ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12626000962336p

Ethics application status

Submitted, not yet approved

Date submitted

15/07/2026

Date registered

6/08/2026

Date last updated

6/08/2026

Date data sharing statement initially provided

6/08/2026

Type of registration

Prospectively registered

Titles & IDs

Public title

Fat Incorporation through omega-3 Supplementation to determine immune cellular changes

Scientific title

Lipid Incorporation through poly-unsaturated fatty acid (PUFA) Supplementation: Yielding Nutrient-driven Cellular responses

Additional trial identifiers [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Related trial records

Health condition

Health condition(s) studied:

Immune cell function

Condition category

Condition code

Inflammatory and Immune System

Normal development and function of the immune system

Intervention/exposure

Study type

Interventional

Description of the intervention or exposure

High-dose omega-3 fatty acid supplementation (Arm 2)
Participants will receive oral omega-3 polyunsaturated fatty acid (n-3 PUFA; approximately 4800 mg/day) supplementation containing eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) for 4 weeks. Participants will consume four capsules daily with food. The study supplement is a Therapeutic Goods Administration (TGA)-registered fish oil preparation. Adherence will be assessed by capsule counts and participant self-report.

Intervention code [1]

Treatment: Drugs

Description of the comparator or control

Low-dose omega-3 fatty acid supplementation (Arm 1)
Participants randomised to Arm 1 (comparator arm) will receive oral omega-3 polyunsaturated fatty acid (n-3 PUFA) supplementation containing approximately 1200 mg/day of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) for 4 weeks. Participants will consume one capsule daily with food. The study supplement is a Therapeutic Goods Administration (TGA)-registered fish oil preparation. Adherence will be assessed by capsule counts and participant self-report.

Control group

Dose comparison

Outcomes

Primary outcome [1]

Change in immune cell membrane omega-3 fatty acid composition

Timepoint [1]

Baseline, Week 4 (end of supplementation) and Week 6 (2 weeks post-supplementation follow-up).

Secondary outcome [1]

Change in immune cell lipid peroxidation

Timepoint [1]

Baseline (Week 0), Week 4 (end of supplementation), and Week 6 (2-week post-supplementation follow-up).

Secondary outcome [2]

Change in intracellular reactive oxygen species (ROS) levels in immune cells

Timepoint [2]

Baseline (Week 0), Week 4 (end of supplementation), and Week 6 (2-week post-supplementation follow-up).

Secondary outcome [3]

Change in immune cell viability following ex vivo oxidative stress

Timepoint [3]

Baseline (Week 0), Week 4 (end of supplementation), and Week 6 (2-week post-supplementation follow-up).

Eligibility

Key inclusion criteria

Healthy male and female volunteers aged 18–45 years with a body mass index (BMI) between 18.5 and 28 kg/m². Participants must be willing and able to provide written informed consent, comply with all study procedures, attend study visits, and consume the allocated omega-3 supplement for 4 weeks.

Minimum age

18 Years

Maximum age

45 Years

Sex

Both males and females

Healthy volunteers

Yes

Key exclusion criteria

Individuals with a history of cardiovascular disease, diabetes, cancer, chronic inflammatory or autoimmune disease, liver or kidney disease, or other clinically significant medical conditions. Current use of omega-3 supplements or medications known to influence lipid metabolism or immune function, allergy to fish or fish oil, pregnancy or breastfeeding, current smoking or excessive alcohol consumption, participation in another clinical trial within the previous 30 days, or any condition that, in the opinion of the investigators, would make participation unsafe or interfere with study completion.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation is not concealed.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computer-generated random sequence

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Pharmacodynamics

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/09/2026

Actual

Date of last participant enrolment

Anticipated

1/09/2028

Actual

Date of last data collection

Anticipated

13/10/2028

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Baker Heart and Diabetes Institute - Melbourne

Recruitment postcode(s) [1]

3004 - Melbourne

Funding & Sponsors

Funding source category [1]

Other

Name [1]

Baker Heart and Diabetes Institute

Address [1]

Country [1]

Australia

Primary sponsor type

Other

Name

Baker Heart and Diabetes Institute

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Alfred Hospital Ethics Committee

Ethics committee address [1]

https://www.alfredhealth.org.au/research/ethics-research-governance

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

27/07/2026

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

Omega-3 fatty acids are widely consumed as dietary supplements and are known to have beneficial effects on health. However, it is not well understood how different doses of omega-3 supplementation change the composition and function of human immune cells. This study will compare two doses of omega-3 supplementation in healthy adults over a 4-week period. Blood samples collected before, during and after supplementation will be used to examine how omega-3 fatty acids are incorporated into immune cells and whether this influences their biological function and responses to oxidative stress. The findings will improve our understanding of how dietary omega-3 fatty acids influence the human immune system and provide important information for future studies investigating omega-3 supplementation in health and disease.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Andrew Murphy

Address

Baker Heart and Diabetes Institute, 75 Commercial Road, Melbourne VIC 3004

Country

Australia

Phone

+61 3 8532 1292

Fax

[email protected]

Contact person for public queries

Name

Pooranee Morgan

Address

Baker Heart and Diabetes Institute, 75 Commercial Road, Melbourne VIC 3004

Country

Australia

Phone

+61 3 8532 1292

Fax

[email protected]

Contact person for scientific queries

Name

Andrew Murphy

Address

Baker Heart and Diabetes Institute, 75 Commercial Rd, Melbourne VIC 3004

Country

Australia

Phone

+61 3 8532 1292

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