Heart Failure
Conditions
Keywords
exercise, heart failure, fatigue, physical endurance, functional food
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.
Interventions
DRUGbeet juice concentrate
single dose of beet juice concentrate, roughly 70 mL
OTHERplacebo
Sponsors
Jason Allen, Ph.D.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exercise Tolerance | Testing Visit 1 (1-2 weeks from baseline) and Testing Visit 2 (2-3 weeks from baseline) | treadmill time to exhaustion, cardiopulmonary exercise test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vascular Function | Testing Visit 1 (1-2 weeks from baseline) and Testing Visit 2 (2-3 weeks from baseline) | flow-mediated dilation (FMD) |
Countries
United States
Participant flow
Recruitment details
6 participants signed consent. 4 participants were screen failures. 2 participants were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Placebo First Then Beet Juice Concentrate Testing visit 1: Participants are given a placebo drink, single dose. The placebo drink is taste and color-matched to the experimental drink.
Testing visit 2: Participants are given a single dose of beet juice concentrate, roughly 70 mL. | 1 |
| Beet Juice Concentrate First, Then Placebo Testing visit 1: Participants are given a single dose of beet juice concentrate, roughly 70 mL.
Testing Visit 2: Participants are given a placebo drink, single dose. The placebo drink is taste and color-matched to the experimental drink. | 1 |
| Total | 2 |
Baseline characteristics
| Characteristic | Placebo First Then Beet Juice Concentrate | Beet Juice Concentrate First, Then Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized White | 1 participants | 0 participants | 1 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 2 | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 | 0 / 2 |
Outcome results
Primary
Exercise Tolerance
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)
Population: Given that only one participant completed each arm of the study, we are unable to report outcomes as group means. To report the individual demographic, clinical, and/or physiological characteristics of these participants would present significant and unnecessary risk of loss of confidentially. Thus, no outcome data is reported.
Secondary
Vascular Function
flow-mediated dilation (FMD)
Time frame: Testing Visit 1 (1-2 weeks from baseline) and Testing Visit 2 (2-3 weeks from baseline)
Population: Given that only one participant completed each arm of the study, we are unable to report outcomes as group means. To report the individual demographic, clinical, and/or physiological characteristics of these participants would present significant and unnecessary risk of loss of confidentially. Thus, no outcome data is reported.