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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01946542
• Other study ID #: Pro00047311
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: September 17, 2013
• Last updated: November 10, 2015
• Start date: February 2014
• Est. completion date: September 2014

Study information

• Verified date: November 2015
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• beet juice concentrate
single dose of beet juice concentrate, roughly 70 mL

Other:
• placebo

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Jason Allen, Ph.D.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Vascular Function	flow-mediated dilation (FMD)	Testing Visit 1 (1-2 weeks from baseline) and Testing Visit 2 (2-3 weeks from baseline)	No