[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100369874":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":28,"locations":34,"responsibleParty":59,"collaborators":11,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":11,"eligibilityCriteria":67,"healthyVolunteers":64,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":11,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":11,"overallStatus":37,"whyStopped":11,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"The Cleveland Clinic","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Ensure Enlive","ACTIVE_COMPARATOR",null,[13,14],"Dietary Supplement: Ensure Enlive","Other: Standard Of Care",{"label":16,"type":17,"description":11,"interventionNames":18},"Standard of Care","PLACEBO_COMPARATOR",[14],[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"DIETARY_SUPPLEMENT","The subjects in the intervention group will receive two Ensure Enlive supplements per day for 180 days.",[9],{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"Standard Of Care","The subjects in the Standard of care group will continue to receive the standard clinical therapy.",[9,16],[29],{"name":30,"role":31,"phone":32,"phoneExt":32,"email":33},"Annette C Bellar","CONTACT","2166365247","bellara@ccf.org",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Cleveland Clinic Foundation","RECRUITING","Cleveland","Ohio","44195","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-81.69541,41.4995,{"lat":47,"lon":46},[50,53,56],{"name":51,"role":31,"phone":52,"phoneExt":11,"email":33},"Annette Bellar, BS","216-445-6268",{"name":54,"role":31,"phone":11,"phoneExt":11,"email":55},"Revathi Penumatsa","penumar@ccf.org",{"name":57,"role":58,"phone":11,"phoneExt":11,"email":11},"Srinivasan Dasarathy, MD","PRINCIPAL_INVESTIGATOR",{"type":58,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Srinivasan Dasarathy","Staff Physician","100369874","late-evening-and-early-morning-protein-supplement-to-reduce-readmissions-for-hepatic-encephalopathy-100369874",false,"NCT04096014","Late Evening and Early Morning Protein Supplement to Reduce Readmissions for Hepatic Encephalopathy","Inclusion Criteria:\n\n* \\> 18 years of age\n* cirrhosis diagnosed by clinical history and liver biopsy and\u002For clinical, biochemical and imaging evidence of cirrhosis\n* at least 1 hospitalization for documented HE within the last 12 months.\n* abdominal CT scan anytime in the past\n\nExclusion Criteria:\n\n* Patients with MELD score \\> 35\n* end stage organ failure (major dysfunction requiring organ support)\n* kidney injury defined by a creatinine \\> 2 mg\u002Fdl or rise in creatinine by 0.5 gm\u002Fdl from baseline that is unresponsive to withholding diuretics and intravenous albumin administration (1 gm\u002Fkg up to 100 gm\u002Fday)\n* active malignancy\n* uncontrolled diabetes mellitus with A1c\\>9.5 (to avoid altered muscle protein metabolism\n* medications (anabolic steroids, corticosteroids) that affect skeletal muscle mass\n* recent gastrointestinal surgery within past 12 months\n* ongoing infection (positive blood or other body fluid cultures)\n* active gastrointestinal bleeding.","ALL","18 Years","75 Years",{"count":72,"type":73},40,"ESTIMATED","INTERVENTIONAL",[76],"NA","Readmission rates for patients with hepatic encephalopathy due to end stage liver disease are high. Hyperammonemia contributes significantly to encephalopathy and occurs because of impaired hepatic ureagenesis and increased skeletal muscle proteolysis. We propose a randomized, 6-month nutritional intervention in cirrhotic patients who have had at least 1 admission for hepatic encephalopathy within the last 6 months. We hypothesize that a combination of late evening and early morning protein supplement (Ensure Enlive) will decrease recurrent hepatic encephalopathy and consequent readmission rates by lowering skeletal muscle proteolysis and improved lean body mass.",[79],"Hepatic Encephalopathy","2025-11-24",{"date":82,"type":83},"2025-11-25","ACTUAL",{"date":85,"type":83},"2019-09-16",{"date":87,"type":73},"2026-10-30",{"name":5,"class":6},1]