Obese IndividualsBEET-DOWNNCT07869472
Post-exercise Blood Pressure With Inorganic Nitrate
A study testing Beetroot Juice - Active + Exercise and Beetroot Juice - Active + No exercise in people with Obese Individuals and Central Adiposity, run by University of Virginia at 1 site in United States.
Trial summary
This study is examining whether acute inorganic nitrate supplementation in the form of beetroot juice, paired with an acute bout of exercise, affects blood pressure and what is the magnitude of the difference compared to exercise alone. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Obese Individuals, Central Adiposity
- What is being tested?
- Beetroot Juice - Active + Exercise and Beetroot Juice - Active + No exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2026to 30 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willingness and ability to comply with scheduled visits and study procedures.
- Males and females, ages 18-40 years old
- Sedentary (<150 minutes of moderate intensity aerobic exercise per week, or not engaged in a regular exercise program at all
- Resting systolic BP ≥ 120 mmHg.
- BMI ≥ 30 kg/m2
- Waist circumference ≥94 cm for males and ≥80 cm for females
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- Be able to perform exercise on a cycle ergometer without assistance
- Stable medication regimen for the last 6 months
- Be able to discontinue the use of inorganic nitrate rich foods such as beets, arugula, spinach, celery, and grapefruit throughout the duration of the study.
Who cannot join
- Body mass index ≤ 29.9 Kg/m2
- Smoker within last 5 years
- Has experienced significant weight loss ~3 kg in the last three months or taking any weight loss drugs
- Current medical condition that prohibits exercising at high intensities
- Currently on hormone replacement of any kind
- History of medical conditions that would prohibit high intensity exercise, such as:, uncontrolled hypertension (≥140/90), diabetes, myocardial infarction, cerebrovascular event, known cardiovascular, pulmonary, renal, metabolic diseases, and acute or unstable disease other than high BMI and waist circumference
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- Current injuries that would prohibit exercising on a stationary bike
- Currently restricted by medical doctor to engage in exercise
- Currently taking or have taken any of the following medications in the last 4 weeks (calcium channel blockers, statins, ACE or renin inhibitors, angiotensin receptor blockers, organic nitrates (e.g., nitroglycerine, alpha- or beta-blockers, diuretics, proton pump inhibitors, PDE-5 inhibitors (e.g., Cialis, Viagra), or xanthine oxidase inhibitors (e.g., Allopurinol))
- Oral antibiotic use within previous four weeks including over-the-counter antibacterial mouthwash or a mouthwash containing chlorhexidine and unwilling to discontinue use
- Oral cancer/severe oral disease
- Had hysterectomy or oophorectomy
- Pregnant women or planning to be pregnant, Fetuses, neonates, children, prisoners, cognitively impaired, non-English speaking participants
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Virginia
Charlottesville, Virginia, 22903
Money Ghimire, M.S., 4349243004, eta8xd@uvahealth.org
About this study
Official title: Effects of Inorganic Nitrate Supplementation on Post-exercise Hypotension Response Following Acute Exercise in Young Adults With Elevated Body Mass Index and Blood Pressure
This study is examining whether acute inorganic nitrate supplementation in the form of beetroot juice, paired with an acute bout of exercise, affects blood pressure and what is the magnitude of the difference compared to exercise alone.
Read the detailed description
Inorganic nitrate supplementation (NS) has gained popularity since the early 2010s as a means to improve exercise performance. The benefits of NS include, but are not limited to, improved exercise tolerance, reduced resting peripheral blood pressure, and improved vascular health. However, the post-exercise hypotension (PEH) effects of NS remain poorly understood, primarily due to poorly controlled studies with heterogeneous populations. NS has been shown to increase nitric oxide (NO) bioavailability (via the nitrate-nitrite-NO pathway), which is independent of endothelial NO synthase and may play a role in conferring additive vascular benefits when combined with acute exercise. Purpose: To assess the effects of NS supplementation on the magnitude of PEH following acute exercise compared to placebo. Methods: Twelve young adults with BMI ≥ 30 kg/m2 with central adiposity (defined by waist circumference of ≥ 94 cm for males, and 80cm for females), and elevated resting BP will participate in a double-blinded crossover design and receive acute exercise + beetroot juice, acute exercise + placebo, no exercise + beetroot juice, and no exercise + placebo. Results: The successful completion of this project will elucidate the role of NS on PEH response with acute exercise and its potential mechanisms.
- Conditions
- Obese Individuals, Central Adiposity
- Being tested
- Beetroot Juice - Active + Exercise, Beetroot juice placebo + Exercise, Beetroot Juice - Active + No exercise, Beetroot juice placebo+ No exercise
- Keywords
- obesity, central adiposity, elevated blood pressure, dietary nitrate
- Medical subject headings
- Obesity, Abdominal, Obesity, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beetroot Juice - Active + ExerciseDietary supplement
Supplement with 140 mL nitrate-rich beverage (800mg NO3-) (~12.9 mmol/L) 1 hour 30 minutes before lab visit after a 3-day washout + ACUTE EXERCISE and post-exercise blood pressure, and central hemodynamics measured via impedance cardiography.
Beetroot juice placebo + ExerciseDietary supplement
Supplement with 140 mL nitrate-depleted beverage (<0.1 mmol/L) after a 3-day washout + ACUTE EXERCISE, and post-exercise blood pressure, and central hemodynamics measured via impedance cardiography
Beetroot Juice - Active + No exerciseDietary supplement
Supplement with 140mL nitrate rich beverage (800mg NO3-) (~12.9 mmol/L) 1 hour 30 minutes before lab visit after a 3 day washout + NO EXERCISE, and blood pressure, and central hemodynamics measured via impedance cardiography.
Beetroot juice placebo+ No exerciseDietary supplement
Supplement with 140 mL nitrate-depleted beverage (<0.1 mmol/L) after a 3-day washout + NO EXERCISE, and blood pressure and central hemodynamics measured via impedance cardiography.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | 1 x 4 crossover design where each participant will be randomized to complete four conditions after at least a 3-day washout period. Receives: Dietary Supplement: Beetroot Juice - Active + Exercise |
| B | Active comparator | 1 x 4 crossover design where each participant will be randomized to complete four conditions after at least a 3-day washout period. Receives: Dietary Supplement: Beetroot juice placebo + Exercise |
| C | Placebo comparator | 1 x 4 crossover design where each participant will be randomized to complete four conditions after at least a 3-day washout period. Receives: Dietary Supplement: Beetroot Juice - Active + No exercise |
| D | Sham comparator | 1 x 4 crossover design where each participant will be randomized to complete four conditions after at least a 3-day washout period. Receives: Dietary Supplement: Beetroot juice placebo+ No exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure (Central and Peripheral)
The central and peripheral blood pressures will be measured using a validated automated system (Oscar 2 (SunTech)/ SphygmoCor system (Atcor Medical). This system processes brachial waveforms using dedicated software with a validated generalized transfer function to derive a corresponding aortic pressure waveform. Aortic waveforms are then further processed to identify systolic (SBP in mmHg), mean (MAP in mmHg), diastolic (DBP in mmHg), and pulse pressure (PP in mmHg). This allows calculation of augmentation pressure (AugP in mmHg) (due to wave reflection) and the augmentation index (AIx = (AugP/PP) × 100) in percentage units. Participants will sit for at least 15 minutes before each measurement.
Measured: Before each condition and after every 15 minutes for 3 hours.
Impedance Cardiography
Measure of central hemodynamics (cardiac output (L/min), stroke volume (mL), and systemic vascular resistance (dyn.s.cm5) etc.) will be non-invasively captured using the PhysioFlow Q-Link System. This system uses electrodes placed on the participant's body and applies the principles of signal-morphology impedance cardiography to estimate central cardiac measures at rest and after exercise.
Measured: Before, during, and after (upto 3 hours post every 15 min) each condition
Plasma/Saliva Nitrate and Nitrate
Plasma/Saliva samples will be collected to assess changes in plasma/saliva nitrate (measured in micromolar- uM) and nitrite (measured in nanomolar- nM) following either BRJ or placebo and in different exercise and control conditions.
Measured: Before and after 2 hours post supplementation of BRJ, Placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obese IndividualsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Allen, University of Virginia
- Investigators
- Jason Allen, Principal investigator, University of VirginiaSiddhartha Angadi, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869472
- Sponsor's protocol ID
- 303609
- Acronym
- BEET-DOWN
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inorganic Nitrate Supplementation on Post-exercise Hypotension Response Following Acute Exercise in Young Adults With Elevated Body Mass Index and Blood Pressure
- ClinicalTrials.gov ID
- NCT07869472
- Acronym / sponsor ID
- BEET-DOWN / 303609
- Conditions
- Obese Individuals, Central Adiposity
- Keywords
- obesity, central adiposity, elevated blood pressure, dietary nitrate
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is examining whether acute inorganic nitrate supplementation in the form of beetroot juice, paired with an acute bout of exercise, affects blood pressure and what is the magnitude of the difference compared to exercise alone.
Detailed description
Inorganic nitrate supplementation (NS) has gained popularity since the early 2010s as a means to improve exercise performance. The benefits of NS include, but are not limited to, improved exercise tolerance, reduced resting peripheral blood pressure, and improved vascular health. However, the post-exercise hypotension (PEH) effects of NS remain poorly understood, primarily due to poorly controlled studies with heterogeneous populations. NS has been shown to increase nitric oxide (NO) bioavailability (via the nitrate-nitrite-NO pathway), which is independent of endothelial NO synthase and may play a role in conferring additive vascular benefits when combined with acute exercise. Purpose: To assess the effects of NS supplementation on the magnitude of PEH following acute exercise compared to placebo. Methods: Twelve young adults with BMI ≥ 30 kg/m2 with central adiposity (defined by waist circumference of ≥ 94 cm for males, and 80cm for females), and elevated resting BP will participate in a double-blinded crossover design and receive acute exercise + beetroot juice, acute exercise + placebo, no exercise + beetroot juice, and no exercise + placebo. Results: The successful completion of this project will elucidate the role of NS on PEH response with acute exercise and its potential mechanisms.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Dietary Supplement: Beetroot Juice - Active + Exercise1 x 4 crossover design where each participant will be randomized to complete four conditions after at least a 3-day washout period. |
| B | Active comparator | Dietary Supplement: Beetroot juice placebo + Exercise1 x 4 crossover design where each participant will be randomized to complete four conditions after at least a 3-day washout period. |
| C | Placebo comparator | Dietary Supplement: Beetroot Juice - Active + No exercise1 x 4 crossover design where each participant will be randomized to complete four conditions after at least a 3-day washout period. |
| D | Sham comparator | Dietary Supplement: Beetroot juice placebo+ No exercise1 x 4 crossover design where each participant will be randomized to complete four conditions after at least a 3-day washout period. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Willingness and ability to comply with scheduled visits and study procedures.
- Males and females, ages 18-40 years old
- Sedentary (<150 minutes of moderate intensity aerobic exercise per week, or not engaged in a regular exercise program at all
- Resting systolic BP ≥ 120 mmHg.
- BMI ≥ 30 kg/m2
Key exclusion criteria (13 listed)
- Body mass index ≤ 29.9 Kg/m2
- Smoker within last 5 years
- Has experienced significant weight loss ~3 kg in the last three months or taking any weight loss drugs
- Current medical condition that prohibits exercising at high intensities
- Currently on hormone replacement of any kind
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beetroot Juice - Active + ExerciseSupplement with 140 mL nitrate-rich beverage (800mg NO3-) (~12.9 mmol/L) 1 hour 30 minutes before lab visit after a 3-day washout + ACUTE EXERCISE and post-exercise blood pressure, and central hemodynamics measured via impedance cardiography. | Dietary supplement | A |
| Beetroot juice placebo + ExerciseSupplement with 140 mL nitrate-depleted beverage (<0.1 mmol/L) after a 3-day washout + ACUTE EXERCISE, and post-exercise blood pressure, and central hemodynamics measured via impedance cardiography | Dietary supplement | B |
| Beetroot Juice - Active + No exerciseSupplement with 140mL nitrate rich beverage (800mg NO3-) (~12.9 mmol/L) 1 hour 30 minutes before lab visit after a 3 day washout + NO EXERCISE, and blood pressure, and central hemodynamics measured via impedance cardiography. | Dietary supplement | C |
| Beetroot juice placebo+ No exerciseSupplement with 140 mL nitrate-depleted beverage (<0.1 mmol/L) after a 3-day washout + NO EXERCISE, and blood pressure and central hemodynamics measured via impedance cardiography. | Dietary supplement | D |
Primary outcome
Blood pressure (Central and Peripheral)
Time frame: Before each condition and after every 15 minutes for 3 hours.
The central and peripheral blood pressures will be measured using a validated automated system (Oscar 2 (SunTech)/ SphygmoCor system (Atcor Medical). This system processes brachial waveforms using dedicated software with a validated generalized transfer function to derive a corresponding aortic pressure waveform. Aortic waveforms are then further processed to identify systolic (SBP in mmHg), mean (MAP in mmHg), diastolic (DBP in mmHg), and pulse pressure (PP in mmHg). This allows calculation of augmentation pressure (AugP in mmHg) (due to wave reflection) and the augmentation index (AIx = (AugP/PP) × 100) in percentage units. Participants will sit for at least 15 minutes before each measurement.
Impedance Cardiography
Time frame: Before, during, and after (upto 3 hours post every 15 min) each condition
Measure of central hemodynamics (cardiac output (L/min), stroke volume (mL), and systemic vascular resistance (dyn.s.cm5) etc.) will be non-invasively captured using the PhysioFlow Q-Link System. This system uses electrodes placed on the participant's body and applies the principles of signal-morphology impedance cardiography to estimate central cardiac measures at rest and after exercise.
Plasma/Saliva Nitrate and Nitrate
Time frame: Before and after 2 hours post supplementation of BRJ, Placebo
Plasma/Saliva samples will be collected to assess changes in plasma/saliva nitrate (measured in micromolar- uM) and nitrite (measured in nanomolar- nM) following either BRJ or placebo and in different exercise and control conditions.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jason Allen principal investigator
University of Virginia
Siddhartha Angadi principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beetroot Juice - Active + Exercise and Beetroot Juice - Active + No exercise in people with Obese Individuals and Central Adiposity, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Money Ghimire, M.S (4349243004, eta8xd@uvahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (Central and Peripheral) (time frame: Before each condition and after every 15 minutes for 3 hours.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.