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

GlaxoSmithKline (GSK)

Status

Completed

Conditions

Growth and Development

Treatments

Other: Emulsified cod liver oil product

Other: Non-emulsified cod liver oil product

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02428699

202359

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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