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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
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Scientific title
The effect of omega-3 supplementation on impulsive behaviour in healthy adults
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Secondary ID [1]
313932
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease
336628
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Depression
336627
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Anxiety
336796
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Impulsive behaviour
336626
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Stress
336797
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Condition category
Condition code
Mental Health
333128
333128
0
0
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Depression
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Mental Health
333126
333126
0
0
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Studies of normal psychology, cognitive function and behaviour
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Cardiovascular
333127
333127
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0
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Coronary heart disease
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Mental Health
333129
333129
0
0
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Anxiety
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
330523
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Treatment: Other
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Validity of the Polyunsaturated Fatty Acid Food Frequency Questionnaire (PUFA FFQ)
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Assessment method [1]
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The polyunsaturated fatty acids levels determined by the PUFA FFQ will be compared with blood sample fatty acid results (plasma fatty acids and erythrocyte fatty acids) as well as the 24-hour dietary recall using the method of triads.
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Timepoint [1]
340682
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Assessed once only at baseline for the validation sub-study
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Primary outcome [2]
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Impulsivity
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Assessment method [2]
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Barrett Impulsiveness Scale (BIS-11)
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Timepoint [2]
340681
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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.
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Secondary outcome [1]
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Blood pressure
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Assessment method [1]
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Blood pressure will be measured using an automated blood pressure monitor.
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Timepoint [1]
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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.
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Secondary outcome [2]
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Plasma C-reactive protein
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Assessment method [2]
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Plasma C-reactive protein will be measured using standard commercially available kits.
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Timepoint [2]
445332
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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.
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Secondary outcome [3]
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Depression, Anxiety and Stress is a composite measure
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Assessment method [3]
444781
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Depression, Anxiety and Stress Scale (DASS-21) short version.
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Timepoint [3]
444781
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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.
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Secondary outcome [4]
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Physical Activity
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Assessment method [4]
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Global Physical Activity questionnaire
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Timepoint [4]
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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.
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Secondary outcome [5]
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Plasma apolipoprotein B to apolipoprotein AI ratio
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Assessment method [5]
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Plasma Apo B, Apo-AI will be measured using standard commercially available kits.
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Timepoint [5]
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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.
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Secondary outcome [6]
445331
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Pro-inflammatory plasma cytokines
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Assessment method [6]
445331
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Plasma Interleukin-6 and tumour necrosis factor alpha will be measured using commercially available ELISA kits.
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Timepoint [6]
445331
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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.
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Pregnant women
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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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)
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
11/04/2025
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Actual
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Date of last participant enrolment
Anticipated
16/05/2025
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Actual
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Date of last data collection
Anticipated
3/11/2025
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Actual
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Sample size
Target
50
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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NuMega Ingredients
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Address [1]
318569
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Country [1]
318569
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Australia
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Funding source category [2]
318417
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University
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Name [2]
318417
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The University of Wollongong
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Address [2]
318417
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Country [2]
318417
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Australia
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Primary sponsor type
University
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Name
The University of Wollongong
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Address
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Country
Australia
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Secondary sponsor category [1]
320806
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None
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Name [1]
320806
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Address [1]
320806
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Country [1]
320806
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
317045
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Joint University of Wollongong and Illawarra Shoalhaven Local Health District Social Science Human Research Ethics Committee
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Ethics committee address [1]
317045
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http://www.uow.edu.au/research/ethics/index.html
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Ethics committee country [1]
317045
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Australia
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Date submitted for ethics approval [1]
317045
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09/09/2024
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Approval date [1]
317045
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30/09/2024
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Ethics approval number [1]
317045
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2024/172
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Summary
Brief summary
The purpose of this research study is to see if omega-3 fats (the healthy fats) can improve on various health conditions, including depression, anxiety, stress, impulsive behaviour, as well as risk factors for heart disease, which will be measured in a blood sample. Study participants that have volunteered for this study will be provided with the omega-3 supplements which they will take daily for up to 16 weeks. They will attend 2 clinic visits before and after omega-3 supplementation, provide blood samples and answer various questionnaires at both clinic visits, so we (the researchers) can see what potential improvements have been made to the various health conditions.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Barbara Meyer
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Address
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School of Medical, Indigenous and Health Sciences, University of Wollongong, Northfields Ave Wollongong, NSW 2522
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Country
139814
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Australia
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Phone
139814
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+61 2 42213459
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Fax
139814
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Email
139814
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[email protected]
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Contact person for public queries
Name
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Barbara Meyer
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Address
139815
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School of Medical, Indigenous and Health Sciences, University of Wollongong, Northfields Ave Wollongong, NSW 2522
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Country
139815
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Australia
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Phone
139815
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+61 2 42213459
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Fax
139815
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Email
139815
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[email protected]
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Contact person for scientific queries
Name
139816
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Barbara Meyer
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Address
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School of Medical, Indigenous and Health Sciences, University of Wollongong, Northfields Ave Wollongong, NSW 2522
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Country
139816
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Australia
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Phone
139816
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+61 2 42213459
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Fax
139816
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Email
139816
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[email protected]
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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.
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