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Recruiting
NCT07422935
Plant-Protein Dominant Tube Feed Study
Conditions: Enteral Nutrition (Food for Special Medical Purposes), Enteral Feeds
Sex: All
Ages: 16 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 110
Sponsor: Nutricia UK Ltd
Location: Nutricia Ltd Trowbridge Wiltshire
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 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.
Source: ClinicalTrials.gov (NCT07422935). StuddyBuddy aggregates publicly available trial information.