Healthy
Conditions
Keywords
Blood Pressure, Sleep
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTActive Beetroot Juice Supplement (aBRJ)
aBRJ will consist of 70ml concentrated beetroot juice with 6.45-7.26mmol inorganic nitrate (range for inter-batch variability) taken orally.
DIETARY_SUPPLEMENTPlacebo Beetroot Juice Supplement (pBRJ)
pBRJ will consist of 70ml concentrated beetroot juice and will be chemically devoid of inorganic nitrate taken orally.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* 18-35 or 65-80 years of age
Exclusion criteria
* Coronary artery disease * Heart failure * Pregnancy * Diabetes * Sleep disorders * Shift workers * Individuals who typically go to sleep after midnight * Individuals who traveled across ≥2 time zones within one week of study visits * Individuals with a history frequent kidney stones * BMI ≥35.0kg/m2 * Use of nicotine-containing products within the two years preceding study visits * Use of allopurinol, proton pump inhibitors, or other medications/supplements which interfere with the nitrate-nitrite-nitric oxide pathway or outcome measures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the amount of time in stage three sleep | Baseline, approximately 30 days, and approximately 60 days | Measured overnight polysomnography (PSG) used to identify sleep staging, reported in minutes |
| Change in sleep quality | Baseline, approximately 30 days, and approximately 60 days | 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. |
| Change in self-reported sleep quality | Baseline, approximately 30 days, and approximately 60 days | 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? |
| Change in sleepiness | Baseline, approximately 30 days, and approximately 60 days | 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. |
| Change in daytime sleepiness | Baseline, approximately 30 days, and approximately 60 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in blood pressure | Baseline, approximately 30 days, and approximately 60 days | Measured in millimeters of mercury (mmHg) |
| Change in sympathetic nerve burst frequency | Baseline, approximately 30 days, and approximately 60 days | Measured by Microneurography reported as number of nerve bursts per minute (burst/min) |
| Change in sympathetic nerve burst incidence | Baseline, approximately 30 days, and approximately 60 days | Measured by Microneurography reported as number of nerve burst per 100 heart beats (burst/100 heart beats) |
| Change in sympathetic nerve burst amplitude (AU) | Baseline, approximately 30 days, and approximately 60 days | Measured by Microneurography reported in arbitrary units (AU) |
| Change in total muscle sympathetic nerve activity (MSNA) | Baseline, approximately 30 days, and approximately 60 days | Measured by Microneurography reported burst arbitrary units per minute (AU/min) |
| Change in arterial stiffness | Baseline, approximately 30 days, and approximately 60 days | Measured by applanation tonometry reported as aortic pulse wave velocity (m/sec) |
| Change in endothelial function | Baseline, approximately 30 days, and approximately 60 days | 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. |
Countries
United States
Contacts
CONTACTJoshua Bock, PhD
CONTACTVirend Somers, MD, PhD
PRINCIPAL_INVESTIGATORJoshua Bock, PhD
Mayo Clinic
Outcome results
None listed