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

Jason Allen, Ph.D.

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Heart Failure

Treatments: Other: placebo; Drug: beet juice concentrate

Study type: Interventional

Funder types: Other

Identifiers

NCT01946542

Pro00047311

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 2 patients

Sex: All

Ages: 55 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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2 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

placebo drink, single dose, taste and color-matched to experimental drink

Treatment:

Other: placebo

beet juice concentrate

Experimental group

Description:

single dose of beet juice concentrate, roughly 70 mL

Treatment:

Drug: beet juice concentrate