2kcal Tube Feed Study

Evaluation of a Nutritionally Complete, Plant-based, High Energy, High Protein, Enteral Tube Feed in Adults

The primary aim of this study is to investigate the effects of a plant-based, high energy, high protein tube feed with and without inclusion of fibre on gastrointestinal tolerance in adult patients who require nutritional support via enteral tube feeding over a 28-day period, followed by a 12-month follow-up. Secondary aims are to determine the effects on compliance, acceptability, anthropometry, nutrient intake, and physical function. This is a prospective, longitudinal, 28-day intervention study with a 1-day baseline period and a 1-year follow-up.

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 1000kcal/day (one bottle) 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.