A Phase 4 interventional study of Product 1 - AquaCelle Fish Oil Triglyceride and Product 2 - AquaCelle Fish Oil Ethyl Ester in Optimal Gastrointestinal Absorption of Omega-3, sponsored by RDC Clinical Pty Ltd. Completed at 1 site in Australia. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-24.
Sponsored by RDC Clinical Pty Ltd · Phase 4, Interventional, and Other
This is a randomised three-way cross over study comparing the optimal absorption of a single dose of fish oil using 3 different forms to one another on increasing blood concentrations of fatty acids in 24 healthy adult participants aged 19 years and over.
RDC Clinical Pty Ltd is the lead sponsor of 34 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.
1 dose of 2 capsules equivalent to 1.6g Fish Oil Triglyceride (standardised to contain 1120 mg of eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA)) and 0.4g AquaCelle The dose will be consumed orally with 250 mL water.
Drug: Product 1 - AquaCelle Fish Oil Triglyceride
1 dose of 2 capsules equivalent to 1.6g Fish Oil Ethyl Ester (standardised to contain 1120 mg of eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA)) and 0.28g AquaCelle The dose will be consumed orally with 250 mL water.
Drug: Product 2 - AquaCelle Fish Oil Ethyl Ester
1 dose of 2 capsules equivalent to 1.6g Fish Oil Triglyceride (standardised to contain 1120 mg of eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA)). The dose will be consumed orally with 250 mL water.
Drug: Product 3 - Standard Fish Oil Triglyceride
1 dose of 2 capsules equivalent to 1.6g Fish Oil Triglyceride (standardised to contain 1120 mg of eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA)) and 0.4g AquaCelle.
1 dose of 2 capsules equivalent to 1.6g Fish Oil Ethyl Ester (standardised to contain 1120 mg of eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA)) and 0.28g AquaCelle
1 dose of 2 capsules equivalent to 1.6g Fish Oil Triglyceride (standardised to contain 1120 mg of eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA)).
Plasma EPA+DHA as measured by AUC0-24
Change in plasma EPA+DHA from baseline as measured by AUC0-24
Time frame: 0, 2, 4, 6, 8, 10, 12 and 24 hours post ingestion
Cmax
Peak plasma concentration
Time frame: 24 hours post ingestion
Tmax
Time to peak plasma concentration
Time frame: 24 hours post ingestion
Plan to share: No — No IPD will be shared
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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RDC Clinical Pty Ltd