antacids, xanthine oxidase inhibitors, or phosphodiesterase inhibitors (like Viagra).Check my eligibility

What is being tested?

The study tests whether beetroot juice (BRJ), which contains dietary nitrates, can improve exercise capacity and efficiency in heart failure patients compared to a placebo. The effects on blood pressure and muscle function are also examined over periods ranging from hours to weeks.See study design

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects from consuming BRJ may include changes in bowel movements, colored urine or stool due to the natural pigments in beets, and possibly low blood pressure.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 or older with a history of heart failure or pulmonary hypertension.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ each subject is tested at maximum over a 4 week period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~each subject is tested at maximum over a 4 week period

This trial's timeline: 3 weeks for screening, Varies for treatment, and each subject is tested at maximum over a 4 week period for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Peak power

Secondary outcome measures

Cardiac function

VO2 peak

pulmonary artery pressure

Other outcome measures

Myocardial perfusion

Myocardium

Nitric oxide and nitrate and nitrite

+2 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Beetroot JuiceActive Control1 Intervention

Beetroot Juice with nitrates. Patients will be studied before and after ingestion of beetroot juice with nitrates

Group II: BRJ crossover to placeboPlacebo Group1 Intervention

Beetroot Juice without nitrate.s Patients will be studied before and after ingestion of beetroot juice

0 / 1Eligibility criteria met

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,940 Previous Clinical Trials

2,303,269 Total Patients Enrolled

18 Trials studying Heart Failure

77,956 Patients Enrolled for Heart Failure

The Foundation for Barnes-Jewish HospitalOTHER

37 Previous Clinical Trials

6,664 Total Patients Enrolled

2 Trials studying Heart Failure

590 Patients Enrolled for Heart Failure

Linda R Peterson, MDPrincipal InvestigatorWashington University School of Medicine

6 Previous Clinical Trials

684 Total Patients Enrolled

2 Trials studying Heart Failure

117 Patients Enrolled for Heart Failure

Media Library

Beetroot Juice (BRJ) (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT01682356 — Phase 1 & 2

Heart Failure Research Study Groups: BRJ crossover to placebo, Beetroot Juice

Heart Failure Clinical Trial 2023: Beetroot Juice (BRJ) Highlights & Side Effects. Trial Name: NCT01682356 — Phase 1 & 2

Beetroot Juice (BRJ) (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01682356 — Phase 1 & 2

Frequently Asked Questions

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

Does this experiment currently accept participants for enrollment?

"It appears that clinicaltrials.gov shows this trial is not presently in the market for participants, as it was initially posted on January 1st of 2012 and last updated August 24th 2022. Despite no longer being recruiters, there are still 1430 other trials actively searching for volunteers right now."

Answered by AI

Recent research and studies

The Journal of PhysiologyJournal

Dietary Nitrate Reduces Muscle Metabolic Perturbation and Improves Exercise Tolerance in Hypoxia

Vanhatalo, Anni, Jonathan Fulford, Stephen J. Bailey, James R. Blackwell, Paul G. Winyard, and Andrew M. Jones. 2011. “Dietary Nitrate Reduces Muscle Metabolic Perturbation and Improves Exercise Tolerance in Hypoxia”. The Journal of Physiology. Wiley. doi:10.1113/jphysiol.2011.216341.

British Journal of NutritionJournal

Blood Pressure-lowering Effects of Beetroot Juice and Novel Beetroot-enriched Bread Products in Normotensive Male Subjects

Hobbs, Ditte A., Nedi Kaffa, Trevor W. George, Lisa Methven, and Julie A. Lovegrove. 2012. “Blood Pressure-lowering Effects of Beetroot Juice and Novel Beetroot-enriched Bread Products in Normotensive Male Subjects”. British Journal of Nutrition. Cambridge University Press (CUP). doi:10.1017/s0007114512000190.

Journal of Applied PhysiologyJournal

Dietary Nitrate Supplementation Reduces the O<sub>2</sub>cost of Low-intensity Exercise and Enhances Tolerance to High-intensity Exercise in Humans

Bailey, Stephen J., Paul Winyard, Anni Vanhatalo, Jamie R. Blackwell, Fred J. DiMenna, Daryl P. Wilkerson, Joanna Tarr, Nigel Benjamin, and Andrew M. Jones. 2009. “Dietary Nitrate Supplementation Reduces the O2cost of Low-intensity Exercise and Enhances Tolerance to High-intensity Exercise in Humans”. Journal of Applied Physiology. American Physiological Society. doi:10.1152/japplphysiol.00722.2009.

Journal of Applied PhysiologyJournal