Optimal Absorption of Omega-3Phase 4GOBONCT06629103
A Study in Healthy Subjects to Compare the Bioavailability of EPA + DHA
A Phase 4 study testing life's Omega 1035DS, Fish Oil and life's Omega O3020DS in people with Optimal Absorption of Omega-3 and Healthy, run by RDC Clinical Pty Ltd at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Optimal Absorption of Omega-3, Healthy
- What is being tested?
- life's Omega 1035DS, Fish Oil and life's Omega O3020DS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteAustralia
- Study dates
- 6 Aug 2025to Apr 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- 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).
- 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.
- Participant's body mass index (BMI) must be between 18 and 30 kg/m2 (inclusive) and considered to be of healthy weight in the opinion of the investigator.
- Intakes of EPA+DHA of less than 300mg per day based on the FFQ
- 6. Agree not to change current diet and exercise frequency or intensity during entire study period
Who cannot join
- 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.
- 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.
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- 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.
- 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.
- Has smoked or used tobacco products within 60 days prior to the first dose of study medication.
- 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.
- Has a positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, opiates).
- Has increased bleeding from existing pathological conditions or anticipates surgery (including dental) prior to, throughout, or within 1 week after study participation.
- Has had a transient ischemic attack (TIA) or stroke or is at high risk for recurrent ischemic events.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
RDC Clinical
Brisbane, Queensland, 4000
David Briskey, +61 (0) 7 3102 4486, david@rdcglobal.com.au
About this study
Official title: A Randomized, Double-blind Placebo-controlled Study in Healthy Subjects to Compare the Bioavailability of EPA + DHA From Two Microalgal Sources to One Fish Source
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.
- Conditions
- Optimal Absorption of Omega-3, Healthy
- Being tested
- life's Omega 1035DS, Fish Oil, Placebo, life's Omega O3020DS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
life's Omega 1035DSDietary supplement
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 OilDietary supplement
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.
PlaceboOther
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 O3020DSDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| life's Omega 1035DS | Active comparator | Not described Receives: Dietary Supplement: life's Omega 1035DS |
| life'sTM Omega O3020DS | Active comparator | Not described Receives: Dietary Supplement: life's Omega O3020DS |
| MEG-3TM 1812 TG | Active comparator | Not described Receives: Dietary Supplement: Fish Oil |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
The change in plasma phospholipids EPA+DHA µg/ml levels from baseline to week 6 between MEG-3, O1035DS and O3020DS and placebo as determined by Gas Chromatography (GC).
Measured: 6 weeks
Secondary outcomes (4)
To compare the bioavailability by 600mg/day of Omega-3 fatty acids by comparing the change from baseline in the sum level of EPA and DHA in plasma phospholipids across all treatments at the end of a 2, 4, and 6 week supplementation study.
The change in plasma phospholipids EPA+DHA µg/ml levels from baseline to week 2, 4, and 6 between MEG-3, O1035DS, O3020DS and placebo as determined by Gas Chromatography (GC).
Measured: 2, 4 and 6 weeks
To compare the bioavailability of 600mg/day of Omega-3 fatty acids by comparing the change from baseline in Omega-3 Index across all treatments at the end of a 6 week supplementation study.
The change in the Omega-3 Index (percent of EPA + DHA in red blood cell membranes) from baseline to week 6 between MEG-3, O1035DS, O3020DS and placebo as determined by Gas Chromatography (GC).
Measured: 6 weeks
To compare the bioavailability of 600mg/day Omega-3 fatty acids by comparing the change from baseline in the plasma phospholipid levels across all treatments at week 2 and week 4 of supplementation.
The change in plasma phospholipids EPA+DHA µg/ml levels from baseline to week 2 and baseline to week 4 between MEG-3, O1035DS, O3020DS and placebo as determined by Gas Chromatography (GC).
Measured: 2 and 4 weeks
To compare the changes from baseline in lipoprotein levels following consumption of the microalgal oils, fish oil or placebo at the end of a 6-week supplementation study.
The change in total cholesterol, HDL- and LDL-cholesterol and triglyceride levels from baseline to week 6 between MEG-3, O1035DS, O3020DS and placebo as determined by a clinical analyser.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start6 Aug 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optimal Absorption of Omega-3Studies of the same condition, open and under way.
- More trials run by RDC Clinical Pty LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RDC Clinical Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anne Birkett, Study director, dsm-firmenich Switzerland AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629103
- Sponsor's protocol ID
- 2023-5-12-GOBO
- Acronym
- GOBO
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Placebo-controlled Study in Healthy Subjects to Compare the Bioavailability of EPA + DHA From Two Microalgal Sources to One Fish Source
- ClinicalTrials.gov ID
- NCT06629103
- Acronym / sponsor ID
- GOBO / 2023-5-12-GOBO
- Conditions
- Optimal Absorption of Omega-3, Healthy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- RDC Clinical Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 6 Aug 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| life's Omega 1035DS | Active comparator | Dietary Supplement: life's Omega 1035DS |
| life'sTM Omega O3020DS | Active comparator | Dietary Supplement: life's Omega O3020DS |
| MEG-3TM 1812 TG | Active comparator | Dietary Supplement: Fish Oil |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
- Contraceptives must be effective before the randomization visit.
- Participant's body mass index (BMI) must be between 18 and 30 kg/m2 (inclusive) and considered to be of healthy weight in the opinion of the investigator.
- Intakes of EPA+DHA of less than 300mg per day based on the FFQ
Key exclusion criteria (14 listed)
- 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.
- History of coagulation disorder or current anticoagulation therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| life's Omega 1035DSA 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. | Dietary supplement | life's Omega 1035DS |
| Fish OilCommercially 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. | Dietary supplement | MEG-3TM 1812 TG |
| PlaceboThe 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. | Other | Placebo |
| life's Omega O3020DSA 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. | Dietary supplement | life'sTM Omega O3020DS |
Primary outcome
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.
Time frame: 6 weeks
The change in plasma phospholipids EPA+DHA µg/ml levels from baseline to week 6 between MEG-3, O1035DS and O3020DS and placebo as determined by Gas Chromatography (GC).
4 secondary outcomes
To compare the bioavailability by 600mg/day of Omega-3 fatty acids by comparing the change from baseline in the sum level of EPA and DHA in plasma phospholipids across all treatments at the end of a 2, 4, and 6 week supplementation study.
Time frame: 2, 4 and 6 weeks
To compare the bioavailability of 600mg/day of Omega-3 fatty acids by comparing the change from baseline in Omega-3 Index across all treatments at the end of a 6 week supplementation study.
Time frame: 6 weeks
To compare the bioavailability of 600mg/day Omega-3 fatty acids by comparing the change from baseline in the plasma phospholipid levels across all treatments at week 2 and week 4 of supplementation.
Time frame: 2 and 4 weeks
To compare the changes from baseline in lipoprotein levels following consumption of the microalgal oils, fish oil or placebo at the end of a 6-week supplementation study.
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anne Birkett study director
dsm-firmenich Switzerland AG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing life's Omega 1035DS, Fish Oil and life's Omega O3020DS in people with Optimal Absorption of Omega-3 and Healthy, run by RDC Clinical Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Briskey (+61 (0) 7 3102 4486, david@rdcglobal.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.