Beetroot nitrate plus exercise intensity for heart and fitness in postmenopausal women
Effects of Exercise Training Intensity and Inorganic Nitrate Supplementation on Vascular Health and Fitness in Post-Menopausal Females
This project will test whether adding inorganic nitrate (beetroot juice) to moderate or high-intensity exercise improves vascular health and fitness in sedentary postmenopausal women.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 45 Years to 75 Years |
| Sex | Female |
| Sponsor | University of Virginia Academic / other |
| Locations | 1 site (Charlottesville, Virginia) |
| Trial ID | NCT06480695 on ClinicalTrials.gov |
What this trial studies
Sedentary postmenopausal women will complete baseline fitness testing (including VO2max and lactate threshold) and then be randomized to one of four groups combining high- or moderate-intensity exercise training with either nitrate-rich beetroot juice or nitrate-depleted placebo. The program compares the effects of exercise intensity and daily inorganic nitrate supplementation on cardiovascular and fitness outcomes over a multi-week supervised training period. Outcomes include changes in vascular function, cardiorespiratory fitness, and other cardiovascular risk markers. The trial builds on prior short-term findings that acute nitrate supplementation can enhance post-exercise vascular function in an intensity-dependent way.
Who should consider this trial
Good fit: Ideal candidates are sedentary postmenopausal women aged 45–74 who are medically able to exercise and have had stable medications and weight for at least three months.
Not a fit: Women with diabetes, recent smokers, unstable weight, poor oral health, current hormone replacement therapy, recent antibiotic or vasoactive medication use, or those already exercising regularly are unlikely to benefit or may be excluded.
Why it matters
Potential benefit: If successful, combining beetroot-derived nitrate with higher-intensity exercise could improve vascular function and fitness, potentially lowering cardiovascular risk in postmenopausal women.
How similar studies have performed: Short-term studies and work in other clinical groups show that inorganic nitrate can improve exercise performance and acute vascular responses, but longer-term training studies in postmenopausal women combining nitrate with different exercise intensities are novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Charlottesville, Virginia
- Student Health and Wellness Building - Department of Kinesiology — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Jason Allen, PhD — Uva
- Study coordinator: Casey Derella, PhD
- Email: bxg7vn@uvahealth.org
- Phone: 434-924-1655
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.