ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12626000924358

Ethics application status

Approved

Date submitted

13/07/2026

Date registered

28/07/2026

Date last updated

31/08/2026

Date data sharing statement initially provided

28/07/2026

Type of registration

Prospectively registered

Titles & IDs

Public title

Personalised omega-3 supplementation in multiple sclerosis – feasibility trial

Scientific title

A personalised omega-3 supplementation intervention aimed to achieve target omega-3 fatty acid status in people with multiple sclerosis – A decentralised feasibility trial

Additional trial identifiers [1]

2026DUCT043 Sponsorship

Universal Trial Number (UTN)

Trial acronym

Related trial records

Health condition

Health condition(s) studied:

Multiple sclerosis

Condition category

Condition code

Neurological

Multiple sclerosis

Intervention/exposure

Study type

Interventional

Description of the intervention or exposure

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.

Intervention code [1]

Treatment: Other

Description of the comparator or control

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Proportion of people achieving Omega-3 index (O3I) greater than or equal to 8% at 12 and 16 weeks of supplementation.

Timepoint [1]

Week 0 (baseline), Week 12 and Week 16 post-commencement of intervention (end of study)

Secondary outcome [1]

Enrolment rate

Timepoint [1]

From commencement of recruitment until enrolment of the thirteenth participant.

Secondary outcome [2]

Retention rate

Timepoint [2]

Week 16 post-commencement of intervention (end of study)

Secondary outcome [3]

Supplement adherence

Timepoint [3]

Assessed throughout the 16-week intervention period, with final assessment at Week 16 post-commencement of intervention

Secondary outcome [4]

Participant engagement

Timepoint [4]

Assessed throughout the 16-week intervention period, with final assessment at Week 16 post-commencement of intervention

Secondary outcome [5]

Acceptability of blood spot self-collection

Timepoint [5]

Baseline, Week 12, and Week 16 post-commencement of intervention

Secondary outcome [6]

Quality of self-collected DBS samples

Timepoint [6]

Baseline, Week 12, and Week 16 post-commencement of intervention

Secondary outcome [7]

Acceptability of omega-3 LCPUFA supplement

Timepoint [7]

Week 16 post-commencement of intervention

Secondary outcome [8]

Trial satisfaction

Timepoint [8]

Week 1, Week 8, and Week 16 post-commencement of intervention

Secondary outcome [9]

Feedback on overall experience

Timepoint [9]

Week 16 post-commencement of intervention

Secondary outcome [10]

Concomitant medications

Timepoint [10]

From screening until Week 16 post-commencement of intervention.

Secondary outcome [11]

Adverse events

Timepoint [11]

From screening until Week 16 post-commencement of intervention

Eligibility

Key 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.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Healthy volunteers

Key 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.

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

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

This is a single-arm feasibility study enrolling 13 participants, a sample size selected in accordance with recommendations for feasibility studies and to allow for up to 20% attrition while providing sufficient data to estimate feasibility parameters and outcome variability. Analyses will be primarily descriptive and will focus on feasibility rather than efficacy. Recruitment, retention, adherence, engagement, acceptability, and DBS sample quality outcomes will be summarised using counts, proportions, means, standard deviations, medians, interquartile ranges, and 95% confidence intervals where appropriate. Omega-3 Index values at baseline, Week 12, and Week 16 will be summarised descriptively and presented graphically. Adverse events will be tabulated by frequency, severity, and causality. Qualitative interview data collected at Week 16 will be analysed using reflexive thematic analysis to explore participant experiences, acceptability, and the usability of decentralised trial procedures, and to inform the design of a future randomised controlled trial.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

20/08/2026

Actual

Date of last participant enrolment

Anticipated

20/10/2026

Actual

Date of last data collection

Anticipated

28/02/2027

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

Deakin Institute for Physical Activity & Nutrition, IPAN seed funding

Address [1]

Country [1]

Australia

Primary sponsor type

University

Name

Deakin Institute for Physical Activity and Nutrition

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Deakin University Human Research Ethics Committee (DUHREC)

Ethics committee address [1]

https://www.deakin.edu.au/research/support-for-researchers/research-integrity?a=438168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

09/07/2026

Approval date [1]

21/07/2026

Ethics approval number [1]

2026/HE000294

Summary

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Hajar Mazahery

Address

Deakin Institute for Physical Activity & Nutrition, School of Exercise and Nutrition Sciences, Melbourne Burwood Campus, 221 Burwood Highway, Burwood VIC 3125

Country

Australia

Phone

+61 3 9246 8294

Fax

[email protected]

Contact person for public queries

Name

Hajar Mazahery

Address

Deakin Institute for Physical Activity & Nutrition, School of Exercise and Nutrition Sciences, Melbourne Burwood Campus, 221 Burwood Highway, Burwood VIC 3125

Country

Australia

Phone

+61 3 9246 8294

Fax

[email protected]

Contact person for scientific queries

Name

Hajar Mazahery

Address

Deakin Institute for Physical Activity & Nutrition, School of Exercise and Nutrition Sciences, Melbourne Burwood Campus, 221 Burwood Highway, Burwood VIC 3125

Country

Australia

Phone

+61 3 9246 8294

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

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.

Trial Review

Documents added manually

Documents added automatically