NCT06480695 Exercise Training Intensity and Nitrate Supplementation in Post-Menopausal Females
| NCT ID | NCT06480695 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Virginia |
| Condition | Menopause |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-07-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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) * Diabetes * 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
Contact & Investigator
Jason Allen, PhD
PRINCIPAL INVESTIGATOR
UVA
Frequently Asked Questions
Who can join the NCT06480695 clinical trial?
This trial is open to female participants only, aged 45 Years or older, up to 75 Years, studying Menopause. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06480695 currently recruiting?
Yes, NCT06480695 is actively recruiting participants. Contact the research team at bxg7vn@uvahealth.org for enrollment information.
Where is the NCT06480695 trial being conducted?
This trial is being conducted at Charlottesville, United States.
Who is sponsoring the NCT06480695 clinical trial?
NCT06480695 is sponsored by University of Virginia. The principal investigator is Jason Allen, PhD at UVA. The trial plans to enroll 40 participants.