CompletedPhase 4

A Study to Determine Optimal Absorption of Single Dose Omega-3

Australia22 participantsStarted 2022-08-04

Plain-language summary

This is a randomised three-way cross over study comparing the optimal absorption of a single dose of fish oil using 3 different forms to one another on increasing blood concentrations of fatty acids in 24 healthy adult participants aged 19 years and over.

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male and females over 19 years and otherwise healthy * Healthy BMI \>18.0 and \<30.0 * Able to provide informed consent * Agree to arrive fasted on the day of the trial * Agree to participate in all arms of the study Exclusion Criteria: * Unstable or serious illness \[e.g. kidney, liver (including NAFLD), GIT, heart conditions, diabetes, thyroid gland function malignancy\]\* * Any treatment that included radiation or chemotherapy within the previous 2 years * Receiving/prescribed coumandin (Warfarin), heparin, daltaparin, enoxaparin or other anticoagulation therapy. * Regular use of supplements containing the investigational material (e.g. Omega-3 fatty acids), in the last 3 months, regular consumption of foods containing the investigational material (e.g. fish for omega-3) # * Active smokers, nicotine, alcohol, drug abuse * Chronic past and/or current alcohol use (\>14 alcoholic drinks week) * Allergic to any of the ingredients (i.e., fish oil) * Pregnant or lactating women * Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion * An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments. * Regular use or consumption is considered if particip…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Plasma EPA+DHA as measured by AUC0-24

Timeframe: 0, 2, 4, 6, 8, 10, 12 and 24 hours post ingestion

Trial details

NCT IDNCT05491759

SponsorRDC Clinical Pty Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-09-28

View on ClinicalTrials.gov More Optimal Gastrointestinal Absorption of Omega-3 trials

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.