[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553048":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":39,"responsibleParty":55,"collaborators":58,"id":63,"slug":26,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":26,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":26,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":84,"overallStatus":42,"whyStopped":26,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"University of Valencia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dietary Supplement","EXPERIMENTAL","PS-containing dietary supplement Sachet containing a powdered microencapsulated free plant sterols (2 g ingredient\u002Fday)",[13],"Dietary Supplement: Plant sterols 2g\u002Fday",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Sachet containing the powdered excipients of the dietary supplement",[19],"Dietary Supplement: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Plant sterols 2g\u002Fday","PS-containing dietary supplement Sachet containing a powdered microencapsulated free plant sterols (2 g ingredient\u002Fday) during 8 weeks",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Sachet containing the powdered excipients of the dietary supplement during 8 weeks",[15],[31],{"name":32,"affiliation":5,"role":33},"Guadalupe Garcia Llatas, Professor","PRINCIPAL_INVESTIGATOR",[35],{"name":32,"role":36,"phone":37,"phoneExt":26,"email":38},"CONTACT","+34 963543766","guadalupe.garcia@uv.es",[40],{"facility":41,"status":42,"city":43,"state":26,"zip":44,"country":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Hospital Universitario y Politécnico La Fe de Valencia","RECRUITING","Valencia","46026","Spain",{"type":47,"coordinates":48},"Point",[49,50],-0.37966,39.47391,{"lat":50,"lon":49},[53],{"name":54,"role":36,"phone":26,"phoneExt":26,"email":26},"Juan Francisco Merino Torres",{"type":33,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Guadalupe García Llatas","Principal investigator",[59,61],{"name":60,"class":6},"Hospital Universitario La Fe",{"name":62,"class":6},"University of Bologna","100553048",false,"NCT06481020","Plant Sterols on Cardiovascular Markers, Microbiota and Sterol Metabolism (Cardiofoodsterol)","Effect of Plant Sterols on Inflammatory, Endothelial Function and Oxidative Stress Markers, Microbiota and Sterol Metabolism in a Cardiovascular Risk Population","Inclusion Criteria:\n\n* BMI: 27-29.9 or 30-39.9\n* Plasmatic glucose: \\\u003C 100mg\u002Fdl or 100-125mg\u002Fdl\n* Glycosylated hemoglobin: \\\u003C 5.7 or 5.7-6.4\n* LDL cholesterol \\> 115mg\u002FdL\n* Serum levels of biochemical and hematological parameters and fat-soluble vitamins within reference ranges.\n\nExclusion Criteria:\n\n* Subjects on cholesterol-lowering pharmacological treatment\n* Smokers\n* Alcohol consumption above 30 g\u002Fday\n* Pregnant or lactating women\n* Any infection, serious illness or co-morbidity that may affect the bioavailability of PS (e.g., malabsorption, celiac disease, allergies or food intolerances)\n* Diseases of the gastrointestinal tract\n* Antibiotic, hormonal or anabolic treatment\n* Participants consuming foods enriched with PS or food supplements that contain PS\n* Participants who follow specialist weight loss diets, vegans or vegetarians","ALL","18 Years","80 Years",{"count":73,"type":74},42,"ESTIMATED","INTERVENTIONAL",[77],"NA","Potential cholesterol-lowering effect of a regular intake of a plant sterol (PS)-containing food supplement, in overweight\u002Fobese type 1 or 2, normoglycemic\u002Fpre-diabetic, with LDL-cholesterol values \\> 115 mg\u002Fdl and not pharmacologically treated participants treated with the PS-containing food supplement or placebo supplement.",[80,81,82,83],"Cardiovascular Diseases","Hypercholesterolemia","Prediabetic State","Overweight and Obesity",[85,86,87,88,89,90,91,92,93,94],"Cholesterol LDL","Plant Sterols","Inflammation","Oxidative Stress","Microbiota","Sterol Metabolites","Endothelial function","Bioimpedance","Dietary Intake","Physical Activity","2024-06-26",{"date":97,"type":98},"2024-07-01","ACTUAL",{"date":100,"type":98},"2024-05-21",{"date":102,"type":74},"2025-02",{"name":5,"class":6},1]