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

NCT06629103 | Active Not Recruiting Phase 4

• 1 other identifier: 2023-5-12-GOBO
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Optimal Absorption of Omega-3; Healthy

Outcome Measures

Primary Outcomes (1)

• 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 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.

  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.

  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.

  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.

  6 weeks

Other Outcomes (17)

• Additional endpoint 1

  2, 4 and 6 weeks

• Additional endpoint 2

  2, 4 and 6 weeks

• Additional endpoint 3 - Cytokines

  Baseline and 6 weeks

Study Arms (4)

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

Interventions

life's Omega 1035DS DIETARY_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.

life's Omega 1035DS

Fish Oil DIETARY_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.

MEG-3TM 1812 TG

Placebo OTHER

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.

Placebo

life's Omega O3020DS DIETARY_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.

life'sTM Omega O3020DS

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.
• 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)
• Intakes of EPA+DHA of less than 200mg per day based on the FFQ
• Omega-3 Index less than 4%
• Agree not to change current diet and exercise frequency or intensity during entire study period

You may not qualify if:

• 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.
• 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.
• More specifically, history or presence of diabetes, high triglycerides (\>150 mg/dL), or high cholesterol (\>200 mg/dL).
• 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.
• 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.
• 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 (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.
• 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 increase bleeding from existing pathological conditions or anticipates surgery prior to, throughout, or within 1 week after study participation.
• Has any dental appointment scheduled throughout or within 1 week after study participation.

Sponsors & Collaborators

• RDC Clinical Pty Ltd: lead

Study Sites (1)

RDC Clinical

Brisbane, Queensland, 4000, Australia

Location

MeSH Terms

Interventions

Fish Oils

Intervention Hierarchy (Ancestors)

Oils; Lipids

Study Officials

• Anne Birkett

  DSM Nutritional Products, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: October 8, 2024
• Study Start: August 6, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-06

Locations

AU (1)