A Study in Healthy Subjects to Compare the Bioavailability of EPA + DHA (GOBO)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy; Optimal Absorption of Omega-3
• Intervention / Treatment: Dietary supplement: life's Omega 1035DS; Dietary supplement: life's Omega O3020DS; Dietary supplement: Fish Oil; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Brisbane, Queensland, Australia, 4000
      • RDC Clinical

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. 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:

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 on medical history and routine laboratory test results.
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).

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
Placebo Comparator: Placebo	Other: 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.
Active Comparator: life's Omega 1035DS	Dietary supplement: 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.
Active Comparator: life'sTM Omega O3020DS	Dietary supplement: 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.
Active Comparator: MEG-3TM 1812 TG	Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	6 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.	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).	2 and 4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Additional endpoint 1	Change from baseline in plasma phospholipid EPA at weeks 2, 4 and 6 in MEG-3, O3020DS, 1035DS and placebo adjusted for intake level.	2, 4 and 6 weeks
Additional endpoint 2	Change from baseline in plasma phospholipid DHA at weeks 2, 4 and 6 in MEG-3, O3020DS, 1035DS and placebo adjusted for intake level.	2, 4 and 6 weeks
Safety Endpoint 1	Screening and final visit clinical chemistry (electrolytes and liver function tests) and haematology (full blood counts) profiles will be assessed by clinical analyser.	6 weeks
Safety Endpoint 2	Vital signs: Heart rate (HR) will be assessed at screening and final visit.	6 weeks
Safety Endpoint 2	Vital signs: Body temperature will be assessed at screening and final visit.	6 weeks
Safety Endpoint 3	Anthropometric: Waist-hip-ratio (WHR) will be assessed at screening and the final visit.	6 weeks
Safety Endpoint 4	Adverse event (AE) listing will be collected.	6 weeks
Safety Endpoint 5	Serious Adverse Event (SAE) will be reported to HREC, United BioSource Corporation (UBC) in Geneva, and the sponsor.	6 weeks
Additional endpoint 3 - Cytokines	Exploratory parameters (Cytokines) at baseline and week 6 will be analysed using ELISA.	Baseline and 6 weeks
Additional endpoint 3 - neurotransmitters	Exploratory parameters (neurotransmitters) at baseline and week 6 will be analysed using ELISA.	Baseline and 6 weeks
Additional endpoint 3 - specialized pro-resolving mediators	Exploratory parameters (specialized pro-resolving mediators) at baseline and week 6 will be analysed using ELISA.	Baseline and 6 weeks
Additional endpoint 3 - PhenoAge Accel 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 and 6 weeks
Additional endpoint 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 and 6 weeks
Additional endpoint 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 and 6 weeks
Additional endpoint 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 and 6 weeks
Safety Endpoint 2	Vital signs: Blood pressure (BP) will be assessed at screening, baseline and final visit.	6 weeks
Safety Endpoint 3	Anthropometric: Weight (kg) will be assessed at screening, baseline and the final visit.	Baseline to 6 weeks

Collaborators and Investigators

• Sponsor: RDC Clinical Pty Ltd
• Investigators: Study Director: Anne Birkett, DSM Nutritional Products, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: September 16, 2024
• First Submitted That Met QC Criteria: October 3, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 16, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lipids; Oils; Fish Oils
• Other Study ID Numbers: 2023-5-12-GOBO

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
• product manufactured in and exported from the U.S.: No