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

Growth and Development Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02428699
• Other study ID #: 202359
• Status: Completed
• Phase: N/A
• Start date: May 20, 2015
• Est. completion date: July 15, 2015

Study information

• Verified date: June 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 15, 2015
• Est. primary completion date: July 15, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Growth and Development

Intervention

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
• 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

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	London

Sponsors (2)

Lead Sponsor	Collaborator
GlaxoSmithKline	Hammersmith Medicines Research

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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