Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000296538
Ethics application status
Approved
Date submitted
21/02/2024
Date registered
21/03/2024
Date last updated
21/03/2024
Date data sharing statement initially provided
21/03/2024
Date results information initially provided
21/03/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Exploring associations between multiple sclerosis (MS) progress and diet.
Scientific title
Using objective clinical measures to explore the associations between disability progression and diet in adults with multiple sclerosis (MS): A prospective pilot study.
Secondary ID [1] 311561 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple sclerosis, MS 332927 0
Condition category
Condition code
Neurological 329640 329640 0 0
Multiple sclerosis
Diet and Nutrition 329641 329641 0 0
Other diet and nutrition disorders
Alternative and Complementary Medicine 329642 329642 0 0
Other alternative and complementary medicine
Neurological 329643 329643 0 0
Multiple sclerosis

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This project will develop pilot data for n=15 people who have been diagnosed by a neurologist with MS using the McDonald criteria. People diagnosed with relapsing remitting MS will be recruited as part of their routine scan (6 monthly) which forms part of usual care for MS. All eligible people living with MS will be included regardless of time since diagnosis. Exclusion criteria, however, will be limited to an ability to speak and communicate in the English language. All eligible participants will complete one MRI scan using a research protocol designed specifically for this study. However, the team are not 'intervening' in any way and the research protocol is purely observational. Prior to attending the scan participants will be sent an online link to a dietary assessment tool to access the ASA-24 AU. The tool uses a recall of the previous 24 hour period of food and beverage intake using validated methodology, taking ~25 minutes to complete. A repeated 24-hour recall will occur within the same week as the MRI to allow for usual intake regression models to be created using the Multiple Source method. Participants will also complete a 5-10 minute interview-administered questionnaire to collect other details of lifestyle management behaviours and practices including physical activity, smoking status, self-perceived stress, height and weight to calculate body mass index, UV exposure, dietary pattern and the presence of comorbidities. These procedures, including a 33 minute MRI scan will be repeated to the 12-month time to monitor any changes that may occur over time. MRI scans will be assessed by two radiologists to determine the number of new and/or enlarging T2 lesions. The T1 images will also be run through a semi-automated pipeline using FreeSurfer software with manual corrections made by the research to accurately calculate whole brain volume.
Intervention code [1] 328015 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337429 0
Composite assessment of feasibility
Timepoint [1] 337429 0
At the conclusion of the data collection phase (i.e. 1-month post data collection of baseline assessment and volumetric analysis of neuroimaging output via FreeSurfer)
Primary outcome [2] 337430 0
Composite assessment of acceptability
Timepoint [2] 337430 0
At the conclusion of the data collection phase (i.e. 1-month post data collection of baseline assessment and volumetric analysis of neuroimaging output via FreeSurfer)
Secondary outcome [1] 431824 0
Composite assessment of preliminary efficacy
Timepoint [1] 431824 0
Baseline and 12-months post completion of the ASA24AU assessment, lifestyle questionnaire and MRI scan. The lifestyle questionnaire was adapted from the 2018 Lifestyle and Environment Survey of the Australian MS Longitudinal Survey by the Menzies Institute for Medical Research, University of Tasmania. This questionnaire has been used for large-scale longitudinal studies in MS research to measure lifestyle behaviours of people living with MS.

Eligibility
Key inclusion criteria
Diagnosed by a neurologist with relapsing remitting MS (RRMS) using the McDonald criteria, ability to speak and communicate in the English language and access to the Internet to complete the online dietary recalls.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Does not meet the above inclusion criteria.

Study design
Purpose
Duration
Longitudinal
Selection
Timing
Prospective
Statistical methods / analysis
Quantification of number of lesions will be read in duplicate for quality assurance by two radiologists. Grey and white matter volumes will be quantified over time using FreesurferMRI (Harvard, v7, 2013 https://surfer.nmr.mgh.harvard.edu/fswiki/rel7downloads). The clinical measures will be correlated with the measures of usual dietary intake looking at a whole of diet and food group based approach, as well as lifestyle characteristics. This will be completed using the appropriate correlation statistical test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
22/04/2021
Date of last participant enrolment
Anticipated
Actual
7/06/2022
Date of last data collection
Anticipated
Actual
26/10/2023
Sample size
Target
15
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 315860 0
University
Name [1] 315860 0
Illawara Health and Medical Research Institute
Country [1] 315860 0
Australia
Funding source category [2] 315861 0
University
Name [2] 315861 0
Illawarra Health and Medical Research Institute
Country [2] 315861 0
Australia
Primary sponsor type
University
Name
Illawarra Health and Medical Research Institute
Address
Country
Australia
Secondary sponsor category [1] 317996 0
None
Name [1] 317996 0
None
Address [1] 317996 0
Country [1] 317996 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314711 0
University of Wollongong Human Research Ethics Committee
Ethics committee address [1] 314711 0
uow-humanethics@uow.edu.au
Ethics committee country [1] 314711 0
Australia
Date submitted for ethics approval [1] 314711 0
10/02/2021
Approval date [1] 314711 0
03/03/2021
Ethics approval number [1] 314711 0
2021/001

Summary
Brief summary
This project aims to create pilot data to determine associations between MRI images as a clinical measure of MS progress and high quality dietary intake and lifestyle data. It is hypothesised that by using objective measures of disease outcomes using high resolution images obtained on a consistent quality scanner will allow for clearer associations between clinical progress and lifestyle management to be explored.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132482 0
A/Prof Yasmine Probst
Address 132482 0
2 Northfields Ave, University of Wollongong, Keiraville, NSW 2500.
Country 132482 0
Australia
Phone 132482 0
+61 2 4221 5302
Fax 132482 0
Email 132482 0
yasmine@uow.edu.au
Contact person for public queries
Name 132483 0
Yasmine Probst
Address 132483 0
2 Northfields Ave, University of Wollongong, Keiraville, NSW 2500.
Country 132483 0
Australia
Phone 132483 0
+61 2 4221 5302
Fax 132483 0
Email 132483 0
yasmine@uow.edu.au
Contact person for scientific queries
Name 132484 0
Yasmine Probst
Address 132484 0
2 Northfields Ave, University of Wollongong, Keiraville, NSW 2500.
Country 132484 0
Australia
Phone 132484 0
+61 2 4221 5302
Fax 132484 0
Email 132484 0
yasmine@uow.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.