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

Study Overview
=================
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.

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.

Conditions
-----------------
Systolic Heart Failure

Intervention / Treatment
-----------------
* Dietary Supplement: nitrate-rich beetroot juice
* Dietary Supplement: nitrate-deplete beetroot juice


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: submaximal steady state exercise<br>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<br>* 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<br>* Other names: Beet It Sport Stamina Shot;Dietary Supplement: nitrate-deplete beetroot juice<br>* 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<br>* Other names: Beet It Sport Stamina Shot;|
| Experimental: six minute walk test<br>subjects performed six-minute walk at self-determined pace 30 minutes after treadmill exercise was performed | Dietary Supplement: nitrate-rich beetroot juice<br>* 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<br>* Other names: Beet It Sport Stamina Shot;Dietary Supplement: nitrate-deplete beetroot juice<br>* 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<br>* 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nitrate-rich beetroot juice, heart failure, exercise performance, oxygen consumption