A Study in Healthy Adults to Compare the Bioavailability of EPA + DHA From Two Microalgal Sources… (NCT07241377) | Clinical Trial Compass
RecruitingPhase 3
A Study in Healthy Adults to Compare the Bioavailability of EPA + DHA From Two Microalgal Sources to One Fish Source and Placebo
Australia120 participantsStarted 2025-10-27
Plain-language summary
This is a randomised, double-blind, parallel, placebo-controlled study in healthy adults to compare the absorption of two microalgal formulations, to a fish oil and a placebo. Participant will take their assigned study product for 6 weeks and attend the clinic for 4 visits.
Who can participate
Age range18 Years – 64 Years
SexALL
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Inclusion criteria
✓. Written informed consent obtained before any trial related assessments are performed.
✓. Healthy adult females ages 18-64 who are neither pregnant nor breastfeeding or healthy adult males ages 18-64 at the time of consent.
✓. 3\. Participant's body mass index (BMI) must be between 18 and 32 kg/m2 (inclusive), and considered to be of healthy weight in the opinion of the investigator.
✓. Intakes of EPA+DHA of \<300 mg per day based on the FFQ
✓. Agree not to change current diet and exercise frequency or intensity during entire study period
Exclusion criteria
✕. Participant has any health conditions that would prevent from fulfilling the study requirements, put the participant at risk or would confound the interpretation of the study results as judged by the Investigator based on medical history and routine laboratory test results.
✕. History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, haematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results.
✕. Has a clinically significant abnormal finding on the medical assessment, medical history, vital signs or clinical laboratory results at screening.
✕. History or presence of allergic or adverse response to omega-3-acid ethyl esters or triglycerides (EPA or DHA), or related drugs, or sensitivity or allergy to fish or shellfish, or soybean or corn.
What they're measuring
1
The change in plasma phospholipids EPA+DHA µg/ml levels from baseline to week 6 between MEG-3 3223, O1035DS nTG and O3020DS nTG and placebo
✕. History of coagulation disorder or current anticoagulation therapy.
✕. Has been on a significantly abnormal\* diet, as deemed by the investigator, during the 4 weeks preceding the first dose of study medication. \*an abnormal diet will be considered if the participant has elected to change to a more or less restricted diet of any description (e.g., change to or from a vegetarian, vegan, gluten-free, lactose-free, etc.) or significantly increases or decreases their daily caloric intake.
✕. Has participated in another clinical trial (randomised participants only) within 30 days prior to the first dose of study medication.
✕. Has used prescription medication (excluding oral contraceptive and hormonal replacement therapy) within 4 weeks of screening or OTC medication within 7 days before the first dose that may affect omega-3 absorption or any study outcomes. This may include but is not limited to: high-dose NSAIDs, bile acid sequestrants, statins, GLP-1 receptor agonists, anticoagulants and anti-inflammatory drugs. Occasional ibuprofen, paracetamol and low-dose aspirin use is permitted.