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

The purpose of the OptiCALS 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 neurone disease.  

Little is currently known regarding how food intake affects ALS and there is a lack of guidance for people with the disease and healthcare professionals on weight and nutrition. 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 disease progression, improving physical function and quality of life for people living with ALS.

To work out whether this is true, we need to conduct a randomised controlled trial, where participants will either get the OptiCALS intervention or continue with treatment as usual. 

The intervention has been designed by a team of 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.

Taking Part

What does taking part involve?

Once consented and baseline measures have been collected, participants will be randomly allocated to one of two groups. Two thirds of participants will receive the OptiCALS intervention (the intervention group) and one third will continue to receive usual care (the control group). Visits will be arranged at a convenient time and may take place at the hospital clinic, at home, or remotely, such as via video call. Participants will also meet with University of Sheffield clinical trials unit staff online via videocall.

A study visit will be arranged around 1 week after participants are randomised. Participants in both groups will be shown how to record food diaries and log their food intake on the OptiCALS website. Intervention participants are given access to additional areas of the OptiCALS website, which contain resources related to eating and drinking. In the week before each study visit, the participant will complete three food diaries and enter them onto the OptiCALS system. At the online study visit, the food diaries will be checked, a questionnaire will be completed with the participant and some measurements will be taken. These visits will last approximately 60 minutes.

The number and frequency of study visits will depend on which group the participant is assigned to. 

Some of the measures collected at some study visits includes:

  • Height 
  • Weight 
  • A set of questionnaires
  • Lung function 
  • Blood test

Participation would last 12 months in total, but participants can withdraw consent to participate at any time throughout the study.
 

Who can take part?
  • People living with MND (within 2.5 years from symptom onset)
  • People over the age of 18
  • Participants must be able to provide consent to take part and be able to understand written and spoken English

 

How can I take part?

For more information or to register interest in taking part, please contact the OptiCALS team by emailing [email protected] or calling 0114 2225158.

Study locations

UK-wide

Funding

This study is funded by the National Institute for Health and Care Research (NIHR)