A Phase 4 interventional study of life's Omega 1035DS and Fish Oil in Optimal Absorption of Omega-3 and Healthy, sponsored by RDC Clinical Pty Ltd. Recruiting at 1 site in Australia. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by RDC Clinical Pty Ltd · Phase 4, Interventional, and Other
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.
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.
6. Agree not to change current diet and exercise frequency or intensity during entire study period
Exclusion criteria:
Dietary Supplement: life's Omega 1035DS
Dietary Supplement: life's Omega O3020DS
Dietary Supplement: Fish Oil
Other: Placebo
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.
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.
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.
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.
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).
Time frame: 6 weeks
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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
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.
Time frame: 6 weeks
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.
Time frame: 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.
Time frame: 2, 4 and 6 weeks
Additional endpoint 3 - Cytokines
Exploratory parameters (Cytokines) at baseline and week 6 will be analysed using ELISA.
Time frame: Baseline and 6 weeks
Additional endpoint 3 - neurotransmitters
Exploratory parameters (neurotransmitters) at baseline and week 6 will be analysed using ELISA.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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 .
Time frame: Baseline 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.
Time frame: 6 weeks
Safety Endpoint 2
Vital signs: Blood pressure (BP) will be assessed at screening, baseline and final visit.
Time frame: 6 weeks
Safety Endpoint 2
Vital signs: Heart rate (HR) will be assessed at screening and final visit.
Time frame: 6 weeks
Safety Endpoint 2
Vital signs: Body temperature will be assessed at screening and final visit.
Time frame: 6 weeks
Safety Endpoint 3
Anthropometric: Weight (kg) will be assessed at screening, baseline and the final visit.
Time frame: Baseline to 6 weeks
Safety Endpoint 3
Anthropometric: Waist-hip-ratio (WHR) will be assessed at screening and the final visit.
Time frame: 6 weeks
Safety Endpoint 4
Adverse event (AE) listing will be collected.
Time frame: 6 weeks
Safety Endpoint 5
Serious Adverse Event (SAE) will be reported to HREC, United BioSource Corporation (UBC) in Geneva, and the sponsor.
Time frame: 6 weeks
Plan to share: Undecided
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RDC Clinical Pty Ltd