MenopauseNCT06480695
Exercise Training Intensity and Nitrate Supplementation in Post-Menopausal Females
A study testing Nitrate-Rich Beetroot Juice, High Intensity Exercise and Moderate Intensity Exercise in people with Menopause, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- Nitrate-Rich Beetroot Juice, High Intensity Exercise and Moderate Intensity Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Student Health and Wellness Building - Department of Kinesiology
Charlottesville, Virginia, 22903
Macy Stahl, 434-924-1655, mes4hm@uvahealth.org
About this study
Official title: Effects of Exercise Training Intensity and Inorganic Nitrate Supplementation on Vascular Health and Fitness in Post-Menopausal Females
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.
- Conditions
- Menopause
- Being tested
- Nitrate-Rich Beetroot Juice, High Intensity Exercise, Moderate Intensity Exercise, Nitrate-Depleted Placebo Beetroot Juice
- Keywords
- Inorganic Nitrate, Menopause, High Intensity Exercise, Vascular Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrate-Rich Beetroot JuiceDietary supplement
Also called Inorganic Nitrate, James White Beet It
subjects will consume 1 bottle of nitrate-rich beetroot juice (~400mg of nitrate each) 2x a day
High Intensity ExerciseBehavioural
exercise at an intensity midway between the lactate threshold and VO2peak, from the screening test at an RPE of ~ 15-17
Moderate Intensity ExerciseBehavioural
exercise at the RPE at LT associated an ~ RPE of 10-12
Nitrate-Depleted Placebo Beetroot JuiceDietary supplement
Subjects will consume 1 bottle of nitrate-depleted beetroot juice 2x a day
| Study group | Role | What they receive |
|---|---|---|
| Nitrate-Rich Beetroot Juice + High Intensity Exercise (HIE) | Experimental | Participants assigned to this group will be instructed to consume 1 bottle of nitrate-rich beetroot juice (~400mg of nitrate each) 2x a day (morning a night) starting 2-hours before the first exercise session. Participants will complete a supervised bout of exercise on a treadmill 3x a week for 1-month. Participants will exercise at an RPE of 15-17 based on the participant's VO2peak test. Receives: Dietary Supplement: Nitrate-Rich Beetroot Juice; Behavioral: High Intensity Exercise |
| Nitrate-Depleted Placebo Beetroot Juice + High Intensity Exercise (HIE) | Placebo comparator | Participants assigned to this group will be instructed to consume 1 bottle of nitrate-depleted beetroot juice 2x a day (morning a night) starting 2-hours before the first exercise session. Participants will complete a supervised bout of exercise on a treadmill 3x a week for 1-month. Participants will exercise at an RPE of 15-17 based on the participant's VO2peak test. Receives: Behavioral: High Intensity Exercise; Dietary Supplement: Nitrate-Depleted Placebo Beetroot Juice |
| Nitrate-Rich Beetroot Juice + Moderate Intensity Exercise (MIE) | Active comparator | Participants assigned to this group will be instructed to consume 1 bottle of nitrate-rich beetroot juice (~400mg of nitrate each) 2x a day (morning a night) starting 2-hours before the first exercise session. Participants will complete a supervised bout of exercise on a treadmill 3x a week for 1-month. Participants will exercise at an RPE of 10-12 based on the participant's VO2peak test. Receives: Dietary Supplement: Nitrate-Rich Beetroot Juice; Behavioral: Moderate Intensity Exercise |
| Nitrate-Depleted Placebo Beetroot Juice + Moderate Intensity Exercise (MIE) | Placebo comparator | Participants assigned to this group will be instructed to consume 1 bottle of nitrate-depleted beetroot juice 2x a day (morning a night) starting 2-hours before the first exercise session. Participants will complete a supervised bout of exercise on a treadmill 3x a week for 1-month. Participants will exercise at an RPE of 10-12 based on the participant's VO2peak test. Receives: Behavioral: Moderate Intensity Exercise; Dietary Supplement: Nitrate-Depleted Placebo Beetroot Juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular Endothelial Function (Flow-Mediated Dilation [FMD])
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.
Measured: Baseline and after 1-month of exercise training
Cardiorespiratory Fitness
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.
Measured: Baseline and after 1-month of exercise training
Secondary outcomes (9)
Oral Nitrate Reducing Capacity
Assessment of the oral microbiome's ability to reduce nitrate to nitrite. This will be measured through an unstimulated saliva sample and a rinse of a standard nitrate solution.
Measured: Baseline and after 1-month of exercise training
Skeletal muscle perfusion
Skeletal Muscle Blood Flow (straight gauge plethysmography) will be measured non-invasively using venous occlusion/strain-gauge plethysmography both at rest and during reactive hyperemia following 5-minutes of occlusion via the Hokanson A16. A strain gauge device will be place around the widest part of the participant's right calf. A blood pressure place around participant's ankle will be inflated for 60 seconds to eliminate foot circulation from the measurement. At the same time, a cuff placed on the thigh will be inflated to block venous blood flow. The cuff occlusion will be held for ~60 seconds ((several cardiac cycles (4-6 cycles)) to obtain resting blood flow measurements.
Measured: Baseline and after 1-month of exercise training
Peripheral and Central Blood Pressures
Brachial artery blood pressures will be obtained using a standard sphygmomanometer. Aortic blood pressures will be obtained using applanation tonometry (SphygmoCor version 8.0, AtCor Medical).
Measured: Baseline and after 1-month of exercise training
24-hour ambulatory blood pressure
Blood pressure will be monitored using a standard ambulatory brachial artery blood pressure cuff (SunTech Oscar 2, SunTech Medical). Blood pressure measurements are programmed to be taken every 30-minutes during the day and every hour at night. This allows for monitoring of nighttime blood pressure changes and variations throughout the day.
Measured: Baseline and after 1-month of exercise training
Skeletal muscle microvascular perfusion (near-infra-red- spectroscopy)
Tissue oxygenation will be captured noninvasively using non-invasive, near-infrared spectrometry (NIRS, PortaMon, Artinis Medical Systems B.V., The Netherlands) positioned on the gastrocnemius or vastus lateralis muscle.
Measured: Baseline and after 1-month of exercise training
Lipids
A blood sample will be obtained to measure lipids.
Measured: Baseline
Hemoglobin
A blood sample will be obtained to measure hemoglobin.
Measured: Baseline and after 1-month of exercise training
Plasma Nitrate
A fasting blood draw will be taken. Following the blood draw, the participant will take one dose of Beetroot juice. The participant will then return to the lab three hours later for a second blood draw to assess level of nitrate in the plasma.
Measured: Baseline and after 1-month of exercise training
Plasma Nitrite
A fasting blood draw will be taken. Following the blood draw, the participant will take one dose of Beetroot juice. The participant will then return to the lab three hours later for a second blood draw to assess level of nitrite in the plasma.
Measured: Baseline and after 1-month of exercise training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start1 Jul 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized to one-month of either high or moderate aerobic exercise training and then further randomized to nitrate or placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Allen, University of Virginia
- Investigators
- Jason Allen, PhD, Principal investigator, UVA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06480695
- Sponsor's protocol ID
- HSR231665
- Status last verified
- Jul 2026
- First submitted
- 17 Jun 2024
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise Training Intensity and Inorganic Nitrate Supplementation on Vascular Health and Fitness in Post-Menopausal Females
- ClinicalTrials.gov ID
- NCT06480695
- Acronym / sponsor ID
- HSR231665
- Conditions
- Menopause
- Keywords
- Inorganic Nitrate, Menopause, High Intensity Exercise, Vascular Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Subjects will be randomized to one-month of either high or moderate aerobic exercise training and then further randomized to nitrate or placebo.
| Arm | Type | Receives |
|---|---|---|
| Nitrate-Rich Beetroot Juice + High Intensity Exercise (HIE) | Experimental | Dietary Supplement: Nitrate-Rich Beetroot Juice, Behavioral: High Intensity ExerciseParticipants assigned to this group will be instructed to consume 1 bottle of nitrate-rich beetroot juice (~400mg of nitrate each) 2x a day (morning a night) starting 2-hours before the first exercise session. Participants will complete a supervised bout of exercise on a treadmill 3x a week for 1-month. Participants will exercise at an RPE of 15-17 based on the participant's VO2peak test. |
| Nitrate-Depleted Placebo Beetroot Juice + High Intensity Exercise (HIE) | Placebo comparator | Behavioral: High Intensity Exercise, Dietary Supplement: Nitrate-Depleted Placebo Beetroot JuiceParticipants assigned to this group will be instructed to consume 1 bottle of nitrate-depleted beetroot juice 2x a day (morning a night) starting 2-hours before the first exercise session. Participants will complete a supervised bout of exercise on a treadmill 3x a week for 1-month. Participants will exercise at an RPE of 15-17 based on the participant's VO2peak test. |
| Nitrate-Rich Beetroot Juice + Moderate Intensity Exercise (MIE) | Active comparator | Dietary Supplement: Nitrate-Rich Beetroot Juice, Behavioral: Moderate Intensity ExerciseParticipants assigned to this group will be instructed to consume 1 bottle of nitrate-rich beetroot juice (~400mg of nitrate each) 2x a day (morning a night) starting 2-hours before the first exercise session. Participants will complete a supervised bout of exercise on a treadmill 3x a week for 1-month. Participants will exercise at an RPE of 10-12 based on the participant's VO2peak test. |
| Nitrate-Depleted Placebo Beetroot Juice + Moderate Intensity Exercise (MIE) | Placebo comparator | Behavioral: Moderate Intensity Exercise, Dietary Supplement: Nitrate-Depleted Placebo Beetroot JuiceParticipants assigned to this group will be instructed to consume 1 bottle of nitrate-depleted beetroot juice 2x a day (morning a night) starting 2-hours before the first exercise session. Participants will complete a supervised bout of exercise on a treadmill 3x a week for 1-month. Participants will exercise at an RPE of 10-12 based on the participant's VO2peak test. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitrate-Rich Beetroot JuiceAlso: Inorganic Nitrate, James White Beet Itsubjects will consume 1 bottle of nitrate-rich beetroot juice (~400mg of nitrate each) 2x a day | Dietary supplement | Nitrate-Rich Beetroot Juice + High Intensity Exercise (HIE), Nitrate-Rich Beetroot Juice + Moderate Intensity Exercise (MIE) |
| High Intensity Exerciseexercise at an intensity midway between the lactate threshold and VO2peak, from the screening test at an RPE of ~ 15-17 | Behavioural | Nitrate-Depleted Placebo Beetroot Juice + High Intensity Exercise (HIE), Nitrate-Rich Beetroot Juice + High Intensity Exercise (HIE) |
| Moderate Intensity Exerciseexercise at the RPE at LT associated an ~ RPE of 10-12 | Behavioural | Nitrate-Depleted Placebo Beetroot Juice + Moderate Intensity Exercise (MIE), Nitrate-Rich Beetroot Juice + Moderate Intensity Exercise (MIE) |
| Nitrate-Depleted Placebo Beetroot JuiceSubjects will consume 1 bottle of nitrate-depleted beetroot juice 2x a day | Dietary supplement | Nitrate-Depleted Placebo Beetroot Juice + High Intensity Exercise (HIE), Nitrate-Depleted Placebo Beetroot Juice + Moderate Intensity Exercise (MIE) |
Primary outcome
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.
9 secondary outcomes
Oral Nitrate Reducing Capacity
Time frame: Baseline and after 1-month of exercise training
Skeletal muscle perfusion
Time frame: Baseline and after 1-month of exercise training
Peripheral and Central Blood Pressures
Time frame: Baseline and after 1-month of exercise training
24-hour ambulatory blood pressure
Time frame: Baseline and after 1-month of exercise training
Skeletal muscle microvascular perfusion (near-infra-red- spectroscopy)
Time frame: Baseline and after 1-month of exercise training
Lipids
Time frame: Baseline
Hemoglobin
Time frame: Baseline and after 1-month of exercise training
Plasma Nitrate
Time frame: Baseline and after 1-month of exercise training
Plasma Nitrite
Time frame: Baseline and after 1-month of exercise training
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jason Allen, PhD principal investigator
UVA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nitrate-Rich Beetroot Juice, High Intensity Exercise and Moderate Intensity Exercise in people with Menopause, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Macy Stahl (434-924-1655, mes4hm@uvahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular Endothelial Function (Flow-Mediated Dilation [FMD]) (time frame: Baseline and after 1-month of exercise training). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.