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

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ClinicalTrials.gov Identifier: NCT02223403
Recruitment Status : Completed
First Posted : August 22, 2014
Last Update Posted : August 22, 2014
Sponsor:
Information provided by (Responsible Party):
Kenneth M Leclerc, Brooke Army Medical Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Systolic Heart Failure Dietary Supplement: nitrate-rich beetroot juice Dietary Supplement: nitrate-deplete beetroot juice Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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.
Study Start Date : October 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: submaximal steady state exercise
90 minutes after respective beetroot juice ingestion, subjects walked on treadmill at a pre-determined steady state workload for a total of 15 minutes with oxygen consumption recorded for the last 10 minutes
Dietary Supplement: nitrate-rich beetroot juice
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 Name: Beet It Sport Stamina Shot

Dietary Supplement: nitrate-deplete beetroot juice
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 Name: Beet It Sport Stamina Shot

Experimental: six minute walk test
subjects performed six-minute walk at self-determined pace 30 minutes after treadmill exercise was performed
Dietary Supplement: nitrate-rich beetroot juice
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 Name: Beet It Sport Stamina Shot

Dietary Supplement: nitrate-deplete beetroot juice
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 Name: Beet It Sport Stamina Shot




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02223403


Sponsors and Collaborators
Brooke Army Medical Center
Investigators
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Principal Investigator: Kenneth M Leclerc, MD Brooke Army Medical Center

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Responsible Party: Kenneth M Leclerc, MD, Brooke Army Medical Center
ClinicalTrials.gov Identifier: NCT02223403     History of Changes
Other Study ID Numbers: 383967-4
First Posted: August 22, 2014    Key Record Dates
Last Update Posted: August 22, 2014
Last Verified: August 2014
Keywords provided by Kenneth M Leclerc, Brooke Army Medical Center:
Nitrate-rich beetroot juice
heart failure
exercise performance
oxygen consumption
Additional relevant MeSH terms:
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Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases