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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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, approximately 30 days, and approximately 60 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in daytime sleepiness

Change in self-reported sleep quality

Change in sleep quality

+2 more

Secondary outcome measures

Change in arterial stiffness

Change in blood pressure

Change in endothelial function

+4 more

Trial 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,216 Previous Clinical Trials

3,767,428 Total Patients Enrolled

Virend Somers, MD, PhDPrincipal InvestigatorMayo Clinic

9 Previous Clinical Trials

5,330 Total Patients Enrolled

Media Library

Active Beetroot Juice Supplement (aBRJ) (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05864521 — N/A

Healthy Subjects Research Study Groups: Active Beetroot Juice Supplement (aBRJ) then Placebo Beetroot Juice Supplement (pBRJ), Placebo Beetroot Juice Supplement (pBRJ) then Active Beetroot Juice Supplement (aBRJ)

Healthy Subjects Clinical Trial 2023: Active Beetroot Juice Supplement (aBRJ) Highlights & Side Effects. Trial Name: NCT05864521 — N/A

Active Beetroot Juice Supplement (aBRJ) (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05864521 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What type of individuals would be most suitable for participation in this trial?

"In order to be eligible for this trial, potential participants must lie between the ages of 18 and 80 years old and demonstrate good health. The researchers are aiming to enrol a total of 60 individuals in the study."

Answered by AI

Is the sample population of this research limited to individuals over 20 years old?

"According to the selection criteria, this trial is only open for individuals between 18-80. For patients below the age of consent or over 65 years old, there are 56 and 382 clinical trials respectively that they can look into."

Answered by AI

Are there any remaining opportunities to participate in this research project?

"Unfortunately, based on the data hosted by clinicaltrials.gov, this trial is not presently searching for enrollees. Although it was originally posted in June of 2023 and last updated in May of that same year; 814 other studies are currently recruiting participants at the present time."

Answered by AI

What is the ultimate goal of this research endeavor?

"The primary evaluation metric of this trial, assessed at the start, 30-day mark and 60 days post-treatment is an alteration in self-reported sleep quality. As secondary objectives, the study will be surveying modification in sympathetic nerve burst amplitude (AU), blood pressure (mmHg) and arterial stiffness (m/sec)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Beetroot Juice and Sleep

Virend Somers, MD, PhD 2023. "Beetroot Juice and Sleep". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05864521.