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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-20

Study Completion Date

2015-07-15

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.

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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.

Conditions

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Growth and Development

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Test

30mL Test contains 10%w/w cod oil + 10%w/w cod liver oil in an emulsion formulation

Group Type EXPERIMENTAL

Emulsified cod liver oil product

Intervention Type OTHER

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

Control

5.8mL of cod liver oil in a free flowing non-emulsified formulation

Group Type ACTIVE_COMPARATOR

Non-emulsified cod liver oil product

Intervention Type OTHER

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

Interventions

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Emulsified cod liver oil product

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

Intervention Type OTHER

Non-emulsified cod liver oil product

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

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes