A randomised study of nutritional management in patients with amyotrophic lateral sclerosis
| ISRCTN | ISRCTN30588041 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30588041 |
| IRAS number | 275949 |
| Secondary identifying numbers | CPMS 46436, IRAS 275949 |
- Submission date
- 07/12/2020
- Registration date
- 11/12/2020
- Last edited
- 19/02/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nervous System Diseases
Plain English Summary
Background and study aims
Amyotrophic lateral sclerosis, or ALS, is a progressive nervous system disease that affects nerve cells in the brain and spinal cord, causing loss of muscle control. ALS is often called Lou Gehrig's disease, after the baseball player who was diagnosed with it.
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 small studies suggests better nutrition helps people with ALS live for longer. In light of this, we have designed a web portal called OptiCALS that people with ALS can use. The OptiCALS intervention has been designed to help people with ALS receive the best diet at the most appropriate time, in the most effective manner. The intervention package includes a range of materials including videos, 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. We will test if using OptiCALS helps people with ALS live for longer than those who do not use OptiCALS.
The purpose of this study is to test a support package (the ‘OptiCALS’ intervention) designed to improve nutritional management for people living with amyotrophic lateral sclerosis (ALS), also known as motor neurone disease.
Who can participate?
Patients diagnosed with Amyotrophic Lateral Sclerosis/Motor neuron disease, within 2.5 years onset of first muscle weakness. Their carers can also participate in qualitative interviews.
What does the study involve?
Participants will be randomly assigned to the control group or the intervention group. The control group will continue to receive their usual care, and be restricted to only completing food diaries on the OptiCALS web portal. They will have subsequent study visits during months 1, 3, 6, 9 and 12 to review their food diaries. During these visits, the participant will have measurements and tests taken.
The intervention group will be shown OptiCALS during their first study visit. Participants will use OptiCALS for 12 months. They will be asked to complete three food diaries before each study visit during months 1, 3, 6, 9 and 12. These visits will be planned around clinic visits or will be planned separately. At each visit, the participant will have measurements and tests taken.
We will also interview 20 participants and their carers to discuss their thoughts on using OptiCALS. Each interview will last an hour and take place in the participant's home or care setting. These interviews will take place 1-3 months after joining the study and then again at 6-12 months.
What are the possible benefits and risks of participating?
None
Where is the study run from?
1. Sponsor - Sheffield Teaching Hospitals NHS Foundation Trust (UK)
2. The University of Sheffield Clinical Trial Research Unit (day-to-day delegated management)
When is the study starting and how long is it expected to run for?
April 2020 to April 2027
Who is funding the study?
National Institute for Health (NIHR) Programme Grant for Applied Research (PGfAR) (UK)
Who is the main contact?
Elaine Scott, Gemma Hackney, OptiCALS@sheffield.ac.uk
Contact information
Public
Sheffield Clinical Trials Research Unit, ScHARR
The University of Sheffield
Innovation Centre
c/o Regent Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom
| Phone | +44 (0)114 2225158 |
|---|---|
| OptiCALS@sheffield.ac.uk |
Public
Sheffield Clinical Trials Research Unit, ScHARR
The University of Sheffield
Innovation Centre
c/o Regent Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom
| Phone | +44 (0)114 2225158 |
|---|---|
| OptiCALS@sheffield.ac.uk |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual |
| Study type | Treatment |
| Participant information sheet | ISRCTN30588041_PIS_v3.0_15Oct2020.pdf |
| Scientific title | OptiCALS: a randomised controlled trial with parallel process evaluation and health economic analysis to evaluate a nutritional management intervention, OptiCALS, for patients with amyotrophic lateral sclerosis |
| Study acronym | OptiCALS |
| Study hypothesis | A high-calorie diet that meets the estimated calorie requirement, factoring in ALS hypermetabolism and physical status, will improve functional outcomes, quality of life and survival in people with ALS |
| Ethics approval(s) | Approved 08/09/2020, North West - Greater Manchester East Research Ethics Committee (Health Research Authority, Ground Floor, Skipton House, 80 London Road, London, SE1 6LH, UK; +44 (0)20 797 22545; HRA.Queries@nhs.net), ref: 20/NW/0334 |
| Condition | Nutritional management in motor neuron disease |
| Intervention | Participants will be randomly assigned to the control group or the intervention group. The control group will continue to receive their usual care, and be restricted to only completing food diaries on the OptiCALS web portal. They will have subsequent study visits during months 1, 3, 6, 9 and 12 to review their food diaries. During these visits, the participant will have measurements and tests taken. The intervention group will be shown OptiCALS during their first study visit. Participants will use OptiCALS for 12 months. They will be asked to complete three food diaries before each study visit during months 1, 3, 6, 9 and 12. These visits will be planned around clinic visits or will be planned separately. At each visit, the participant will have measurements and tests taken. They will also set targets regarding their food intake. If they are not meeting their targets, they will be given oral nutritional supplements, to help them meet their targets. We will also interview 20 participants and their carers to discuss their thoughts on using OptiCALS. Each interview will last an hour and take place in the participant's home or care setting. These interviews will take place 1-3 months after joining the study and then again at 6-12 months. |
| Intervention type | Behavioural |
| Primary outcome measure | Daily functional abilities will be assessed using the The Amyotrophic Lateral Sclerosis Rating Scale (ALSFRSR), a validated rating scale. This will be assessed at baseline, month1, 3, 6, 9 and 12 |
| Secondary outcome measures | 1.CAFS, calculated using survival and ALSFRSR scores, at baseline, month 1, 3, 6, 9 and 12 2. Quality of life via WHOQOL-BREF questionnaire at baseline, month 1, 3, 6, 9 and 12 3. Health status via EQ-5D-3L questionnaire at baseline, month 1, 3, 6, 9 and 12 4. Total calorie intake using food diaries at week 1, month 1, 3, 6, 9 and 12 5. Healthcare resource use questionnaire at baseline, month 3, 6, 9 and 12 6. Adverse events at month 1, 3, 6, 9 and 12 7. Slow vital capacity / FEV6 using spirometer at baseline, month 1, 3, 6, 9 and 12 8. Mid arm circumference at baseline, month 1, 3, 6, 9 and 12 9. Triceps skin fold thickness at baseline, month 1, 3, 6, 9 and 12 10. Calf circumference at baseline, month 1, 3, 6, 9 and 12 11. Weight measured at baseline, month 1, 3, 6, 9 and 12 12. Height measured at baseline, month 1, 3, 6, 9 and 12 13. Acceptability of intervention questionnaire at months 3 and 12 14. Overall survival at months 1, 3, 6, 9, 12 and last patient/last visit 15. Fasting lipids via blood sample at baseline, month 1,3,6,9 and 12 16. Albumin via blood sample at baseline, month 1,3,6,9 and 12 17. Lactate via blood sample at baseline, month 1,3,6,9 and 12 18. Renal function via blood sample at baseline, month 1,3,6,9 and 12 19. Creatinine via blood sample at baseline, month 1,3,6,9 and 12 20. C-reactive protein via blood sample at baseline, month 1,3,6,9 and 12 21. Neurofilament serum via blood sample at baseline, months 6 and 12 22. HbA1c via blood sample at baseline, month 1,3,6,9 and 12 23. Thyroid function via blood sample at baseline |
| Overall study start date | 01/04/2020 |
| Overall study end date | 01/04/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 259; UK Sample Size: 259 |
| Participant inclusion criteria | Current inclusion criteria as of 04/06/2024: 1. Age 18 years or older 2. Diagnosis of clinically definite, lab supported, clinically probable, or possible ALS by the Gold Coast criteria and additionally the PMA variant where appropriate investigation has excluded mimics of motor neuron disease 3. Within 2.5 years of onset of first muscle weakness 4. Stabilised on riluzole for 1 month or not on riluzole Previous inclusion criteria: 1. Age 18 years or older 2. Diagnosis of clinically definite, lab supported, clinically probable, or possible ALS by the El-Escorial criteria and additionally the PMA variant where appropriate investigation has excluded mimics of motor neuron disease 3. Within 2 years of onset of first muscle weakness 4. Stabilised on riluzole for 1 month or not on riluzole |
| Participant exclusion criteria | 1. Co-morbidity that would affect survival or metabolic state (e.g. unstable thyroid disease or unstable diabetes mellitus) 2. BMI >=35kg/m² 3. 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. 4. Previous participation in the HighCALS PGfAR research programme 5. Unable to understand written and spoken English 6. Using a gastrostomy tube for feeding (those using a gastrostomy tube for fluid or medication are not excluded) |
| Recruitment start date | 15/01/2021 |
| Recruitment end date | 30/09/2025 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
Herries Road
Sheffield
S5 7AU
United Kingdom
Denmark Hill
London
SE5 9RS
United Kingdom
Leicester Road
Leicester
LE3 9QE
United Kingdom
Liverpool
L9 7LJ
United Kingdom
Stott lane
Salford
M6 8HD
United Kingdom
Headley Way
Oxford
OX3 9DU
United Kingdom
Derriford Road
Crownhill
Plymouth
PL6 8DH
United Kingdom
Sharoe Green Lane North
Fulwood
Preston
PR2 9HT
United Kingdom
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
Newcastle Road
Stoke-on-Trent
ST4 6QG
United Kingdom
Clepington Road
Dundee
DD3 8EA
United Kingdom
Bradford-on-avon
BA15 2LE
United Kingdom
Cwmrhydyceirw
Swansea
SA6 6NL
United Kingdom
London
NW1 2PG
United Kingdom
180-194 High Street
Teddington
TW11 8HU
United Kingdom
Sponsor information
Hospital/treatment centre
Northern General Hospital
Herries Road
Sheffield
S5 7AU
England
United Kingdom
| Phone | +44 (0)114 215 9426 |
|---|---|
| alessia.dunn@nhs.net | |
| Website | http://www.sth.nhs.uk/ |
"ROR" |
https://ror.org/018hjpz25 |
Funders
Funder type
Government
No information available
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/03/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | Data availability statement Deidentified participant data and statistical code will be made available upon reasonable request. Requests should be made via email to ctru@sheffield.ac.uk, stating the data fields required and the purpose of the request (ideally with a protocol but, at a minimum, with a research plan). The data dictionary and statistical analysis plan can also be made available. Requests will be considered on a case-by-case basis and requestors will be asked to complete a data sharing agreement with the sponsor before data transfer. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version v3.0 | 15/10/2020 | 11/12/2020 | No | Yes |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | version 5.0 | 30/04/2024 | 04/06/2024 | No | Yes |
Additional files
- ISRCTN30588041_PIS_v3.0_15Oct2020.pdf
- uploaded 11/12/2020
- ISRCTN30588041_PIS_V5.0_30Apr24.pdf
Editorial Notes
19/02/2025: The individual participant data (IPD) sharing plan and summary were added.
04/06/2024: The following changes were made to the study record:
1. The inclusion criteria and contact details were updated.
2. The target number of participants was changed from 334 to 259.
3. The recruitment end date was changed from 05/12/2022 to 30/09/2025.
4. The overall study end date was changed from 01/04/2024 to 01/04/2027.
5. The intention to publish date was changed from 31/03/2025 to 31/03/2027.
6. The study participating centres were updated to remove Addenbrookes Hospital, West Suffolk NHS Foundation Trust, St George’s Hospital, St Thomas' Hospital, NHS Ayrshire and Arran, Southampton General Hospital and add Dorothy House Hospice, Morriston Hospital, University College London Hospitals NHS Foundation Trust, Hounslow and Richmond Community Healthcare NHS Trust.
7. Wales was added to the countries of recruitment.
8. Participant information sheet uploaded.
11/12/2020: The participant information sheet was uploaded as an additional file.
07/12/2020: Trial’s existence confirmed by National Institute for Health Research (NIHR)
