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

Not Applicable

Completed

• Conditions: Growth and Development
• Interventions: Other: Non-emulsified cod liver oil product; Other: Emulsified cod liver oil product

• Registration Number: NCT02428699
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-04-09
• Study First Submitted QC: 2015-04-23
• Study First Posted: 2015-04-29
• Study Start: 2015-05-20
• Primary Completion: 2015-07-15
• Study Completion: 2015-07-15
• Results First Submitted: 2017-07-20
• Status Verified: 2018-06
• Results First Submitted QC: 2018-06-15
• Last Update Submitted: 2018-06-15
• Results First Posted: 2018-08-28
• Last Update Posted: 2018-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Healthy volunteers aged 18 to 45 years (both inclusive)
• Body mass index (BMI) of 18.5-29.9 kg/m2 inclusive

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control	Non-emulsified cod liver oil product	5.8mL of cod liver oil in a free flowing non-emulsified formulation
Test	Emulsified cod liver oil product	30mL Test contains 10%w/w cod oil + 10%w/w cod liver oil in an emulsion formulation

Primary Outcome Measures

Name	Time	Method
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)	Baseline and up to Day 2	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.

Secondary Outcome Measures

Name	Time	Method
Maximum Concentration (Cmax) of Sum of Total and Free DHA and EPA	Baseline and up to Day 2	Blood sampleswere taken at time points 0,2,4,6,8,10,12 and 24h. Maximum plasma concentration was determined.
Tmax of Sum of Total and Free DHA	Baseline and up to Day 2	Blood samples will be taken at time points 0,2,4,6,8,10,12 and 24h. Time to maximum concentration was determined.
Tmax of Sum of Total and Free EPA	Baseline and up to Day 2	Blood samples will be taken at time points 0,2,4,6,8,10,12 and 24h.Time to maximum concentration was determined.
iAUC0-24h of Sum of Total and Free DHA	Baseline and up to Day 2	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.
Cmax of Sum of Total and Free DHA	Baseline and up to Day 2	Blood samples were taken at time points 0,2,4,6,8,10,12 and 24h. Maximum plasma concentration was determined.
iAUC0-24h of Sum of Total and Free EPA	Baseline and up to Day 2	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.
iAUC0-10h of Sum of Total and Free DHA and EPA	Upto 10 h	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.
Cmax of Sum of Total and Free EPA	Baseline and up to Day 2	Blood sampleswere taken at time points 0,2,4,6,8,10,12 and 24h. Maximum plasma concentration was determined.
iAUC0-10h of Sum of Total and Free DHA	Upto 10 h	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.
iAUC0-10h of Sum of Total and Free EPA	Upto 10 h	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.
Time to Maximum Concentration (Tmax) of Sum of Total and Free DHA and EPA	Baseline and up to Day 2	Blood samples will be taken at time points 0,2,4,6,8,10,12 and 24h. Time to maximum concentration was determined.

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 London, United Kingdom