Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000253404
Ethics application status
Approved
Date submitted
10/02/2025
Date registered
7/04/2025
Date last updated
7/04/2025
Date data sharing statement initially provided
7/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Omega-3 supplementation on behaviour, mental health and cardiovascular health
Scientific title
The effect of omega-3 supplementation on impulsive behaviour in healthy adults
Secondary ID [1] 313932 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Impulsive behaviour 336626 0
Depression 336627 0
Cardiovascular disease 336628 0
Anxiety 336796 0
Stress 336797 0
Condition category
Condition code
Mental Health 333126 333126 0 0
Studies of normal psychology, cognitive function and behaviour
Cardiovascular 333127 333127 0 0
Coronary heart disease
Mental Health 333128 333128 0 0
Depression
Mental Health 333129 333129 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial is a proof of concept, open label, pilot feasibility clinical trial assessing the effect of Omega-3 supplementation on behaviour and mental health (including impulsivity, anxiety, depression and stress) and cardiovascular health (risk biomarkers), with the validation of the updated PUFA FFQ embedded in the baseline measures being collected.
Study participants are healthy adults who are consuming various habitual diets (vegan, vegetarian or non-restricted diets) and a convenience sample will be recruited from the University of Wollongong and via social media.
The two clinic visits will be conducted at the Clinical Trial Research Unit at the University of Wollongong.
Baseline measures include providing a fasted blood sample, blood pressure, height, weight, waist circumference, completing questionnaires (demographic, dietary (Polyunsaturated Fatty Acid Food Frequency Questionnaire (PUFA FFQ) and Intake24), physical activity, behavioural, and mental health). Total clinic visit time is 90 minutes (clinic measures approx 45 minutes and questionnaires approx 45 minutes). Specifically, for the Validation sub-study, all clinical measures (including blood omegas-3 levels) are required and the dietary measures (Polyunsaturated Fatty Acid Food Frequency Questionnaire (PUFA FFQ) and Intake24).
Intervention is 1g algal omega-3 supplementation per day (oral powder dissolved in half cup of water) for up to 4 months. Study participants will monitor their own omega-3 blood levels via Omega-Quant fingerprick assessment and once study participants reach a target level of omega-3 index of 8%, they will attend the post-intervention clinic visit and cease taking omega-3 supplements. Therefore the post-intervention clinic visit may be 4 weeks, 8 weeks, 12 weeks or 16 weeks after the baseline clinic visit.
Post-intervention clinic visit measures will be the same as baseline clinic visit, except for height and demographic questionnaire. Total clinic visit time 90 minutes.
Any unused algal omega-3 sachets and Omega-Quant fingerprick kits will be returned. Adherence to study protocol will be assessed by the omega-3 index assessment at baseline and post-intervention.
Intervention code [1] 330523 0
Treatment: Other
Comparator / control treatment
No control group for the intervention trial.
For the Validation sub-study, the PUFA FFQ will be validated against 24-hour dietary recall (Intake24) and blood biomarkers (plasma fatty acids and erythrocyte fatty acids) using the methods of triads.
Control group
Active

Outcomes
Primary outcome [1] 340681 0
Impulsivity
Timepoint [1] 340681 0
Baseline and 16 weeks post-intervention when Omega-3 Index has reached 8%. Some participants may reach Omega-3 Index of 8% earlier and if so, their post-intervention timepoint would be 4 weeks, 8 weeks or 12 weeks.
Primary outcome [2] 340682 0
Validity of the Polyunsaturated Fatty Acid Food Frequency Questionnaire (PUFA FFQ)
Timepoint [2] 340682 0
Assessed once only at baseline for the validation sub-study
Secondary outcome [1] 444781 0
Depression, Anxiety and Stress is a composite measure
Timepoint [1] 444781 0
Baseline and 16 weeks post-intervention when Omega-3 Index has reached 8%. Some participants may reach Omega-3 Index of 8% earlier and if so, their post-intervention timepoint would be 4 weeks, 8 weeks or 12 weeks.
Secondary outcome [2] 444782 0
Physical Activity
Timepoint [2] 444782 0
Baseline and 16 weeks post-intervention when Omega-3 Index has reached 8%. Some participants may reach Omega-3 Index of 8% earlier and if so, their post-intervention timepoint would be 4 weeks, 8 weeks or 12 weeks.
Secondary outcome [3] 444786 0
Blood pressure
Timepoint [3] 444786 0
Baseline and 16 weeks post-intervention when Omega-3 Index has reached 8%. Some participants may reach Omega-3 Index of 8% earlier and if so, their post-intervention timepoint would be 4 weeks, 8 weeks or 12 weeks.
Secondary outcome [4] 444793 0
Plasma apolipoprotein B to apolipoprotein AI ratio
Timepoint [4] 444793 0
Baseline and 16 weeks post-intervention when Omega-3 Index has reached 8%. Some participants may reach Omega-3 Index of 8% earlier and if so, their post-intervention timepoint would be 4 weeks, 8 weeks or 12 weeks.
Secondary outcome [5] 445331 0
Pro-inflammatory plasma cytokines
Timepoint [5] 445331 0
Baseline and 16 weeks post-intervention when Omega-3 Index has reached 8%. Some participants may reach Omega-3 Index of 8% earlier and if so, their post-intervention timepoint would be 4 weeks, 8 weeks or 12 weeks.
Secondary outcome [6] 445332 0
Plasma C-reactive protein
Timepoint [6] 445332 0
Baseline and 16 weeks post-intervention when Omega-3 Index has reached 8%. Some participants may reach Omega-3 Index of 8% earlier and if so, their post-intervention timepoint would be 4 weeks, 8 weeks or 12 weeks.

Eligibility
Key inclusion criteria
age 18 years or older, can speak English, maintained a constant diet over the last 3 months - which is assessed by one of the questions in the polyunsaturated fatty acid food frequency questionnaire
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnant women

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
Other
Other design features
The omega-3 intervention study is a single group study design, where all study participants receive omega-3 supplements.
The validation of the updated polyunsaturated fatty acid food frequency questionnaire (PUFA FFQ) is a comparison study where the PUFA FFQ is compared to 24 hour dietary recall intakes as well as blood biomarkers (plasma and erythrocyte fatty acids)
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/04/2025
Actual
Date of last participant enrolment
Anticipated
16/05/2025
Actual
Date of last data collection
Anticipated
3/11/2025
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 318417 0
University
Name [1] 318417 0
The University of Wollongong
Country [1] 318417 0
Australia
Funding source category [2] 318569 0
Commercial sector/Industry
Name [2] 318569 0
NuMega Ingredients
Country [2] 318569 0
Australia
Primary sponsor type
University
Name
The University of Wollongong
Address
Country
Australia
Secondary sponsor category [1] 320806 0
None
Name [1] 320806 0
Address [1] 320806 0
Country [1] 320806 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317045 0
Joint University of Wollongong and Illawarra Shoalhaven Local Health District Social Science Human Research Ethics Committee
Ethics committee address [1] 317045 0
Ethics committee country [1] 317045 0
Australia
Date submitted for ethics approval [1] 317045 0
09/09/2024
Approval date [1] 317045 0
30/09/2024
Ethics approval number [1] 317045 0
2024/172

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 139814 0
Prof Barbara Meyer
Address 139814 0
School of Medical, Indigenous and Health Sciences, University of Wollongong, Northfields Ave Wollongong, NSW 2522
Country 139814 0
Australia
Phone 139814 0
+61 2 42213459
Fax 139814 0
Email 139814 0
[email protected]
Contact person for public queries
Name 139815 0
Barbara Meyer
Address 139815 0
School of Medical, Indigenous and Health Sciences, University of Wollongong, Northfields Ave Wollongong, NSW 2522
Country 139815 0
Australia
Phone 139815 0
+61 2 42213459
Fax 139815 0
Email 139815 0
[email protected]
Contact person for scientific queries
Name 139816 0
Barbara Meyer
Address 139816 0
School of Medical, Indigenous and Health Sciences, University of Wollongong, Northfields Ave Wollongong, NSW 2522
Country 139816 0
Australia
Phone 139816 0
+61 2 42213459
Fax 139816 0
Email 139816 0
[email protected]

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.