Active — Not RecruitingPhase 4

A Study in Healthy Subjects to Compare the Bioavailability of EPA + DHA

Australia120 participantsStarted 2025-08-06

Plain-language summary

This is a randomised, double-blind, parallel, placebo-controlled study in healthy subjects to compare the absorption of two microalgal formulations, to a fish oil and a placebo.

Who can participate

Age range18 Years – 64 Years

SexALL

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

✓. Written informed consent obtained before any trial related assessments are performed.
✓. 2\. Healthy adult females ages 18-64 who are neither pregnant nor breastfeeding or healthy adult males ages 18-64 at the time of consent.
✓. Participant's body mass index (BMI) must be between 18 and 30 kg/m2 (inclusive) and participant must weigh a minimum of 50 kg (110 lbs)
✓. Intakes of EPA+DHA of less than 200mg per day based on the FFQ
✓. Omega-3 Index less than 4%
✓. 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 on medical history and routine laboratory test results.
✕. History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, 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 participant or the validity of the study results.
✕. More specifically, history or presence of diabetes, high triglycerides (\>150 mg/dL), or high cholesterol (\>200 mg/dL).
✕. 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.
✕. 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.

What they're measuring

To compare the bioavailability of 600 mg/day of Omega-3 fatty acids (EPA+DHA) from two microalgal sources to a fish source by comparing the change from baseline in the sum level of EPA and DHA in plasma phospholipids across all treatments.

Timeframe: 6 weeks

Trial details

NCT IDNCT06629103

SponsorRDC Clinical Pty Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12

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