Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07422935). StuddyBuddy aggregates publicly available trial information.