What is the Purpose of the Study?
The purpose of this study is to test a support package (the 'OptiCALS' intervention) designed to increase energy available to people living with amyotrophic lateral sclerosis (ALS), also known as motor neuron disease (MND).
People with ALS often face challenges in maintaining their weight due to increased energy demands and difficulties with adequate food intake. Evidence from some small studies suggests that increasing the available energy for nerve cells may make them more resistant to the degenerative process in ALS. This may lead to a slowing down of ALS progression, improving physical function and quality of life for people living with ALS.
To work out whether this is true, we are conducting a large-scale randomised controlled trial, where two thirds of participants will get the OptiCALS intervention and one third continue with treatment as usual.
What Does Taking Part Involve?
People in the intervention group will meet regularly with a specially trained health care professional who will provide help, support and guidance on how best to achieve a high energy diet. This will include setting calorie targets, tailored advice including the potential use of high energy supplement drinks, and monitoring of your progress. People in the control group will continue to receive normal care from their local MND team, which will include standard dietary advice and management.
Participating in the OptiCALS trial involves several visits spread out over a 12 month period. These will take place in clinic and/or via phone appointments. Once you agree to take part in the study, you'll receive a package containing equipment to help you measure various aspects for our research. Your initial meeting will focus on gathering baseline information, led by one of our researchers. They'll also guide you on how to log and input your food diaries into the OptiCALS system.
Follow-up visits will depend on your group assignment, but our research team will regularly measure your progress and review your food diary entries. Additionally, you may have additional appointments with a healthcare professional from your local team.
If you have any questions, please don't hesitate to reach out to us. Our information can be found on the Contact Us page.
Who Can Take Part?
We've created a dedicated page where individuals with ALS and their caregivers can find out more about participating in OptiCALS. You can explore it here.
OptiCALS Participating Centres
OptiCALS Participating Centres
Centres marked in blue are currently recruiting participants for OptiCALS.
We hope to enrol up to 259 individuals with ALS by September 2025 in specialist clinical centres across the United Kingdom and Ireland.
We are currently recruiting at 17 sites. You can see the full list of these sites here.
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