Beetroot Juice and Sleep

Effects of Nocturnal Inorganic Nitrate Supplementation on Physiological Function

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 Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Active Beetroot Juice Supplement (aBRJ); Dietary supplement: Placebo Beetroot Juice Supplement (pBRJ)

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joshua Bock, PhD; Phone Number: (507) 422-0768; Email: bock.joshua@mayo.edu
• Study Contact Backup: Name: Virend Somers, MD, PhD; Phone Number: (507) 255-1144; Email: Somers.Virend@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Joshua Bock, PhD; Phone Number: (507) 422-0768; Email: bock.joshua@mayo.edu
      • Contact: Virend Somers, MD, PhD; Phone Number: (507) 255-1144; Email: Somers.Virend@mayo.edu
      • Principal Investigator: Joshua Bock, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Beetroot Juice Supplement (aBRJ) then Placebo Beetroot Juice Supplement (pBRJ); 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); aBRJ will consist of 70ml concentrated beetroot juice with 6.45-7.26mmol inorganic nitrate (range for inter-batch variability) taken orally.; Dietary supplement: Placebo Beetroot Juice Supplement (pBRJ); pBRJ will consist of 70ml concentrated beetroot juice and will be chemically devoid of inorganic nitrate taken orally.
Active Comparator: Placebo Beetroot Juice Supplement (pBRJ) then Active Beetroot Juice Supplement (aBRJ); 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); aBRJ will consist of 70ml concentrated beetroot juice with 6.45-7.26mmol inorganic nitrate (range for inter-batch variability) taken orally.; Dietary supplement: Placebo Beetroot Juice Supplement (pBRJ); pBRJ will consist of 70ml concentrated beetroot juice and will be chemically devoid of inorganic nitrate taken orally.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Joshua Bock, PhD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2023
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: May 9, 2023
• First Submitted That Met QC Criteria: May 9, 2023
• First Posted (Actual): May 18, 2023

Study Record Updates

• Last Update Posted (Actual): September 8, 2026
• Last Update Submitted That Met QC Criteria: September 2, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Sleep; Blood Pressure
• Other Study ID Numbers: 23-000874

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No