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Dietary Supplement
Beetroot Juice for Sleep Quality in Healthy Subjects
N/A
Recruiting
Led By Virend Somers, MD, PhD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, approximately 30 days, and approximately 60 days
Summary
This trial looks at how nitrate from beetroot can affect sleep and brain blood flow.
Who is the study for?
This trial is for healthy adults aged either 18-30 or 65-80. Participants should not have heart conditions, sleep disorders, diabetes, a high body mass index (BMI over 35), or be pregnant. They also shouldn't work night shifts, go to bed very late, have traveled across time zones recently, have frequent kidney stones or use certain medications.
What is being tested?
The study is looking at how beetroot juice affects sleep and brain blood flow. It compares two groups: one drinking a placebo beetroot juice (no active ingredients) and the other consuming an active beetroot juice supplement rich in nitrates.
What are the potential side effects?
While the side effects are not explicitly listed for this trial, typical concerns with supplements like beetroot juice may include stomach upset or allergic reactions. However, as it's a natural product being tested in healthy individuals, significant side effects are unlikely.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, approximately 30 days, and approximately 60 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, approximately 30 days, and approximately 60 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in daytime sleepiness
Change in self-reported sleep quality
Change in sleep quality
+2 moreSecondary study objectives
Change in arterial stiffness
Change in blood pressure
Change in endothelial function
+4 moreTrial Design
2Treatment groups
Active Control
Group I: Active Beetroot Juice Supplement (aBRJ) then Placebo Beetroot Juice Supplement (pBRJ)Active Control2 Interventions
Subjects randomized to this arm of the study will have aBRJ administered during Visit 2 and then pBRJ administered during Visit 3.
Group II: Placebo Beetroot Juice Supplement (pBRJ) then Active Beetroot Juice Supplement (aBRJ)Active Control2 Interventions
Subjects randomized to this arm of the study will have pBRJ administered during Visit 2 and then aBRJ administered during Visit 3.
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,362 Previous Clinical Trials
3,066,064 Total Patients Enrolled
Virend Somers, MD, PhDPrincipal InvestigatorMayo Clinic
9 Previous Clinical Trials
5,315 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have heart failure.I have been diagnosed with coronary artery disease.I have diabetes.I have a diagnosed sleep disorder.I often have kidney stones.I am not taking medications like allopurinol or proton pump inhibitors.I am either 18-30 or 65-80 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Active Beetroot Juice Supplement (aBRJ) then Placebo Beetroot Juice Supplement (pBRJ)
- Group 2: Placebo Beetroot Juice Supplement (pBRJ) then Active Beetroot Juice Supplement (aBRJ)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.