Study Comparing Blood Levels of Fatty Acids After Consuming Two Forms of Cod Liver Oil

Study Overview
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Brief Summary
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This study is designed to compare the incremental area under the curve from 0 to 24h (iAUC0-24h) of plasma levels of n-3 fatty acids (sum of total and free eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)) after ingestion of an emulsified product and a non-emulsified reference control of free flowing cod liver oil at the lowest appropriate dose that is practically acceptable, and as near as possible to the test products' recommended daily dose.

Detailed Description
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Many dietary lipids are in the form of triglycerides, ethyl esters or phospholipids. During digestion these lipids are subject to hydrolysis, in particular by pancreatic triglyceride lipase. To facilitate the action of the enzyme, lipids are emulsified by the action of bile salts. By increasing the surface area of the fat globules, emulsification increases access to the lipids by pancreatic triglyceride lipase. This study is designed to compare iAUC0-24h of plasma levels of n-3 fatty acids (sum of total and free EPA and DHA) after ingestion of an emulsified product and a non-emulsified reference control of free flowing cod liver oil at the lowest appropriate dose that is practically acceptable, and as near as possible to the test products' recommended daily dose.

Official Title
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Comparison of Plasma Levels of n-3 Fatty Acids After Ingestion of an Emulsified Cod Liver Oil Product and a Non Emulsified Cod Liver Oil Product

Conditions
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Growth and Development

Intervention / Treatment
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* Other: Emulsified cod liver oil product
* Other: Non-emulsified cod liver oil product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers aged 18 to 45 years (both inclusive) Body mass index (BMI) of 18.5-29.9 kg/m2 inclusive Exclusion Criteria: Pregnant or lactating women Allergy/intolerance to any study material Current or recurrent disease, within 12 months of screening that could affect the metabolism of drug Participants who have taken any drug known to induce or inhibit hepatic drug metabolism in 30 days prior to screening Positive serum Hepatitis B surface antigen, Hepatitis C antibodies or Human Immunodeficiency Virus (HIV), alcohol or drug abuse Smokers taking >5 cigarettes/day; prior or current use of any other nicotine containing product Blood donated within 3 months of screening Consumed n-3 rich food or beverage or n-3 fortified food or beverage within 72h prior to each study session

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test<br>30mL Test contains 10%w/w cod oil + 10%w/w cod liver oil in an emulsion formulation | Other: Emulsified cod liver oil product<br>* Participants are required to consume the dose (30 mL) within 1 min, followed by up to 300 mL of apple juice which needs to be consumed within 2 min<br>|
| Active Comparator: Control<br>5.8mL of cod liver oil in a free flowing non-emulsified formulation | Other: Non-emulsified cod liver oil product<br>* Participants are required to consume the dose (5.8 mL) within 1 min, followed by up to 300 mL of apple juice which needs to be consumed within 2 min<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incremental Area Under the Curve to 24 Hours (h) (iAUC0-24h) of the Sum of Plasma Total and Free n-3 Fatty Acids (Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA) | The AUC was calculated using the trapezoidal method and using nominal time points from 0, 2, 4, 6, 8, 10, 12 and 24 h respectively. The AUC was divided by the total duration to represent a weighted mean incremental change over time. Higher values of AUC demonstrate better rate of absorption over time than lower values. | Baseline and up to Day 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| iAUC0-24h of Sum of Total and Free DHA | The AUC was calculated using the trapezoidal method and using nominal time points from 0, 2, 4, 6, 8, 10, 12 and 24 h respectively. The AUC was divided by the total duration to represent a weighted mean incremental change over time. Higher values of AUC demonstrate better rate of absorption over time than lower values. | Baseline and up to Day 2 | 
| iAUC0-24h of Sum of Total and Free EPA | The AUC was calculated using the trapezoidal method and using nominal time points from 0, 2, 4, 6, 8, 10, 12 and 24 h respectively. The AUC was divided by the total duration to represent a weighted mean incremental change over time. Higher values of AUC demonstrate better rate of absorption over time than lower values. | Baseline and up to Day 2 | 
| iAUC0-10h of Sum of Total and Free DHA | The AUC was calculated using the trapezoidal method and using nominal time points from 0, 2, 4, 6, 8, and 10h respectively. The AUC was divided by the total duration to represent a weighted mean incremental change over time. Higher values of AUC demonstrate better rate of absorption over time than lower values. | Upto 10 h | 
| iAUC0-10h of Sum of Total and Free EPA | The AUC was calculated using the trapezoidal method and using nominal time points from 0, 2, 4, 6, 8, and 10h respectively. The AUC was divided by the total duration to represent a weighted mean incremental change over time. Higher values of AUC demonstrate better rate of absorption over time than lower values. | Upto 10 h | 
| iAUC0-10h of Sum of Total and Free DHA and EPA | The AUC was calculated using the trapezoidal method and using nominal time points from 0, 2, 4, 6, 8, and 10h respectively. The AUC was divided by the total duration to represent a weighted mean incremental change over time. Higher values of AUC demonstrate better rate of absorption over time than lower values. | Upto 10 h | 
| Maximum Concentration (Cmax) of Sum of Total and Free DHA and EPA | Blood sampleswere taken at time points 0,2,4,6,8,10,12 and 24h. Maximum plasma concentration was determined. | Baseline and up to Day 2 | 
| Cmax of Sum of Total and Free DHA | Blood samples were taken at time points 0,2,4,6,8,10,12 and 24h. Maximum plasma concentration was determined. | Baseline and up to Day 2 | 
| Cmax of Sum of Total and Free EPA | Blood sampleswere taken at time points 0,2,4,6,8,10,12 and 24h. Maximum plasma concentration was determined. | Baseline and up to Day 2 | 
| Time to Maximum Concentration (Tmax) of Sum of Total and Free DHA and EPA | Blood samples will be taken at time points 0,2,4,6,8,10,12 and 24h. Time to maximum concentration was determined. | Baseline and up to Day 2 | 
| Tmax of Sum of Total and Free DHA | Blood samples will be taken at time points 0,2,4,6,8,10,12 and 24h. Time to maximum concentration was determined. | Baseline and up to Day 2 | 
| Tmax of Sum of Total and Free EPA | Blood samples will be taken at time points 0,2,4,6,8,10,12 and 24h.Time to maximum concentration was determined. | Baseline and up to Day 2 |