Not yet recruitingNAINTERVENTIONAL

Protein Supplementation During Dialysis (PROSED)

When you have dialysis, some important nutrients, including protein, are lost from your body. These nutrients are vital for your overall health, including your immune system. Current guidance suggests people on dialysis need more protein than the general population, but this advice is quite old. Over the last 40 years, dialysis treatments have changed a lot, and we don't know if replacing these lost nutrients still has a big impact on a person's health and survival. This study, called PROSED, aims to find out if giving people on dialysis a higher protein diet or protein supplements can help reduce hospital stays and improve how well they do overall.

At a glance

Status

Not yet recruiting

Phase

Sponsor

University of Nottingham

Enrolment target

114

Start

05 Jan 2026

Estimated completion

30 Oct 2029

Dialysis Patients Dialysis Protein Energy Wasting Protein Intake High Protein Dietary Intake Diet Diet Therapy Hospitalisation Muscle Mass and Strength Muscle Mass

What is this study about?

When your kidneys aren't working properly and you need dialysis, your body cleans your blood using a special machine or fluid. While this process is life-saving, it can also lead to the loss of important nutrients, such as protein, certain vitamins, and minerals. Protein, in particular, is essential for building and repairing tissues, supporting your immune system, and keeping you strong. For example, during one dialysis session, you might lose the amount of protein found in a whole egg.

Currently, it's recommended that people on dialysis eat more protein than the general population to make up for these losses. However, this advice is based on older research. Dialysis treatments have advanced significantly over the years, and we need to understand if these nutritional losses are still as significant and if replacing them makes a real difference to your health. This study wants to investigate if increasing protein intake, either through diet or supplements, can lead to better outcomes for people on dialysis.

This study will help us understand if a higher protein intake can reduce the number of times people on dialysis need to be admitted to the hospital and generally improve their health. We're also looking at different types of dialysis, including those done at home, where there's very little research on this topic. The results of this study could help update nutritional guidelines and improve care for all people undergoing dialysis.

Key takeaways

Dialysis can cause loss of important nutrients like protein.
This study investigates if a higher protein intake improves health for people on dialysis.
It aims to reduce hospital stays and improve general well-being.
The research will look at different types of dialysis, including home-based treatments.
Current protein guidelines for dialysis patients are old; this study seeks up-to-date information.
Participation involves diet changes or supplements, with regular monitoring.

Who may be eligible?

To join this study, you need to be at least 18 years old and have been receiving regular dialysis for at least three months. You also need to be able to understand the study and agree to take part.

There are some reasons why you might not be able to join. For example, if you are planning to have a kidney transplant soon, are likely to switch your type of dialysis during the study, or if you have severe malnutrition. We also can't include you if you have certain medical conditions like active infections, cancer requiring treatment, or severe wounds or burns that cause a lot of protein loss. Pregnant or breastfeeding individuals, or those planning pregnancy, cannot participate.

Additionally, if you have difficulty swallowing, are already on special feeding methods like intravenous feeding, or are taking certain medications such as levodopa or high doses of steroids, you wouldn't be able to join. People who already eat a very high protein diet (more than 1.5g of protein per kg of body weight), or those with strict dietary restrictions (like vegans), who couldn't take the supplements, also wouldn't be eligible. Finally, if the study team believes you wouldn't be able to follow the study plan, you wouldn't be able to participate.

Quick self-check

Are you 18 years or older?
Have you been on regular dialysis for at least three months?
Are you able to understand and agree to take part in the study?
Are you not currently pregnant or breastfeeding, or planning pregnancy soon?
Do you not have any active severe infections, certain cancers, or severe wounds?
Are you not on specific medications like levodopa or high-dose steroids, or on special IV feeding?

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

What does participation involve?

If you join the study, you would be asked to follow either a high protein diet or take modular protein supplements. The study aims to see how different protein levels affect your health outcomes. This could involve regular check-ups, potentially some blood tests, and keeping track of your diet. The exact number of visits and tests would be clearly explained to you before you agree to take part. The total duration of your participation would depend on the study design, but the specifics would be outlined in detail. All aspects of your involvement, including any diet changes or supplements, would be carefully monitored by the study team.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as a better understanding of how diet can support your health while on dialysis, which could lead to improved outcomes like fewer hospital admissions. However, there may also be potential risks, such as temporary dietary changes or needing to take supplements, which will be fully explained to you. You are free to withdraw from the study at any time, for any reason, without your medical care being affected.

Locations (1)

Centre for Kidney Research and Innovation (CKRI), Academic Unit for Translational Medical Sciences School of Medicine (Royal Derby Hospital Campus)
Nottingham, United Kingdom

Common questions

What is protein-energy wasting (PEW)?

PEW is a type of malnutrition that can happen to people on dialysis, meaning their bodies aren't getting enough energy and protein, which can affect their overall health.

Why is protein important for people on dialysis?

Protein is vital for building muscles, healing tissues, and keeping your immune system strong. During dialysis, some protein is lost, so getting enough is very important.

What kind of protein supplementation will be used?

The study will use either a high protein diet or special protein supplements that can be added to your food or drinks.

Will my regular dialysis treatment change if I join?

No, your regular dialysis treatment will continue as normal. This study focuses on how diet and protein intake affect your health alongside your dialysis.

What happens if I want to stop participating?

You are free to leave the study at any time, for any reason, and it will not affect the medical care you receive.

How to find out more

Bruno Mafrici, MSc, BSc

bruno.mafrici2@nottingham.ac.uk 0044 +115 9691169 Official trial record

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