Absorption of Omega-3Phase 3GOBO 2NCT07241377
A Study in Healthy Adults to Compare the Bioavailability of EPA + DHA From Two Microalgal Sources to One Fish Source and Placebo
A Phase 3 study testing life'sTM omega O1035DS nTG, life'sTM omega O3020DS nTG and MEG-3 3323rTG in people with Absorption of Omega-3 and Omega-3 Supplementation, 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 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Absorption of Omega-3, Omega-3 Supplementation, Healthy Participants
- What is being tested?
- life'sTM omega O1035DS nTG, life'sTM omega O3020DS nTG and MEG-3 3323rTG
- 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
- 27 Oct 2025to 5 Aug 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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.
- 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.
- 3. Participant's body mass index (BMI) must be between 18 and 32 kg/m2 (inclusive), and considered to be of healthy weight in the opinion of the investigator.
- Intakes of EPA+DHA of <300 mg per day based on the FFQ
- 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.
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 in Natural Triglyceride Form to One Fish Source in Re-esterified Triglyceride Form (GOBO 2 Study)
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.
- Being tested
- life'sTM omega O1035DS nTG, life'sTM omega O3020DS nTG, MEG-3 3323rTG, Placebo
- Keywords
- GOBO 2, Omega-3, Fish oil, microalgal oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
life'sTM omega O1035DS nTGDietary supplement
Also called Microalgal oil
All Omega-3 oils will be diluted with high oleic sunflower oil for a total (EPA + DHA) content of 300 mg/capsule. Each subject will consume three capsules for a total intake of 900 mg (EPA+DHA)/day for 6 weeks.
life'sTM omega O3020DS nTGDietary supplement
Also called Microalgal oil
All Omega-3 oils will be diluted with high oleic sunflower oil for a total (EPA + DHA) content of 300 mg/capsule. Each subject will consume three capsules for a total intake of 900 mg (EPA+DHA)/day.
MEG-3 3323rTGDietary supplement
Also called Fish oil
All Omega-3 oils will be diluted with high oleic sunflower oil for a total (EPA + DHA) content of 300 mg/capsule. Each subject will consume three capsules for a total intake of 900 mg (EPA+DHA)/day.
PlaceboOther
The placebo capsules will be a mixture of corn and soybean oils. 515 mg corn oil and 515 mg soybean oil. Each subject will consume three capsules a day.
| Study group | Role | What they receive |
|---|---|---|
| life'sTM Omega O1035DS nTG | Experimental | life'sTM Omega O1035DS is a nTG derived from microalgae with minimum 365 mg DHA, minimum 100 mg EPA, and minimum 520 mg/g DHA + EPA. All Omega-3 oils will be diluted with high oleic sunflower oil for a total (EPA + DHA) content of 300 mg/capsule. Each subject will consume three capsules for a total intake of 900 mg (EPA+DHA)/day for 6 weeks. Receives: Dietary Supplement: life'sTM omega O1035DS nTG |
| life'sTM Omega O3020DS nTG | Experimental | life'sTM Omega O3020DS is a nTG derived from microalgae with minimum 210 mg DHA, minimum 300 mg EPA, and minimum 510 mg/g DHA + EPA. All Omega-3 oils will be diluted with high oleic sunflower oil for a total (EPA + DHA) content of 300 mg/capsule. Each subject will consume three capsules for a total intake of 900 mg (EPA+DHA)/day for 6 weeks. Receives: Dietary Supplement: life'sTM omega O3020DS nTG |
| MEG-3TM 3223 rTG | Active comparator | The fish oil will be MEG-3TM 3223 rTG with minimum 230 mg DHA, minimum 320 mg EPA, and minimum 640 mg/g Omega-3. All Omega-3 oils will be diluted with high oleic sunflower oil for a total (EPA + DHA) content of 300 mg/capsule. Each subject will consume three capsules for a total intake of 900 mg (EPA+DHA)/day for 6 weeks. Receives: Dietary Supplement: MEG-3 3323rTG |
| Placebo | Placebo comparator | The placebo capsules will be a mixture of corn and soybean oils. 515 mg corn oil and 515 mg soybean oil. Each subject will consume three capsules for a day for 6 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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).
Measured: Baseline to week 6
Secondary outcomes (4)
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.
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).
Measured: Baseline, week 2, week 4, week 6
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.
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).
Measured: Baseline to week 6
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.
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).
Measured: Baseline, week 2, week 4
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.
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.
Measured: Baseline, week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start27 Oct 2025
- Primary completion5 Aug 2026
- Study completion5 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled, parallel assignment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- RDC Clinical Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- dsm-firmenich Switzerland AG
- Responsible party
- Sponsor
- Investigators
- Anne Birkett, Study director, dsm-firmenich Switzerland AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07241377
- Sponsor's protocol ID
- 2024-20-08-GOBO2
- Acronym
- GOBO 2
- Status last verified
- Sep 2025
- First submitted
- 22 Sep 2025
- 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 in Natural Triglyceride Form to One Fish Source in Re-esterified Triglyceride Form (GOBO 2 Study)
- ClinicalTrials.gov ID
- NCT07241377
- Acronym / sponsor ID
- GOBO 2 / 2024-20-08-GOBO2
- Keywords
- GOBO 2, Omega-3, Fish oil, microalgal oil
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- RDC Clinical Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- dsm-firmenich Switzerland AG
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- 5 Aug 2026 (actual)
- Study completion
- 5 Aug 2026 (actual)
- First posted
- 21 Nov 2025 (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 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Randomized, double-blind, placebo-controlled, parallel assignment
| Arm | Type | Receives |
|---|---|---|
| life'sTM Omega O1035DS nTG | Experimental | Dietary Supplement: life'sTM omega O1035DS nTGlife'sTM Omega O1035DS is a nTG derived from microalgae with minimum 365 mg DHA, minimum 100 mg EPA, and minimum 520 mg/g DHA + EPA. All Omega-3 oils will be diluted with high oleic sunflower oil for a total (EPA + DHA) content of 300 mg/capsule. Each subject will consume three capsules for a total intake of 900 mg (EPA+DHA)/day for 6 weeks. |
| life'sTM Omega O3020DS nTG | Experimental | Dietary Supplement: life'sTM omega O3020DS nTGlife'sTM Omega O3020DS is a nTG derived from microalgae with minimum 210 mg DHA, minimum 300 mg EPA, and minimum 510 mg/g DHA + EPA. All Omega-3 oils will be diluted with high oleic sunflower oil for a total (EPA + DHA) content of 300 mg/capsule. Each subject will consume three capsules for a total intake of 900 mg (EPA+DHA)/day for 6 weeks. |
| MEG-3TM 3223 rTG | Active comparator | Dietary Supplement: MEG-3 3323rTGThe fish oil will be MEG-3TM 3223 rTG with minimum 230 mg DHA, minimum 320 mg EPA, and minimum 640 mg/g Omega-3. All Omega-3 oils will be diluted with high oleic sunflower oil for a total (EPA + DHA) content of 300 mg/capsule. Each subject will consume three capsules for a total intake of 900 mg (EPA+DHA)/day for 6 weeks. |
| Placebo | Placebo comparator | Other: PlaceboThe placebo capsules will be a mixture of corn and soybean oils. 515 mg corn oil and 515 mg soybean oil. Each subject will consume three capsules for a day for 6 weeks. |
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.
- Healthy adult females ages 18-64 who are neither pregnant nor breastfeeding or healthy adult males ages 18-64 at the time of consent.
- 3. Participant's body mass index (BMI) must be between 18 and 32 kg/m2 (inclusive), and considered to be of healthy weight in the opinion of the investigator.
- Intakes of EPA+DHA of <300 mg per day based on the FFQ
- Agree not to change current diet and exercise frequency or intensity during entire study period
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'sTM omega O1035DS nTGAlso: Microalgal oilAll Omega-3 oils will be diluted with high oleic sunflower oil for a total (EPA + DHA) content of 300 mg/capsule. Each subject will consume three capsules for a total intake of 900 mg (EPA+DHA)/day for 6 weeks. | Dietary supplement | life'sTM Omega O1035DS nTG |
| life'sTM omega O3020DS nTGAlso: Microalgal oilAll Omega-3 oils will be diluted with high oleic sunflower oil for a total (EPA + DHA) content of 300 mg/capsule. Each subject will consume three capsules for a total intake of 900 mg (EPA+DHA)/day. | Dietary supplement | life'sTM Omega O3020DS nTG |
| MEG-3 3323rTGAlso: Fish oilAll Omega-3 oils will be diluted with high oleic sunflower oil for a total (EPA + DHA) content of 300 mg/capsule. Each subject will consume three capsules for a total intake of 900 mg (EPA+DHA)/day. | Dietary supplement | MEG-3TM 3223 rTG |
| PlaceboThe placebo capsules will be a mixture of corn and soybean oils. 515 mg corn oil and 515 mg soybean oil. Each subject will consume three capsules a day. | Other | Placebo |
Primary outcome
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
Time frame: 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).
4 secondary outcomes
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.
Time frame: Baseline, week 2, week 4, week 6
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.
Time frame: Baseline to week 6
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.
Time frame: Baseline, week 2, week 4
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.
Time frame: Baseline, week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Study also registered on ISRCTN registryLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
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 3 study testing life'sTM omega O1035DS nTG, life'sTM omega O3020DS nTG and MEG-3 3323rTG in people with Absorption of Omega-3 and Omega-3 Supplementation, 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: finished, 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Baseline to week 6). 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.