OptiCALS

A Randomised Controlled Trial to evaluate a nutritional management intervention, OptiCALS for people living with ALS

This study looks to investigate if getting nutrition right for people living with MND can improve quality of life and survival. OptiCALS is a complex intervention for people with ALS to enable them to track their calorie intake and set personalised calorie goals.

Research shows that there is a lack of knowledge in healthcare professionals around the nutritional management of people living with ALS. There is also evidence to suggest that personalised dietary targets may offer some survival benefit but further research is needed to confirm what benefit, if any, a personalised diet may offer people living with ALS.

Using a food first approach, people living with MND will be encouraged to follow a diet that meets an individualised calorie target from food before prescribing oral nutritional supplements.All participants will receive usual care, but only half will be allocated to the group, who receive the OptiCALS. Those participants in the group allocated to receive the OptiCALS intervention will have a daily calorie target set that is informed by an ALS specific total daily energy expenditure (TDEE) predictive equation, their current calorie intake and the direction in which their weight is moving.

What does taking part involve?

Taking part will involve being randomised to either the OptiCALS intervention with standard of care or to receive standard or care alone.

Participants will be set a calorie target and will be encouraged to follow a diet that meets their personalised calorie goals. Participants will record their dietary intake using the myfood24 dietary assessment tool embedded within the OptiCALS online portal. Participants will be encouraged to use the OptiCALS website which will provide advice on how to meet their individual calorie goal and how to manage common barriers to eating and drinking faced by people living with ALS.

Both groups will log their calorie intake in OptiCALS and complete study questionnaires during the 12-month follow-up period. Within this period, participants will have remote visits from the central OptiCALS team, where physical measurements will be taken. This will include height, weight, arms and leg measurements and spirometry measurements. Additionally, during these visits, participants will be asked to complete questionnaires and these visits will occur seven times over the 12 month period.

Study location

Currently recruiting at:

  • Bradford-upon-Avon
  • Middlesbrough
  • Dundee
  • Oxford
  • London
  • Plymouth
  • Liverpool
  • Salford
  • Leicester
  • Sheffield

 

Recruitment is expected to open in additional sites through the UK soon.

Funding

National Institute for Health and Care Research (NIHR)

Who can take part?

• People living with ALS and their carers

How can I take part?

For further information, please contact Shamila Ditta - shamila.ditta@nhs.net

Inclusion and Exclusion Criteria

People living with ALS 

Inclusion criteria:

  1. Aged 18+ 
  2. Diagnosis of definite, probable or possible ALS by the EIEscorial criteria and the PMA variant where mimics of MND have been excluded 
  3. Within 2 years of onset of first muscle weakness
  4. Stabilised on riluzole for one month or not on riluzole

Exclusion criteria:

  1. Comorbidity that would affect survival or metabolic state (e.g. unstable thyroid disease or unstable
    diabetes mellitus).
  2. Using a gastrostomy tube for feeding (those using a gastrostomy tube for fluid or medication are not excluded).
  3. BMI ≥ 35kg/m2.
  4. Cannot provide informed consent
  5. Previous participation in the HighCALS research project
  6. Unable to understand written and spoken English

Carers

Inclusion criteria:

  1. Aged 18+ 
  2. Primary informal caregiver of a person with ALS who has consented to participate in the trial (either living with the person with ALS or a close family member/friend)

Exclusion criteria:

  1. Cannot provide informed consent
  2. Previous participation in the HighCALS research project
  3. Unable to understand written and spoken English

For further information and support contact our MND Connect helpline

mndconnect 0808 802 6262