Plant-protein dominant tube feeding for adults at home
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
NA · Nutricia UK Ltd · NCT07422935
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Nutricia UK Ltd (industry) |
| Locations | 1 site (Trowbridge, Wiltshire) |
| Trial ID | NCT07422935 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Trowbridge, Wiltshire
- Nutricia Ltd — Trowbridge, Wiltshire, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Sophie Bell
- Email: sophie.bell@nutricia.com
- Phone: +7717498628
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Enteral Nutrition, Enteral Feeds