[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100414149":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":38,"responsibleParty":56,"collaborators":12,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":12,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":12,"enrollmentInfo":68,"targetDuration":12,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":12,"overallStatus":41,"whyStopped":12,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Mayo Clinic","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of Care Group","NO_INTERVENTION","Subjects will participate in a standardized Transplant Nutrition class between day 21-40 as per institutional protocol and will be counseled as per the Mayo Clinic standard of care vis a vis dietary intervention, standard aerobic and resistance exercise recommendations (consistent with AASLD guidelines) and other lifestyle interventions.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Behavioral: Structured Modified Mediterranean Diet","EXPERIMENTAL","Subjects will participate in a one-on-one counselling session with a dietician, as opposed to attending the standardized Transplant Nutrition class. Counselling will be provided on the elements of the modified Mediterranean diet which emphasizes consumption of fruits, vegetables, whole grains, beans and nuts, in addition to low salt, moderate amounts of lean protein (primarily fish and poultry) in addition to low to moderate quantities of monounsaturated fats.",[18],"Behavioral: Dietary Intervention",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"BEHAVIORAL","Dietary Intervention","Modified Mediterranean diet approved by the Nutrition Team at the Transplant Center and it emphasizes consumption of fruits, vegetables, whole grains, beans and nuts, in addition to low salt (2-2.4g\u002Fday), moderate amounts of lean protein (primarily fish and poultry) in addition to low to moderate quantities of monounsaturated fats. The modifications to the traditional Mediterranean diet are: no alcohol consumption and fewer added fats. In addition, close scheduled followup on diet and progress with study team.",[14],[26],{"name":27,"affiliation":5,"role":28},"Kymberly Watt, MD","PRINCIPAL_INVESTIGATOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":12,"email":34},"Mohammad Qasim Khan, M.B.B.S.","CONTACT","507-284-3917","khan.mohammadqasim@mayo.edu",{"name":27,"role":32,"phone":36,"phoneExt":12,"email":37},"507-266-1586","watt.kymberly@mayo.edu",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Mayo Clinic in Rochester","RECRUITING","Rochester","Minnesota","55905","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-92.4699,44.02163,{"lat":51,"lon":50},[54],{"name":27,"role":32,"phone":55,"phoneExt":12,"email":37},"5072661586",{"type":28,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Kymberly D. Watt","Principal Investigator","100414149","mediterranean-diet-post-liver-transplantation-100414149",false,"NCT04672863","Mediterranean Diet Post-liver Transplantation","Effects of a Structured, Modified Mediterranean Dietary Intervention After Liver Transplantation","Inclusion Criteria\n\n* Adult patients ≥ 18 years of age undergoing primary liver transplant\n* Ascites-adjusted BMI ≥ 25 kg\u002Fm2\n* Acceptable graft function (total bilirubin level \\\u003C 5 mg\u002FdL and doppler ultrasound with patent hepatic artery, hepatic veins and portal veins)\n\nExclusion Criteria\n\n* Hepatocellular carcinoma (HCC) that did not fulfill Milan criteria as per explant histology\n* Untreated post-transplant vascular complications or biliary strictures\n* Multi-organ transplantation\n* Urine protein excretion ≥2.0 g\u002Fday\n* Uncontrolled diabetes mellitus (HbA1c \\> 10%)\n* Associated medical conditions incompatible with safe participation in a nutritional intervention study, including digestive diseases with fat intolerance, neurological, psychiatric or endocrine disorders\n* Active eating disorder (e.g. bulimia nervosa, anorexia nervosa)\n* History of bariatric surgery\n* Pregnancy or planning on pregnancy in the next year","ALL","18 Years",{"count":69,"type":70},80,"ESTIMATED","INTERVENTIONAL",[73],"NA","The purpose of this study is to study the effects of a structured Mediterranean dietary program on prevention of weight gain, promotion of heart health and prevention of fatty liver disease after liver transplantation.",[76],"Liver Transplantation","2026-01-05",{"date":79,"type":80},"2026-01-07","ACTUAL",{"date":82,"type":80},"2021-01-19",{"date":84,"type":70},"2027-11",{"name":5,"class":6},1]