Beetroot Juice and Sleep

NCT05864521 | Recruiting

• 1 other identifier: 23-000874
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Blood Pressure; Sleep

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• Change in blood pressure

  Baseline, approximately 30 days, and approximately 60 days

• Change in sympathetic nerve burst frequency

  Baseline, approximately 30 days, and approximately 60 days

• Change in sympathetic nerve burst incidence

  Baseline, approximately 30 days, and approximately 60 days

• Change in sympathetic nerve burst amplitude (AU)

  Baseline, approximately 30 days, and approximately 60 days

• Change in total muscle sympathetic nerve activity (MSNA)

  Baseline, approximately 30 days, and approximately 60 days

Study Arms (2)

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.

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.

Dietary Supplement: Active Beetroot Juice Supplement (aBRJ); Dietary Supplement: Placebo Beetroot Juice Supplement (pBRJ)

Interventions

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.

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) DIETARY_SUPPLEMENT

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

Active Beetroot Juice Supplement (aBRJ) then Placebo Beetroot Juice Supplement (pBRJ); Placebo Beetroot Juice Supplement (pBRJ) then Active Beetroot Juice Supplement (aBRJ)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• or 65-80 years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Study Officials

• Joshua Bock, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joshua Bock, PhD

CONTACT

(507) 422-0768; Bock.Joshua@mayo.edu

Virend Somers, MD, PhD

CONTACT

(507) 255-1144; Somers.Virend@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: May 18, 2023
• Study Start: September 28, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)