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
Nutricia UK Ltd
110 participants
Jan 1, 2026
INTERVENTIONAL
Conditions
Summary
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 Criteria4
- 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 Criteria8
- 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.
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Interventions
Patients randomised to the Intervention Group will continue their existing tube feed for 3 days (baseline period) after which they will then receive one (or a combination) of the 4 plant-protein dominant enteral feeds (1kcal/ml or 1.5kcal/ml, with or without fibre) for 3 months. Patients who chose to remain on the study feed following the duration of the trial will be invited to participate in the full 12-month follow up (an additional 9 months), where data will be collected at 6- and 12-months. The feed prescription will be determined on an individual basis by the dietitian responsible for the patient's nutritional management but will be a minimum of 500ml feed per day (providing ≥500kcal).
Patients randomised to the Control Group will continue their existing tube feed for 3 days (baseline period) after which they will then receive one (or a combination) of the 4 animal-protein dominant control feeds (1kcal/ml or 1.5kcal/ml, with or without fibre) for 3 months. Patients who chose to remain on the study feed following the duration of the trial will be invited to participate in the full 12-month follow up (an additional 9 months), where data will be collected at 6- and 12-months. The feed prescription will be determined on an individual basis by the dietitian responsible for the patient's nutritional management but will be a minimum of 500ml feed per day (providing ≥500kcal).
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07422935