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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Product 1 - AquaCelle Fish Oil Triglyceride | Experimental | 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. |
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| Product 2 - AquaCelle Fish Oil Ethyl Ester | Experimental | 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. |
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| Product 3 - Standard Fish Oil Triglyceride | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Product 1 - AquaCelle Fish Oil Triglyceride | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma EPA+DHA as measured by AUC0-24 | Change in plasma EPA+DHA from baseline as measured by AUC0-24 | 0, 2, 4, 6, 8, 10, 12 and 24 hours post ingestion |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Peak plasma concentration | 24 hours post ingestion |
| Tmax | Time to peak plasma concentration | 24 hours post ingestion |
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Inclusion Criteria:
Exclusion Criteria:
Unstable or serious illness [e.g. kidney, liver (including NAFLD), GIT, heart conditions, diabetes, thyroid gland function malignancy]*
Any treatment that included radiation or chemotherapy within the previous 2 years
Receiving/prescribed coumandin (Warfarin), heparin, daltaparin, enoxaparin or other anticoagulation therapy.
Regular use of supplements containing the investigational material (e.g. Omega-3 fatty acids), in the last 3 months, regular consumption of foods containing the investigational material (e.g. fish for omega-3) #
Active smokers, nicotine, alcohol, drug abuse
Chronic past and/or current alcohol use (>14 alcoholic drinks week)
Allergic to any of the ingredients (i.e., fish oil)
Pregnant or lactating women
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.
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| Name | Affiliation | Role |
|---|---|---|
| David Briskey, PhD | The University of Queensland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RDC Global Pty Ltd | Brisbane | Queensland | 4006 | Australia |
No IPD will be shared
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| Product 2 - AquaCelle Fish Oil Ethyl Ester | Drug | 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 |
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| Product 3 - Standard Fish Oil Triglyceride | Drug | 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)). |
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