A Study in Healthy Subjects to Compare the Bioavailability of EPA + DHA
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-64
SponsorRDC Clinical Pty Ltd
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Participant's body mass index (BMI) must be between 18 and 30 kg/m2 (inclusive) and considered to be of healthy weight in the opinion of the investigator.
Intakes of EPA+DHA of less than 300mg per day based on the FFQ
Disqualifiers
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.
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.
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, or soybean or corn.
Trial design
Design model
Parallel
Treatments tested in this trial
life's Omega 1035DS
Dietary supplementA 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.
Fish Oil
Dietary supplementCommercially 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.
Placebo
Other interventionThe 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.
life's Omega O3020DS
Dietary supplementA 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.
Treatment groups
120 Participants
are divided into 4 treatment groupsGroup A: life's Omega 1035DSActive comparator 1 intervention
Group B: life'sTM Omega O3020DSActive comparator 1 intervention
Group C: MEG-3TM 1812 TGActive comparator 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention
Trial outcomes
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).
Time frame
6 weeksSecondary outcomes
1
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 weeks2
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 weeks3
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 weeks4
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 weeksOther outcomes
1
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 weeks2
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 weeks3
Additional endpoint 3 - Cytokines
Exploratory parameters (Cytokines) at baseline and week 6 will be analysed using ELISA.
Time frame
Baseline and 6 weeks4
Additional endpoint 3 - neurotransmitters
Exploratory parameters (neurotransmitters) at baseline and week 6 will be analysed using ELISA.
Time frame
Baseline and 6 weeksSponsors and contacts
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Source ClinicalTrials.gov