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

Phase 4

Not yet recruiting

• Conditions: Optimal Absorption of Omega-3; Healthy

• Registration Number: NCT06629103
• Lead Sponsor: RDC Clinical Pty Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-16
• Study First Submitted QC: 2024-10-03
• Study First Posted: 2024-10-08
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-18
• Last Update Posted: 2025-06-24
• Study Start: 2025-07-01
• Primary Completion: 2026-07
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.	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).

Secondary Outcome Measures

Name	Time	Method
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	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).
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	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).
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	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).
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	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.

Trial Locations

Locations (1)

RDC Clinical; 🇦🇺 Brisbane, Queensland, Australia