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OpenTrials
Completed

NCT Number: NCT02223403

Effect of Nitrate-rich Beetroot Juice on Exercise Performance in Heart Failure Patients

Nitrate-rich beetroot juice supplementation has demonstrated reduced oxygen consumption and submaximal exercise performance in healthy adults. Investigation for similar effects in patients with heart failure has not previously been conducted.

This was a randomized, double-blind, placebo controlled trial. Following ingestion of the active agent or placebo, subjects with systolic heart failure underwent submaximal steady state exercise with gas exchange analysis followed thirty minutes later by a six minute walk test. Second testing sessions were performed ten days.

There were no significant differences in the treatment and placebo arms in average oxygen consumption or six minute walk distance.

In conclusion, in patients with heart failure who have ingested a single dose of nitrate-rich beetroot juice concentrate, there is no significant difference with regard to oxygen consumption during submaximal steady state exercise or six minute walk testing distance.

Further study is warranted to determine the true efficacy of nitrate consumption in this population with adjustments in acute or chronic dosing, exercise duration, or intensity.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Local institutional beneficiaries between the ages of 18 and 80
  • Documentation of left ventricular systolic dysfunction with ejection fraction < 40% by any modality within the past six months
  • Documentation of New York Heart Association class II or III status.

Exclusion criteria

  • > 80 years of age
  • Unable to adequately or safely perform treadmill exercise
  • Pulmonary disease deemed significant enough to be a limitation to exercise
  • Greater than moderate stenotic or regurgitant valvular heart disease
  • Presence of atrial fibrillation or other uncontrolled arrhythmias
  • Uncompensated heart failure
  • Continuously paced rhythms
  • Pregnant females
  • Chronic nitroglycerine use (oral isosorbide di or mono-nitrate, or topical nitroglycerine)
  • Phosphodiesterase inhibitor (sildenafil or tadalafil) use within a week

Treatment and study plan

Nitrate-rich beetroot Juice

Dietary Supplement

3 ounces of nitrate-rich beetroot juice ingested orally once 90 minutes before exercise interventions of steady state treadmill exercise followed 30 minutes later by six minute walk

Other names: Beet It Sport Stamina Shot

Nitrate-deplete Beetroot Juice

Dietary Supplement

3 ounces of nitrate-deplete beetroot juice ingested orally once 90 minutes before exercise interventions of steady state treadmill exercise followed 30 minutes later by six minute walk

Other names: Beet It Sport Stamina Shot

Primary outcomes

  1. steady state exercise oxygen consumption

    Time frame: 10 minutes

    Subjects performed steady state treadmill walking at a pre-determine submaximal workload. Oxygen consumption was measured for the last 10 minutes.

  2. six minute walk distance

    Time frame: six minutes

    subjects walked at their chosen pace for six minutes on a pre-determined course. Total distance was recorded.

Sponsors and collaborators

Lead sponsor

Brooke Army Medical Center

Fed

Registry information

Official study title

Single Dose of Nitrate-rich Beetroot Juice Does Not Improve Steady State Oxygen Consumption or Six-minute Walk Distance in Patients With Systolic Heart Failure.

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 22, 2014
Registry last updated
Aug 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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