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

November 10, 2015 updated by: Jason Allen, Ph.D.
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
placebo drink, single dose, taste and color-matched to experimental drink
Other: placebo
Other Names:
  • placebo drink, single dose, taste and color-matched to experimental drink
Experimental: beet juice concentrate
single dose of beet juice concentrate, roughly 70 mL
Drug: beet juice concentrate
single dose of beet juice concentrate, roughly 70 mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise Tolerance
Time Frame: Testing Visit 1 (1-2 weeks from baseline) and Testing Visit 2 (2-3 weeks from baseline)
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
Time Frame: Testing Visit 1 (1-2 weeks from baseline) and Testing Visit 2 (2-3 weeks from baseline)
flow-mediated dilation (FMD)
Testing Visit 1 (1-2 weeks from baseline) and Testing Visit 2 (2-3 weeks from baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jason Allen, Ph.D.

Investigators

  • Principal Investigator: William Kraus, MD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

September 17, 2013

First Submitted That Met QC Criteria

September 17, 2013

First Posted (Estimate)

September 19, 2013

Study Record Updates

Last Update Posted (Estimate)

December 14, 2015

Last Update Submitted That Met QC Criteria

November 10, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00047311

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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