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Completed

NCT Number: NCT02428699

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

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.

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Key information

Conditions

Growth and Development

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GSK Investigational Site

London, NW10 7EW, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Emulsified cod liver oil product

Other

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

Other

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

Primary outcomes

  1. 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

  1. iAUC0-24h of Sum of Total and Free DHA

    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.

  2. iAUC0-24h of Sum of Total and Free 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.

  3. iAUC0-10h of Sum of Total and Free DHA

    Time frame: Upto 10 h

    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.

  4. iAUC0-10h of Sum of Total and Free EPA

    Time frame: Upto 10 h

    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.

  5. iAUC0-10h of Sum of Total and Free DHA and EPA

    Time frame: Upto 10 h

    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.

  6. Maximum Concentration (Cmax) of Sum of Total and Free DHA and EPA

    Time frame: Baseline and up to Day 2

    Blood sampleswere taken at time points 0,2,4,6,8,10,12 and 24h. Maximum plasma concentration was determined.

  7. Cmax of Sum of Total and Free DHA

    Time frame: Baseline and up to Day 2

    Blood samples were taken at time points 0,2,4,6,8,10,12 and 24h. Maximum plasma concentration was determined.

  8. Cmax of Sum of Total and Free EPA

    Time frame: Baseline and up to Day 2

    Blood sampleswere taken at time points 0,2,4,6,8,10,12 and 24h. Maximum plasma concentration was determined.

  9. Time to Maximum Concentration (Tmax) of Sum of Total and Free DHA and EPA

    Time frame: Baseline and up to Day 2

    Blood samples will be taken at time points 0,2,4,6,8,10,12 and 24h. Time to maximum concentration was determined.

  10. Tmax of Sum of Total and Free DHA

    Time frame: Baseline and up to Day 2

    Blood samples will be taken at time points 0,2,4,6,8,10,12 and 24h. Time to maximum concentration was determined.

  11. Tmax of Sum of Total and Free EPA

    Time frame: Baseline and up to Day 2

    Blood samples will be taken at time points 0,2,4,6,8,10,12 and 24h.Time to maximum concentration was determined.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Collaborators

  • Hammersmith Medicines Research

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 29, 2015
Registry last updated
Aug 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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