RecruitingNAINTERVENTIONAL

Plant-Protein Dominant Tube Feed Study

This study wants to find out if new plant-based liquid food given through a tube is just as good as the usual animal-based liquid food. It's for adults who rely on tube feeding at home. Researchers will compare revamped plant-based feeds with current animal-based feeds over three months, with check-ups for a year. They'll be looking at things like how well people tolerate the food, if they use it consistently, how happy they are with it, their weight and body measurements, how many nutrients they get, and their physical strength.

At a glance

Status

Recruiting

Phase

Sponsor

Nutricia UK Ltd

Enrolment target

110

Start

01 Jan 2026

Estimated completion

01 Mar 2027

Enteral Nutrition (Food for Special Medical Purposes)Enteral Feeds

What is this study about?

This study is looking into a really important question for people who use tube feeding at home: can plant-based liquid food be just as effective as the animal-based liquid food they currently use? Many products available for tube feeding today are made from animal protein. Researchers have now developed new versions of four common liquid feeds, replacing most of the animal protein with plant protein.

The main goal is to see if these new plant-based feeds work just as well as the animal-based ones. This includes checking if they are easy to digest and don't cause side effects, if people are happy to use them, and if they provide all the nutrition needed to stay healthy and strong. Finding a good plant-based alternative could give people more options for their dietary needs.

This is an `exploratory randomised, controlled trial`, which means people will be randomly put into two groups – one getting the plant-based feed and the other getting the animal-based feed. This helps to make sure the comparison is fair. By carefully looking at digestion, nutrition, and well-being over time, the study hopes to provide valuable information about tube feeding options.

Key takeaways

Compares plant-based vs. animal-based tube feeds for home use.
Aims to see if plant-based feeds are equally effective and well-tolerated.
Involves adults aged 16+ who are tube-fed at home.
Study lasts for 3 months with follow-ups for a year.
Looks at digestion, nutrition, physical ability, and satisfaction.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be able to join this study, you need to be an adult aged 16 or older and currently using, or needing, tube feeding as part of your regular nutritional care at home. You should also be getting at least 500ml (which is about 500 calories) of liquid food each day from one of the feeds being tested.

There are some reasons why you might not be able to take part. For example, if you are also receiving nutrition directly into your bloodstream (called parenteral nutrition), or if you have serious liver problems or advanced kidney disease that requires special treatment like dialysis. Similarly, if you are currently staying in hospital, are pregnant or breastfeeding, or have taken part in another medical study in the last month, you wouldn't be able to join.

Finally, if you have allergies to any of the ingredients in the study products, or if the research team thinks you might struggle to follow the study's instructions, then it wouldn't be suitable for you to participate.

Quick self-check

Are you 16 years old or older?
Do you currently use tube feeding as your main way of getting nutrition at home?
Are you expecting to get at least 500ml of liquid feed a day from the study product?
Are you not currently pregnant or breastfeeding?
Do you have any serious liver or kidney problems?
Do you have allergies to common food ingredients?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll first have a three-day period where your current feeding routine is noted down. After this, you'll be randomly assigned to receive either the new plant-based tube feed or a standard animal-based tube feed for three months. You'll switch from your usual feed to one of these study feeds. The team will ask you to keep track of how much feed you use and if you have any tummy problems. You'll also have assessments to measure your weight, body size, and physical abilities.

After the three-month feeding period, you'll go back to your usual tube feed. There will then be follow-up check-ins at 6 months and 12 months after the start of the study. These check-ups will likely involve questions about your health and possibly some measurements. The total time you'll be involved in the study, including all the follow-ups, is about a year.

Potential risks and benefits

Taking part in this study could offer some benefits, such as potentially trying a new plant-based tube feed that might suit your needs better. Your health and nutritional intake will be closely monitored by the study team, which could be reassuring. However, there are potential risks, such as experiencing digestive discomfort or other side effects when changing your tube feed, though these would be carefully monitored. You might find the study's requirements, like recording information and attending follow-ups, to be demanding. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Nutricia Ltd
Trowbridge, United Kingdom· Recruiting

Common questions

What is 'enteral tube feed'?

It's a way of giving liquid food through a small tube directly into your stomach or small intestine when you can't eat enough by mouth.

Will I know if I'm getting the plant-based or animal-based feed?

Because this is a 'randomised controlled trial', you might not know which feed you are getting, to keep the comparison fair.

What kind of 'outcomes' will they be looking at?

They'll check things like how well you digest the food, if you like it, your weight, and your general strength and movement.

How long will I be on the study feed?

You'll use the study's assigned tube feed for three months, followed by check-ups for up to a year after the study starts.

Can I stop participating if I want to?

Yes, you can leave the study at any time, and it won't affect the care you usually receive.

How to find out more

Sophie Bell

sophie.bell@nutricia.com +7717498628 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.