Beetroot Juice and Sleep

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Nocturnal Inorganic Nitrate Supplementation on Physiological Function

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Active Beetroot Juice Supplement (aBRJ)
* Dietary Supplement: Placebo Beetroot Juice Supplement (pBRJ)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-30 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Beetroot Juice Supplement (aBRJ) then Placebo Beetroot Juice Supplement (pBRJ)<br>Subjects randomized to this arm of the study will have aBRJ administered during Visit 2 and then pBRJ administered during Visit 3. | Dietary Supplement: Active Beetroot Juice Supplement (aBRJ)<br>* aBRJ will consist of 70ml concentrated beetroot juice with 6.45-7.26mmol inorganic nitrate (range for inter-batch variability) taken orally.<br>Dietary Supplement: Placebo Beetroot Juice Supplement (pBRJ)<br>* pBRJ will consist of 70ml concentrated beetroot juice and will be chemically devoid of inorganic nitrate taken orally.<br>|
| Active Comparator: Placebo Beetroot Juice Supplement (pBRJ) then Active Beetroot Juice Supplement (aBRJ)<br>Subjects randomized to this arm of the study will have pBRJ administered during Visit 2 and then aBRJ administered during Visit 3. | Dietary Supplement: Active Beetroot Juice Supplement (aBRJ)<br>* aBRJ will consist of 70ml concentrated beetroot juice with 6.45-7.26mmol inorganic nitrate (range for inter-batch variability) taken orally.<br>Dietary Supplement: Placebo Beetroot Juice Supplement (pBRJ)<br>* pBRJ will consist of 70ml concentrated beetroot juice and will be chemically devoid of inorganic nitrate taken orally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood Pressure, Sleep