NCT06480695 · University of Virginia
Exercise Training Intensity and Nitrate Supplementation in Post-Menopausal Females
What this study is about
Menopause greatly increases cardiovascular disease risk (CVD). Current exercise guidelines are inadequate to ameliorate this risk and higher intensity exercise may be necessary for cardiovascular benefits in postmenopausal females. taken by mouth nitrate supplementation enhances exercise performance and CVD risk profile in several clinical conditions.
View original scientific description
Menopause greatly increases cardiovascular disease risk (CVD). Current exercise guidelines are inadequate to ameliorate this risk and higher intensity exercise may be necessary for cardiovascular benefits in postmenopausal females. Oral nitrate supplementation enhances exercise performance and CVD risk profile in several clinical conditions. The investigators recently reported that 3-days of nitrate supplementation in postmenopausal females enhances acute post-exercise vascular function, in an intensity dependent manner. The effects of nitrate supplementation and exercise training over a longer training program remains unexplored. This investigation will examine the impact of exercise training intensity with and without inorganic nitrate supplementation, on CVD and fitness outcomes. Postmenopausal females will be tested for maximal oxygen uptake and lactate threshold before randomization to one of four groups: that inorganic nitrate-rich beetroot juice, or beetroot juice with nitrate extracted; and assigned to one-month of calorie matched high-intensity or moderate-intensity exercise training. Vascular function and fitness will be evaluated before and after training.
Interventions
DIETARY_SUPPLEMENT
Nitrate-Rich Beetroot Juice
subjects will consume 1 bottle of nitrate-rich beetroot juice (\~400mg of nitrate each) 2x a day
BEHAVIORAL
High Intensity Exercise
exercise at an intensity midway between the lactate threshold and VO2peak, from the screening test at an RPE of \~ 15-17
BEHAVIORAL
Moderate Intensity Exercise
exercise at the RPE at LT associated an \~ RPE of 10-12
DIETARY_SUPPLEMENT
Nitrate-Depleted Placebo Beetroot Juice
Subjects will consume 1 bottle of nitrate-depleted beetroot juice 2x a day
Primary outcome measures
Vascular Endothelial Function (Flow-Mediated Dilation [FMD])
Time frame: Baseline and after 1-month of exercise training
Participants will be placed in a supine position with their left forearm slightly extended and supinated with legs straight. The arteries will be imaged using a high-resolution 7.5MHz linear array transducer at rest, during 5 minutes of forearm occlusion via cuff inflation, and continuously for 3 minutes post-occlusion; an EKG trigger will be used to capture images during end-diastole of the cardiac cycle.
Cardiorespiratory Fitness
Time frame: Baseline and after 1-month of exercise training
Peak aerobic capacity (VO2peak) will be assessed using a symptom-limited graded exercise test on a treadmill. An IV will be placed and lactate measured during rest and after the completion of every 3-minute stage to determine lactate threshold at VO2peak.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Post-menopausal female (greater than age 45 but less than age 75)
- Sedentary (does not exercise regularly or less than 2 bouts of exercise per week)
- No major changes in medication in the last 3 months
Exclusion criteria
- Smokers within last 5 years
- Weight unstable (loss/gain of more than 3kg in the past 3 months)
- Any medical condition that prevents the subject from exercising safely
- Hormone replacement therapy (current or within last 3 months)
- Currently or recently on vasoactive medications (i.e., calcium channel blockers, statins, ACE or renin inhibitors, ARBs, nitrates, alpha- or beta-blockers, diuretics, proton pump inhibitors, etc.)
- Oral antibiotic use within previous four weeks
- Oral disease or poor oral health as determined by the Oral Health Questionnaire
- Using an antibacterial mouthwash or a mouthwash containing chlorhexidine and unwilling to discontinue use
Where
- Charlottesville, Virginia
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Data: ClinicalTrials.gov · synced Jul 17, 2026 · Source of record for eligibility and locations