Postmenopausal Female PatientsBEET-MHTNCT07871396
Exercise Training Intensity and Nitrate Supplementation in Post-Menopausal Females on Hormone Therapy
A study testing Moderate Intensity Exercise (MIE) and High intensity exercise (HIE) in people with Postmenopausal Female Patients and Vasomotor Symptoms, run by University of Virginia at 1 site in United States.
Trial summary
This study is examining whether short-term supplementation with inorganic nitrate in the form of beetroot juice can enhance vascular function in postmenopausal females taking hormone therapy compared to placebo. Read more about this study
- Who is it for?
- Ages 45 to 75 years, women only
- Conditions the study is for
- Postmenopausal Female Patients, Vasomotor Symptoms, Menopausal Hormone Therapy
- What is being tested?
- Moderate Intensity Exercise (MIE) and High intensity exercise (HIE)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2026to 30 Jan 2028
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -- Willingness and ability to comply with schedules and study procedures
- Postmenopausal females aged 45-75, defined as having not had a menstrual cycle for at least 1 year
- BMI <35 kg/m2
- Currently taking hormone replacement therapy with transdermal estrogen (spray/gel/patches) combined with progesterone for at least 3 months
- MHT regimen started within 10 years of last menses
- MHT regimen started before the age of 60
- Physically inactive (less than 3 bouts of moderate exercise per week or less than a total of 150 minutes per week [i.e. walking at a brisk pace 3x a week for 50 minutes, leisure sport activity 3x a week for 50 minutes)
- No major changes in medication in the last 3 months
Who cannot join
- Smokers within the last 5 years
- Weight unstable (loss/gain of more than 3kg in the past 3 months) or currently taking weight loss medications
- Any medical condition that prevents the subject from exercising safely
- Diabetes
- Currently or recently on the following medications (i.e., organic and inorganic nitrates, diuretics, proton pump inhibitors, xanthine oxidase inhibitors etc.)
- Oral antibiotic use now or within the previous four weeks
Show all 12Show fewer
- Diagnosed with Oral disease or poor oral health
- Using an antibacterial mouthwash or a mouthwash containing chlorhexidine and unwilling to discontinue use
- Cancer diagnosis
- Cardiovascular disease
- Hysterectomy or oophorectomy
- Prisoners, cognitively impaired individuals, and non-English speaking individuals
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
University of Virginia
Charlottesville, Virginia, 22903
Money Ghimire Ghimire, M.S., 4349243004, eta8xd@uvahealth.org
About this study
Official title: Effects of Exercise Intensity and Inorganic Nitrate Supplementation on Vascular Health and Fitness in Post-Menopausal Females Taking Hormone Therapy
This study is examining whether short-term supplementation with inorganic nitrate in the form of beetroot juice can enhance vascular function in postmenopausal females taking hormone therapy compared to placebo.
Read the detailed description
Menopause is associated with a loss of endogenous nitric oxide (NO) bioavailability and an increased risk of cardiovascular disease. The FDA "black box" guidelines on menopausal hormone therapy (MHT) to mitigate vasomotor symptoms for postmenopausal females (PMF) were recently withdrawn, stimulating a large uptake in usage. However, HRT does not fully restore NO bioavailability, endothelial function, and the response to exercise stress to premenopausal levels, leaving residual vascular risk. To address this knowledge gap, we will use oral inorganic nitrate supplementation (INS) as an exogenous source of NO. We hypothesize that INS will interact with exercise stress of different intensities to improve vascular health by increasing bioavailable NO in PMF taking HRT. This study will recruit 24 PMF on MHT in a double-blind, parallel-group design to assess the effects of INS, compared with placebo, in combination with acute moderate- and high-intensity exercise on vascular health assessed via flow-mediated dilation (FMD) in PMF on MHT.
- Being tested
- Moderate Intensity Exercise (MIE), High intensity exercise (HIE), Control (No exercise)
- Keywords
- exercise intensity, vascular function, inorganic nitrate, beetroot juice, blood pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate Intensity Exercise (MIE)Other
MIE bout of exercise will be completed after 3 days of supplementation with BRJ/placebo. This intensity will be equivalent to the watts at the lactate threshold. (7-day washout between each condition)
High intensity exercise (HIE)Other
HIE bout of exercise will be completed after 3 days of supplementation with BRJ/placebo. This intensity will be equivalent to the watts at Lactate threshold + 75% ∆ (VO2peak - LT). (7-day washout between each condition)
Control (No exercise)Other
The control session will involve passive rest. (7-day washout between each condition)
| Study group | Role | What they receive |
|---|---|---|
| Beetroot juice | Experimental | Participants will supplement with nitrate-rich beetroot juice (BRJ) for 3 days: 6.45 mmol of NO3 in the morning and 6.45 mmol in the evening for 2 days, and 12.9 mmol 2 hours before the lab visit. The order of intervention is also randomized. Receives: Other: Moderate Intensity Exercise (MIE); Other: High intensity exercise (HIE); Other: Control (No exercise) |
| Placebo | Placebo comparator | Participants will supplement with nitrate-depleted beetroot juice (BRJ) for 3 days. This placebo is identical in color, taste, and packaging. The order of intervention is also randomized. Receives: Other: Moderate Intensity Exercise (MIE); Other: High intensity exercise (HIE); Other: Control (No exercise) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular Endothelial Function (Flow-Mediated Dilation [FMD])
FMD- Participants will be placed in a supine position with their right forearm slightly extended and supinated, and their legs straight. The arteries will be imaged using a high-resolution 7.5 MHz 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. The change in FMD is the change from baseline and is reported as a percentage
Measured: MIE, HIE, and control: measurements at baseline and after 3-day supplementation, before and after exercise/rest, and at 60, 90, 120, 150, and 180 min post-condition.
Skin microvascular function using post-occlusive reactive hyperemia (PORH)
Skin microvascular function will be measured using Moor Instruments' FLPI-2 laser speckle imaging system. PORH will also be measured during the FMD measurement. Baseline measures will be captured, and the cuff will be inflated for 5 minutes, with the post-occlusion reactive period being measured. The laser positioned above the forearm skin will measure skin blood flow at all these time points. From this, data such as peak perfusion, percent change in hyperemia, area under the curve, and time to peak will be extracted.
Measured: PORH will only be measured at baseline to assess baseline microvascular function.
Vascular Endothelial Function (Pulse wave analysis and velocity [PWA/V])
PWA/V- These measures will be calculated using the SphygmoCor XCEL system (AtCor Medical). This system will provide arterial stiffness, central, and peripheral pressure waveforms. Pressure data are reported in mmHg and PWV in m/s.
Measured: MIE, HIE, and control: measurements at baseline and after 3-day supplementation, before and after exercise/rest, and at 60, 90, 120, 150, and 180 min post-condition.
Plasma/ Saliva nitrate and nitrite
Plasma/Saliva samples will be collected to assess changes in plasma nitrate (uM) and nitrite (nM) following either BRJ or placebo and in different exercise and control conditions.
Measured: MIE, HIE, and control: at baseline and 3 days after the supplementation
Secondary outcomes (2)
Oral Nitrate reducing capacity
To assess the oral microbiome's ability to reduce nitrate to nitrite, the participant will rinse their mouth with a solution of potassium nitrate and ultra-pure water for five minutes. The rinsed solution will be collected into a 50ml Falcon tube. The nitrite (nM) concentration will be measured to determine ONRC
Measured: MIE, HIE, and control: at baseline and 3 days after the supplementation
Biomarker analysis: concentration of Inflammatory/oxidative stress markers in fasting blood plasma, as well as hormonal measures
The investigators plan to assess various markers of inflammation, oxidative stress, and hormonal markers. A fasting blood sample will be collected.
Measured: MIE, HIE, and control: at baseline and 3 days after the supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal Female PatientsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 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, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871396
- Sponsor's protocol ID
- 303781
- Acronym
- BEET-MHT
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2026
- Last updated
- 16 Oct 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 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise Intensity and Inorganic Nitrate Supplementation on Vascular Health and Fitness in Post-Menopausal Females Taking Hormone Therapy
- ClinicalTrials.gov ID
- NCT07871396
- Acronym / sponsor ID
- BEET-MHT / 303781
- Keywords
- exercise intensity, vascular function, inorganic nitrate, beetroot juice, blood pressure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 13 Oct 2026 (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.
This study is examining whether short-term supplementation with inorganic nitrate in the form of beetroot juice can enhance vascular function in postmenopausal females taking hormone therapy compared to placebo.
Detailed description
Menopause is associated with a loss of endogenous nitric oxide (NO) bioavailability and an increased risk of cardiovascular disease. The FDA "black box" guidelines on menopausal hormone therapy (MHT) to mitigate vasomotor symptoms for postmenopausal females (PMF) were recently withdrawn, stimulating a large uptake in usage. However, HRT does not fully restore NO bioavailability, endothelial function, and the response to exercise stress to premenopausal levels, leaving residual vascular risk. To address this knowledge gap, we will use oral inorganic nitrate supplementation (INS) as an exogenous source of NO. We hypothesize that INS will interact with exercise stress of different intensities to improve vascular health by increasing bioavailable NO in PMF taking HRT. This study will recruit 24 PMF on MHT in a double-blind, parallel-group design to assess the effects of INS, compared with placebo, in combination with acute moderate- and high-intensity exercise on vascular health assessed via flow-mediated dilation (FMD) in PMF on MHT.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beetroot juice | Experimental | Other: Moderate Intensity Exercise (MIE), Other: High intensity exercise (HIE), Other: Control (No exercise)Participants will supplement with nitrate-rich beetroot juice (BRJ) for 3 days: 6.45 mmol of NO3 in the morning and 6.45 mmol in the evening for 2 days, and 12.9 mmol 2 hours before the lab visit. The order of intervention is also randomized. |
| Placebo | Placebo comparator | Other: Moderate Intensity Exercise (MIE), Other: High intensity exercise (HIE), Other: Control (No exercise)Participants will supplement with nitrate-depleted beetroot juice (BRJ) for 3 days. This placebo is identical in color, taste, and packaging. The order of intervention is also randomized. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- -- Willingness and ability to comply with schedules and study procedures
- Postmenopausal females aged 45-75, defined as having not had a menstrual cycle for at least 1 year
- BMI <35 kg/m2
- Currently taking hormone replacement therapy with transdermal estrogen (spray/gel/patches) combined with progesterone for at least 3 months
- MHT regimen started within 10 years of last menses
Key exclusion criteria (12 listed)
- Smokers within the last 5 years
- Weight unstable (loss/gain of more than 3kg in the past 3 months) or currently taking weight loss medications
- Any medical condition that prevents the subject from exercising safely
- Diabetes
- Currently or recently on the following medications (i.e., organic and inorganic nitrates, diuretics, proton pump inhibitors, xanthine oxidase inhibitors etc.)
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 |
|---|---|---|
| Moderate Intensity Exercise (MIE)MIE bout of exercise will be completed after 3 days of supplementation with BRJ/placebo. This intensity will be equivalent to the watts at the lactate threshold. (7-day washout between each condition) | Other | Beetroot juice, Placebo |
| High intensity exercise (HIE)HIE bout of exercise will be completed after 3 days of supplementation with BRJ/placebo. This intensity will be equivalent to the watts at Lactate threshold + 75% ∆ (VO2peak - LT). (7-day washout between each condition) | Other | Beetroot juice, Placebo |
| Control (No exercise)The control session will involve passive rest. (7-day washout between each condition) | Other | Beetroot juice, Placebo |
Primary outcome
Vascular Endothelial Function (Flow-Mediated Dilation [FMD])
Time frame: MIE, HIE, and control: measurements at baseline and after 3-day supplementation, before and after exercise/rest, and at 60, 90, 120, 150, and 180 min post-condition.
FMD- Participants will be placed in a supine position with their right forearm slightly extended and supinated, and their legs straight. The arteries will be imaged using a high-resolution 7.5 MHz 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. The change in FMD is the change from baseline and is reported as a percentage
Skin microvascular function using post-occlusive reactive hyperemia (PORH)
Time frame: PORH will only be measured at baseline to assess baseline microvascular function.
Skin microvascular function will be measured using Moor Instruments' FLPI-2 laser speckle imaging system. PORH will also be measured during the FMD measurement. Baseline measures will be captured, and the cuff will be inflated for 5 minutes, with the post-occlusion reactive period being measured. The laser positioned above the forearm skin will measure skin blood flow at all these time points. From this, data such as peak perfusion, percent change in hyperemia, area under the curve, and time to peak will be extracted.
Vascular Endothelial Function (Pulse wave analysis and velocity [PWA/V])
Time frame: MIE, HIE, and control: measurements at baseline and after 3-day supplementation, before and after exercise/rest, and at 60, 90, 120, 150, and 180 min post-condition.
PWA/V- These measures will be calculated using the SphygmoCor XCEL system (AtCor Medical). This system will provide arterial stiffness, central, and peripheral pressure waveforms. Pressure data are reported in mmHg and PWV in m/s.
Plasma/ Saliva nitrate and nitrite
Time frame: MIE, HIE, and control: at baseline and 3 days after the supplementation
Plasma/Saliva samples will be collected to assess changes in plasma nitrate (uM) and nitrite (nM) following either BRJ or placebo and in different exercise and control conditions.
2 secondary outcomes
Oral Nitrate reducing capacity
Time frame: MIE, HIE, and control: at baseline and 3 days after the supplementation
Biomarker analysis: concentration of Inflammatory/oxidative stress markers in fasting blood plasma, as well as hormonal measures
Time frame: MIE, HIE, and control: at baseline and 3 days after the supplementation
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 16 Oct 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 principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate Intensity Exercise (MIE) and High intensity exercise (HIE) in people with Postmenopausal Female Patients and Vasomotor Symptoms, 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 8 inclusion and 12 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: opening soon, as of the sponsor's last update on 16 Oct 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 Money Ghimire, M.S (4349243004, eta8xd@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: MIE, HIE, and control: measurements at baseline and after 3-day supplementation, before and after exercise/rest, and at 60, 90, 120, 150, and 180 min post-condition.). The study lists 4 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 16 Oct 2026.