Last updated: 11/07/2018 12:32:32

Study comparing blood levels of fatty acids after consuming two forms of cod liver oil

GSK study ID
202359
See study documents
Clinicaltrials.gov ID
NCT02428699
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
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)

Timeframe: Baseline and up to Day 2

Secondary outcomes:

iAUC0-24h of sum of total and free DHA

Timeframe: Baseline and up to Day 2

iAUC0-24h of sum of total and free EPA

Timeframe: Baseline and up to Day 2

iAUC0-10h of sum of total and free DHA

Timeframe: Upto 10 h

iAUC0-10h of sum of total and free EPA

Timeframe: Upto 10 h

iAUC0-10h of sum of total and free DHA and EPA

Timeframe: Upto 10 h

Maximum concentration (Cmax) of sum of total and free DHA and EPA

Timeframe: Baseline and up to Day 2

Cmax of sum of total and free DHA

Timeframe: Baseline and up to Day 2

Cmax of sum of total and free EPA

Timeframe: Baseline and up to Day 2

Time to maximum concentration (Tmax) of sum of total and free DHA and EPA

Timeframe: Baseline and up to Day 2

Tmax of sum of total and free DHA

Timeframe: Baseline and up to Day 2

Tmax of sum of total and free EPA

Timeframe: Baseline and up to Day 2

Interventions:
  • Other: Emulsified cod liver oil product
  • Other: Non-emulsified cod liver oil product
    • Enrollment:
    50
    Primary completion date:
    2015-15-07
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    https://www.tandfonline.com/doi/abs/10.1080/03007995.2018.1512479
    Medical condition
    Growth and Development
    Product
    SB274273, colecalciferol, retinol, vitamin A/vitamin D3
    Collaborators
    Hammersmith Medicines Research Ltd
    Study date(s)
    May 2015 to July 2015
    Type
    Interventional
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 45 years
    Accepts healthy volunteers
    Yes
    • Healthy volunteers aged 18 to 45 years (both inclusive)
    • Body mass index (BMI) of 18.5-29.9 kg/m2 inclusive
    • Pregnant or lactating women
    • Allergy/intolerance to any study material
    Inclusion and exclusion 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

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    London, United Kingdom, NW10 7EW
    Status
    Study Complete
    Contact us

    Study documents

    Statistical analysis plan
    Available language(s): English
    Download document(s)
    Clinical study report
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2015-15-07
    Actual study completion date
    2015-15-07

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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