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

Primary Purpose

Heart Failure

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
beet juice concentrate
placebo
Sponsored by
Jason Allen, Ph.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure focused on measuring exercise, heart failure, fatigue, physical endurance, functional food

Eligibility Criteria

55 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

placebo

beet juice concentrate

Arm Description

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

single dose of beet juice concentrate, roughly 70 mL

Outcomes

Primary Outcome Measures

Exercise Tolerance
treadmill time to exhaustion, cardiopulmonary exercise test

Secondary Outcome Measures

Vascular Function
flow-mediated dilation (FMD)

Full Information

First Posted
September 17, 2013
Last Updated
November 10, 2015
Sponsor
Jason Allen, Ph.D.
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1. Study Identification

Unique Protocol Identification Number
NCT01946542
Brief Title
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

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment
Study Start Date
February 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jason Allen, Ph.D.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
exercise, heart failure, fatigue, physical endurance, functional food

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo drink, single dose, taste and color-matched to experimental drink
Arm Title
beet juice concentrate
Arm Type
Experimental
Arm Description
single dose of beet juice concentrate, roughly 70 mL
Intervention Type
Drug
Intervention Name(s)
beet juice concentrate
Intervention Description
single dose of beet juice concentrate, roughly 70 mL
Intervention Type
Other
Intervention Name(s)
placebo
Other Intervention Name(s)
placebo drink, single dose, taste and color-matched to experimental drink
Primary Outcome Measure Information:
Title
Exercise Tolerance
Description
treadmill time to exhaustion, cardiopulmonary exercise test
Time Frame
Testing Visit 1 (1-2 weeks from baseline) and Testing Visit 2 (2-3 weeks from baseline)
Secondary Outcome Measure Information:
Title
Vascular Function
Description
flow-mediated dilation (FMD)
Time Frame
Testing Visit 1 (1-2 weeks from baseline) and Testing Visit 2 (2-3 weeks from baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Kraus, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21454745
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.
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Acute Effects of Beet Juice Consumption on Exercise Capacity in Heart Failure

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