RecruitingInterventional

A pilot study investigating the benefits of a new form of nutritional supplement called “immuno-nutrition” on muscle mass and strength in people on haemodialysis

Many people receiving haemodialysis for kidney failure lose muscle mass and strength over time. This often happens because kidney disease causes swelling and irritation inside the body, known as inflammation. Inflammation prevents standard nutritional supplements from turning protein into strong muscle. This study tests a new supplement called 'immuno-nutrition'. It provides extra protein and energy like regular supplements, but also includes special nutrients designed to lower inflammation. Researchers want to know whether taking this drink daily helps patients stay stronger. Participants at Derby and Lichfield dialysis units will take either the new drink or a standard supplement daily for 24 weeks. Researchers will check grip strength, balance, and general well-being during normal dialysis appointments. Because this is a pilot study, the main goal is to test the study procedures to prepare for a larger future trial.

At a glance

Status

Recruiting

Sponsor

University Hospitals of Derby and Burton NHS Foundation Trust

Enrolment target

Start

28 Sep 2026

Estimated completion

31 Jan 2027

Renal failure

What is this study about?

Living with kidney failure and having regular haemodialysis can place heavy demands on the body. Many patients find that their muscles become smaller and weaker over time. This loss of strength can make everyday activities, like walking to the shops or standing up from a chair, feel much harder. It can also have a major impact on overall health and quality of life.

A key cause of this muscle weakness is long-term inflammation, which happens when the immune system stays active for long periods. In people on dialysis, this inflammation stops the body from using protein properly to rebuild muscle. Because of this barrier, ordinary food supplements provided by hospitals often do not restore muscle strength as well as hoped.

To address this, scientists have developed a supplement called 'immuno-nutrition'. Along with protein and calories, it contains specific ingredients that help calm down inflammation. It has already shown encouraging results in cancer patients and in a very small trial of kidney patients. Researchers now want to see if it can help a wider group of dialysis patients build and keep their strength.

This trial is a feasibility study taking place at renal units in Derby and Lichfield. Its main purpose is to test the practical details—such as whether patients find the drinks easy to take each day and whether the health checks run smoothly. The findings will help doctors design a larger, definitive study in the future.

Key takeaways

Tests a new anti-inflammatory drink designed to help haemodialysis patients maintain muscle strength.
Compares the new drink against a standard nutritional supplement over 24 weeks.
All assessments occur during your scheduled dialysis sessions, avoiding extra clinic visits.
Being carried out at renal units in Derby and Lichfield and funded by the NIHR.
Taking part is voluntary, and you can withdraw at any time without affecting your NHS care.

Who may be eligible?

This study is open to adults aged 18 and over who have kidney failure and receive haemodialysis at least three times a week, with each session lasting three hours or longer. To take part, your blood tests must show that your potassium levels are in a safe, normal range.

You cannot take part if you take medications that dampen your immune system (immunosuppressants) or if your body mass index (BMI) is over 35. It is also not suitable for people who are pregnant, breastfeeding, currently staying as an inpatient in hospital, or who have known allergies to ingredients in nutritional drinks.

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.

I am aged 18 or older.
I receive haemodialysis at least 3 times a week for 3 hours or more each time.
My recent blood potassium levels are within the normal range.
I do not take medicines that suppress my immune system.
My body mass index (BMI) is 35 or lower.
I am not pregnant, breastfeeding, or currently admitted to hospital.

Answer every question to see your result.

What does participation involve?

Taking part lasts for 24 weeks (about six months). You will be randomly placed into one of two groups by chance, like drawing names from a hat. One group will take the new immuno-nutrition drink once a day, and the other group will take a standard nutritional drink once a day. You will also continue to receive your usual dietary guidance from NHS renal dietitians.

All study assessments will be carried out while you are already at the clinic for your regular dialysis appointments, so you will not need to make extra trips. At the start of the study, and again at weeks 12, 18, and 24, the team will test your handgrip strength, measure your muscle and body fat using a specialist scale, check your walking and balance, ask you to complete a brief food diary and quality-of-life survey, and review your routine blood tests.

Potential risks and benefits

The nutritional drinks used in this study are safe, and taking them is not expected to cause any serious health risks. If you do notice any unexpected stomach upset or other symptoms, the research team will monitor you closely until you feel better. While you may not experience direct health improvements from taking part, your muscle strength and nutrition will be monitored very carefully throughout the study. The information gained will help improve future nutritional care for people with kidney disease. Taking part is completely up to you, and you are free to stop at any time without your standard NHS care being affected.

Locations (1)

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

University Hospitals of Derby and Burton NHS Foundation Trust
City only
Derby, England

Common questions

Will I need to travel to extra hospital appointments?

No. All checks, measurements, and tests are planned to take place during your routine haemodialysis visits.

What is a 'feasibility' study?

It is a smaller practice study designed to check if the daily routine, drinks, and tests work well for patients before investing in a large-scale clinical trial.

Can I pick which nutritional drink I receive?

No. A computer system chooses your group at random to make sure the comparison between the two drinks is completely fair.

Will this replace my usual kidney diet advice?

No. You will continue to follow your normal dietary advice from your NHS renal dietitian alongside having the daily drink.

What happens if I decide I want to stop?

You can leave the study whenever you wish. Leaving will not change your relationship with your healthcare team or alter your regular dialysis treatment.

How to find out more

Kirsty Brown

kirsty.brown69@nhs.net +44 (0) 1332 724639 Official trial record

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