Last updated: 11/07/2018 12:32:32
Study comparing blood levels of fatty acids after consuming two forms of cod liver oil
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2015-15-07
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)
Study documents
Statistical analysis plan
Available language(s): English
Clinical study report
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
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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