Overview
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
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.