Tolerance and Acceptability Evaluation of an Oral Nutrition Supplement
This study is about a new protein drink designed to help people who are not getting enough nutrition, often due to an illness. It's called an "Oral Nutrition Supplement." We want to understand two main things: first, how well people tolerate it, meaning if it causes any tummy problems like sickness or bloating. Second, we want to know if people find it acceptable and easy to use in their daily lives. This includes if they like the taste (if drinking it) or if it works well with a feeding tube. The information we gather will help make sure this supplement is a good option for people who need extra nutritional support.
At a glance
What is this study about?
This study is looking at a special protein drink that's designed to help people who aren't getting enough nutrients because of an illness. This problem is sometimes called 'disease-related malnutrition'. It means your body isn't getting all the energy and building blocks it needs, which can make you feel weak and slow down your recovery.
We want to find out how well people 'tolerate' this new protein drink. This means checking if it causes any unwanted side effects like tummy aches or feeling sick. We also want to understand if people find it 'acceptable' – basically, if it's easy and comfortable to use, whether they drink it themselves or receive it through a feeding tube. Your feedback on things like taste, convenience, and if you can stick to using it, is very important.
The main goal is to gather information that could help make this protein drink available on prescription through the NHS in the future. This would make it easier for more people to access it if they need extra nutritional help to stay healthy and recover from illness.
Key takeaways
- This study is testing a protein drink for people with poor nutrition.
- It aims to see if the drink is easy to tolerate and use.
- Your feedback could help make this supplement available on the NHS.
- You must be an adult with specific nutritional needs to join.
- Taking part means using the drink daily and having regular check-ups.
- You can leave the study at any time if you wish.
Who may be eligible?
To join this study, you need to be an adult, 18 years old or older, and be able to talk about how you're feeling and experiencing the study product. The study is for people who have kidney disease or have been told by a doctor or dietitian that they specifically need more protein.
You should also have been identified as having, or being at risk of, malnutrition. This might be found through a special health check or by a healthcare professional. You should expect to need nutritional support for at least 28 days. If you meet these points, and give your full permission, you might be able to take part.
There are some reasons why you might not be able to join. For example, if you are currently in another medical study or if you have certain health problems like serious liver issues, specific swallowing difficulties, or uncontrolled bowel conditions. Also, if you've recently taken antibiotics, have severe allergies to any ingredients in the drink, or can't understand the study information (for example, due to dementia), you wouldn't be able to participate.
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 18 years old or older?
- Has a doctor or dietitian said you need more protein, perhaps due to kidney disease?
- Have you been identified as being malnourished or at risk of it?
- Do you expect to need nutritional support for at least 28 days?
- Are you able to speak and understand English well enough for the study?
What does participation involve?
This study will involve you using the new protein drink every day for a period of time, at least 28 days. You'll either drink it directly or receive it through a feeding tube, depending on your situation. We will ask you to keep track of any tummy upsets, how much you use, and your general experience with the product. There will be regular check-ups to see how you're getting on and if you're finding it helpful. The healthcare team will tell you exactly what each visit involves and how long the study will last for you.
Potential risks and benefits
Locations (1)
- UCLH NHS Foundation TrustVerified postcodeLondon, United Kingdom· Recruiting
Common questions
What is 'malnutrition'?
It means your body isn't getting enough important nutrients, often because of an illness, which can make you feel weak or unwell.
Will I have to stop my usual medicines?
The study team will check all your current medicines to make sure there are no problems. You should not stop any medicines without talking to your doctor.
What happens if I don't like the supplement?
It's important that you tell the study team. Your feedback, whether positive or negative, is very helpful for the study. You can also leave the study at any time.
Is this a new medicine?
No, it's a nutritional supplement, like a special food product, not a drug. It's designed to give you extra protein and energy.
Who is paying for this study?
The study aims to gather evidence to help the supplement be available on the NHS in the future, meaning the NHS would cover the cost for those who need it.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.