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Low enrollment
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | placebo drink, single dose, taste and color-matched to experimental drink |
|
| beet juice concentrate | Experimental | single dose of beet juice concentrate, roughly 70 mL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| beet juice concentrate | Drug | single dose of beet juice concentrate, roughly 70 mL |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Vascular Function | flow-mediated dilation (FMD) | Testing Visit 1 (1-2 weeks from baseline) and Testing Visit 2 (2-3 weeks from baseline) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Kraus, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21454745 | Background | 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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6 participants signed consent. 4 participants were screen failures. 2 participants were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Testing Visit 1 |
| |||||||||||||
| Testing Visit 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Exercise Tolerance | treadmill time to exhaustion, cardiopulmonary exercise test | 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. | Posted | Testing Visit 1 (1-2 weeks from baseline) and Testing Visit 2 (2-3 weeks from baseline) |
|
For the duration of study enrollment (Approximately 30 - 45 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo |
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The study was terminated due to low enrollment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William Kraus | Duke University Medical Center | 919-684-2063 | william.kraus@duke.edu |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D009043 | Motor Activity |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D013649 | Taste |
| ID | Term |
|---|---|
| D012677 | Sensation |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| placebo | Other |
|
|
| NOT COMPLETED |
|
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| 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. |
|
| Secondary | Vascular Function | flow-mediated dilation (FMD) | 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. | Posted | Testing Visit 1 (1-2 weeks from baseline) and Testing Visit 2 (2-3 weeks from baseline) |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Beet Juice Concentrate | 0 | 2 | 0 | 2 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |