[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625461":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":40,"responsibleParty":55,"collaborators":57,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":26,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":26,"enrollmentInfo":90,"targetDuration":26,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":26,"overallStatus":43,"whyStopped":26,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Nutricia UK Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Plant-Protein Dominant Intervention","EXPERIMENTAL","During the 3-day baseline period, each patient will receive their usual enteral tube feeding prescription as determined by their dietitian. Following the 3-day baseline period, all patients will enter the 90-day intervention period, where they will receive one (or a combination) of the plant-protein dominant feeds.",[13],"Dietary Supplement: Plant-protein dominant enteral feed",{"label":15,"type":16,"description":17,"interventionNames":18},"Animal-Protein Dominant Control","ACTIVE_COMPARATOR","During the 3-day baseline period, each patient will receive their usual enteral tube feeding prescription as determined by their dietitian. Following the 3-day baseline period, all patients will enter the 90-day intervention period, where they will receive one (or a combination) of the animal-protein dominant feed (control) daily.",[19],"Dietary Supplement: Animal-protein dominant enteral feed",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Plant-protein dominant enteral feed","Patients randomised to the Intervention Group will continue their existing tube feed for 3 days (baseline period) after which they will then receive one (or a combination) of the 4 plant-protein dominant enteral feeds (1kcal\u002Fml or 1.5kcal\u002Fml, with or without fibre) for 3 months. Patients who chose to remain on the study feed following the duration of the trial will be invited to participate in the full 12-month follow up (an additional 9 months), where data will be collected at 6- and 12-months. The feed prescription will be determined on an individual basis by the dietitian responsible for the patient's nutritional management but will be a minimum of 500ml feed per day (providing ≥500kcal).",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Animal-protein dominant enteral feed","Patients randomised to the Control Group will continue their existing tube feed for 3 days (baseline period) after which they will then receive one (or a combination) of the 4 animal-protein dominant control feeds (1kcal\u002Fml or 1.5kcal\u002Fml, with or without fibre) for 3 months. Patients who chose to remain on the study feed following the duration of the trial will be invited to participate in the full 12-month follow up (an additional 9 months), where data will be collected at 6- and 12-months. The feed prescription will be determined on an individual basis by the dietitian responsible for the patient's nutritional management but will be a minimum of 500ml feed per day (providing ≥500kcal).",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Sophie Bell","CONTACT","+7717498628","sophie.bell@nutricia.com",{"name":38,"role":34,"phone":26,"phoneExt":26,"email":39},"Ellen Taylor","ellen.taylor@nutricia.com",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":26},"Nutricia Ltd","RECRUITING","Trowbridge","Wiltshire","BA14 0XQ","United Kingdom","UK",{"type":50,"coordinates":51},"Point",[52,53],-2.20861,51.31889,{"lat":53,"lon":52},{"type":56,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[58,61,63,65,68,70,72,74,76,78],{"name":59,"class":60},"University Hospitals Coventry and Warwickshire NHS Trust","OTHER",{"name":62,"class":60},"Gateshead Health NHS Foundation Trust",{"name":64,"class":60},"University Hospitals of Derby and Burton NHS Foundation Trust",{"name":66,"class":67},"Bradford Teaching Hospitals NHS Foundation Trust","OTHER_GOV",{"name":69,"class":60},"University College London Hospitals",{"name":71,"class":60},"South Warwickshire NHS Foundation Trust",{"name":73,"class":67},"Birmingham Community Healthcare NHS",{"name":75,"class":60},"University Hospital Birmingham",{"name":77,"class":60},"Nottingham University Hospitals NHS Trust",{"name":79,"class":80},"NORFOLK COMMUNITY HEALTH AND CARE NHS TRUST","UNKNOWN","100625461","plant-protein-dominant-tube-feed-study-100625461",false,"NCT07422935","Plant-Protein Dominant Tube Feed Study","Exploratory Randomised, Controlled Trial To Evaluate The Impact Of Four Nutritionally Complete, Plant-Protein Dominant, Enteral Tube Feeds On Long Term Outcomes In Community-Based Adults","Inclusion Criteria:\n\n* Male or female\n\n  -≥16 years of age\n* Using or requiring an enteral tube feed in the community as part of nutritional management plan\n* Expected to receive at least 500ml (≥500kcal) per day from one of the study products\n\nExclusion Criteria:\n\n* Receiving parenteral nutrition\n* Patients with major hepatic dysfunction (i.e., decompensated liver disease)\n* Patients with major renal dysfunction (i.e., requiring filtration or stage 4\u002F5 chronic kidney disease (CKD))\n* Patients receiving inpatient care\n* Known pregnancy or lactation\n* Participation in other clinical intervention studies within 1 month of this study\n* Allergy to any study product ingredients\n* Investigator concern regarding ability or willingness of patient to comply with the study requirements.","ALL","16 Years",{"count":91,"type":92},110,"ESTIMATED","INTERVENTIONAL",[95],"NA","This study aims to determine whether a reformulated plant-protein dominant protein blend in four existing enteral tube feeds is as effective as animal-protein dominant formulations in patients who are tube fed at home. This is an exploratory randomised, controlled, trial with a 3-day baseline period. Adult home tube feeding patients will be randomised to receive either a plant-protein dominant formulation or a control product (an animal-protein dominant formulation) for a 3-month intervention period followed by a 6-month and 12-month follow-up. The outcomes include gastrointestinal tolerance, compliance, acceptability, anthropometry, nutrient intake, and physical function",[98,99],"Enteral Nutrition (Food for Special Medical Purposes)","Enteral Feeds","2026-02-13",{"date":102,"type":103},"2026-02-20","ACTUAL",{"date":105,"type":103},"2026-01-01",{"date":107,"type":92},"2027-03",{"name":5,"class":6},1]