RecruitingInterventional

REFRESH study: nutRition intervEntions For malnouRished oldEr adultS in care Homes - A parallel, superiority, three-arm cluster randomised controlled trial

The REFRESH study aims to help older people in care homes who are not getting enough nutrients, a condition called malnutrition. Malnutrition can lead to poor health and more infections. This study compares three approaches: special protein and vitamin-rich food, nutritional drink supplements, or the care homes' usual methods. Around 1,530 residents from 90 care homes will take part for 12 months. The goal is to find out which method best improves nutrition and overall well-being, helping to provide better care for older adults in the future. The study hopes to make a real difference in their health and quality of life.

At a glance

Status

Recruiting

Sponsor

University of Plymouth

Enrolment target

1,530

Start

01 Nov 2025

Estimated completion

31 May 2027

Malnutrition

What is this study about?

Many older people living in care homes struggle with malnutrition, which simply means they're not getting all the important nutrients their bodies need. This can make them feel unwell, lead to more falls, and make them more likely to catch infections. The REFRESH study wants to find the best way to help these residents.

This study will compare three different approaches to nutrition. Some residents will receive special foods with added nutrients, others will get nutritional drink supplements, and a third group will continue with the care home's usual way of helping residents with malnutrition. Researchers will look at how these different approaches affect residents' health and their overall quality of life.

About 1,530 older residents from 90 care homes across the UK will join the study. By comparing these different methods over 12 months, the study hopes to discover which one is most effective. The results will help care homes and doctors make better decisions about how to support older people's nutrition in the future, ultimately improving their health and well-being.

Key takeaways

The study aims to help older people in care homes with malnutrition.
It compares special food, nutritional drinks, and usual care.
About 1,530 residents from 90 care homes will take part for 12 months.
Participation helps improve future care for older adults.
There's a small risk of side effects like bloating or changes in blood sugar.
You can stop participating at any time.

Who may be eligible?

This study is looking for older adults who live permanently in a care home and are aged 65 or over. You should be able to eat and drink by mouth, rather than needing a feeding tube.

To join, you must also be considered to be malnourished or at risk of not getting enough nutrients. This is usually checked by care home staff. However, you can't join if you're already receiving special nutritional drinks or fortified foods because a doctor or dietitian has recommended them.

You also can't take part if you are currently having cancer treatment, have recently had major surgery, or if care home staff feel that you are nearing the end of your life and joining the study wouldn't be appropriate for your comfort and care.

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 65 years old or older?
Do you live permanently in a care home?
Are you able to eat and drink normally (not through a tube)?
Have care home staff said you are malnourished or at risk of it?
Are you not currently receiving nutritional support (like special drinks or fortified meals) because a doctor has told you to?
Are you not currently having cancer treatment or recently had major surgery, or considered to be at the end of life?

Answer every question to see your result.

What does participation involve?

If you or your loved one agrees to take part, some initial information will be collected about your health and usual diet. Each participating care home will then be randomly assigned to one of three groups, meaning you won't get to choose which group you join. For 12 months, residents in that care home will receive one of the following:

* **Nutritional drinks:** You'll have two special drinks each day in between your meals, alongside your normal food. * **Fortified food:** Your meals, snacks, and drinks will be made with extra protein, calories, vitamins, and minerals, in addition to your usual diet. * **Usual care:** The care home will continue providing nutrition support in the way they normally would for residents who are malnourished.

The researchers will then collect more information about your health and well-being after 6 months and again after 12 months to see how you are doing.

Potential risks and benefits

It's important to know that we can't promise that you or your loved one will directly benefit from taking part in this study. We won't know the full results until the study is finished. However, by participating, you will be helping researchers learn more about how to best support older people with malnutrition in care homes, which could improve care for many others in the future. There's a small chance that the nutritional drinks or fortified foods could cause side effects like constipation, bloating, feeling sick, or for those with diabetes, changes in blood sugar levels. If any of these problems occur, the care home staff would stop the food or drink that is thought to be causing the issue. Remember, you have the right to withdraw from the study at any time without giving a reason, and your usual care will not be affected.

Locations (39)

Hill House Nursing Home
Approximate
Brixham, England
Chestnut Lodge
City only
Yeovil, England
Primley Court Nursing Home
City only
Paignton, England
Camelot House and Lodge
City only
Wellington, England
Sheridan House
City only
Exmouth, England
Mulberry House
Unverified
Newton Abbot, England
Mount Olivet Nursing Home
Unverified
Paignton, England
West Eaton House
Unverified
Leominster, England
Summerdyne Nursing Home
Unverified
Bewdley, England
The Cottage Christian Nursing Home
Unverified
Newport, England
The Lawns Nursing Home
Unverified
Worcester, England
Atholl House Nursing Home
Unverified
Wolverhampton, England

Common questions

What does 'malnutrition' mean?

Malnutrition means your body isn't getting enough important nutrients, which can make you feel weak or unwell.

Who is funding this study?

The study is funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) Programme in the UK.

How long will I be involved in the study?

If you take part, you will be involved for 12 months, during which your nutritional support will be given and your progress checked.

Can I choose which treatment group I'm in?

No, the care homes are randomly assigned to a group, so you wouldn't be able to choose whether you receive fortified food, nutritional drinks, or usual care.

What if I have diabetes?

Participants with diabetes will have their blood sugar levels closely monitored, as there's a chance the special foods or drinks could affect them.

How to find out more

. Refresh PenCTU

refresh.penctu@plymouth.ac.uk - Official trial record

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