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The purpose of this study is to investigate the effects of acute inorganic nitrate supplementation (with beetroot) on the regulation of sleep and neurovascular physiology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Beetroot Juice Supplement (aBRJ) then Placebo Beetroot Juice Supplement (pBRJ) | Active Comparator | Subjects randomized to this arm of the study will have aBRJ administered during Visit 2 and then pBRJ administered during Visit 3. |
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| Placebo Beetroot Juice Supplement (pBRJ) then Active Beetroot Juice Supplement (aBRJ) | Active Comparator | Subjects randomized to this arm of the study will have pBRJ administered during Visit 2 and then aBRJ administered during Visit 3. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Beetroot Juice Supplement (aBRJ) | Dietary Supplement | aBRJ will consist of 70ml concentrated beetroot juice with 6.45-7.26mmol inorganic nitrate (range for inter-batch variability) taken orally. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the amount of time in stage three sleep | Measured overnight polysomnography (PSG) used to identify sleep staging, reported in minutes | Baseline, approximately 30 days, and approximately 60 days |
| Change in sleep quality | Measured by Pittsburgh Sleep Quality Index which measures the severity of sleep disturbances. Possible scores range from 0 to 21 with higher scores indicating a worse outcome/more severe symptoms of sleep disturbance. | Baseline, approximately 30 days, and approximately 60 days |
| Change in self-reported sleep quality | Measured on a visual analog scale of 1-10, where 1 is not at all sleepy and 10 is as sleepy as you can imagine, how sleepy are you right now? | Baseline, approximately 30 days, and approximately 60 days |
| Change in sleepiness | Measured by the Stanford Sleepiness Scale that asks participate to rank their degree of sleepiness where 1 would indicate the subject currently feels least sleepy and 7 would indicate the subject feels the most sleepy. | Baseline, approximately 30 days, and approximately 60 days |
| Change in daytime sleepiness | Measured by Epworth Sleepiness Scale. The test is a list of eight situations in which you rate your tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing. Total score is graded from 0-24. 0-7:It is unlikely that you are abnormally sleepy. 8-9:You have an average amount of daytime sleepiness. 10-15:You may be excessively sleepy depending on the situation. You may want to consider seeking medical attention. 16-24:You are excessively sleepy and should consider seeking medical attention. | Baseline, approximately 30 days, and approximately 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood pressure | Measured in millimeters of mercury (mmHg) | Baseline, approximately 30 days, and approximately 60 days |
| Change in sympathetic nerve burst frequency | Measured by Microneurography reported as number of nerve bursts per minute (burst/min) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joshua Bock, PhD | Contact | (507) 422-0768 | Bock.Joshua@mayo.edu | |
| Virend Somers, MD, PhD | Contact | (507) 255-1144 | Somers.Virend@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Joshua Bock, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Placebo Beetroot Juice Supplement (pBRJ) | Dietary Supplement | pBRJ will consist of 70ml concentrated beetroot juice and will be chemically devoid of inorganic nitrate taken orally. |
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| Baseline, approximately 30 days, and approximately 60 days |
| Change in sympathetic nerve burst incidence | Measured by Microneurography reported as number of nerve burst per 100 heart beats (burst/100 heart beats) | Baseline, approximately 30 days, and approximately 60 days |
| Change in sympathetic nerve burst amplitude (AU) | Measured by Microneurography reported in arbitrary units (AU) | Baseline, approximately 30 days, and approximately 60 days |
| Change in total muscle sympathetic nerve activity (MSNA) | Measured by Microneurography reported burst arbitrary units per minute (AU/min) | Baseline, approximately 30 days, and approximately 60 days |
| Change in arterial stiffness | Measured by applanation tonometry reported as aortic pulse wave velocity (m/sec) | Baseline, approximately 30 days, and approximately 60 days |
| Change in endothelial function | Ultrasound assessment of flow-mediated vasodilation of the brachial artery. Brachial artery diameter and blood velocity will be measured after deflation to measure endothelial function. | Baseline, approximately 30 days, and approximately 60 days |