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

NCT ID: NCT02223403

Last Updated: 2014-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2014-05-31

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.

Conditions

Systolic Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

nitrate-rich beetroot juice

Intervention Type: DIETARY_SUPPLEMENT

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

nitrate-deplete beetroot juice

Intervention Type: DIETARY_SUPPLEMENT

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

six minute walk test

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

Group Type: EXPERIMENTAL

nitrate-rich beetroot juice

Intervention Type: DIETARY_SUPPLEMENT

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

nitrate-deplete beetroot juice

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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

Intervention Type: 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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Beet It Sport Stamina Shot; Beet It Sport Stamina Shot

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brooke Army Medical Center

FED

Sponsor Role: lead

Responsible Party

Kenneth M Leclerc

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kenneth M Leclerc, MD

Role: PRINCIPAL_INVESTIGATOR

Brooke Army Medical Center

Other Identifiers

383967-4

Identifier Type: -

Identifier Source: org_study_id