Plant-Protein Dominant Tube Feed Study

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

Conditions

• Enteral Nutrition (Food for Special Medical Purposes)
• Enteral Feeds

Interventions

DIETARY_SUPPLEMENT

Plant-protein dominant enteral feed

Patients randomised to the Intervention Group will continue their existing tube feed for 3 days (baseline period) after which they will then receive one (or a combination) of the 4 plant-protein dominant enteral feeds (1kcal/ml or 1.5kcal/ml, with or without fibre) for 3 months. Patients who chose to remain on the study feed following the duration of the trial will be invited to participate in the full 12-month follow up (an additional 9 months), where data will be collected at 6- and 12-months. The feed prescription will be determined on an individual basis by the dietitian responsible for the patient's nutritional management but will be a minimum of 500ml feed per day (providing ≥500kcal).

DIETARY_SUPPLEMENT

Animal-protein dominant enteral feed

Patients randomised to the Control Group will continue their existing tube feed for 3 days (baseline period) after which they will then receive one (or a combination) of the 4 animal-protein dominant control feeds (1kcal/ml or 1.5kcal/ml, with or without fibre) for 3 months. Patients who chose to remain on the study feed following the duration of the trial will be invited to participate in the full 12-month follow up (an additional 9 months), where data will be collected at 6- and 12-months. The feed prescription will be determined on an individual basis by the dietitian responsible for the patient's nutritional management but will be a minimum of 500ml feed per day (providing ≥500kcal).

Sponsors & Collaborators

• University Hospitals Coventry and Warwickshire NHS Trust

  collaborator OTHER

• Gateshead Health NHS Foundation Trust

  collaborator OTHER

• University Hospitals of Derby and Burton NHS Foundation Trust

  collaborator OTHER

• Bradford Teaching Hospitals NHS Foundation Trust

  collaborator OTHER_GOV

• University College London Hospitals

  collaborator OTHER

• South Warwickshire NHS Foundation Trust

  collaborator OTHER

• Birmingham Community Healthcare NHS

  collaborator OTHER_GOV

• University Hospital Birmingham

  collaborator OTHER

• Nottingham University Hospitals NHS Trust

  collaborator OTHER

• NORFOLK COMMUNITY HEALTH AND CARE NHS TRUST

  collaborator UNKNOWN

• Nutricia UK Ltd

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-01

Primary Completion

2027-03-31

Completion

2027-03-31

Countries

• United Kingdom

Study Locations