Plant-protein dominant tube feeding for adults at home
Official title: 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
Run by Nutricia UK Ltd · NCT07422935 · Data updated 2026-11-12
This trial tests whether reformulated plant-protein dominant tube feeds work as well as animal-protein feeds for adults who receive tube feeding at home.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 16 Years and up |
| Sex | All |
| Enrollment | 110 (estimated) |
| Sponsor | Nutricia UK Ltd Industry-sponsored |
| Locations | 1 site (Trowbridge, Wiltshire) |
| Status | Recruiting |
| Started | January 1, 2026 |
| Main results expected | July 2028 |
| Study ends | July 2028 |
| Registry record updated | August 21, 2026 |
| Trial ID | NCT07422935 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (age ≥16) who use or require enteral tube feeds at home and are expected to receive at least 500 ml (≈500 kcal) per day from a study product, and who are not receiving parenteral nutrition or inpatient care, are ideal candidates.
✕Probably not a fit
Patients with major hepatic or renal dysfunction, those receiving parenteral nutrition or inpatient care, pregnant or lactating people, or anyone allergic to study product ingredients are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an exploratory, randomized controlled trial in adults using home enteral tube feeding that begins with a 3-day baseline period. Participants aged 16 and older who receive at least 500 ml per day of study product are randomized to receive either a plant-protein dominant formulation or an animal-protein dominant control for a 3-month intervention. Outcomes measured include gastrointestinal tolerance, compliance and acceptability, anthropometry, nutrient intake, and physical function, with follow-up visits at 6 and 12 months. The study is run by Nutricia UK with collaborating NHS hospital sites and uses commercially formulated enteral feeds delivered in the community.
Why it matters
Potential benefit: If successful, patients could have a plant-based tube feed option that provides similar tolerance, nutritional intake, and functional outcomes to conventional animal-protein feeds.
How similar studies have gone: Some previous product development and small studies suggest plant-protein blends can meet basic nutritional needs, but direct randomized comparisons in home tube-fed adult populations are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Nutricia Ltd
Trowbridge, Wiltshire, United Kingdom Recruiting
Study contacts
- Study coordinator: Sophie Bell
- Email: sophie.bell@nutricia.com
- Phone: +7717498628
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.