A Study in Healthy Subjects to Compare the Bioavailability of EPA + DHA
NCT ID: NCT06629103
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE4
120 participants
INTERVENTIONAL
2025-08-06
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study in Healthy Adults to Compare the Bioavailability of EPA + DHA From Two Microalgal Sources to One Fish Source and Placebo
NCT07241377
Comparison of EPA and DHA-Rich Fish Oils on Lipoprotein Metabolism In Adults
NCT02514070
Study to Evaluate the Acute Bioavailability of EPA and DHA From a DietarySupplement in Healthy Men and Women
NCT02865044
Bioavailability of EPA and DHA From Two Dietary Supplements
NCT01908374
Bioavailability of EPA + DHA in a SMEDS Formulation
NCT03443076
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
life's Omega 1035DS
life's Omega 1035DS
A natural triglyceride derived from microalgae with minimum 365 mg DHA, minimum 100 mg EPA, and minimum 520 mg/g DHA + EPA. Participants receive 600mg/d of omega-3 fatty acids from the microalgal oil.
life'sTM Omega O3020DS
life's Omega O3020DS
A natural triglyceride derived from microalgae with minimum 210 mg DHA, minimum 300 mg EPA, and minimum 510 mg/g DHA + EPA. Participants receive 600mg/d of omega-3 fatty acids from the microalgal oil.
MEG-3TM 1812 TG
Fish Oil
Commercially available fish oil product MEG-3 1812 TG with a minimum 100 mg DHA/capsule, minimum 160 mg EPA/capsule, and minimum 300 mg/g DHA+EPA. Participants receive 600mg/d of omega-3 fatty acids from the fish oil.
Placebo
Placebo
The placebo capsules will be a mixture of corn and soybean oils. Participants receive 600mg/d of omega-3 fatty acids from the corn/soy placebo.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
life's Omega 1035DS
A natural triglyceride derived from microalgae with minimum 365 mg DHA, minimum 100 mg EPA, and minimum 520 mg/g DHA + EPA. Participants receive 600mg/d of omega-3 fatty acids from the microalgal oil.
Fish Oil
Commercially available fish oil product MEG-3 1812 TG with a minimum 100 mg DHA/capsule, minimum 160 mg EPA/capsule, and minimum 300 mg/g DHA+EPA. Participants receive 600mg/d of omega-3 fatty acids from the fish oil.
Placebo
The placebo capsules will be a mixture of corn and soybean oils. Participants receive 600mg/d of omega-3 fatty acids from the corn/soy placebo.
life's Omega O3020DS
A natural triglyceride derived from microalgae with minimum 210 mg DHA, minimum 300 mg EPA, and minimum 510 mg/g DHA + EPA. Participants receive 600mg/d of omega-3 fatty acids from the microalgal oil.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. 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).
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 less than 200mg per day based on the FFQ
5. Omega-3 Index less than 4%
6. Agree not to change current diet and exercise frequency or intensity during entire study period
Exclusion Criteria
2. 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.
3. More specifically, history or presence of diabetes, high triglycerides (\>150 mg/dL), or high cholesterol (\>200 mg/dL).
4. Has a clinically significant abnormal finding on the medical assessment, medical history, vital signs or clinical laboratory results at screening.
5. 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.
6. History of coagulation disorder or current anticoagulation therapy.
7. 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.
8. Has participated in another clinical trial (randomised participants only) within 30 days prior to the first dose of study medication.
9. 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.
10. Regular use (more than once per week) of omega-3 supplements (e.g., fish/krill/algae/flaxseed oil) within 2 months; or has consumed any omega-3 supplements or omega-3-rich foods (e.g., fortified products, or fatty fish \>2x/week) within 14 days before the first dose.
11. Has smoked or used tobacco products within 60 days prior to the first dose of study medication.
12. 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.
13. Has a positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, opiates).
14. Has increase bleeding from existing pathological conditions or anticipates surgery prior to, throughout, or within 1 week after study participation.
15. Has any dental appointment scheduled throughout or within 1 week after study participation.
16. Has had a transient ischemic attack (TIA) or stroke or is at high risk for recurrent ischemic events.
17. Has had or currently has lesions with a propensity to bleed (such as ulcers).
18 Years
64 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
RDC Clinical Pty Ltd
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Anne Birkett
Role: STUDY_DIRECTOR
DSM Nutritional Products, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
RDC Clinical
Brisbane, Queensland, Australia
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-5-12-GOBO
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.