Actively Recruiting
A Study in Healthy Adults to Compare the Bioavailability of EPA + DHA From Two Microalgal Sources to One Fish Source and Placebo
Led by RDC Clinical Pty Ltd · Updated on 2026-04-29
120
Participants Needed
1
Research Sites
57 weeks
Total Duration
On this page
Sponsors
R
RDC Clinical Pty Ltd
Lead Sponsor
D
DSM-Firmenich AG
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study in Healthy Adults to Compare the Bioavailability of EPA + DHA From Two Microalgal Sources to One Fish Source and Placebo
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent obtained before any trial related assessments are performed.
- Healthy adult females aged 18 to 64 who are neither pregnant nor breastfeeding.
- Healthy adult males aged 18 to 64.
- Female participants of child-bearing potential must have a negative pregnancy test at screening and agree to use effective contraception or sexual abstinence until the last visit.
- Body mass index (BMI) between 18 and 32 kg/m2, considered healthy by the investigator.
- Intake of EPA+DHA less than 300 mg per day based on food frequency questionnaire.
- Agree not to change current diet and exercise frequency or intensity during the entire study period.
You will not qualify if you...
- Presence of any health condition that could prevent fulfilling study requirements, pose risk, or affect study results as judged by the investigator.
- History or presence of significant cardiovascular, pulmonary, liver, kidney, blood, gastrointestinal, endocrine, immune, skin, nervous system, cancer, psychiatric diseases, or any condition jeopardizing safety or study validity.
- Clinically significant abnormal findings on medical assessment, vital signs, or lab results at screening.
- Allergy or adverse response to omega-3-acid ethyl esters, triglycerides, fish, shellfish, soybean, or corn.
- History of coagulation disorders or current anticoagulation therapy.
- Abnormal diet changes in the 4 weeks before study medication.
- Participation in another clinical trial within 30 days before study medication.
- Use of medications within 4 weeks (prescription) or 7 days (OTC) before study medication that affect omega-3 absorption or study outcomes, except occasional ibuprofen, paracetamol, or low-dose aspirin.
- Regular omega-3 supplement or fatty fish consumption more than once per week within 2 months.
- Smoking or tobacco use within 60 days before study medication.
- History of substance abuse or treatment including more than 14 alcoholic drinks per week within past 2 years.
- Positive urine drug screen for substances of abuse.
- Increased bleeding risk or planned surgery within study period.
- History of transient ischemic attack, stroke, or high risk for recurrent ischemic events.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
RDC Clinical
Fortitude Valley, Queensland, Australia, 4006
Actively Recruiting
Research Team
D
David Briskey
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
4
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