A Study in Healthy Adults to Compare the Bioavailability of EPA + DHA From Two Microalgal Sources to One Fish Source and Placebo

Not Applicable

Recruiting

• Conditions: Absorption of Omega-3; Omega-3 Supplementation; Healthy Participants

• Registration Number: NCT07241377
• Lead Sponsor: RDC Clinical Pty Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-22
• Study Start: 2025-10-27
• Study First Submitted QC: 2025-11-16
• Last Update Submitted: 2025-11-16
• Study First Posted: 2025-11-21
• Last Update Posted: 2025-11-21
• Primary Completion: 2026-12
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. 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.

   a. Female participants of child-bearing potential (females who are post-menopausal, i.e., when there has been no menstruation for a minimum of 12 months prior to screening, are considered not to be of child-bearing potential), who are not surgically sterilized, must have a negative pregnancy test at screening and be willing to practice one of the following appropriate contraceptive methods until the last visit: i. Sexual abstinence. ii. Oral contraceptives. iii. Trans dermal patches or depot injection of a progestogen drug (starting at least 4 weeks prior to product administration).

   iv. Intrauterine device (IUD), intrauterine system (IUS), subdermal implant, or vaginal ring (placed at least 4 weeks prior to product administration).

   v. Contraceptives must be effective before the randomization visit.

3. 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).

4. Intakes of EPA+DHA of <200 mg per day based on the FFQ

5. Agree not to change current diet and exercise frequency or intensity during entire study period

Exclusion Criteria

1. 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.
2. 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.
3. Has a clinically significant abnormal finding on the medical assessment, medical history, vital signs or clinical laboratory results at screening.
4. 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.
5. History of coagulation disorder or current anticoagulation therapy.
6. 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.
7. Has participated in another clinical trial (randomised participants only) within 30 days prior to the first dose of study medication.
8. 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.
9. Regular use* of omega-3 supplements and/or regular fatty fish consumption within 2 months. *Regular use is defined as more than once per week of either fish oil, krill oil, microalgal oil supplements, or fatty fish.
10. Has smoked or used tobacco products within 60 days prior to the first dose of study medication.
11. History of substance abuse or treatment (including more than 14 alcoholic drinks per week) within the past 2 years based on the judgement of the investigator.
12. Has a positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, opiates).
13. Has increased bleeding from existing pathological conditions or anticipates surgery (including dental) prior to, throughout, or within 1 week after study participation.
14. Has had a transient ischemic attack (TIA) or stroke or is at high risk for recurrent ischemic events

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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	Baseline to week 6	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 as determined by Gas Chromatography (GC).

Secondary Outcome Measures

Name	Time	Method
To compare changes from baseline in lipoprotein levels (total cholesterol, HDL- and LDL-cholesterol and triglyceride levels) after supplementation of MEG-3 3223, O1035DS nTG, O3020DS nTG and placebo at the end of a 6-week study.	Baseline, week 6	The change in total cholesterol, HDL- and LDL-cholesterol and triglyceride levels from baseline to week 6 between MEG-3 3223, O1035DS nTG, O3020DS nTG and placebo as determined by a clinical analyser.
To compare the bioavailability of Omega-3 fatty acids after the supplementation of O1035DS nTG, O3020DS nTG, MEG-3 3223rTG to placebo by comparing the changes from baseline in the sum level of plasma phospholipids at 2, 4 and 6 weeks of supplementation.	Baseline, week 2, week 4, week 6	The change in plasma phospholipids EPA+DHA µg/ml levels from baseline to week 2, 4, and 6 between MEG-3 3223 rTG, O1035DS nTG, O3020DS nTG and placebo as determined by Gas Chromatography (GC).
To compare the bioavailability of Omega-3 fatty acids (EPA+DHA) from MEG-3 3223, O1035DS nTG, O3020DS nTG to placebo by comparing the change from baseline in the Omega-3 Index at the end of 6 weeks supplementation.	Baseline to week 6	The change in the Omega-3 Index from baseline to week 6 between MEG-3 3223, O1035DS nTG, O3020DS nTG and placebo as determined by Gas Chromatography (GC).
To assess the bioavailability of Omega-3 fatty acids after the supplementation of MEG-3 3223, O1035DS nTG, O3020DS nTG and placebo by comparing the changes in the sum level of plasma phospholipids from baseline at 2 and 4 weeks of supplementation.	Baseline, week 2, week 4	The change in plasma phospholipids EPA+DHA µg/ml levels from baseline to week 2 and 4 after supplementation of MEG-3 3223, O1035DS nTG, O3020DS nTG and placebo as determined by Gas Chromatography (GC).

Trial Locations

Locations (1)

RDC Clinical; 🇦🇺 Fortitude Valley, Queensland, Australia