Health TrialsbyHealthPanel

Post-exercise Blood Pressure With Inorganic Nitrate

ConditionsObese IndividualsCentral Adiposity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorUniversity of Virginia

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

  • 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

  • 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.

  • 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.

Treatment groups

12 Participants
are divided into 4 treatment groups
Group A: AExperimental treatment 1 intervention
Group B: BActive comparator 1 intervention
Group C: CPlacebo comparator 1 intervention
Group D: DSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Before each condition and after every 15 minutes for 3 hours.
2

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.

Time frame
Before, during, and after (upto 3 hours post every 15 min) each condition
3

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.

Time frame
Before and after 2 hours post supplementation of BRJ, Placebo

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Virginia

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: