The role of dietary improvement in the prevention of disability in Multiple Sclerosis: A neuro-metabolic MRI evaluatio

Not Applicable

Recruiting

• Conditions: Multiple Sclerosis; Neurological - Multiple sclerosis

• Registration Number: ACTRN12624000162516
• Lead Sponsor: niversity of Newcastle

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-02-20
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

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.

Exclusion Criteria

•Any contraindication to MRI scanning including:
oCardiac pacemaker
oCardiac defibrillator
oMetal fragments in the eye
oAny other non-MRI compatible medical device/implant or medical condition
oSevere 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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Classification of MS disability [Expanded Disability Status Scale (EDSS) Baseline and 13 weeks after intervention commencement.];Diet Quality[Australian Eating Survey (AES) and Australian Recommended Food Score (ARFS )– a diet quality sub-scale provided by the AES online tool. Baseline and 13 weeks after intervention commencement.];Quality of Life[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. Baseline and 13 weeks after intervention commencement.]

Secondary Outcome Measures

Name	Time	Method
The impact of cognitive and physical fatigue. Cognitive and physical fatigue will be assessed as a composite secondary outcome.[Modified Fatigue Impact Scale (MFIS). Baseline and 13 weeks after intervention commencement.];Cognition (information processing speed evaluation)[Symbol Digit Modalities Test (SDMT) Baseline and 13 weeks after intervention commencement.];Mental health status[Depression, Anxiety Stress Scale (DASS21) Baseline and 13 weeks after intervention commencement.]