Beetroot Juice for Sleep Quality in Healthy Subjects

Overseen By Virend Somers, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Allopurinol, Proton pump inhibitors

Disqualifiers: Coronary artery disease, Heart failure, Diabetes, Sleep disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: Approximately 60 days

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you stop taking allopurinol, proton pump inhibitors, or any other medications or supplements that interfere with the nitrate-nitrite-nitric oxide pathway.

Is beetroot juice safe for human consumption?

Research on beetroot juice, including studies on its use for muscle performance and recovery, generally suggests it is safe for human consumption. However, most studies focus on its effects rather than detailed safety evaluations, so it's always a good idea to consult with a healthcare provider before starting any new supplement. ^{1 2 3 4 5}

How does beetroot juice differ from other treatments for improving sleep quality?

Beetroot juice is unique because it is a natural supplement rich in inorganic nitrate, which is known for enhancing physical performance and muscle function, but its use for sleep quality is novel and not well-studied compared to traditional sleep aids. ^{2 6 7 8 9}

What data supports the effectiveness of the treatment Beetroot Juice for Sleep Quality in Healthy Subjects?

Beetroot juice is rich in nitrates, which have been shown to improve cardiovascular function and exercise performance, and it can lower blood pressure. These benefits might indirectly support better sleep quality by improving overall health and reducing stress on the body. ^{2 6 10 11 12}

Who Is on the Research Team?

Virend Somers, MD, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am either 18-30 or 65-80 years old.

Exclusion Criteria

Pregnancy

I have heart failure.

I have been diagnosed with coronary artery disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either active or placebo beetroot juice supplementation during visits 2 and 3

Approximately 60 days

2 visits (in-person)

Follow-up

Participants are monitored for changes in sleepiness, endothelial function, and other physiological measures

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Active Beetroot Juice Supplement (aBRJ)
• Placebo Beetroot Juice Supplement (pBRJ)

Trial Overview 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.

How Is the Trial Designed?

Group I: Active Beetroot Juice Supplement (aBRJ) then Placebo Beetroot Juice Supplement (pBRJ) Active Control 2 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 Control 2 Interventions

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) is already approved in United States, European Union for the following indications:

Approved in United States as Beet Juice for:

• Dietary supplement
• Food coloring

Approved in European Union as Beetroot Juice for:

• Food ingredient
• Dietary supplement

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

Beetroot-based supplements (BRS) have a positive effect on muscular endurance, with a moderate effect size (SMD: 0.31) based on 16 studies, indicating they can help improve performance during physical activities.

BRS also show a significant effect on muscular strength, particularly when measured in a fatigued state (SMD: 0.64), suggesting they may help maintain strength levels during intense exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Beetroot-Based Supplements on Muscular Endurance and Strength in Healthy Male Individuals: A Systematic Review and Meta-Analysis. Evangelista, JF., Meirelles, CM., Aguiar, GS., et al.[2023]

Different forms of beetroot, such as juice, chips, powder, and cooked beetroot, have varying levels of beneficial nutrients, with beetroot juice having the highest amounts of total sugars, phenolic compounds, and nitrates.

Beetroot chips and powder contain higher levels of total antioxidant potential and organic acids, making them effective options for improving cardiovascular function and exercise performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of total antioxidant potential, and total phenolic, nitrate, sugar, and organic acid contents in beetroot juice, chips, powder, and cooked beetroot. Vasconcellos, J., Conte-Junior, C., Silva, D., et al.[2020]

In a study involving 12 well-trained male triathletes, acute supplementation with beetroot juice did not lead to significant improvements in cardioventilatory responses, exercise efficiency, or time trial performance during endurance tests.

The results suggest that higher doses of beetroot juice may be necessary to observe any performance benefits in well-trained athletes, as no significant effects were found at the tested dosage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a single dose of beetroot juice on cycling time trial performance at ventilatory thresholds intensity in male triathletes. Garnacho-Castaño, MV., Palau-Salvà, G., Cuenca, E., et al.[2018]

Beetroot juice supplementation significantly lowers both systolic blood pressure (SBP) by an average of 3.55 mm Hg and diastolic blood pressure (DBP) by 1.32 mm Hg compared to control groups, based on a systematic review of 22 randomized clinical trials involving 650 participants.

The effectiveness of beetroot juice in reducing blood pressure is enhanced with longer supplementation durations (≥14 days) and higher doses (500 mL), suggesting a dose-response relationship, while also indicating potential NO3-independent effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Nitrate-Independent Blood Pressure-Lowering Effect of Beetroot Juice: A Systematic Review and Meta-Analysis. Bahadoran, Z., Mirmiran, P., Kabir, A., et al.[2023]

In a study involving 15 COPD patients, consuming beetroot juice rich in nitrates improved sleep quality by reducing disordered sleep transitions and increasing time spent in REM sleep, despite no change in total sleep duration.

The beetroot juice also led to a significant increase in plasma nitrate levels and sustained higher oxygen saturation during wake episodes, suggesting that improved oxygen delivery may contribute to better sleep quality in COPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Dietary Nitrate Supplementation on Sleep in Chronic Obstructive Pulmonary Disease Patients. Wisor, JP., Holmedahl, NH., Saxvig, IW., et al.[2022]

Beetroot juice was found to be safe for consumption in tested doses (200-3000 mg/kg) over a 28-day period, with no significant toxic effects observed in the liver, kidney, or pancreas of the animal model.

The study indicated that beetroot juice may have beneficial effects on liver enzymes, as it significantly reduced AST levels at higher doses, suggesting potential health benefits without causing organ damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biochemical and histopathological evaluation of liver, kidney, and pancreas in normal Sprague Dawley rats administered aqueous extract of beetroot (Beta vulgaris). Olumese, FE., Oboh, HA.[2022]

In a study involving nine trained apneists, acute supplementation with nitrate-rich beetroot juice did not significantly affect heart rate (HR), peripheral oxygen saturation (SpO2), or pulmonary gas exchange during submaximal static and dynamic apneas.

The results suggest that consuming beetroot juice prior to apnea exercises does not provide any physiological benefits for free divers, as there were no notable differences compared to a placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of a Dietary Nitrate Supplementation in the Form of a Single Shot of Beetroot Juice on Static and Dynamic Apnea Performance. Barlow, MJ., Elia, A., Shannon, OM., et al.[2018]

In a study involving 12 young female volleyball players, beetroot juice (BRJ) supplementation significantly improved muscle endurance (measured by wall-sit performance) and reduced perceived muscle soreness and thigh swelling after exercise-induced muscle damage (EIMD).

While BRJ showed benefits in certain recovery indicators, it did not significantly affect vertical jump height or flexibility compared to a placebo, suggesting its effects may be more pronounced in endurance and soreness rather than overall performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Beetroot Juice Supplementation on Muscle Soreness and Performance Recovery after Exercise-Induced Muscle Damage in Female Volleyball Players. Hemmatinafar, M., Zaremoayedi, L., Koushkie Jahromi, M., et al.[2023]

In a study involving 16 semi-professional male soccer players, the co-ingestion of beetroot juice and caffeine did not significantly enhance team-sport-specific performance compared to a placebo, indicating that these supplements may not provide the expected ergogenic benefits in this context.

While there were no performance improvements, the study noted that caffeine alone led to a higher average heart rate during exercise, and the combination of beetroot juice and caffeine resulted in greater gastrointestinal discomfort compared to the placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute effects of beetroot juice and caffeine co-ingestion during a team-sport-specific intermittent exercise test in semi-professional soccer players: a randomized, double-blind, placebo-controlled study. Berjisian, E., McGawley, K., Saunders, B., et al.[2022]

In a study with 15 participants, supplementation with nitrate-rich beetroot juice significantly improved performance in a 30-second Wingate cycling test, increasing peak power output by 4.4% and reducing the time to reach peak power.

Beetroot juice also positively affected mood states by increasing tension before exercise and lowering perceived exertion in the muscles after the test, suggesting both physical and psychological benefits from the supplementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Beetroot Juice Supplementation on Mood, Perceived Exertion, and Performance During a 30-Second Wingate Test. Jodra, P., Domínguez, R., Sánchez-Oliver, AJ., et al.[2020]

In a study involving 13 well-trained tennis players, the consumption of 70 mL of beetroot juice did not significantly improve physical performance in various tests, including serve velocity and agility.

The results indicate that low doses of beetroot juice may not enhance performance in intermittent sports like tennis, despite its known benefits in endurance activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Beetroot Juice Ingestion on Physical Performance in Highly Competitive Tennis Players. López-Samanes, Á., Pérez-López, A., Moreno-Pérez, V., et al.[2020]

Beetroot juice (BJ) supplementation significantly enhances both mean and peak power output during concentric and eccentric muscle contractions in a half-squat exercise, based on a study involving 18 adult males.

The study used a randomized, double-blind, placebo-controlled crossover design, showing that BJ can improve muscle performance, which may benefit athletes in sports requiring high power output.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beetroot juice supplementation increases concentric and eccentric muscle power output. Original investigation. Rodríguez-Fernández, A., Castillo, D., Raya-González, J., et al.[2021]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Effects of Beetroot-Based Supplements on Muscular Endurance and Strength in Healthy Male Individuals: A Systematic Review and Meta-Analysis. [2023]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Comparison of total antioxidant potential, and total phenolic, nitrate, sugar, and organic acid contents in beetroot juice, chips, powder, and cooked beetroot. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of a single dose of beetroot juice on cycling time trial performance at ventilatory thresholds intensity in male triathletes. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

The Nitrate-Independent Blood Pressure-Lowering Effect of Beetroot Juice: A Systematic Review and Meta-Analysis. [2023]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Effect of Dietary Nitrate Supplementation on Sleep in Chronic Obstructive Pulmonary Disease Patients. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Biochemical and histopathological evaluation of liver, kidney, and pancreas in normal Sprague Dawley rats administered aqueous extract of beetroot (Beta vulgaris). [2022]

7. United States pubmed.ncbi.nlm.nih.gov

The Effect of a Dietary Nitrate Supplementation in the Form of a Single Shot of Beetroot Juice on Static and Dynamic Apnea Performance. [2018]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Beetroot Juice Supplementation on Muscle Soreness and Performance Recovery after Exercise-Induced Muscle Damage in Female Volleyball Players. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Acute effects of beetroot juice and caffeine co-ingestion during a team-sport-specific intermittent exercise test in semi-professional soccer players: a randomized, double-blind, placebo-controlled study. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Effect of Beetroot Juice Supplementation on Mood, Perceived Exertion, and Performance During a 30-Second Wingate Test. [2020]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Beetroot Juice Ingestion on Physical Performance in Highly Competitive Tennis Players. [2020]

12. Australia pubmed.ncbi.nlm.nih.gov

Beetroot juice supplementation increases concentric and eccentric muscle power output. Original investigation. [2021]