Acute Effects of Beet Juice Consumption on Exercise Capacity in Heart Failure

Study Overview
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Brief Summary
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The purpose of this project will be to determine whether consumption of beet juice concentrate prior to exercise may acutely improve exercise tolerance in patients with heart failure.

Detailed Description
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Participants will complete up to four study visits. The first visit will involve completion of the informed consent process followed by a screening for study eligibility. The screening will consist of questionnaires pertaining to detailed medical history, diet, physical activity, and health-related quality of life (KCCQ). Anthropometric measures and a general health screening (including heart rate, resting blood pressure, and small blood (<15 mL) and urine samples will be collected). Volunteers meeting eligibility requirements will be scheduled for a screening maximal cardiopulmonary exercise test. Immediately prior to the exercise treadmill test, each subject will have a resting ECG and blood pressure to determine whether there are any abnormalities that would contraindicate exercise testing. Qualified subjects will then undergo a maximal cardiopulmonary exercise (CPX) test. Following successful completion of the screening CPX test, volunteers meeting eligibility requirements will be scheduled for two testing visits, at least one week apart. At one visit, participants will consume a small cup of beet juice concentrate, and at the other, they will consume placebo. Treatment will be double-blinded and administered in random order.

Official Title
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Acute Effects of Beet Juice Consumption on Exercise Capacity in Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Drug: beet juice concentrate
* Other: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: New York Heart Association (NYHA) class II-III heart failure receiving optimal medical therapy sedentary Exclusion Criteria: smoking changes in medication or major cardiovascular (CV) event or procedure within the previous 6 wk fixed rate pacemaker unstable angina other co-morbidities or limitations that preclude safe participation in the exercise testing plans for hospitalization or cardiac transplantation within the next 2 months type 1 diabetes refusal or inability to provide informed consent

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>placebo drink, single dose, taste and color-matched to experimental drink | Other: placebo<br> <br> * Other names: placebo drink, single dose, taste and color-matched to experimental drink;|
| Experimental: beet juice concentrate<br>single dose of beet juice concentrate, roughly 70 mL | Drug: beet juice concentrate<br>* single dose of beet juice concentrate, roughly 70 mL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise Tolerance | treadmill time to exhaustion, cardiopulmonary exercise test | Testing Visit 1 (1-2 weeks from baseline) and Testing Visit 2 (2-3 weeks from baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascular Function | flow-mediated dilation (FMD) | Testing Visit 1 (1-2 weeks from baseline) and Testing Visit 2 (2-3 weeks from baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, heart failure, fatigue, physical endurance, functional food