Recruiting NCT05864521
Beetroot Juice and Sleep
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Active Beetroot Juice Supplement (aBRJ), Placebo Beetroot Juice Supplement (pBRJ).
- Who it may be relevant to
- Registry conditions: Healthy. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Nocturnal Inorganic Nitrate Supplementation on Physiological Function
Overview
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.
Interventions
- Dietary supplement 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 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 measures
- 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]
Secondary outcome measures (7)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT05864521 · 23-000874