About this trial
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
Eligibility criteria
Qualifiers
Male or female
Using or requiring an enteral tube feed in the community as part of nutritional management plan
Expected to receive at least 500ml (≥500kcal) per day from one of the study products
Disqualifiers
Receiving parenteral nutrition
Patients with major hepatic dysfunction (i.e., decompensated liver disease)
Patients with major renal dysfunction (i.e., requiring filtration or stage 4/5 chronic kidney disease (CKD))
Patients receiving inpatient care
Trial design
Treatments tested in this trial
- Plant-protein dominant enteral feed
- Animal-protein dominant enteral feed
Treatment groups
Sponsors and collaborators
Nutricia UK Ltd
Lead sponsor
University Hospitals Coventry and Warwickshire NHS Trust
Collaborator
Gateshead Health NHS Foundation Trust
Collaborator
University Hospitals of Derby and Burton NHS Foundation Trust
Collaborator
Bradford Teaching Hospitals NHS Foundation Trust
Collaborator
University College London Hospitals
Collaborator
South Warwickshire NHS Foundation Trust
Collaborator
Birmingham Community Healthcare NHS
Collaborator
University Hospital Birmingham
Collaborator
Nottingham University Hospitals NHS Trust
Collaborator
NORFOLK COMMUNITY HEALTH AND CARE NHS TRUST
Collaborator