Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Older adults with coronary artery disease (CAD) have impaired vascular and inspiratory muscle function. The overarching goal of this double-blind, randomized, crossover, placebo-controlled pilot trial was to inform the development of a fully powered trial to evaluate the effects of dietary nitrate supplementation in older adults with CAD. We aimed to address the following objectives: (a) assess the feasibility, tolerability, and safety of the study protocol; (b) gather preliminary evidence on the effects of nitrate-rich beetroot juice compared with nitrate-depleted beetroot juice (placebo), and estimate the effect sizes; and (c) determine if a full-scale definitive trial is justified.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nitrate rich beetroot juice | Active Comparator |
| |
| Nitrate depleted beetroot juice | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitrate rich beetroot juice | Dietary Supplement | Participants will drink nitrate rich beetroot juice (2.4 floz ; Beet It Sport Nitrate 400 concentrated beetroot shot; James White Drink, ltd) twice daily for two weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in endothelial function | Endothelial function will be determined using brachial artery flow-mediated dilation via high resolution duplex ultrasonography. Reactive hyperemia will be produced by inflating a forearm cuff to ~250 mmHg for 5 minutes followed by rapid deflation. | Baseline up to following 2 weeks of experimental condition |
| Change in inspiratory muscle function | Inspiratory muscle function including strength, power and endurance will be assessed using the POWERbreathe KH2 device | Baseline up to following 2 weeks of experimental condition |
| Measure | Description | Time Frame |
|---|---|---|
| Change in microvascular function | Microvascular function will be assessed using the forearm blood flow response to submaximal handgrip exercise. Brachial artery blood flow and diameter will be assessed using ultrasound. | Baseline up to following 2 weeks of experimental condition |
| Change in central arterial stiffness |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Integrative Cardiovascular Physiology Laboratory, University of Florida | Gainesville | Florida | 32611 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Nitrate depleted beetroot juice | Dietary Supplement | Participants will drink nitrate depleted beetroot juice (2.4 floz ; Beet It placebo concentrated beetroot shot; James White Drink, ltd) twice daily for two weeks. |
|
The SphygmoCor XCEL device will be used to measure carotid to femoral pulse wave velocity. |
| Baseline up to following 2 weeks of experimental condition |
| Change in central arterial hemodynamics | The SphygmoCor XCEL device will be used to obtain central pulse wave analysis. | Baseline up to following 2 weeks of experimental condition |
| Change in functional capacity | Using the Duke Activity Status Index we will assess participants' ability to perform daily activities. | Baseline up to following 2 weeks of experimental condition |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |