[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100430760":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":11,"centralContacts":11,"locations":43,"responsibleParty":56,"collaborators":11,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":11,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":11,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":81,"whyStopped":11,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Queen Mary University of London","OTHER",[8,14,17,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A: Male healthy volunteers","EXPERIMENTAL",null,[13],"Biological: COVID-19 vaccine",{"label":15,"type":10,"description":11,"interventionNames":16},"Part A: Female healthy volunteers",[13],{"label":18,"type":19,"description":20,"interventionNames":21},"Part B: Nitrate-rich beetroot juice","ACTIVE_COMPARATOR","Dietary Supplement: Concentrate beetroot Juice (70 ml) containing \\~5mmol of inorganic nitrate",[13,22],"Biological: Concentrate beetroot Juice",{"label":24,"type":25,"description":26,"interventionNames":27},"Part B: Nitrate-deplete beetroot juice","PLACEBO_COMPARATOR","Dietary Supplement: Concentrate beetroot Juice (70 ml) which is nitrate-depleted",[13,28],"Biological: Nitrate-deplete beetroot juice",[30,35,39],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":11},"BIOLOGICAL","COVID-19 vaccine","COVID-19 vaccine as offered by NHS England",[15,9,24,18],{"type":31,"name":36,"description":37,"armGroupLabels":38,"otherNames":11},"Concentrate beetroot Juice","Beetroot juice containing approximately 5mmol\u002Fl nitrate",[18],{"type":31,"name":40,"description":41,"armGroupLabels":42,"otherNames":11},"Nitrate-deplete beetroot juice","Beetroot juice with nitrate removed",[24],[44],{"facility":45,"status":11,"city":46,"state":11,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":11},"The William Harvey Research Institute","London","EC1M 6BQ","United Kingdom","UK",{"type":51,"coordinates":52},"Point",[53,54],-0.12574,51.50853,{"lat":54,"lon":53},{"type":57,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100430760","phase-1-investigation-of-the-effects-of-dietary-nitrate-and-sex-on-covid-19-vaccine-induced-vascular-dysfunction-in-healthy-men-and-women-dinovasc-covid-19-100430760",false,"NCT04889274","Investigation of the Effects of Dietary Nitrate and Sex on COVID-19 Vaccine Induced Vascular Dysfunction in Healthy Men and Women (DiNOVasc-COVID-19)","A Double-blind, Randomised, Placebo-controlled Parallel Study to Investigate the Effect of Dietary Nitrate and Sex on COVID-19 Vaccine Induced Vascular Dysfunction in Healthy Men and Women","Inclusion Criteria:\n\n1. Healthy volunteers with a booking for COVID-19 vaccination slot as per government guidelines\n2. Aged 18-60\n3. Volunteers who are willing to sign the consent form\n\nExclusion Criteria:\n\n1. Aged \\\u003C18 or \\>60 years\n2. Healthy subjects unwilling to consent\n3. Pregnant, or any possibility that a subject may be pregnant\n4. History of any serious illnesses, including recent infections or trauma\n5. Subjects taking systemic medication (other than the oral contraceptive pill)\n6. Subjects with self-reported use of mouthwash or tongue scrapes\n7. Subjects with recent (2 weeks) or current antibiotic use\n8. Subjects with a history, or recent treatment of (within last 3 months) any oral condition (excluding caries), including gingivitis, periodontitis and halitosis\n9. Subjects with a history of COVID-19 vaccination\n10. Subjects with any history of a blood-borne infectious",true,"ALL","18 Years","60 Years",{"count":70,"type":71},98,"ESTIMATED","INTERVENTIONAL",[74],"PHASE1","Inorganic nitrate can protect blood vessels from the damage that occurs during cardiovascular disease. Early experimental work suggests that nitrate-induced improvements in vascular function relate to the suppression of inflammatory pathways. Whether this protection against inflammation-induced damage to the blood vessel wall might also be functional in the setting of COVID-19 vaccination will be investigated.\n\nVascular function will be assessed before and after the healthy participant has received their COVID-19-vaccination. Whether there might be differences in the response to the vaccine between the sexes and whether a dietary nitrate intervention impacts upon the effects of vaccination will be investigated.\n\nThe study is in two parts:\n\nPart A: To assess sex differences in the vascular response to COVID-19 vaccination.\n\nPart B: To assess whether inorganic nitrate, in the form of dietary inorganic nitrate supplementation compared to placebo control, can raise circulating plasma nitrite levels and thereby prevent the systemic inflammation that causes vascular dysfunction.",[77,78],"Cardiovascular Diseases","Endothelial Dysfunction",[80],"COVID-19, endothelial dysfunction, nitrate, nitrite, sex","ACTIVE_NOT_RECRUITING","2025-08-01",{"date":84,"type":85},"2025-08-06","ACTUAL",{"date":87,"type":85},"2021-05-10",{"date":89,"type":71},"2026-04-30",{"name":5,"class":6},1]