Post-exercise Blood Pressure With Inorganic Nitrate

NCT07869472 | Not Yet Recruiting

• 1 other identifier: 303609
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obese Individuals; Central Adiposity

Keywords

obesity; central adiposity; elevated blood pressure; dietary nitrate

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Before and after 2 hours post supplementation of BRJ, Placebo

Study Arms (4)

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.

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.

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.

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.

Dietary Supplement: Beetroot juice placebo+ No exercise

Interventions

Beetroot Juice - Active + Exercise DIETARY_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.

A

Beetroot juice placebo + Exercise DIETARY_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

B

Beetroot Juice - Active + No exercise DIETARY_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.

C

Beetroot juice placebo+ No exercise DIETARY_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.

D

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Obesity, Abdominal; Obesity; Hypertension

Interventions

Exercise

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jason Allen

  University of Virginia

  PRINCIPAL INVESTIGATOR

• Siddhartha Angadi

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Money Ghimire, M.S

CONTACT

4349243004; eta8xd@uvahealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 30, 2026
• First Posted: October 9, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 30, 2027
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)