Beetroot Juice and Sleep

Healthy Clinical Trial

Official title:

Effects of Nocturnal Inorganic Nitrate Supplementation on Physiological Function

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05864521
• Other study ID #: 23-000874
• Status: Recruiting
• Phase: N/A
• Start date: September 28, 2023
• Est. completion date: June 2026

Study information

• Verified date: October 2023
• Source: Mayo Clinic
• Contact: Joshua Bock, PhD
• Phone: (507) 422-0768
• Email: Bock.Joshua[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Active 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.
• Placebo Beetroot Juice Supplement (pBRJ)
pBRJ will consist of 70ml concentrated beetroot juice and will be chemically devoid of inorganic nitrate taken orally.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Change in blood pressure	Measured in millimeters of mercury (mmHg)	Baseline, approximately 30 days, and approximately 60 days
Secondary	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
Secondary	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
Secondary	Change in sympathetic nerve burst amplitude (AU)	Measured by Microneurography reported in arbitrary units (AU)	Baseline, approximately 30 days, and approximately 60 days
Secondary	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
Secondary	Change in arterial stiffness	Measured by applanation tonometry reported as aortic pulse wave velocity (m/sec)	Baseline, approximately 30 days, and approximately 60 days
Secondary	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

External Links

•   Mayo Clinic Clinical Trials