Active not recruitingNAINTERVENTIONAL

Evaluation of Four New Ready to Drink Oral Nutritional Supplements: Adult ONS Trial

This study is looking at four new ready-to-drink nutritional supplements designed for people who are not getting enough nutrients from their regular diet. These supplements are important because being malnourished can make you unwell and slow down recovery. The researchers want to find out if these new drinks are easy for people to use, taste good, don't cause stomach upset, and help improve their nutritional health. Over 28 days, participants will drink one of these supplements daily alongside their usual food. The study aims to make sure these new options are safe, effective, and liked by patients, which could lead to better health outcomes and fewer hospital visits for those who need them.

At a glance

Status

Active not recruiting

Phase

Sponsor

Nutricia UK Ltd

Enrolment target

100

Start

27 Sep 2021

Estimated completion

31 Dec 2027

Malnutrition

What is this study about?

Many people in the UK don't get enough nutrients from their everyday meals, a condition called malnutrition. This can make them feel unwell, slow down their recovery from illness, and generally impact their health and quality of life. Doctors often recommend special nutritional drinks, called Oral Nutritional Supplements (ONS), to help bridge this gap and ensure people get the energy and nutrients they need.

These nutritional drinks are known to be very helpful. They can aid recovery, improve strength, and overall make people feel better. However, sometimes people find it hard to stick with these drinks, perhaps because of the taste, the amount they need to drink, or stomach upset. Also, with more people choosing plant-based diets, there's a growing need for different types of supplements to suit everyone.

This study aims to find better options. Researchers are testing four brand-new ready-to-drink nutritional supplements. They want to understand if these new drinks are easy and enjoyable to take, don't cause tummy troubles, and effectively help people get healthier. By finding supplements that people are more likely to stick with, this study could lead to better health for many.

Key takeaways

This study tests new nutritional drinks for malnourished people.
It aims for better-tasting, easier-to-take supplements.
Participation involves drinking one supplement daily for 28 days.
Your health and how you feel about the drink will be monitored.
The study could lead to improved nutritional options for patients.

Who may be eligible?

You might be able to take part in this study if you are 16 years old or older and have been identified as being malnourished, or are at risk of not getting enough nutrients. This usually means your doctor or another healthcare professional thinks you would benefit from a nutritional supplement.

However, there are some reasons why you wouldn't be able to join. For example, if you are currently receiving food directly into your veins or mostly through a feeding tube, or if you have serious kidney or liver problems. People with certain severe stomach or bowel conditions, or those who have trouble swallowing safely, also can't take part.

Additionally, if you are undergoing cancer treatment that might cause significant stomach problems or changes in taste, or if you have any allergies to the ingredients in the study drinks, you wouldn't be eligible. The team also needs to be sure you can understand and agree to take part, and that you'll be able to follow the study instructions.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 16 years old or older?
Has a doctor or nurse said you are malnourished or at risk?
Do you currently get food and nutrients mainly through eating and drinking (not feeding tubes or drips)?
Do you NOT have severe kidney or liver disease, or certain serious gut problems?
Are you NOT currently undergoing cancer treatment that causes major taste changes or stomach upset?

Answer every question to see your result.

What does participation involve?

If you join this study, we'll first spend a day collecting some information about your usual diet and health. Then, for the next 28 days (about four weeks), you will drink one of the four new nutritional supplements every day, alongside your regular meals. The researchers will check in with you regularly to see how you're feeling, if you're enjoying the drink, if you have any stomach issues, and if it's helping you get the nutrients you need. The total duration of your active involvement in the study will be about 29 days, with some follow-up checks afterwards.

Potential risks and benefits

Taking part in this study could potentially offer you a new nutritional supplement that might be more enjoyable or easier to tolerate than existing options, helping to improve your overall health and well-being. However, like all studies, there's always a chance you might experience mild side effects, such as a mild stomach upset, from the new drinks. The researchers will closely monitor you for any such effects to ensure your safety. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (19)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Ashford and St Peter's Hospitals NHS Foundation Trust
Verified postcode
Ashford, United Kingdom
West Walk Surgery
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Bristol, United Kingdom
Rowden Surgery
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Chippenham, United Kingdom
Sirona Care & Health
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Clevedon, United Kingdom
Mountainhall Treatment Centre
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Dumfries, United Kingdom
Royal Surrey NHS Foundation Trust
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Guildford, United Kingdom
Preston Hill Surgery
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Harrow, United Kingdom
Honiton Surgery
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Honiton, United Kingdom
James Alexander Family Practice
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Hull, United Kingdom
NHS Highland
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Inverness, United Kingdom
Airedale NHS Foundation Trust
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Keighley, United Kingdom
Kings Cross Hospital
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London, United Kingdom

Common questions

What is malnutrition?

Malnutrition means your body isn't getting enough important nutrients, which can make you feel weak or unwell.

What are Oral Nutritional Supplements (ONS)?

These are special drinks packed with energy and nutrients, designed to help you get what you need when your regular diet isn't enough.

How long will I need to take the study drink?

You will take one of the study drinks daily for 28 days, after an initial assessment day.

Will I know which drink I am taking?

The study design will determine whether you know which of the four drinks you're receiving. The research team will explain this to you.

What happens if I don't feel well during the study?

The study team will monitor you closely, and you can tell them immediately if you experience any discomfort or side effects. You can also leave the study at any time.