Actively Recruiting

Phase Not Applicable
Age: 16Years +
All Genders
NCT07422935

Plant-Protein Dominant Tube Feed Study

Led by Nutricia UK Ltd · Updated on 2026-02-20

110

Participants Needed

1

Research Sites

60 weeks

Total Duration

On this page

Sponsors

N

Nutricia UK Ltd

Lead Sponsor

U

University Hospitals Coventry and Warwickshire NHS Trust

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Plant-Protein Dominant Tube Feed Study

Who Can Participate

Age: 16Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 16 years or older
  • Using or requiring an enteral tube feed at home as part of nutritional management
  • Expected to receive at least 500ml (500 kcal) per day from one of the study products
Not Eligible

You will not qualify if you...

  • Receiving nutrition through parenteral nutrition
  • Major liver dysfunction such as decompensated liver disease
  • Major kidney dysfunction requiring filtration or stage 4/5 chronic kidney disease
  • Currently receiving inpatient care
  • Known pregnancy or breastfeeding
  • Participation in other clinical intervention studies within 1 month
  • Allergy to any ingredients in the study products
  • Investigator concerns about ability or willingness to comply with study requirements

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Nutricia Ltd

Trowbridge, Wiltshire, United Kingdom, BA14 0XQ

Actively Recruiting

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Research Team

S

Sophie Bell

CONTACT

E

Ellen Taylor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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