A Study to Determine Optimal Absorption of Single Dose Omega-3

Study Overview
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Brief Summary
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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.

Official Title
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A Randomised Three-way Cross Over Study to Determine the Optimal Absorption of an Omega-3 Supplement Administered as a Single Oral Dose to Healthy Volunteers

Conditions
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Optimal Gastrointestinal Absorption of Omega-3

Intervention / Treatment
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* Drug: Product 1 - AquaCelle Fish Oil Triglyceride
* Drug: Product 2 - AquaCelle Fish Oil Ethyl Ester
* Drug: Product 3 - Standard Fish Oil Triglyceride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and females over 19 years and otherwise healthy Healthy BMI &gt;18.0 and &lt;30.0 Able to provide informed consent Agree to arrive fasted on the day of the trial Agree to participate in all arms of the study 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 (&gt;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. Regular use or consumption is considered if participants are consuming omega containing supplements or foods on 3 or more days per week.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Product 1 - AquaCelle Fish Oil Triglyceride<br>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<br>* 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.<br>|
| Experimental: Product 2 - AquaCelle Fish Oil Ethyl Ester<br>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<br>* 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<br>|
| Experimental: Product 3 - Standard Fish Oil Triglyceride<br>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<br>* 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)).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Peak plasma concentration | 24 hours post ingestion | 
| Tmax | Time to peak plasma concentration | 24 hours post ingestion |