OptiCALS RCT

OptiCALS RCT

UK Chief Investigator

Professor Christopher McDermott

Research summary

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.

Current status

Active – recruiting

Recruitment groups

Participant groups:

1. Patients with MND

2. Family members of patients with MND (including pre-symptomatic gene carriers)

3. Healthcare professionals

Recruitment targets

• 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) 

Locations

• Dublin, Principal Investigator: Orla Hardiman Site in set-up, opening soon

• 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

• 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 in set-up, opening soon 

• Middlesbrough, Principal Investigator: Anthony Hanratty. 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. To be confirmed if site is open for recruitment locally or out-of-area

• Wiltshire - Dorothy House Hospice, Principal Investigator: Edward Presswood. To be confirmed if site is open for recruitment locally or out-of-area

Information about study sites

Key dates

Recruitment open date: 10 August 2021

Planned recruitment end date: 30 September 2025

Inclusion / exclusion criteria

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).

Funder

National Institute for Health Research (NIHR)

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Phase

3