You can find out more about the OptiCALS Trial, including a short video providing a study overview, on the study website: https://www.opticalstrial.co.uk
Professor Christopher McDermott
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.
Little is currently known regarding how food intake affects ALS and there is a lack of guidance for patients and healthcare professionals on weight and nutrition in ALS. 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. However, to work out whether this is true, we need to conduct a large randomised controlled trial, where participants will get the OptiCALS intervention and/or continue with treatment as usual.
The OptiCALS intervention has been designed by a team of MND specialists to help people with ALS receive a tailored, high-energy diet at the most appropriate time, in the most effective manner. The OptiCALS nutritional intervention package is available via an online portal which includes videos, dietary information, advice, and interactive tools designed to assist people with ALS to optimise their nutrition. This will be provided alongside support from a healthcare professional.
Active – recruiting
Participant groups:
Patients with MND
Family members of patients with MND (including pre-symptomatic gene carriers)
Healthcare professionals
259 patients with MND
30 healthcare professionals
(No specific recruitment target for family members)
Click here to see how many participants have been recruited into this study to date (external link to the NIHR public study search)
Bath - Dorothy House Hospice, Principal Investigator: Edward Presswood. To be confirmed if site is open for recruitment locally or out-of-area
Bournemouth, Principal Investigator: Annemieke Fox. To be confirmed if site is open for recruitment locally or out-of-area
Dublin, Principal Investigator: Orla Hardiman To be confirmed if site is open for recruitment locally or out-of-area
Dundee, Principal Investigator: Ian Morrison. Site now closed to recruitment
Hounslow and Richmond Community NHS Trust, Principal Investigator: Andrea Foreroozer. To be confirmed if site is open for recruitment locally or out-of-area
Hywel Dda University Health Board, Principal Investigator: Joe Annandale. To be confirmed if site is open for recruitment locally or out-of-area
Leicestershire - LOROS hospice, Principal Investigator: Christina Faull. To be confirmed if site is open for recruitment locally or out-of-area
Liverpool, Principal Investigator: Carolyn Young. Recruitment currently paused - hoping to re-open
London - King's College Hospital, Principal Investigator: Ammar Al-Chalabi. Site open for recruitment out-of-area
London - University College London, Principal Investigator: Andrea Malaspina. Site open for local recruitment only
London - St George's, Principal Investigator: Clare Galtrey. Site open for recruitment out-of-area
Middlesbrough, Principal Investigator: Anthony Hanratty. To be confirmed if site is open for recruitment locally or out-of-area
Norwich, Principal Investigator: Caroline Barry. Site open for recruitment out-of-area
Nottingham, Principal Investigator: TBC. To be confirmed if site is open for recruitment locally or out-of-area
Oxford, Principal Investigator: Martin Turner. Site open for local recruitment only
Plymouth, Principal Investigator: Oliver Hanemann. Site open for recruitment out-of-area
Preston, Principal Investigator: Suresh Chettri. To be confirmed if site is open for recruitment locally or out-of-area
Salford, Principal Investigator: Christina Federico. Site open for local recruitment only
Sheffield, Principal Investigator: Chris McDermott. Site open for local recruitment only
Stoke, Principal Investigator: Tom Lambert. Site open for recruitment out-of-area
Swansea, Principal Investigator: Idris Baker. Site open for local recruitment (South Wales network) only
Recruitment open date: 10 August 2021
Planned recruitment end date: 30 September 2025
Inclusion criteria
Age 18 years or older.
Diagnosis of ALS by the Gold Coast criteria
Within 2.5 years of onset of first muscle weakness.
Stabilised on riluzole for one month or not on riluzole.
Exclusion criteria
Co-morbidity that would affect survival or metabolic state (eg unstable thyroid disease or unstable diabetes mellitus) – BMI > = 35kg/m2.
Lacking capacity to provide fully informed written consent, verbal consent (for those who cannot provide written consent), or consent via the use of a communication aid.
Previous participation in the HighCALS PGfAR research programme.
Unable to understand written and spoken English.
Using a gastrostomy tube for feeding (those using a gastrostomy tube for fluid or medication are not excluded).
National Institute for Health Research (NIHR)
Sheffield Teaching Hospitals NHS Foundation Trust
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