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
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
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
NCT ID
NCT02223403
First Posted
August 20, 2014
Last Updated
August 21, 2014
Sponsor
Brooke Army Medical Center
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
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Effect of Nitrate-rich Beetroot Juice on Exercise Performance in Heart Failure Patients
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