Plant-Protein Dominant Tube Feed Study
Recruiting now · Not applicable
Conditions studied: Enteral Nutrition (Food for Special Medical Purposes), Enteral Feeds
In brief
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
Key facts
- Study ID
- NCT07422935
- Run by
- Nutricia UK Ltd
- People needed
- 110
- Starts
- 2026-01-01
- Expected to finish
- 2027-03-01
- Last updated by the study team
- 2026-02-20
Who can join
Age: 16 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Nutricia Ltd — Trowbridge, Wiltshire, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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