Recruiting

Beetroot Juice

Sponsor:

Mayo Clinic

Code:

NCT05864521

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Active Beetroot Juice Supplement (aBRJ)

Placebo Beetroot Juice Supplement (pBRJ)

Study Details

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

Study ID

NCT05864521

Start date

Sep 28, 2023

Status verified date

Sep, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • Change in the amount of time in stage three sleep [ Time Frame: Baseline, approximately 30 days, and approximately 60 days ]
  • Change in sleep quality [ Time Frame: Baseline, approximately 30 days, and approximately 60 days ]
  • Change in self-reported sleep quality [ Time Frame: Baseline, approximately 30 days, and approximately 60 days ]
  • Change in sleepiness [ Time Frame: Baseline, approximately 30 days, and approximately 60 days ]
  • Change in daytime sleepiness [ Time Frame: Baseline, approximately 30 days, and approximately 60 days ]

Central Contacts and Locations

Central contacts

Joshua Bock, PhD

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

Virend Somers, MD, PhD

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

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Joshua Bock, PhD

(507) 422-0768bock.joshua@mayo.edu

Virend Somers, MD, PhD

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

Principal Investigator:

Joshua Bock, PhD

More Information

Sponsor

Mayo Clinic

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

  • Blood Pressure
  • Sleep

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-09-08.