[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642733":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":19,"locations":20,"responsibleParty":78,"collaborators":80,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":91,"sex":97,"minAge":98,"maxAge":19,"enrollmentInfo":99,"targetDuration":19,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":41,"whyStopped":19,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"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,[21,39,64],{"facility":22,"status":23,"city":24,"state":19,"zip":19,"country":25,"countryCode":26,"cosmosGeoPoint":27,"geoPoint":32,"contacts":33},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Internal Medicine and Liver Transplantation Unit","NOT_YET_RECRUITING","Roma","Italy","IT",{"type":28,"coordinates":29},"Point",[30,31],11.10642,44.99364,{"lat":31,"lon":30},[34],{"name":35,"role":36,"phone":37,"phoneExt":19,"email":38},"Luca Miele","CONTACT","00390630154469","luca.miele@policlinicogemelli.it",{"facility":40,"status":41,"city":42,"state":19,"zip":19,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":49,"contacts":50},"Hospital Universitario Virgen del Rocío de Sevilla","RECRUITING","Seville","Spain","ES",{"type":28,"coordinates":46},[47,48],-5.97317,37.38283,{"lat":48,"lon":47},[51,55,58,60,62],{"name":52,"role":36,"phone":53,"phoneExt":19,"email":54},"Manuel Romero-Gómez","+34954786587","mromerogomez@us.es",{"name":56,"role":36,"phone":19,"phoneExt":19,"email":57},"Luis Calzadilla-Bertot","luis.calzadilla@ciberehd.org",{"name":52,"role":59,"phone":19,"phoneExt":19,"email":19},"PRINCIPAL_INVESTIGATOR",{"name":56,"role":61,"phone":19,"phoneExt":19,"email":19},"SUB_INVESTIGATOR",{"name":63,"role":61,"phone":19,"phoneExt":19,"email":19},"Rocío Gallego-Durán",{"facility":65,"status":23,"city":66,"state":19,"zip":19,"country":67,"countryCode":19,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Hacettepe University","Ankara","Turkey (Türkiye)",{"type":28,"coordinates":69},[70,71],32.85427,39.91987,{"lat":71,"lon":70},[74],{"name":75,"role":36,"phone":76,"phoneExt":19,"email":77},"Yasemin Balaban","+90 533 234 4232","ybalaban@hacettepe.edu.tr",{"type":79,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[81,84,86,87],{"name":82,"class":83},"Instituto de Salud Carlos III","OTHER_GOV",{"name":85,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"name":65,"class":6},{"name":88,"class":83},"Consorcio Centro de Investigación Biomédica en Red (CIBER)","100642733","unmask-unveiling-the-pathobiology-of-metabolic-dysfunction-associated-steatotic-liver-disease-for-the-discovery-of-novel-therapeutics-and-biomarkers-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":100,"type":101},450,"ESTIMATED","INTERVENTIONAL",[104],"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.",[107],"MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)",[109,110,111,112,113],"Fibrosis","Obesity","Personalised Medicine","Patient Phenotyping","Lifestyle intervention","2026-06-18",{"date":116,"type":117},"2026-06-23","ACTUAL",{"date":119,"type":117},"2026-01-20",{"date":121,"type":101},"2027-02",{"name":5,"class":6},3]