Beetroot Juice and Sleep

NCT ID: NCT05864521

Last Updated: 2025-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-28

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Active Beetroot Juice Supplement (aBRJ)

Intervention Type 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)

Intervention Type DIETARY_SUPPLEMENT

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

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.

Group Type ACTIVE_COMPARATOR

Active Beetroot Juice Supplement (aBRJ)

Intervention Type 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)

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Joshua M. Bock

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joshua Bock, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Joshua Bock, PhD

Role: CONTACT

(507) 422-0768

Virend Somers, MD, PhD

Role: CONTACT

(507) 255-1144

Facility Contacts

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Joshua Bock, PhD

Role: primary

(507) 422-0768

Virend Somers, MD, PhD

Role: backup

(507) 255-1144

Other Identifiers

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23-000874

Identifier Type: -

Identifier Source: org_study_id

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