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

Sponsor

Brooke Army Medical Center (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT02223403

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Systolic Heart Failure	Dietary Supplement: nitrate-rich beetroot juice Dietary Supplement: nitrate-deplete beetroot juice	N/A

Study Design

Study Type:

Interventional

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 :

Oct 1, 2012

Actual Primary Completion Date :

May 1, 2014

Actual Study Completion Date :

May 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

steady state exercise oxygen consumption [10 minutes]
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 [six minutes]
subjects walked at their chosen pace for six minutes on a pre-determined course. Total distance was recorded.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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