None listed
Conditions
Brief summary
This study will evaluate the feasibility of a personalised omega-3 supplementation intervention in people with multiple sclerosis (MS) using a fully decentralised, home-based trial design. Participants will receive an individualised omega-3 dose based on their baseline Omega-3 Index (O3I), with the aim of achieving an O3I of at least 8% over 16 weeks. The study addresses limitations of previous MS omega-3 trials that used fixed supplement doses despite individual variation in omega-3 requirements. All study procedures, including blood sample collection, supplement delivery, surveys, and telemedicine consultations, will be conducted remotely to improve accessibility and reduce participant burden. The primary objectives are to determine the feasibility and acceptability of this personalised, home-based approach and to estimate the proportion of participants who achieve the target O3I.
Interventions
This is a single-arm feasibility trial evaluating a personalised omega-3 long-chain polyunsaturated fatty acid (LCPUFA) supplementation intervention in people with multiple sclerosis.
Participants will receive oral soft-gel capsules containing EPA- and DHA-rich Schizochytrium sp. algal oil (Wagner Plant Omega-3 Algae Oil; Wagner Health, RF Six Pty Ltd, Victoria, Australia; ARTG ID 454627). Each capsule contains 1 g algal oil and provides 150 mg eicosapentaenoic acid (EPA) and 300 mg docosahexae
This is a single-arm feasibility trial evaluating a personalised omega-3 long-chain polyunsaturated fatty acid (LCPUFA) supplementation intervention in people with multiple sclerosis. Participants will receive oral soft-gel capsules containing EPA- and DHA-rich Schizochytrium sp. algal oil (Wagner Plant Omega-3 Algae Oil; Wagner Health, RF Six Pty Ltd, Victoria, Australia; ARTG ID 454627). Each capsule contains 1 g algal oil and provides 150 mg eicosapentaenoic acid (EPA) and 300 mg docosahexaenoic acid (DHA) (EPA:DHA ratio 1:2), with omega-3 LCPUFAs predominantly present in triglyceride form. Prior to commencing supplementation, eligible participants will undergo assessment of their baseline Omega-3 Index (O3I). Individual baseline O3I results will be entered into validated predictive equations to calculate a personalised daily omega-3 LCPUFA dose designed to achieve an O3I of at least 8%. Following dose determination, supplements will be mailed directly to participants together with written instructions regarding dosage and administration. Participants will commence supplementation at Week 0 and consume their allocated personalised dose daily for 16 weeks. The prescribed dose will remain unchanged throughout the intervention period. Adherence will be monitored using weekly online diaries/surveys in which participants will report supplement consumption. At the completion of the 16-week intervention, participants will return any unused capsules using a prepaid return envelope. Adherence will be assessed using both self-reported supplement intake and returned capsule counts. All trial procedures, including baseline O3I assessment, personalised dose determination, supplement distribution, adherence monitoring, and study coordination, will be conducted remotely by appropriately trained members of the research team with experience in clinical trial management.
Sponsors
Deakin Institute for Physical Activity and Nutrition
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants must have a confirmed diagnosis of multiple sclerosis, be able to independently follow study procedures, provide informed consent, communicate in English, have access to the internet and a suitable digital device for study activities, and provide written confirmation from their treating healthcare provider that participation is safe and appropriate.
Exclusion criteria
Omega-3 LCPUFA supplement use within the previous 3 months : To avoid residual effects on baseline Omega-3 Index measurements. Unwilling to discontinue non-study omega-3 supplements during the trial: To ensure accurate assessment of the intervention and avoid confounding. Residence outside Australia: To enable delivery of study materials and compliance with study procedures and regulations. Co-morbid neurological, cognitive, or psychological conditions affecting participation: To ensure participants can safely and reliably complete study procedures. Pregnant or breastfeeding: To minimise potential risks and avoid physiological factors that may influence study outcomes. Bleeding disorders or recent anticoagulant use: To minimise potential risks associated with omega-3 supplementation. Dysphagia (difficulty swallowing): To ensure safe consumption of the study supplement. Significant gastrointestinal disease or impairment: To avoid impaired absorption of the omega-3 supplement and unreliable treatment response. Current or planned hospitalisation during the study: To reduce the likelihood of study interruption and incomplete data collection. Use of investigational medicines within the previous 3 months: To avoid potential interference with study outcomes and participant safety. Allergy, hypersensitivity, or previous adverse reaction to the study supplement or its ingredients: To minimise the risk of allergic or adverse reactions.
Outcome results
None listed