[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642733":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":19,"locations":20,"responsibleParty":76,"collaborators":78,"id":87,"slug":19,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":88,"sex":94,"minAge":95,"maxAge":19,"enrollmentInfo":96,"targetDuration":19,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":40,"whyStopped":19,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Fundación Pública Andaluza para la gestión de la Investigación en Sevilla","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Multimodal lifestyle intervention","EXPERIMENTAL","Mediterranean diet (MD) rich in olive oil, nuts and coffee, combined with structured exercise through a lifestyle intervention (LSI)",[13],"Behavioral: Multimodal lifestyle intervention",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"BEHAVIORAL","Mediterranean diet plus structured lifestyle intervention (150 min\u002Fweek of moderate-intensity or 75 min\u002Fweek of high-intensity exercise) for a total of 16 weeks.",[9],null,[21,38,62],{"facility":22,"status":23,"city":24,"state":19,"zip":19,"country":25,"cosmosGeoPoint":26,"geoPoint":31,"contacts":32},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Internal Medicine and Liver Transplantation Unit","NOT_YET_RECRUITING","Roma","Italy",{"type":27,"coordinates":28},"Point",[29,30],11.10642,44.99364,{"lat":30,"lon":29},[33],{"name":34,"role":35,"phone":36,"phoneExt":19,"email":37},"Luca Miele","CONTACT","00390630154469","luca.miele@policlinicogemelli.it",{"facility":39,"status":40,"city":41,"state":19,"zip":19,"country":42,"cosmosGeoPoint":43,"geoPoint":47,"contacts":48},"Hospital Universitario Virgen del Rocío de Sevilla","RECRUITING","Seville","Spain",{"type":27,"coordinates":44},[45,46],-5.97317,37.38283,{"lat":46,"lon":45},[49,53,56,58,60],{"name":50,"role":35,"phone":51,"phoneExt":19,"email":52},"Manuel Romero-Gómez","+34954786587","mromerogomez@us.es",{"name":54,"role":35,"phone":19,"phoneExt":19,"email":55},"Luis Calzadilla-Bertot","luis.calzadilla@ciberehd.org",{"name":50,"role":57,"phone":19,"phoneExt":19,"email":19},"PRINCIPAL_INVESTIGATOR",{"name":54,"role":59,"phone":19,"phoneExt":19,"email":19},"SUB_INVESTIGATOR",{"name":61,"role":59,"phone":19,"phoneExt":19,"email":19},"Rocío Gallego-Durán",{"facility":63,"status":23,"city":64,"state":19,"zip":19,"country":65,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Hacettepe University","Ankara","Turkey (Türkiye)",{"type":27,"coordinates":67},[68,69],32.85427,39.91987,{"lat":69,"lon":68},[72],{"name":73,"role":35,"phone":74,"phoneExt":19,"email":75},"Yasemin Balaban","+90 533 234 4232","ybalaban@hacettepe.edu.tr",{"type":77,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[79,82,84,85],{"name":80,"class":81},"Instituto de Salud Carlos III","OTHER_GOV",{"name":83,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"name":63,"class":6},{"name":86,"class":81},"Consorcio Centro de Investigación Biomédica en Red (CIBER)","100642733",false,"NCT07652151","UNMASK: Unveiling the Pathobiology of Metabolic Dysfunction-Associated Steatotic Liver Disease for the Discovery of Novel Therapeutics and Biomarkers","UNMASK: Unveiling the Pathobiology of Metabolic Dysfunction-Associated Steatotic Liver Disease for the Discovery of Novel Therapeutics and Biomarkers - Study Protocol Version 2.0","UNMASK","Inclusion Criteria:\n\n* Metabolic disarrangements following ATPIII criteria (i.e. comorbidities such as Type 2 diabetes, central obesity, BMI≥\\>25 kg\u002Fm2, hypertension, dyslipidaemia.\n* Written informed consent\n* No dietetical counsellor\u002Fweight loss higher than 10% within the prior 6 months\n* Age over 18 years old\n* Liver stiffness measurement by Fibroscan ≥ 8, CAP ≥ 248 db\u002Fm and MRI PDFF ≥ 5%. ,\n\nExclusion Criteria:\n\n* Significant alcohol intake (≥30 g\u002Fday in men and ≥20 g\u002Fday in women)\n* Other causes of liver disease (evidence of viral or autoimmune hepatitis, HIV, drug-induced fatty liver or other metabolic liver diseases)\n* Use of recreational drugs\n* Decompensated acute or chronic liver disease\n* Cirrhosis or transplant waitlist\n* Pregnancy or parenteral nutrition\n* No nutritional interventions, medications for weight loss or weight loss higher than 5% within the last year\n* Presence of other comorbidities that would impact lifestyle intervention (i. e. prosthesis)\n* Absence of a personal smartphone with a compatible operating system capable of supporting the Amazfit Bip 6 accelerometer app's functionalities: Android 7.0 or iOS 14.0, or later.","ALL","18 Years",{"count":97,"type":98},450,"ESTIMATED","INTERVENTIONAL",[101],"NA","Overall design: The study will include one intervention based on Mediterranean diet plus structured lifestyle intervention (150 min\u002Fweek of moderate-intensity or 75 min\u002Fweek of high-intensity exercise) for a total of 16 weeks. Following a screening period of up to 12 months, eligible participants will be included in a single cohort.\n\nStudy details include:\n\n* Study duration will be up to 36 months including the screening period.\n* Intervention will be up to 16 weeks.\n* Visit frequency will be every 4 weeks for the interventional period and every 12 weeks during follow-up.",[104],"MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)",[106,107,108,109,110],"Fibrosis","Obesity","Personalised Medicine","Patient Phenotyping","Lifestyle intervention","2026-06-18",{"date":113,"type":114},"2026-06-23","ACTUAL",{"date":116,"type":114},"2026-01-20",{"date":118,"type":98},"2027-02",{"name":5,"class":6},3]