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Sponsor: Nutricia UK Ltd
Conditions: Enteral Nutrition (Food for Special Medical Purposes), Enteral Feeds
Interventions: Plant-protein dominant enteral feed, Animal-protein dominant enteral feed
Countries: United Kingdom
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
Sex: ALL
Age: 16 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * Male or female -≥16 years of age * 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 Exclusion Criteria: * 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 * Known pregnancy or lactation * Participation in other clinical intervention studies within 1 month of this study * Allergy to any study product ingredients * Investigator concern regarding ability or willingness of patient to comply with the study requirements.
- Trowbridge, Wiltshire, United Kingdom