[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570976":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":35,"responsibleParty":56,"collaborators":58,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":11,"enrollmentInfo":72,"targetDuration":11,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":11,"overallStatus":38,"whyStopped":11,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Maastricht University Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Normal protein amount","ACTIVE_COMPARATOR",null,[13],"Dietary Supplement: Nutritionally complete Tube Feed with standard protein levels",{"label":15,"type":16,"description":11,"interventionNames":17},"Elevated protein amount","EXPERIMENTAL",[18],"Dietary Supplement: Nutritionally complete Tube Feed with higher protein levels",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DIETARY_SUPPLEMENT","Nutritionally complete Tube Feed with standard protein levels","Containing standard protein levels to target normal protein amount of 0.8 g of protein\u002Fkg body weight\u002Fday",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Nutritionally complete Tube Feed with higher protein levels","Containing higher protein levels to target elevated protein amount of 1.3 g of protein\u002Fkg body weight\u002Fday.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Michèlle Hendriks, MSc","CONTACT","+31 43 388 1184","michelle.hendriks@maastrichtuniversity.nl",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Jessa Hospital Campus Virga Jesse","RECRUITING","Hasselt","Limburg","3500","Belgium","BE",{"type":45,"coordinates":46},"Point",[47,48],5.33781,50.93106,{"lat":48,"lon":47},[51,55],{"name":52,"role":32,"phone":53,"phoneExt":11,"email":54},"Björn Stessel, Prof. Dr.","+3211 33 55 77","bjorn.stessel@jessazh.be",{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},{"type":57,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[59],{"name":60,"class":61},"Danone Global Research & Innovation Center","INDUSTRY","100570976","enhanced-protein-intake-to-support-muscle-protein-synthesis-in-icu-100570976",false,"NCT06714240","Enhanced Protein Intake to Support Muscle Protein Synthesis in ICU","Increased Protein Amount as a Nutritional Strategy to Enhance Muscle Protein Synthesis in ICU Patients","IPA-IC","Inclusion Criteria:\n\n* Aged ≥ 18 years\n* Suitability for enteral nutrition (i.e., no GI failure, absence of complete intestinal obstruction, no major intra-abdominal sepsis)\n* Expected mechanical ventilation of minimal three days\n* Expected ICU stay of at least seven days\n\nExclusion Criteria:\n\n* BMI ≥ 40 kg\u002Fm²\n* Spinal cord injury\n* Chronic corticosteroid use before hospital admission\n* severe allergies or intolerances (e.g., to cow's milk protein, fish, soy, pea protein or galactosemia)\n* Severe kidney and\u002For liver failure\n* Requirements for dialysis\n* Bleeding disorders, including anticoagulant and antiplatelet therapy","ALL","18 Years",{"count":73,"type":74},26,"ESTIMATED","INTERVENTIONAL",[77],"NA","Rationale - Critically ill patients often experience severe skeletal muscle wasting due to an imbalance between muscle protein synthesis (MPS) and degradation, contributing to long-term impairments such as ICU-acquired weakness (ICU-AW) and post-intensive care syndrome (PICS). Effective interventions to mitigate muscle wasting remain a critical unmet need. Protein intake has been identified as a potential modulator of MPS, but anabolic resistance and conflicting evidence regarding optimal protein intake necessitate further investigation.\n\nObjective\u002FHypothesis - This study aims to evaluate the effect of a normal (target: 0.8 g protein\u002Fkg\u002Fday) versus elevated (target: 1.3 g protein\u002Fkg\u002Fday) protein intake on MPS rates over four days in critically ill patients.\n\nPopulation - 26 critically ill patients who are suitable for enteral nutrition, mechanically ventilated (min 3 days), and stay at the ICU for at least 7 days will be included.\n\nMethod: Patients are randomly assigned to two groups (normal or higher protein intake). Muscle biopsies and blood samples will be collected to assess muscle protein synthesis rates.",[80,81],"Critical Illness","Muscle Protein Synthetic Response to Protein","2025-12-03",{"date":84,"type":85},"2025-12-10","ACTUAL",{"date":87,"type":85},"2025-09-01",{"date":89,"type":74},"2028-09",{"name":5,"class":6},1]