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

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

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.