RecruitingInterventional

Implementation of a formula low-energy diet programme for weight loss in a renal transplant service

This study aims to find out if a special low-energy diet helps people with kidney failure on dialysis lose weight. Many people with obesity struggle to get on the waiting list for a kidney transplant, even though guidelines say obesity alone shouldn't stop them. This research hopes to provide clearer guidance on weight management for these patients. Participants will either follow a special diet of shakes and soups or receive standard care. Researchers will monitor their health closely over 12 months. The study is important because it could help more people become suitable for a life-changing kidney transplant.

At a glance

Status

Recruiting

Sponsor

University College London

Enrolment target

Start

13 Apr 2026

Estimated completion

01 May 2027

Specialty: Renal, Primary sub-specialty: Renal Disorders; Health Category: Renal and Urogenital; Disease/Condition: Obesity and other hyperalimentation, Renal failure

What is this study about?

Access to kidney transplants can be difficult for people living with obesity, even though health guidelines suggest obesity shouldn't be the only reason to stop someone from being considered. At the moment, there isn't much scientific evidence to help doctors and patients decide on the best ways to manage weight for those with kidney failure who are on haemodialysis and hoping for a transplant.

This study aims to change that. It will test if a special low-energy diet, made up of formula-based meal replacements, can help these patients lose weight. The main goal is to see if this diet can help them become eligible for a kidney transplant, which is a life-changing procedure.

If successful, this research could provide important information to healthcare teams. This would allow them to better support people with kidney failure and obesity, helping more individuals get on the transplant waiting list. The study is carefully designed to make sure it's safe and effective for participants.

Key takeaways

The study explores a low-energy diet for kidney patients on dialysis.
Aims to help patients with obesity become eligible for kidney transplant.
Participants will be randomly assigned to a special diet or usual care.
Involves regular health checks and support over 12 months.
Funded by a UK government research body (NIHR).
Compensation (£25 voucher) for time spent at each study visit.

Who may be eligible?

This study is looking for adults aged between 18 and 70 who have kidney failure and are receiving haemodialysis. A key requirement is that your obesity is the main reason preventing you from being considered for a kidney transplant, and you're aiming to lose a specific amount of weight.

You should have a Body Mass Index (BMI) generally between 32.5 and 45 kg/m2, or slightly lower if you are from certain ethnic minority groups. It's also important that your weight has been stable for the past three months. You should be able to physically follow the study plan, have internet access, and be able to read and write in English. A doctor will also need to confirm that the low-energy diet is safe for you.

However, you cannot take part if you are on peritoneal dialysis, have certain mental health conditions (like uncontrolled depression or active eating disorders), have had weight-loss surgery in the past, or if you are pregnant or breastfeeding. You also can't join if you have recently started new weight-loss medicines or have severe allergies that would make it hard to follow the diet.

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 between 18 and 70 years old?
Do you have kidney failure and receive haemodialysis?
Is obesity the main reason you can't get on the kidney transplant list?
Has your weight been stable for the last three months?
Can you access the internet and read/write in English?
Your doctor thinks a low-energy diet would be safe for you.

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll have a few visits with the research team. The first will be a 1-hour 'screening' visit to check if the study is right for you, often during your dialysis session. If you qualify, you'll have a longer 'baseline' visit (up to 3 hours) where initial measurements like weight, body fat, and blood pressure will be taken, along with some questionnaires and blood tests.

After the baseline visit, you'll be randomly assigned to one of two groups, like flipping a coin. You'll have an equal chance of being in either group. One group will follow a special low-energy diet (about 850 calories a day) using provided shakes, soups, and porridges. This group will also have extra online check-ups (8 sessions, 30 minutes each), regular calls/meetings with the research team, access to a health coach, group sessions for wellbeing, and a support group.

The other group will receive 'usual care,' meaning they continue with their regular hospital appointments and care from their kidney team. Both groups will have five main assessment visits (up to 3 hours each) at the start, then at 3, 6, 9, and 12 months. The study will run until April 2028, and you can withdraw at any time.

Potential risks and benefits

There are no guaranteed personal benefits from joining this study. While you might lose weight and become suitable for a transplant sooner, this isn't certain. However, you will be paid £25 for each study visit you complete to thank you for your time. Your participation will also help design better ways to support other patients with obesity who need a kidney transplant, which could make a real difference to many lives. You might also gain a better understanding of your own health. As for risks, there's a chance you might not lose weight and might not get listed for a transplant, even if you follow the diet. For those on the low-energy diet, there can be side effects, usually mild and temporary, and the research team will closely monitor you for these. They will ask about any side effects at your hospital visits and may arrange further tests if needed. You are always free to leave the study at any point, without giving a reason.

Locations (3)

Royal Free Hospital
Approximate
London, England
The Royal London Hospital
Approximate
London, England
King's College Hospital NHS Foundation Trust
City only
London, England

Common questions

What is the main goal of this study?

The main goal is to see if a special low-energy diet can help people with kidney failure on dialysis lose weight and become eligible for a kidney transplant.

Who is funding this research?

The study is funded by the National Institute for Health Research (NIHR) in the UK.

What does 'randomisation' mean?

It means you'll be put into one of two study groups by chance, like flipping a coin, giving you an equal opportunity to be in either group.

Will I have to pay for the diet products?

No, if you are in the low-energy diet group, the meal replacement products will be given to you at no cost.

How long will I be involved in the study?

If you take part, you'll be involved for about 12 months, with several visits over this period.

How to find out more

Adrian Brown

a.c.brown@ucl.ac.uk - Official trial record

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