Clinical trial NCT02428699: Study Comparing Blood Levels of Fatty Acids After Consuming Two Forms of Cod Liver Oil
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Growth and Development
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: Hammersmith Medicines Research
First posted: 2015-04-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: Baseline and up to Day 2
Secondary outcomes:
measure: iAUC0-24h of Sum of Total and Free DHA
timeFrame: Baseline and up to Day 2
measure: iAUC0-24h of Sum of Total and Free EPA
timeFrame: Baseline and up to Day 2
measure: iAUC0-10h of Sum of Total and Free DHA
timeFrame: Upto 10 h
measure: iAUC0-10h of Sum of Total and Free EPA
timeFrame: Upto 10 h
measure: iAUC0-10h of Sum of Total and Free DHA and EPA
timeFrame: Upto 10 h
measure: Maximum Concentration (Cmax) of Sum of Total and Free DHA and EPA
timeFrame: Baseline and up to Day 2
measure: Cmax of Sum of Total and Free DHA
timeFrame: Baseline and up to Day 2
measure: Cmax of Sum of Total and Free EPA
timeFrame: Baseline and up to Day 2
measure: Time to Maximum Concentration (Tmax) of Sum of Total and Free DHA and EPA
timeFrame: Baseline and up to Day 2
measure: Tmax of Sum of Total and Free DHA
timeFrame: Baseline and up to Day 2
measure: Tmax of Sum of Total and Free EPA
timeFrame: Baseline and up to Day 2
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.