Clinical trial NCT01946542: Acute Effects of Beet Juice Consumption on Exercise Capacity in Heart Failure
Official title: Acute Effects of Beet Juice Consumption on Exercise Capacity in Heart Failure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Heart Failure
Keywords: exercise
heart failure
fatigue
physical endurance
functional food
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-09-19
Enrollment: 2
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Exercise Tolerance
timeFrame: Testing Visit 1 (1-2 weeks from baseline) and Testing Visit 2 (2-3 weeks from baseline)
Secondary outcomes:
measure: Vascular Function
timeFrame: Testing Visit 1 (1-2 weeks from baseline) and Testing Visit 2 (2-3 weeks from baseline)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: William Kraus, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kenjale AA, Ham KL, Stabler T, Robbins JL, Johnson JL, Vanbruggen M, Privette G, Yim E, Kraus WE, Allen JD. Dietary nitrate supplementation enhances exercise performance in peripheral arterial disease. J Appl Physiol (1985). 2011 Jun;110(6):1582-91. doi: 10.1152/japplphysiol.00071.2011. Epub 2011 Mar 31.