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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
60
aBRJ will consist of 70ml concentrated beetroot juice with 6.45-7.26mmol inorganic nitrate (range for inter-batch variability) taken orally.
pBRJ will consist of 70ml concentrated beetroot juice and will be chemically devoid of inorganic nitrate taken orally.
Mayo Clinic in Rochester
Rochester, Minnesota, United States
RECRUITINGChange in the amount of time in stage three sleep
Measured overnight polysomnography (PSG) used to identify sleep staging, reported in minutes
Time frame: 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.
Time frame: 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?
Time frame: 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.
Time frame: 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.
Time frame: Baseline, approximately 30 days, and approximately 60 days
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Change in blood pressure
Measured in millimeters of mercury (mmHg)
Time frame: 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)
Time frame: 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)
Time frame: Baseline, approximately 30 days, and approximately 60 days
Change in sympathetic nerve burst amplitude (AU)
Measured by Microneurography reported in arbitrary units (AU)
Time frame: 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)
Time frame: Baseline, approximately 30 days, and approximately 60 days
Change in arterial stiffness
Measured by applanation tonometry reported as aortic pulse wave velocity (m/sec)
Time frame: 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.
Time frame: Baseline, approximately 30 days, and approximately 60 days