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

Primary Purpose

Systolic Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
nitrate-rich beetroot juice
nitrate-deplete beetroot juice
Sponsored by
Brooke Army Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systolic Heart Failure focused on measuring Nitrate-rich beetroot juice, heart failure, exercise performance, oxygen consumption

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    submaximal steady state exercise

    six minute walk test

    Arm Description

    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

    subjects performed six-minute walk at self-determined pace 30 minutes after treadmill exercise was performed

    Outcomes

    Primary Outcome Measures

    steady state exercise oxygen consumption
    Subjects performed steady state treadmill walking at a pre-determine submaximal workload. Oxygen consumption was measured for the last 10 minutes.
    six minute walk distance
    subjects walked at their chosen pace for six minutes on a pre-determined course. Total distance was recorded.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 20, 2014
    Last Updated
    August 21, 2014
    Sponsor
    Brooke Army Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02223403
    Brief Title
    Effect of Nitrate-rich Beetroot Juice on Exercise Performance in Heart Failure Patients
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2012 (undefined)
    Primary Completion Date
    May 2014 (Actual)
    Study Completion Date
    May 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Brooke Army Medical Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Systolic Heart Failure
    Keywords
    Nitrate-rich beetroot juice, heart failure, exercise performance, oxygen consumption

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    submaximal steady state exercise
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    six minute walk test
    Arm Type
    Experimental
    Arm Description
    subjects performed six-minute walk at self-determined pace 30 minutes after treadmill exercise was performed
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    nitrate-rich beetroot juice
    Other Intervention Name(s)
    Beet It Sport Stamina Shot
    Intervention Description
    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
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    nitrate-deplete beetroot juice
    Other Intervention Name(s)
    Beet It Sport Stamina Shot
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    steady state exercise oxygen consumption
    Description
    Subjects performed steady state treadmill walking at a pre-determine submaximal workload. Oxygen consumption was measured for the last 10 minutes.
    Time Frame
    10 minutes
    Title
    six minute walk distance
    Description
    subjects walked at their chosen pace for six minutes on a pre-determined course. Total distance was recorded.
    Time Frame
    six minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kenneth M Leclerc, MD
    Organizational Affiliation
    Brooke Army Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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