Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05864521

Beetroot Juice and Sleep

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Healthy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active Beetroot Juice Supplement (aBRJ)

Dietary Supplement

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)

Dietary Supplement

pBRJ will consist of 70ml concentrated beetroot juice and will be chemically devoid of inorganic nitrate taken orally.

Primary outcomes

  1. Change in the amount of time in stage three sleep

    Time frame: Baseline, approximately 30 days, and approximately 60 days

    Measured overnight polysomnography (PSG) used to identify sleep staging, reported in minutes

  2. Change in sleep quality

    Time frame: 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.

  3. Change in self-reported sleep quality

    Time frame: 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?

  4. Change in sleepiness

    Time frame: 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.

  5. Change in daytime sleepiness

    Time frame: 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 outcomes

  1. Change in blood pressure

    Time frame: Baseline, approximately 30 days, and approximately 60 days

    Measured in millimeters of mercury (mmHg)

  2. Change in sympathetic nerve burst frequency

    Time frame: Baseline, approximately 30 days, and approximately 60 days

    Measured by Microneurography reported as number of nerve bursts per minute (burst/min)

  3. Change in sympathetic nerve burst incidence

    Time frame: 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)

  4. Change in sympathetic nerve burst amplitude (AU)

    Time frame: Baseline, approximately 30 days, and approximately 60 days

    Measured by Microneurography reported in arbitrary units (AU)

  5. Change in total muscle sympathetic nerve activity (MSNA)

    Time frame: Baseline, approximately 30 days, and approximately 60 days

    Measured by Microneurography reported burst arbitrary units per minute (AU/min)

  6. Change in arterial stiffness

    Time frame: Baseline, approximately 30 days, and approximately 60 days

    Measured by applanation tonometry reported as aortic pulse wave velocity (m/sec)

  7. Change in endothelial function

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Joshua Bock, PhD

CONTACT

[email protected]

(507) 422-0768

Virend Somers, MD, PhD

CONTACT

[email protected]

(507) 255-1144

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Effects of Nocturnal Inorganic Nitrate Supplementation on Physiological Function

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 18, 2023
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.