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Effect of beetroot juice on blood pressure in unmedicated adults with high blood pressure

Dose-Response Effects of Nitrate-Rich Beetroot Drink on Blood Pressure in Adults with Untreated High Blood Pressure (systolic blood pressure 120-159/ diastolic blood pressure 80-99 mmHg): A Randomised Controlled Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000489493
Enrollment
30
Registered
2025-05-20
Start date
2025-06-01
Completion date
2026-03-01
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The Beet-Pressure Study investigates the effects of different doses of nitrate-rich beetroot juice on blood pressure in adults with untreated high blood pressure. Individuals with untreated high blood pressure exhibit a heightened sensitivity to nitrate supplementation. However, existing cohort studies on this population are limited, and the available data present conflicting outcomes. The study aims to find the optimal dose to lower systolic blood pressure by at least 5 mmHg, exploring the dose-response relationship, baseline blood pressure influence, and cardiovascular effects. Participants will undergo six visits for health screenings and measurements before and after beetroot juice consumption. The hypothesis is that untreated individuals with high blood pressure will respond positively to nitrate levels, but the optimal dose may not be the highest.

Interventions

The Intervention is nitrate-rich beetroot juice. This study is an acute dose-response, crossover, double-blinded, randomised, placebo-controlled trial (RCT). Materials: Nitrate-Rich Beetroot Juice: The beetroot juice was prepared at the FoodBowl in Auckland, New Zealand. The concentrated beetroot juice drink, which includes natural flavours and contains no added sweeteners or preservatives, is pasteurised at 90°C for 5 seconds and then filled into Polyethylene Terephthalate (PET) bottles under

The Intervention is nitrate-rich beetroot juice. This study is an acute dose-response, crossover, double-blinded, randomised, placebo-controlled trial (RCT). Materials: Nitrate-Rich Beetroot Juice: The beetroot juice was prepared at the FoodBowl in Auckland, New Zealand. The concentrated beetroot juice drink, which includes natural flavours and contains no added sweeteners or preservatives, is pasteurised at 90°C for 5 seconds and then filled into Polyethylene Terephthalate (PET) bottles under aseptic conditions. The drinks are stored at -20°C until use and tested for microbial safety. Quality Control: Drinks are stored at -20°C. Thawing will be done at 4°C before administration, and disposed of if not used on the trial day. Placebo Drink: Similar in appearance and taste to beetroot juice but with minimal nitrate content. Each drink contains varying nitrate concentrations: * Placebo: less than 62 mg (1 mmol) * Low Dose: 400 mg (6.45 mmol) nitrate. * Medium Dose: 600 mg (9.68 mmol) nitrate. * High Dose: 800 mg (12.9 mmol) nitrate. Health Screening Questionnaire: Used to assess participants' eligibility. Blood Pressure Monitor: Riester Ri-champion 'Registered Trademark' N monitor. Ultrasonographic Cardiac Output Measurement Device: For haemodynamic measurements. Two-Day Food Diary: To record dietary intake before trial visits. Informed Consent Forms: Detailed participant information and consent documentation. These materials are provided to participants during the study visits and can be accessed through the study team at Massey University. Procedures: Screening Visits: The study consists of two health screenings and familiarisation sessions to confirm the eligibility of participants. Trial Visits: The study consists of four trial visits. Each participant will consume all four nitrate concentrations across separate visits, with one specific concentration consumed per visit. The order of the concentrations will be randomised for each participant. At the end of the first trial visit, the participant will be asked to visit for the next trial date (second) after at least a 7-day washout period. On the subsequent trial visits, these steps will be repeated with the remaining beetroot juice doses. Participants will complete pre-supplementation (baseline) measures, and then will be provided a randomly assigned (double blind) beetroot juice. Dosage: Participants consume a single shot of 100 ml of beetroot juice within 10 minutes. Administration: Participants consume the randomly assigned drink on-site with a standardised breakfast. A waiting time for 2.5-3.5 hours (the time it takes for the plasma nitrate and nitrite levels to peak) will be followed, and then post-supplementation measures will be taken. * The standardised isocaloric breakfast consists either cereal with milk or toast with peanut butter, designed to provide a balanced macronutrient intake of approximately 15 grams of protein, 30 grams of carbohydrates, and 10 grams of fat; this meal will be consumed alongside 100 ml of one of four different nitrate dosages of beetroot juice. * The total duration of each trial visit is approximately 4 hours. The pre-supplementation (baseline) assessment comprises measures that will be repeated post-supplementation, including: * Data Collection: Recording of blood pressure and haemodynamic measurements (heart rate, stroke volume, cardiac output, and systemic vascular resistance). * Blood Sample Collection: For plasma nitrate and nitrite analysis, serving as biomarkers for nitric oxide bioavailability Personalisation: The intervention is not personalised or titrated. All participants receive the same four doses of BRJ in a randomised order. Intervention Providers: * Co-ordinating Investigator: Prof Ajmol Ali, expertise in sport and exercise science. * PhD Candidate: Reder Mohammedsalih (10+ years academic experience, nutritionist registered in NZ, Medically Laboratory Registered (MLT) in NZ, certified in Comprehensive First Aid), responsible for day-to-day study management. * Study Management Group: Experienced researchers and academic staff from Massey University. * Medically Qualified Clinician: Dr. Sadiq Al-Sakini, MBChB, MSc, FRCPA, MCNZ Registration Number: 23030. Dr. Al-Sakini will review blood pressure results, medical history, and other relevant data to ensure participant safety. Location: The study will be conducted at the Sport and Exercise Science Research Laboratory, School of Sport, Exercise and Nutrition, Massey University, Auckland. The facility is equipped with the necessary infrastructure for conducting clinical trials, including private rooms for health screenings and laboratory space for trial visits. Adherence and fidelity will be assessed through direct observation by the research team and participant self-reports. Participants will be monitored during each visit to ensure they follow the study protocols, including the consumption of the assigned beetroot juice dose and adherence to pre-visit instructions (e.g., fasting, avoiding certain foods). Additionally, participants will have the opportunity to contact the researcher to provide feedback and report any issues. The research team, including the Co-ordinating Investigator, PhD candidate, study management group, and medically qualified clinician, will be responsible for assessing adherence and fidelity. To maintain or improve fidelity, several strategies will be employed. Participants will receive reminders about study protocols and the importance of adherence during each visit. All procedures, including the preparation and administration of the beetroot juice, will follow standardised protocols to ensure consistency. During the pre-assessment baseline, participants with blood pressure outside the predefined range (120-159/80-99 mmHg) at screening or subsequent visits will be withdrawn, considering pre- and post-supplementation readings and the rate of blood pressure change. The clinician will review blood pressure results, medical history, and other relevant data to ensure participant safety during the screening process and throughout the study.

Sponsors

Massey University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
30 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

All participants are required to meet the following criteria: * High blood pressure individuals with SBP greater than 120-159 mmHg and/or DBP less than 81–99 mmHg * BMI range greater than or equal to 18 kg/m2 and less than or equal to 35 kg/m2 * Do not take antihypertensive medications [e.g., diuretics, angiotensin-converting enzyme (ACE) inhibitors, angiotensin-II receptor blockers (ARBs), beta-blockers, alpha-blockers, nitrate-derived agents, or calcium channel blockers (CCBs)] * Not diagnosed with any heart (e.g., congestive heart failure), vascular (e.g., atherosclerosis of peripheral vascular disease) or cerebrovascular (e.g. stroke) conditions. * Not diagnosed with a metabolic disease (e.g., diabetes mellitus, Cushing’s Syndrome), or gastrointestinal disease or disorder (e.g., chronic gastritis). * Do not use supplements that may affect study outcomes (e.g., tetrahydrobiopterin [BH4], a cofactor involved in the synthesis of NO, and amino acid supplements such as L-arginine and L-citrulline, which may influence NO production and vascular function) * Do not take other non-hypertension medications that could interfere with the study's mechanisms and outcomes (e.g., oral corticosteroids, laxatives, anticoagulants, and antimuscarinic medications) * Do not use hormonal therapies (e.g., cortisol treatments, hormone replacement therapy) * Not currently pregnant or breastfeeding * Not currently using or having used any form of hormonal contraceptive therapy (e.g., oral contraceptives, intrauterine devices, patches, or hormonal injections) within the past 6 months. * Follow a sedentary lifestyle, participants must perform no more than one 60-minute dedicated exercise session (e.g., running, cycling, swimming) per week for at least 6 months before the study. This does not include regular physical activities that maintain a normal heart rate, such as walking, gardening, low-intensity cycling (e.g., commuting), and general household chores.

Exclusion criteria

* Individuals with SBP less than or equal to 120 mmHg or greater than or equal to 160 mmHg, and/or DBP less than or equal to 80 mmHg or greater than or equal to 100 mmHg. * Self-reported diagnosis of any heart (e.g. congestive heart failure), vascular (e.g. atherosclerosis of peripheral vascular disease) or cerebrovascular (e.g. stroke) conditions. * Self-reported diagnosis of a metabolic disease (e.g., diabetes mellitus, Cushing’s Syndrome) or gastrointestinal disease or disorder (e.g., chronic gastritis). * Use of supplements (e.g., BH4, L-arginine and L-citrulline), or other non-hypertension medications (e.g., oral corticosteroids, laxatives, anticoagulants, and antimuscarinic medications) that may affect study outcomes * Currently using hormonal therapies * Be pregnant or breastfeeding * Currently using or having used any form of hormonal contraceptive therapy (e.g., oral contraceptives, intrauterine devices, patches, or hormonal injections) within the past 6 months. * Have menstrual cycles that typically occur more than 60 days apart. * Engaging in physical activity that exceeds 60 minutes on more than one day per week. * Be unable to consume the study beverage due to allergy or intolerance to BRJ * Currently smoke or vape, or have done so in the last 6 months * Have a bleeding disorder that would prevent blood draws by venipuncture.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026