[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559731":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":39,"responsibleParty":60,"collaborators":64,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":12,"enrollmentInfo":76,"targetDuration":12,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":92,"whyStopped":12,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Universidad de los Andes, Chile","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Control group (without EVOO supplementation)","NO_INTERVENTION","No intervention will be performed in this group of participants",null,{"label":14,"type":15,"description":16,"interventionNames":17},"EVOO group (with EVOO supplementation)","EXPERIMENTAL","The intervention will be daily EVOO suplementation (36mL) form gestational week 28 until delivery",[18],"Dietary Supplement: Extra Virgin Olive Oil (EVOO)",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DIETARY_SUPPLEMENT","Extra Virgin Olive Oil (EVOO)","This is the first time that prengnt women with maternal supraphysiological hypercholesterolemia will be suplemented with EVOO during pregnancy. The intervention will be daily EVOO suplementation (36mL) form gestational week 28 until delivery",[14],[26],{"name":27,"affiliation":28,"role":29},"Andrea Leiva, PhD","Universidad San Sebastian","PRINCIPAL_INVESTIGATOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":12,"email":35},"Sebastian Illanes, MD","CONTACT","56 982338204","sillanes@uandes.cl",{"name":27,"role":33,"phone":37,"phoneExt":12,"email":38},"56988091715","andrea.leiva@uss.cl",[40],{"facility":41,"status":12,"city":42,"state":43,"zip":12,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Clinica Universidad de los Andes","Santiago","Las Condes","Chile","CL",{"type":47,"coordinates":48},"Point",[49,50],-70.64827,-33.45694,{"lat":50,"lon":49},[53,55,57,58],{"name":32,"role":33,"phone":54,"phoneExt":12,"email":35},"+56982338204",{"name":27,"role":33,"phone":56,"phoneExt":12,"email":38},"+56988091715",{"name":27,"role":29,"phone":12,"phoneExt":12,"email":12},{"name":32,"role":59,"phone":12,"phoneExt":12,"email":12},"SUB_INVESTIGATOR",{"type":29,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":63,"oldNameTitle":12,"oldOrganization":12},"Andrea Leiva","Principal Investigator","Universidad San Sebastián",[65],{"name":63,"class":6},"100559731","extra-virgin-olive-oil-supplementation-in-pregnancies-with-increased-cholesterol-levels-100559731",false,"NCT06567951","Extra Virgin Olive Oil Supplementation in Pregnancies With Increased Cholesterol Levels","Maternal Supraphysiological Hypercholesterolemia: Extra Virgin Olive Oil as a Nutritional Intervention During Pregnancy to Reduce the Impact of This Maternal Condition","MaterLIP","Inclusion Criteria:\n\n* Pregnant women at 26-28 weeks of gestation\n* Singleton pregnancies\n* Pregnancies without fetal malformations\n\nExclusion Criteria:\n\n* Pregnant women with pre-gestational and\u002For gestational diabetes mellitus\n* Pregnant women with obesity before or during pregnancy\n* Pregnant women with pre-eclampsia,\n* Pregnant women with pregnancy hypertensive syndrome\n* Pregnant women with fetal growth retardation","FEMALE","18 Years",{"count":77,"type":78},120,"ESTIMATED","INTERVENTIONAL",[81],"NA","The objective of this clinical trial is to know if supplementation with extra virgin olive oil (EVOO) during pregnancy, improves the maternal and neonatal lipoprotein profile, lipoprotein function, oxidative status and vascular dysfunction markers in pregnancies with maternal supraphysiological hypercholesterolemia (MSPH).\n\nThe main questions to be answered are:\n\n1. Does 12 weeks of EVOO supplementation improve lipid and vascular outcomes in MSPH women at the end of pregnancy?\n2. Does 12 weeks of EVOO supplementation improve lipid and vascular outcomes in MSPH neonates at the end of pregnancy? The investigators will compare regular diet supplemented with EVOO vs. intake of a non-supplemented regular diet to determine if EVOO reduces impaired vascular and lipid outcomes in the mother and her newborn.\n\nParticipants:\n\nThe recruited pregnant women will eat their normal diet (control group) or the same diet supplemented with 36 mL of EVOO daily (EVOO group). The protocol will be carried out from gestational week 28 to the end of pregnancy.\n\nA nutritional specialist will evaluate every 4 weeks the EVOO consumption through surveys developed through a zoom interview.\n\nThe recruited pregnant women will have the regular obstetric control every 4 weeks.\n\nAt delivery, a maternal sample of blood as well as umbilical cord blood and the placenta will be obtained for experimental analysis.",[84,85],"Pregnancy Related","Hypercholesterolemia",[87,88,89,90,91],"Pregnancy","Cholesterol","Vascular function","Lipoprotein function","Extra virgin olive oil","NOT_YET_RECRUITING","2024-08-22",{"date":95,"type":96},"2024-08-23","ACTUAL",{"date":98,"type":78},"2024-09-10",{"date":100,"type":78},"2025-09-01",{"name":5,"class":6},1]