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

NCT ID: NCT01946542

Last Updated: 2015-12-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-09-30

Brief Summary

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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

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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.

Conditions

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Heart Failure

Keywords

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exercise heart failure fatigue physical endurance functional food

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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placebo

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

beet juice concentrate

single dose of beet juice concentrate, roughly 70 mL

Group Type EXPERIMENTAL

beet juice concentrate

Intervention Type DRUG

single dose of beet juice concentrate, roughly 70 mL

Interventions

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beet juice concentrate

single dose of beet juice concentrate, roughly 70 mL

Intervention Type DRUG

placebo

Intervention Type OTHER

Other Intervention Names

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

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jason Allen, Ph.D.

OTHER

Sponsor Role lead

Responsible Party

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Jason Allen, Ph.D.

Assistant Professor of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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William Kraus, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 21454745 (View on PubMed)

Other Identifiers

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Pro00047311

Identifier Type: -

Identifier Source: org_study_id