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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- 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)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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)
Time Frame: 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 Outcomes
- Maximum Concentration (Cmax) of Sum of Total and Free DHA and EPA(Baseline and up to Day 2)
- Tmax of Sum of Total and Free DHA(Baseline and up to Day 2)
- Tmax of Sum of Total and Free EPA(Baseline and up to Day 2)
- iAUC0-24h of Sum of Total and Free DHA(Baseline and up to Day 2)
- Cmax of Sum of Total and Free DHA(Baseline and up to Day 2)
- iAUC0-24h of Sum of Total and Free EPA(Baseline and up to Day 2)
- iAUC0-10h of Sum of Total and Free DHA and EPA(Upto 10 h)
- Cmax of Sum of Total and Free EPA(Baseline and up to Day 2)
- iAUC0-10h of Sum of Total and Free DHA(Upto 10 h)
- iAUC0-10h of Sum of Total and Free EPA(Upto 10 h)
- Time to Maximum Concentration (Tmax) of Sum of Total and Free DHA and EPA(Baseline and up to Day 2)