An interventional study of Moderate Intensity Exercise (MIE) and High intensity exercise (HIE) in Postmenopausal Female Patients, Vasomotor Symptoms and Menopausal Hormone Therapy, sponsored by University of Virginia. Not yet recruiting at 1 site in United States. Open to female participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by University of Virginia · Not applicable, Interventional, and Other
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.
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on menopausal hormone therapy (MHT) to mitigate vasomotor symptoms for postmenopausal females (PMF) were recently withdrawn, stimulating a large uptake in usage.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.
University of Virginia is the lead sponsor of 672 studies on the registry; 138 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
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-- Willingness and ability to comply with schedules and study procedures
Exclusion Criteria:
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.
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.
Other: Moderate Intensity Exercise (MIE) · Other: High intensity exercise (HIE) · Other: Control (No exercise)
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)
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)
The control session will involve passive rest. (7-day washout between each condition)
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
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.
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.
Time frame: 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.
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.
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.
Time frame: MIE, HIE, and control: at baseline and 3 days after the supplementation
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
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
The investigators plan to assess various markers of inflammation, oxidative stress, and hormonal markers. A fasting blood sample will be collected.
Time frame: MIE, HIE, and control: at baseline and 3 days after the supplementation
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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