Study Comparing Blood Levels of Fatty Acids After Consuming Two Forms of Cod Liver Oil
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| ClinicalTrials.gov Identifier: NCT02428699 |
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Recruitment Status :
Completed
First Posted : April 29, 2015
Results First Posted : August 28, 2018
Last Update Posted : August 28, 2018
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Sponsor:
GlaxoSmithKline
Collaborator:
Hammersmith Medicines Research
Information provided by (Responsible Party):
GlaxoSmithKline
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Growth and Development | Other: Emulsified cod liver oil product Other: Non-emulsified cod liver oil product | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 50 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Other |
| 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 |
| Actual Study Start Date : | May 20, 2015 |
| Actual Primary Completion Date : | July 15, 2015 |
| Actual Study Completion Date : | July 15, 2015 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Cod liver oil
| Arm | Intervention/treatment |
|---|---|
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Experimental: Test
30mL Test contains 10%w/w cod oil + 10%w/w cod liver oil in an emulsion formulation
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Other: Emulsified cod liver oil product
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 |
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Active Comparator: Control
5.8mL of cod liver oil in a free flowing non-emulsified formulation
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Other: Non-emulsified cod liver oil product
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 Outcome Measures :
- 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 Outcome Measures :
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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| Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02428699
Locations
| United Kingdom | |
| GSK Investigational Site | |
| London, United Kingdom, NW10 7EW | |
Sponsors and Collaborators
GlaxoSmithKline
Hammersmith Medicines Research
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT02428699 |
| Other Study ID Numbers: |
202359 |
| First Posted: | April 29, 2015 Key Record Dates |
| Results First Posted: | August 28, 2018 |
| Last Update Posted: | August 28, 2018 |
| Last Verified: | June 2018 |
Additional relevant MeSH terms:
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Cod Liver Oil Liver Extracts Hematinics |
Vitamins Micronutrients Physiological Effects of Drugs |