[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556130":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":38,"responsibleParty":60,"collaborators":18,"id":62,"slug":18,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":18,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":18,"enrollmentInfo":70,"targetDuration":18,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":18,"overallStatus":41,"whyStopped":18,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Duke University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Enhanced Protein Supplementation","EXPERIMENTAL","Oral nutrition supplements (ONS) will be given, at maximum, three times per day throughout hospitalization. Upon discharge, participants will be given 4-weeks' worth of oral supplements to take. Adjustments may be made based on indirect calorimetry (IC) measurements.",[13],"Dietary Supplement: Nutrition Supplements - Fresubin KCAL Drinks",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Pathway","NO_INTERVENTION","Standard of care nutrition delivery throughout hospitalization. Upon discharge participants will be sent home with standard nutrition information without Indirect Calorimetry (IC) guidance.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DIETARY_SUPPLEMENT","Nutrition Supplements - Fresubin KCAL Drinks","Fresubin drinks will be taken up to 3 times a day throughout hospitalization and for 4 weeks after discharge.",[9],[26],{"name":27,"affiliation":5,"role":28},"Paul Wischmeyer, MD","PRINCIPAL_INVESTIGATOR",[30,34],{"name":27,"role":31,"phone":32,"phoneExt":18,"email":33},"CONTACT","919-681-9660","paul.wischmeyer@duke.edu",{"name":35,"role":31,"phone":36,"phoneExt":18,"email":37},"Krista Haines, MD","919-681-3784","krista.haines@duke.edu",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Duke University Hospital","RECRUITING","Durham","North Carolina","27710","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-78.89862,35.99403,{"lat":51,"lon":50},[54,58],{"name":55,"role":31,"phone":56,"phoneExt":18,"email":57},"Lynnette Moats","919-681-3399","lynnette.moats@duke.edu",{"name":35,"role":59,"phone":18,"phoneExt":18,"email":18},"SUB_INVESTIGATOR",{"type":61,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100556130",false,"NCT06521086","Optimizing Recovery in Trauma Patients by Integrating Enhanced Nutrition Delivery","Optimizing Recovery in Trauma Patients: Integrating Enhanced Nutrition Delivery With Muscle Assessments, Functional Outcomes and Quality of Life","Inclusion Criteria:\n\n* Patients who are at least 45 years old and presented to the Emergency Department as a leveled trauma\n* Patients who have the ability to tolerate oral nutrition\n* Patients who have had a standard of care CT scan this admission\n\nExclusion Criteria:\n\n* Expected withdrawal of life-sustaining treatment within 48 hours\n* Traumatic Brain Injury\n* Presence of lower extremity fracture(s)\n* Mechanical Ventilation\n* Subjects for who the Investigator would recommend a different supplement based on their medical condition.\n* Prisoner\n* Pregnancy for women of child-bearing potential","ALL","45 Years",{"count":71,"type":72},60,"ESTIMATED","INTERVENTIONAL",[75],"NA","This is a prospective, randomized, controlled trial designed to evaluate the impact of enhanced protein supplementation compared to a standard of care nutrition delivery in critically ill older adult trauma patients. Subjects will be randomized 1:1 to either enhanced nutrition or control arm. Subjects randomized to the enhanced nutrition arm will receive oral nutrition supplements (ONS) up to 3 times per day while in the hospital and for 4 weeks after discharge. Subjects in the standard of care arm will receive normal nutrition recommendations from their clinical providers. Participants in both groups will undergo non-invasive tests that measure how much energy (calories) they are using, body composition, and muscle mass.",[78,79],"Trauma","Critical Illness","2026-06-01",{"date":82,"type":83},"2026-06-03","ACTUAL",{"date":85,"type":83},"2026-02-18",{"date":87,"type":72},"2028-05-30",{"name":5,"class":6},1]