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

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

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.

Study Overview

• Status: Completed
• Conditions: Growth and Development
• Intervention / Treatment: Other: Emulsified cod liver oil product; Other: Non-emulsified cod liver oil product

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, NW10 7EW
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test; 30mL Test contains 10%w/w cod oil + 10%w/w cod liver oil in an emulsion formulation	Other: 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
Active Comparator: Control; 5.8mL of cod liver oil in a free flowing non-emulsified formulation	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Collaborators: Hammersmith Medicines Research

Publications and helpful links

General Publications

• Conus N, Burgher-Kennedy N, van den Berg F, Kaur Datta G. A randomized trial comparing omega-3 fatty acid plasma levels after ingestion of emulsified and non-emulsified cod liver oil formulations. Curr Med Res Opin. 2019 Apr;35(4):587-593. doi: 10.1080/03007995.2018.1512479. Epub 2018 Sep 28.

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2015
• Primary Completion (Actual): July 15, 2015
• Study Completion (Actual): July 15, 2015

Study Registration Dates

• First Submitted: April 9, 2015
• First Submitted That Met QC Criteria: April 23, 2015
• First Posted (Estimate): April 29, 2015

Study Record Updates

• Last Update Posted (Actual): August 28, 2018
• Last Update Submitted That Met QC Criteria: June 15, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Vitamins; Hematinics; Liver Extracts; Cod Liver Oil
• Other Study ID Numbers: 202359