Plant-Protein Dominant Tube Feed Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorNutricia UK Ltd

About this trial

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

Qualifiers

Male or female

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Plant-protein dominant enteral feed
  • Animal-protein dominant enteral feed

Treatment groups

110 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Nutricia UK Ltd

Lead sponsor

University Hospitals Coventry and Warwickshire NHS Trust

Collaborator

Gateshead Health NHS Foundation Trust

Collaborator

University Hospitals of Derby and Burton NHS Foundation Trust

Collaborator

Bradford Teaching Hospitals NHS Foundation Trust

Collaborator

University College London Hospitals

Collaborator

South Warwickshire NHS Foundation Trust

Collaborator

Birmingham Community Healthcare NHS

Collaborator

University Hospital Birmingham

Collaborator

Nottingham University Hospitals NHS Trust

Collaborator

NORFOLK COMMUNITY HEALTH AND CARE NHS TRUST

Collaborator