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

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.

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.

Study Overview

• Status: Completed
• Conditions: Systolic Heart Failure
• Intervention / Treatment: Dietary supplement: nitrate-rich beetroot juice; Dietary supplement: nitrate-deplete beetroot juice

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: 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 Names: Beet It Sport Stamina Shot

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 minutes
six minute walk distance	subjects walked at their chosen pace for six minutes on a pre-determined course. Total distance was recorded.	six minutes

Collaborators and Investigators

• Sponsor: Brooke Army Medical Center
• Investigators: Principal Investigator: Kenneth M Leclerc, MD, Brooke Army Medical Center

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: August 20, 2014
• First Submitted That Met QC Criteria: August 21, 2014
• First Posted (Estimate): August 22, 2014

Study Record Updates

• Last Update Posted (Estimate): August 22, 2014
• Last Update Submitted That Met QC Criteria: August 21, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: heart failure; oxygen consumption; exercise performance; Nitrate-rich beetroot juice
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Murmurs; Heart Failure; Systolic Murmurs; Heart Failure, Systolic
• Other Study ID Numbers: 383967-4