A Study in Healthy Adults to Compare the Bioavailability of EPA + DHA From Two Microalgal Sources to One Fish Source and Placebo (GOBO 2)

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Participants; Omega-3 Supplementation; Absorption of Omega-3
• Intervention / Treatment: Dietary supplement: life'sTM omega O1035DS nTG; Dietary supplement: life'sTM omega O3020DS nTG; Dietary supplement: MEG-3 3323rTG; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: David Briskey; Phone Number: +61 (0) 7 3102 4486; Email: research@rdcglobal.com.au

Study Locations

• Australia
  • Queensland
    • Fortitude Valley, Queensland, Australia, 4006
      • Recruiting
      • RDC Clinical
      • Contact: David Briskey; Phone Number: +61 (07) 3102 4486; Email: research@rdcglobal.com.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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. 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.
4. Intakes of EPA+DHA of <300 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: life'sTM Omega O1035DS nTG; 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.	Dietary supplement: life'sTM omega O1035DS nTG; 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.; Other Names: Microalgal oil
Experimental: life'sTM Omega O3020DS nTG; 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.	Dietary supplement: life'sTM omega O3020DS nTG; 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.; Other Names: Microalgal oil
Active Comparator: MEG-3TM 3223 rTG; 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.	Dietary supplement: MEG-3 3323rTG; 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.; Other Names: Fish oil
Placebo Comparator: Placebo; 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.	Other: Placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline to week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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.	Baseline, week 6

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Additional 1: Change from baseline in plasma phospholipid EPA at weeks 2, 4 and 6 across the groups adjusted for intake level	Change from baseline in plasma phospholipid EPA at weeks 2, 4 and 6 in MEG-3 3223, O3020DS nTG, O1035DS nTG and placebo adjusted for intake level.	Baseline, week 2, week 4, week 6
Additional 2: Change from baseline in plasma phospholipid DHA at weeks 2, 4 and 6 across the treatment groups adjusted for intake level.	Change from baseline in plasma phospholipid DHA at weeks 2, 4 and 6 in MEG-3 3223, O3020DS nTG, O1035DS nTG and placebo adjusted for intake level.	Baseline, week 2, week 4, week 6
Additional 3: Cytokines/Inflammatory markers	Exploratory parameters [e.g., Cytokines and inflammatory markers (e.g., TNF-alpha, IL-1alpha, IL1beta, IL-6, IL-10, hs-CRP, HbA1c) will be assessed at baseline and week 6.	Baseline, week 6
Additional 3: Neurotransmitters	Exploratory parameters: neurotransmitters (e.g., GABA, BDNF, serotonin, cortisol) will be assessed at baseline and week 6.,	Baseline, week 6
Additional 3: Oxylipins	Exploratory parameters: oxylipins (e.g. resolvins, maresins, protectins) will be assessed at baseline and week 6.	Baseline, week 6
Additional 3: PhenoAgeAccel index	Exploratory parameters (PhenoAge Accel Index) at baseline and week 6. This is a metric calculated from phenotypic and chronological age, albumin, creatinine, alkaline phosphatase, glycated haemoglobin, WBC count, lymphocyte percentage, haemoglobin, red cell distribution width, MCV and, glucose).	Baseline, week 6
Additional 3: Aging Clock (iAge)	Exploratory parameters (Aging Clock) at baseline and week 6. This is a metric calculated from CXCL9, CCL11, CCL3, leptin, IL-1beta, IL-5, IFN-alpha, IFN-gamma, IL-4.	Baseline, week 6
Additional 3: PhenoAge Clock	Exploratory parameters (PhenoAge Clock) at baseline and week 6. An epigenetic clock comprised of DNA methylation (DNAm) algorithms that combine information from measurements across the genome to quantify variations in biological versus chronological aging.	Baseline, week 6
Additional 3: Brain Health Score	Exploratory parameters (Brain Health Score) at baseline and week 6. Brain health score derived from plasma proteomic and metabolomic biomarkers.	Baseline, week 6
Safety Endpoint 1: Clinical Chemistry	Screening and final visit clinical chemistry profiles will be assessed from a blood sample by a clinical analyser. Tests included in the clinical chemistry profile include sodium, potassium, chloride, bicarbonate, anion gap, calcium (corrected), phosphate, urea, urate, creatinine, eGFR, glucose, total protein, albumin, globulins, total bilirubin, direct bilirubin, alkaline phosphatase (ALP), aspartate transaminase (AST), alanine transaminase (ALT), GGT, lactate dehydrogenase, iron studies, creatine kinase, magnesium, cholesterol, triglycerides, HDL and LDL.	Screening, week 6
Safety Endpoint 1: Haematology	Screening and final visit haematology profiles will be assessed from a blood sample by a clinical analyser. Tests included in the haematology profile are haemoglobin, MCV, RCC, haematocrit, MCH, MCHC, RDW%, reticulocytes, ESR, platelets, white cell count, neutrophils, lymphocytes, monocytes, eosinophils and basophils.	Screening, week 6
Safety Endpoint 2: BP	Vital signs: Blood pressure (BP) will be assessed at screening/baseline and final visit.	Screening, baseline and week 6
Safety Endpoint 2: HR	Vital signs: Heart rate (HR) will be assessed at screening/baseline and final visit.	Screening, baseline, week 6
Safety Endpoint 2: Body temperature	Vital signs: Body temperature will be assessed at screening/baseline and final visit.	Screening, baseline, week 6
Safety Endpoint 3: Weight	Anthropometric: Weight (kg) will be assessed at screening, baseline and the final visit.	Screening, baseline, week 6
Safety Endpoint 3: WHR	Anthropometric: Waist-hip-ratio (WHR) will be assessed at baseline and the final visit.	Baseline, week 6
Safety Endpoint 4: AEs	Adverse event (AE) listing will be collected.	Screening to week 6
Safety Endpoint 5: SAEs	SAEs will be collected and reported.	Baseline to week 6

Collaborators and Investigators

• Sponsor: RDC Clinical Pty Ltd
• Collaborators: DSM-Firmenich AG
• Investigators: Study Director: Anne Birkett, dsm-firmenich Switzerland AG

Publications and helpful links

Helpful Links

• Study also registered on ISRCTN registry

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: September 22, 2025
• First Submitted That Met QC Criteria: November 16, 2025
• First Posted (Actual): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Omega-3; Fish oil; GOBO 2; microalgal oil
• Additional Relevant MeSH Terms: Lipids; Oils; Fish Oils
• Other Study ID Numbers: 2024-20-08-GOBO2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No