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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
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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
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Scientific title
The Impact of Dietary Improvement on Disability Prevention in Patients with Multiple Sclerosis: A Neuro-Metabolic MRI Evaluation
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Secondary ID [1]
311191
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis
332367
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Condition category
Condition code
Neurological
329076
329076
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0
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Multiple sclerosis
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
327637
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Lifestyle
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Intervention code [2]
327638
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Prevention
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Classification of MS disability
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Assessment method [1]
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Expanded Disability Status Scale (EDSS)
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Timepoint [1]
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Baseline and 13 weeks after intervention commencement.
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Primary outcome [2]
336889
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Diet Quality
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Assessment method [2]
336889
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Australian Eating Survey (AES) and Australian Recommended Food Score (ARFS )– a diet quality sub-scale provided by the AES online tool.
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Timepoint [2]
336889
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Baseline and 13 weeks after intervention commencement.
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Primary outcome [3]
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Quality of Life
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Assessment method [3]
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EQ-5D-5L a descriptive system for health-related quality of life states in adults, consisting of 5 dimensions (Mobility, Self-care, Usual activities, Pain & discomfort, Anxiety & depression), each has 5 severity levels.
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Timepoint [3]
336890
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Baseline and 13 weeks after intervention commencement.
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Secondary outcome [1]
430044
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The impact of cognitive and physical fatigue. Cognitive and physical fatigue will be assessed as a composite secondary outcome.
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Assessment method [1]
430044
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Modified Fatigue Impact Scale (MFIS).
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Timepoint [1]
430044
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Baseline and 13 weeks after intervention commencement.
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Secondary outcome [2]
430045
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Cognition (information processing speed evaluation)
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Assessment method [2]
430045
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Symbol Digit Modalities Test (SDMT)
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Timepoint [2]
430045
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Baseline and 13 weeks after intervention commencement.
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Secondary outcome [3]
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Mental health status
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Assessment method [3]
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Depression, Anxiety Stress Scale (DASS21)
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Timepoint [3]
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Baseline and 13 weeks after intervention commencement.
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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.
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Minimum age
20
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
12/01/2024
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Date of last participant enrolment
Anticipated
6/09/2024
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Actual
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Date of last data collection
Anticipated
13/12/2024
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Actual
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Sample size
Target
60
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Accrual to date
10
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
25949
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John Hunter Hospital - New Lambton
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Recruitment postcode(s) [1]
41783
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2305 - New Lambton
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Funding & Sponsors
Funding source category [1]
315450
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University
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Name [1]
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University of Newcastle
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Address [1]
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Lot 1 Kookaburra Cct, New Lambton Heights NSW 2305
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Country [1]
315450
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Australia
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Primary sponsor type
University
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Name
University of Newcastle
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Address
Lot 1 Kookaburra Cct, New Lambton Heights NSW 2305
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
317526
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Address [1]
317526
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Country [1]
317526
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
314360
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Hunter New England Human Research Ethics Committee
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Ethics committee address [1]
314360
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HMRI building, Level 3, Kookaburra Ct. New Lambton Heights, NSW 2305
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Ethics committee country [1]
314360
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Australia
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Date submitted for ethics approval [1]
314360
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28/07/2023
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Approval date [1]
314360
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24/08/2023
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Ethics approval number [1]
314360
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2023/ETH01215
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Jeannette Lechner-Scott
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Address
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John Hunter Hospital, Department of Neurology, Lookout Road, New Lambton Heights, NSW 2305
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Country
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Australia
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Phone
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+61 249213540
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Jeannette Lechner-Scott
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Address
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John Hunter Hospital, Department of Neurology, Lookout Road, New Lambton Heights, NSW 2305
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Country
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Australia
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Phone
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+61 249213540
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Jeannette Lechner-Scott
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Address
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John Hunter Hospital, Department of Neurology, Lookout Road, New Lambton Heights, NSW 2305
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Country
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Australia
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Phone
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+61 249213540
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Fax
131312
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Email
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
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.
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