RecruitingNAINTERVENTIONAL

Oral Nutritional Supplement in Adults With or at Risk of Malnutrition

This study is investigating a special nutritional drink for adults who are either malnourished or at risk of becoming malnourished. The main goal is to see how well people tolerate this drink and if it causes any stomach-related side effects. Participants may be involved if a dietitian or doctor thinks they need extra nutritional support due to recent weight loss, illness, or are already using similar supplements. It's a single-group study, meaning everyone receives the same nutritional drink, and we'll track their progress. The study aims to provide important information about the benefits and tolerability of this specific nutritional product in a real-world setting for people needing improved nutrition.

At a glance

Status

Recruiting

Phase

Sponsor

Abbott Nutrition

Enrolment target

Start

22 Mar 2026

Estimated completion

01 Jul 2026

Gastrointestinal Tolerance

What is this study about?

This study is about a special nutritional drink, often called an Oral Nutritional Supplement (ONS). These drinks are designed to give extra calories, protein, and other important nutrients to people who aren't getting enough from their regular food. You might be offered such a drink if you've been unwell, lost weight, or your doctor or dietitian thinks you're at risk of becoming malnourished.

In this study, we want to find out how well people 'tolerate' this particular nutritional drink. This means we're looking to see if it causes any unwanted side effects, especially tummy upsets like bloating, sickness, or diarrhoea. Your comfort and health are really important, so understanding how easily people can take these supplements is key to helping patients get the nutrition they need.

This isn't a study where some people get the drink and others don't, or where different drinks are compared. Everyone who joins will receive the same nutritional product. We'll be carefully monitoring how participants feel and how their bodies react to the drink over a short period. The information we gather will help healthcare professionals better understand when and how to use this type of nutritional support for patients in the future.

Key takeaways

Tests a special nutritional drink for malnourished adults.
Looks at how well people tolerate the drink, especially tummy-wise.
Everyone in the study uses the same nutritional drink.
Participation is voluntary and you can stop anytime.
A dietitian or doctor must decide if you need extra nutrition.

Who may be eligible?

This study is looking for adults aged 18 or over. You might be considered if a dietitian or doctor believes you are malnourished, or at risk of becoming malnourished. This could be because you're already using nutritional drinks, have recently been identified as needing extra nutrition, or have lost weight due to an illness or hospital stay within the last two months. Importantly, your stomach and digestive system should generally be working normally.

If you're a woman of childbearing age, you'll need to confirm you're not pregnant or breastfeeding, and agree to use effective contraception during the study. If you've recently given birth, you need to be at least six weeks postpartum. Women who are postmenopausal for over a year or have had certain surgeries are considered not of childbearing potential.

However, you won't be able to join if you have certain conditions that might make it difficult to take the drink or follow the study rules. This includes severe memory problems or confusion, eating disorders, or significant mental health issues that affect your ability to answer questions. Also, if you have uncontrolled diabetes, or have taken antibiotics very recently (within the last week), or have had major stomach surgery in the last three months, you won't be eligible. Alcohol or drug abuse would also prevent participation.

Quick self-check

Are you 18 years old or older?
Has a doctor or dietitian said you are malnourished or at risk, or are you already using nutritional drinks?
Do you generally have a healthy and normally functioning digestive system?
Are you able to follow study instructions for at least 7 days?
Are you pregnant or breastfeeding (if female)? (No, if you want to join)
Have you had major stomach surgery in the last 3 months? (No, if you want to join)

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 screening visit to check if you're suitable for the study based on the criteria mentioned. If you qualify, you'll be asked to drink the special nutritional supplement for at least 7 days. During this time, the study team will monitor how you're tolerating the drink, meaning they'll check for any side effects like stomach discomfort. This involves regularly checking in with you and asking questions about how you're feeling. There won't be any other medicines prescribed as part of this study, as it's purely focused on the nutritional drink. The total time you'll be actively involved in the study will be at least 7 days, but the exact duration of follow-up will be explained by the study team. You'll need to be willing to follow the study instructions carefully for this period.

Potential risks and benefits

Taking part in any study has potential benefits and risks. The main benefit here is that you'll receive a nutritional supplement that could help improve your overall nutrition, which is particularly important if you're malnourished or at risk. This could help with your general well-being. However, there's always a chance of side effects, particularly stomach-related issues like bloating, nausea, or changes in bowel habits, even though the study aims to assess tolerance. The study team will closely monitor you and ensure your safety. It's vital to remember that joining is entirely voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

North Coast Medical
Newquay, United Kingdom· Recruiting
Atlantic Medical Group
Penzance, United Kingdom· Recruiting
Hull University Teaching Hospital
Anlaby, United Kingdom· Recruiting

Common questions

What is an Oral Nutritional Supplement (ONS)?

It's a special drink packed with extra calories, protein, and other nutrients, designed to top up what you get from your regular food, especially if you're unwell or not eating enough.

What does 'Gastrointestinal Tolerance' mean?

It means how well your stomach and digestive system handle the drink. We're checking if it causes any tummy upsets like bloating, discomfort, or changes in how often you go to the toilet.

Do I have to take part if I'm asked?

No, absolutely not. Taking part is completely your choice, and you can change your mind and stop at any time without it affecting your usual medical care.

Will I get a different treatment than other people?

No, in this study, everyone who takes part will receive the same specific nutritional drink. It's not comparing different treatments.

How long will I be involved in the study?

You will need to take the nutritional drink and be monitored for at least 7 days. The study team will give you a precise schedule.

How to find out more

Kristen DeLuca

kristen.deluca@abbott.com 6145653522 Official trial record

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