RecruitingNot Applicable

Plant-Protein Dominant Tube Feed Study

United Kingdom110 participantsStarted 2026-01-01

Plain-language 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

Who can participate

Age range

16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

≥16 years of age

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in gastrointestinal tolerance

Timeframe: Change from baseline (Day 1) to end of intervention (Day 93) and end of follow up (12 months)

Acceptability

Timeframe: Baseline (Day 1) to end of intervention (Day 93) and end of follow up (12 months)

Compliance

Timeframe: Baseline to end of intervention (93 days) and end of follow-up (12 months)

Nutritional intake

Timeframe: Baseline to end of intervention (Day 93) and end of follow-up (12 months)

Body weight

Timeframe: Baseline to end of intervention (Day 93) and end of follow-up (12 months)

Height

Timeframe: Baseline to end of intervention (Day 93) and end of follow-up (12 months)

Calf circumference

Timeframe: Baseline to end of intervention (Day 93) and end of follow-up (12 months)

Trial details

NCT IDNCT07422935

SponsorNutricia UK Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03

Contact for this trial

Sophie Bell

+7717498628 sophie.bell@nutricia.com

View on ClinicalTrials.gov More Enteral Nutrition (Food for Special Medical Purposes) trials

Plain-language summary

What they're measuring

Change in gastrointestinal tolerance

Timeframe: Change from baseline (Day 1) to end of intervention (Day 93) and end of follow up (12 months)

Acceptability

Timeframe: Baseline (Day 1) to end of intervention (Day 93) and end of follow up (12 months)

Compliance

Timeframe: Baseline to end of intervention (93 days) and end of follow-up (12 months)

Nutritional intake

Timeframe: Baseline to end of intervention (Day 93) and end of follow-up (12 months)

Body weight

Timeframe: Baseline to end of intervention (Day 93) and end of follow-up (12 months)

Height

Timeframe: Baseline to end of intervention (Day 93) and end of follow-up (12 months)

Calf circumference

Timeframe: Baseline to end of intervention (Day 93) and end of follow-up (12 months)