Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000162516
Ethics application status
Approved
Date submitted
15/12/2023
Date registered
20/02/2024
Date last updated
20/02/2024
Date data sharing statement initially provided
20/02/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
The role of dietary improvement in the prevention of disability in Multiple Sclerosis: A neuro-metabolic MRI evaluation
Scientific title
The Impact of Dietary Improvement on Disability Prevention in Patients with Multiple Sclerosis: A Neuro-Metabolic MRI Evaluation
Secondary ID [1] 311191 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 332367 0
Condition category
Condition code
Neurological 329076 329076 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The dietary intervention involves the following: All participants will receive personalised dietary advice from a dietitian for the 3-month intervention, where the dietitian will provide instructions and nutritional advice, with the end goal of improving diet quality.
Five telehealth sessions over three months facilitated by a dietitian experienced in motivational interviewing (MI).
These consultations (5 telehealth appointments for improving diet quality) will occur at baseline, 2 weeks, 4 weeks, 8 weeks, and 3 months. The duration of the telehealth intervention consultations will be as follows:
Baseline: 45 minutes
Weeks 2, 4, and 8: 30 minutes each
3-month session: 45 minutes.
The dietary intervention will be administered by a qualified and experienced dietitian.
These periodic telehealth sessions will monitor and motivate the participants to adhere to the diet intervention.
Also to ensure optimal dietary intake which will be facilitated via the provision of weekly boxes of fruits and vegetables for 3 months.
The dietary intervention is not individualised,
All MRIs will be conducted on a 3T Siemens Clinical Research Scanner (Prisma) at the Hunter Medical Research Institute (HMRI) using a 64-channel head and neck coil.
• Participants will undergo two MRI scans: one at baseline (prior to the intervention) and another at three months (post-intervention).
• Each MRI scan session will require 60 minutes in total and will take place at the HMRI Imaging Centre.
MRI Measurements:
Three-dimensional MRI for the evaluation of total brain volumes, lesion volumes, and thalamic volumes.
MRSpectroscopy for the quantification of brain metabolites in multiple brain regions.


.
Intervention code [1] 327637 0
Lifestyle
Intervention code [2] 327638 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336888 0
Classification of MS disability
Timepoint [1] 336888 0
Baseline and 13 weeks after intervention commencement.
Primary outcome [2] 336889 0
Diet Quality
Timepoint [2] 336889 0
Baseline and 13 weeks after intervention commencement.
Primary outcome [3] 336890 0
Quality of Life
Timepoint [3] 336890 0
Baseline and 13 weeks after intervention commencement.
Secondary outcome [1] 430044 0
The impact of cognitive and physical fatigue. Cognitive and physical fatigue will be assessed as a composite secondary outcome.
Timepoint [1] 430044 0
Baseline and 13 weeks after intervention commencement.
Secondary outcome [2] 430045 0
Cognition (information processing speed evaluation)
Timepoint [2] 430045 0
Baseline and 13 weeks after intervention commencement.
Secondary outcome [3] 430046 0
Mental health status
Timepoint [3] 430046 0
Baseline and 13 weeks after intervention commencement.

Eligibility
Key inclusion criteria
• people with Multiple Sclerosis
• Age 20-65 years
• EDSS 0.0-6.0
• Disease duration <15 years
• Clinically stable (no relapse or DMT change within last 6 months)
• On regular and unspecialised diet for at least 6 months.
Minimum age
20 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Any contraindication to MRI scanning including:
o Cardiac pacemaker
o Cardiac defibrillator
o Metal fragments in the eye
o Any other non-MRI compatible medical device/implant or medical condition
o Severe claustrophobia
• Special dietary requirements, nutritional deficiencies or people with haemochromatosis or dysphagia
• Diabetes
• Food allergies or coeliac disease
• Vegetarians or vegans
• Severe depression or suicidal thoughts
• Individuals with diagnosed and/or history of eating disorders.
• Pregnant/planning to fall pregnant for the duration of the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
12/01/2024
Date of last participant enrolment
Anticipated
6/09/2024
Actual
Date of last data collection
Anticipated
13/12/2024
Actual
Sample size
Target
60
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25949 0
John Hunter Hospital - New Lambton
Recruitment postcode(s) [1] 41783 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 315450 0
University
Name [1] 315450 0
University of Newcastle
Country [1] 315450 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
Lot 1 Kookaburra Cct, New Lambton Heights NSW 2305
Country
Australia
Secondary sponsor category [1] 317526 0
None
Name [1] 317526 0
Address [1] 317526 0
Country [1] 317526 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314360 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 314360 0
HMRI building, Level 3, Kookaburra Ct. New Lambton Heights, NSW 2305
Ethics committee country [1] 314360 0
Australia
Date submitted for ethics approval [1] 314360 0
28/07/2023
Approval date [1] 314360 0
24/08/2023
Ethics approval number [1] 314360 0
2023/ETH01215

Summary
Brief summary
Poor diet is common and is associated with suboptimal outcomes for people with MS leading to higher health care expenditure. The impact of dietary patterns on disease incidence and progression in MS remains controversial with limited interventional studies. Moreover, the impact of improved diet quality on brain biochemical composition of MS has not been explored. This study intends to investigate the effects of improving diet quality in MS . Online telehealth dietary intervention by professional dietitians will measure diet quality and intake to ensure optimal dietary intake. A novel MRI method will be used to measure neurometabolites changes pre- and post-intervention which is able to assess the value of dietary improvement in an effective time frame.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131310 0
Prof Jeannette Lechner-Scott
Address 131310 0
John Hunter Hospital, Department of Neurology, Lookout Road, New Lambton Heights, NSW 2305
Country 131310 0
Australia
Phone 131310 0
+61 249213540
Fax 131310 0
Email 131310 0
[email protected]
Contact person for public queries
Name 131311 0
Jeannette Lechner-Scott
Address 131311 0
John Hunter Hospital, Department of Neurology, Lookout Road, New Lambton Heights, NSW 2305
Country 131311 0
Australia
Phone 131311 0
+61 249213540
Fax 131311 0
Email 131311 0
[email protected]
Contact person for scientific queries
Name 131312 0
Jeannette Lechner-Scott
Address 131312 0
John Hunter Hospital, Department of Neurology, Lookout Road, New Lambton Heights, NSW 2305
Country 131312 0
Australia
Phone 131312 0
+61 249213540
Fax 131312 0
Email 131312 0
[email protected]

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.