Beetroot Juice and Sleep

Not Applicable

Recruiting

• Conditions: Healthy
• Interventions: Dietary Supplement: Active Beetroot Juice Supplement (aBRJ); Dietary Supplement: Placebo Beetroot Juice Supplement (pBRJ)

• Registration Number: NCT05864521
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2023-05-09
• Study First Submitted QC: 2023-05-09
• Study First Posted: 2023-05-18
• Study Start: 2023-09-28
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-02
• Last Update Posted: 2023-10-03
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 18-30 or 65-80 years of age

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo Beetroot Juice Supplement (pBRJ) then Active Beetroot Juice Supplement (aBRJ)	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.
Placebo Beetroot Juice Supplement (pBRJ) then Active Beetroot Juice Supplement (aBRJ)	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.
Active Beetroot Juice Supplement (aBRJ) then Placebo Beetroot Juice Supplement (pBRJ)	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 Beetroot Juice Supplement (aBRJ) then Placebo Beetroot Juice Supplement (pBRJ)	Active Beetroot Juice Supplement (aBRJ)	Subjects randomized to this arm of the study will have aBRJ administered during Visit 2 and then pBRJ administered during Visit 3.

Primary Outcome Measures

Name	Time	Method
Change in sleep quality	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 daytime sleepiness	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.
Change in the amount of time in stage three sleep	Baseline, approximately 30 days, and approximately 60 days	Measured overnight polysomnography (PSG) used to identify sleep staging, reported in minutes
Change in self-reported sleep quality	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	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.

Secondary Outcome Measures

Name	Time	Method
Change in sympathetic nerve burst incidence	Baseline, approximately 30 days, and approximately 60 days	Measured by Microneurography reported as number of nerve burst per 100 heart beats (burst/100 heart beats)
Change in arterial stiffness	Baseline, approximately 30 days, and approximately 60 days	Measured by applanation tonometry reported as aortic pulse wave velocity (m/sec)
Change in total muscle sympathetic nerve activity (MSNA)	Baseline, approximately 30 days, and approximately 60 days	Measured by Microneurography reported burst arbitrary units per minute (AU/min)
Change in blood pressure	Baseline, approximately 30 days, and approximately 60 days	Measured in millimeters of mercury (mmHg)
Change in endothelial function	Baseline, approximately 30 days, and approximately 60 days	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.
Change in sympathetic nerve burst frequency	Baseline, approximately 30 days, and approximately 60 days	Measured by Microneurography reported as number of nerve bursts per minute (burst/min)
Change in sympathetic nerve burst amplitude (AU)	Baseline, approximately 30 days, and approximately 60 days	Measured by Microneurography reported in arbitrary units (AU)

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States