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

Phase 1

Terminated

• Conditions: Heart Failure
• Interventions: Drug: beet juice concentrate; Other: placebo

• Registration Number: NCT01946542
• Lead Sponsor: Jason Allen, Ph.D.

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2013-09-17
• Study First Submitted QC: 2013-09-17
• Study First Posted: 2013-09-19
• Study Start: 2014-02
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Results First Submitted: 2015-09-28
• Status Verified: 2015-11
• Results First Submitted QC: 2015-11-10
• Last Update Submitted: 2015-11-10
• Results First Posted: 2015-12-14
• Last Update Posted: 2015-12-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
beet juice concentrate	beet juice concentrate	single dose of beet juice concentrate, roughly 70 mL
placebo	placebo	placebo drink, single dose, taste and color-matched to experimental drink

Primary Outcome Measures

Name	Time	Method
Exercise Tolerance	Testing Visit 1 (1-2 weeks from baseline) and Testing Visit 2 (2-3 weeks from baseline)	treadmill time to exhaustion, cardiopulmonary exercise test

Secondary Outcome Measures

Name	Time	Method
Vascular Function	Testing Visit 1 (1-2 weeks from baseline) and Testing Visit 2 (2-3 weeks from baseline)	flow-mediated dilation (FMD)

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States