HealthyNCT05864521
Beetroot Juice and Sleep
A study testing Active Beetroot Juice Supplement (aBRJ) in people with Healthy, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Active Beetroot Juice Supplement (aBRJ)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2023to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-35 or 65-80 years of age
Who cannot join
- Coronary artery disease
- Heart failure
- Pregnancy
- Diabetes
- Sleep disorders
- Shift workers
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Joshua Bock, PhD, (507) 422-0768, bock.joshua@mayo.edu
Virend Somers, MD, PhD, (507) 255-1144, Somers.Virend@mayo.edu
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Active Beetroot Juice Supplement (aBRJ), Placebo Beetroot Juice Supplement (pBRJ)
- Keywords
- Blood Pressure, Sleep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Beetroot Juice Supplement (aBRJ) then Placebo Beetroot Juice Supplement (pBRJ) | Active comparator | Subjects randomized to this arm of the study will have aBRJ administered during Visit 2 and then pBRJ administered during Visit 3. Receives: Dietary Supplement: Active Beetroot Juice Supplement (aBRJ); Dietary Supplement: Placebo Beetroot Juice Supplement (pBRJ) |
| Placebo Beetroot Juice Supplement (pBRJ) then Active Beetroot Juice Supplement (aBRJ) | Active comparator | Subjects randomized to this arm of the study will have pBRJ administered during Visit 2 and then aBRJ administered during Visit 3. Receives: Dietary Supplement: Active Beetroot Juice Supplement (aBRJ); Dietary Supplement: Placebo Beetroot Juice Supplement (pBRJ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the amount of time in stage three sleep
Measured overnight polysomnography (PSG) used to identify sleep staging, reported in minutes
Measured: 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.
Measured: 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?
Measured: 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.
Measured: 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.
Measured: Baseline, approximately 30 days, and approximately 60 days
Secondary outcomes (7)
Change in blood pressure
Measured in millimeters of mercury (mmHg)
Measured: 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)
Measured: 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)
Measured: Baseline, approximately 30 days, and approximately 60 days
Change in sympathetic nerve burst amplitude (AU)
Measured by Microneurography reported in arbitrary units (AU)
Measured: 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)
Measured: Baseline, approximately 30 days, and approximately 60 days
Change in arterial stiffness
Measured by applanation tonometry reported as aortic pulse wave velocity (m/sec)
Measured: 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.
Measured: Baseline, approximately 30 days, and approximately 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start28 Sep 2023
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua M. Bock, Mayo Clinic
- Investigators
- Joshua Bock, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05864521
- Sponsor's protocol ID
- 23-000874
- Status last verified
- Sep 2026
- First submitted
- 9 May 2023
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nocturnal Inorganic Nitrate Supplementation on Physiological Function
- ClinicalTrials.gov ID
- NCT05864521
- Acronym / sponsor ID
- 23-000874
- Conditions
- Healthy
- Keywords
- Blood Pressure, Sleep
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Beetroot Juice Supplement (aBRJ) then Placebo Beetroot Juice Supplement (pBRJ) | Active comparator | Dietary Supplement: Active Beetroot Juice Supplement (aBRJ), Dietary Supplement: 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. |
| Placebo Beetroot Juice Supplement (pBRJ) then Active Beetroot Juice Supplement (aBRJ) | Active comparator | Dietary Supplement: Active Beetroot Juice Supplement (aBRJ), Dietary Supplement: Placebo Beetroot Juice Supplement (pBRJ)Subjects randomized to this arm of the study will have pBRJ administered during Visit 2 and then aBRJ administered during Visit 3. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18-35 or 65-80 years of age
Key exclusion criteria (12 listed)
- Coronary artery disease
- Heart failure
- Pregnancy
- Diabetes
- Sleep disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Active Beetroot Juice Supplement (aBRJ) then Placebo Beetroot Juice Supplement (pBRJ), Placebo Beetroot Juice Supplement (pBRJ) then Active Beetroot Juice Supplement (aBRJ) |
| Placebo Beetroot Juice Supplement (pBRJ)pBRJ will consist of 70ml concentrated beetroot juice and will be chemically devoid of inorganic nitrate taken orally. | Dietary supplement | Active Beetroot Juice Supplement (aBRJ) then Placebo Beetroot Juice Supplement (pBRJ), Placebo Beetroot Juice Supplement (pBRJ) then Active Beetroot Juice Supplement (aBRJ) |
Primary outcome
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
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.
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?
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.
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.
7 secondary outcomes
Change in blood pressure
Time frame: Baseline, approximately 30 days, and approximately 60 days
Change in sympathetic nerve burst frequency
Time frame: Baseline, approximately 30 days, and approximately 60 days
Change in sympathetic nerve burst incidence
Time frame: Baseline, approximately 30 days, and approximately 60 days
Change in sympathetic nerve burst amplitude (AU)
Time frame: Baseline, approximately 30 days, and approximately 60 days
Change in total muscle sympathetic nerve activity (MSNA)
Time frame: Baseline, approximately 30 days, and approximately 60 days
Change in arterial stiffness
Time frame: Baseline, approximately 30 days, and approximately 60 days
Change in endothelial function
Time frame: Baseline, approximately 30 days, and approximately 60 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joshua Bock, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Beetroot Juice Supplement (aBRJ) in people with Healthy, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joshua Bock, PhD ((507) 422-0768, Bock.Joshua@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the amount of time in stage three sleep (time frame: Baseline, approximately 30 days, and approximately 60 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.