[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659999":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":45,"studyPopulation":34,"armGroups":46,"interventions":60,"overallOfficials":73,"centralContacts":77,"locations":83,"responsibleParty":99,"collaborators":34,"id":101,"slug":102,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":103,"sex":109,"minAge":110,"maxAge":111,"enrollmentInfo":112,"targetDuration":34,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":123,"overallStatus":129,"whyStopped":34,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"University of Virginia","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":25,"otherOutcomes":34},[9,13,17,21],{"measure":10,"description":11,"timeFrame":12},"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.","At baseline on each condition and following 3-day supplementation before and after exercise\u002Frest conditions up to 3 hours post (60, 90, 120, 150, and 180 min post)",{"measure":14,"description":15,"timeFrame":16},"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.","PORH will only be measured at baseline to assess baseline microvascular function",{"measure":18,"description":19,"timeFrame":20},"Vascular Endothelial Function (Pulse wave analysis and velocity [PWA\u002FV])","PWA\u002FV- These measures will be calculated using the SphygmoCor XCEL system (AtCor Medical). This system will provide arterial stiffness, central, and peripheral pressure waveforms.","PWA\u002FV was measured at baseline on each condition and following 3-day supplementation PWA before and after exercise\u002Frest conditions up to 3 hours post (60, 90, 120, 150, and 180 min post)",{"measure":22,"description":23,"timeFrame":24},"Plasma\u002F Saliva nitrate and nitrite","Plasma\u002FSaliva samples will be collected to assess changes in plasma nitrate and nitrite following either BRJ or placebo and in different exercise and control conditions.","At baseline and before each exercise condition.",[26,30],{"measure":27,"description":28,"timeFrame":29},"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 concentration will be measured to determine ONRC","Before and after 3 days of supplementation in each condition.",{"measure":31,"description":32,"timeFrame":33},"Biomarker analysis: concentration of Inflammatory\u002Foxidative 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.","At baseline and 3 days after BRJ or placebo.",null,{"allocation":36,"interventionModel":37,"interventionModelDescription":34,"primaryPurpose":6,"observationalModel":34,"timePerspective":34,"maskingInfo":38},"RANDOMIZED","PARALLEL",{"masking":39,"maskingDescription":34,"whoMasked":40},"QUADRUPLE",[41,42,43,44],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","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.",[47,55],{"label":48,"type":49,"description":50,"interventionNames":51},"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.",[52,53,54],"Other: Moderate Intensity Exercise (MIE)","Other: High intensity exercise (HIE)","Other: Control (No exercise)",{"label":56,"type":57,"description":58,"interventionNames":59},"Placebo","PLACEBO_COMPARATOR","Participants will supplement with nitrate-depleted 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.",[52,53,54],[61,65,69],{"type":6,"name":62,"description":63,"armGroupLabels":64,"otherNames":34},"Moderate Intensity Exercise (MIE)","MIE bout of exercise will be completed after 3 days of supplementation with BRJ\u002Fplacebo. This intensity will be equivalent to the watts at lactate threshold.",[48,56],{"type":6,"name":66,"description":67,"armGroupLabels":68,"otherNames":34},"High intensity exercise (HIE)","HIE bout of exercise will be completed after 3 days of supplementation with BRJ\u002Fplacebo. This intensity will be equivalent to the watts at Lactate threshold + 75% ∆ (VO2peak - LT).",[48,56],{"type":6,"name":70,"description":71,"armGroupLabels":72,"otherNames":34},"Control (No exercise)","The control session will involve passive rest.",[48,56],[74],{"name":75,"affiliation":5,"role":76},"Jason Allen","PRINCIPAL_INVESTIGATOR",[78],{"name":79,"role":80,"phone":81,"phoneExt":34,"email":82},"Money Ghimire, M.S","CONTACT","4349243004","eta8xd@uvahealth.org",[84],{"facility":5,"status":34,"city":85,"state":86,"zip":87,"country":88,"countryCode":89,"cosmosGeoPoint":90,"geoPoint":95,"contacts":96},"Charlottesville","Virginia","22903","United States","US",{"type":91,"coordinates":92},"Point",[93,94],-78.47668,38.02931,{"lat":94,"lon":93},[97],{"name":98,"role":80,"phone":81,"phoneExt":34,"email":82},"Money Ghimire Ghimire, M.S.",{"type":76,"investigatorFullName":75,"investigatorTitle":100,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"Professor","100659999","exercise-training-intensity-and-nitrate-supplementation-in-post-menopausal-females-on-hormone-therapy-100659999",false,"NCT07871396","Exercise Training Intensity and Nitrate Supplementation in Post-Menopausal Females on Hormone Therapy","Effects of Exercise Intensity and Inorganic Nitrate Supplementation on Vascular Health and Fitness in Post-Menopausal Females Taking Hormone Therapy","BEET-MHT","Inclusion Criteria:\n\n\\-- Willingness and ability to comply with schedules and study procedures\n\n* Postmenopausal females aged 45-75, defined as having not had a menstrual cycle for at least 1 year\n* BMI \\\u003C35 kg\u002Fm2\n* Currently taking hormone replacement therapy with transdermal estrogen (spray\u002Fgel\u002Fpatches) combined with progesterone for at least 3 months\n* MHT regimen started within 10 years of last menses\n* MHT regimen started before the age of 60\n* 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)\n* No major changes in medication in the last 3 months\n\nExclusion Criteria:\n\n* Smokers within the last 5 years\n* Weight unstable (loss\u002Fgain of more than 3kg in the past 3 months) or currently taking weight loss medications\n* Any medical condition that prevents the subject from exercising safely\n* Diabetes\n* Currently or recently on the following medications (i.e., organic and inorganic nitrates, diuretics, proton pump inhibitors, xanthine oxidase inhibitors etc.)\n* Oral antibiotic use now or within the previous four weeks\n* Diagnosed with Oral disease or poor oral health\n* Using an antibacterial mouthwash or a mouthwash containing chlorhexidine and unwilling to discontinue use\n* Cancer diagnosis\n* Cardiovascular disease\n* Hysterectomy or oophorectomy\n* Prisoners, cognitively impaired individuals, and non-English speaking individuals","FEMALE","45 Years","75 Years",{"count":113,"type":114},24,"ESTIMATED","INTERVENTIONAL",[117],"NA","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.",[120,121,122],"Postmenopausal Female Patients","Vasomotor Symptoms","Menopausal Hormone Therapy",[124,125,126,127,128],"exercise intensity","vascular function","inorganic nitrate","beetroot juice","blood pressure","NOT_YET_RECRUITING","2026-09-30",{"date":132,"type":133},"2026-10-13","ACTUAL",{"date":135,"type":114},"2026-10-15",{"date":137,"type":114},"2028-01-30",{"name":5,"class":6},1]