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

NCT02223403 | Completed DMC

• 1 other identifier: 383967-4
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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

Keywords

Nitrate-rich beetroot juice; heart failure; exercise performance; oxygen consumption

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

submaximal steady state exercise

EXPERIMENTAL

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; Dietary Supplement: nitrate-deplete beetroot juice

six minute walk test

EXPERIMENTAL

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

Dietary Supplement: nitrate-rich beetroot juice; Dietary Supplement: nitrate-deplete beetroot juice

Interventions

nitrate-rich beetroot juice 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

Also known as: Beet It Sport Stamina Shot

six minute walk test; submaximal steady state exercise

nitrate-deplete beetroot juice 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

Also known as: Beet It Sport Stamina Shot

six minute walk test; submaximal steady state exercise

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \> 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

Sponsors & Collaborators

• Brooke Army Medical Center: lead

MeSH Terms

Conditions

Heart Failure, Systolic; Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Kenneth M Leclerc, MD

  Brooke Army Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 20, 2014
• First Posted: August 22, 2014
• Study Start: October 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: August 22, 2014

Record last verified: 2014-08