Growth and DevelopmentNCT02428699

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

A study testing Emulsified cod liver oil product and Non-emulsified cod liver oil product in people with Growth and Development, run by GlaxoSmithKline at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Growth and Development
What is being tested?: Emulsified cod liver oil product and Non-emulsified cod liver oil product
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteUnited Kingdom
Study dates: 20 May 2015to 15 Jul 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy volunteers aged 18 to 45 years (both inclusive)
Body mass index (BMI) of 18.5-29.9 kg/m2 inclusive

Who cannot join

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 locations and contacts

1 site in 1 country.

United Kingdom1 site

GSK Investigational Site
London, NW10 7EW

Other trials in United Kingdom

About this study

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

Read the 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.

Conditions: Growth and Development
Being tested: Emulsified cod liver oil product, Non-emulsified cod liver oil product

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Emulsified cod liver oil productOther
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 productOther
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

Study groups in NCT02428699
Study group	Role	What they receive
Test	Experimental	30mL Test contains 10%w/w cod oil + 10%w/w cod liver oil in an emulsion formulation Receives: Other: Emulsified cod liver oil product
Control	Active comparator	5.8mL of cod liver oil in a free flowing non-emulsified formulation Receives: Other: Non-emulsified cod liver oil product

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
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.
Measured: Baseline and up to Day 2

Secondary outcomes (11)

iAUC0-24h of Sum of Total and Free DHA
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.
Measured: Baseline and up to Day 2
iAUC0-24h of Sum of Total and Free EPA
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.
Measured: Baseline and up to Day 2
iAUC0-10h of Sum of Total and Free DHA
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.
Measured: Upto 10 h
iAUC0-10h of Sum of Total and Free EPA
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.
Measured: Upto 10 h
iAUC0-10h of Sum of Total and Free DHA and EPA
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.
Measured: Upto 10 h
Maximum Concentration (Cmax) of Sum of Total and Free DHA and EPA
Blood sampleswere taken at time points 0,2,4,6,8,10,12 and 24h. Maximum plasma concentration was determined.
Measured: Baseline and up to Day 2
Cmax of Sum of Total and Free DHA
Blood samples were taken at time points 0,2,4,6,8,10,12 and 24h. Maximum plasma concentration was determined.
Measured: Baseline and up to Day 2
Cmax of Sum of Total and Free EPA
Blood sampleswere taken at time points 0,2,4,6,8,10,12 and 24h. Maximum plasma concentration was determined.
Measured: Baseline and up to Day 2
Time to Maximum Concentration (Tmax) of Sum of Total and Free DHA and EPA
Blood samples will be taken at time points 0,2,4,6,8,10,12 and 24h. Time to maximum concentration was determined.
Measured: Baseline and up to Day 2
Tmax of Sum of Total and Free DHA
Blood samples will be taken at time points 0,2,4,6,8,10,12 and 24h. Time to maximum concentration was determined.
Measured: Baseline and up to Day 2
Tmax of Sum of Total and Free EPA
Blood samples will be taken at time points 0,2,4,6,8,10,12 and 24h.Time to maximum concentration was determined.
Measured: Baseline and up to Day 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 May 201515 Jul 2015

First posted29 Apr 2015 (estimated)
Study start20 May 2015
Primary completion15 Jul 2015
Study completion15 Jul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Growth and DevelopmentStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02428699
Sponsor's protocol ID: 202359
Status last verified: Jun 2018
First submitted: 9 Apr 2015
Last updated: 28 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Conus N, Burgher-Kennedy N, van den Berg F, Kaur Datta G. A randomized trial comparing omega-3 fatty acid plasma levels after ingestion of emulsified and non-emulsified cod liver oil formulations. Curr Med Res Opin. 2019 Apr;35(4):587-593. doi: 10.1080/03007995.2018.1512479. Epub 2018 Sep 28.
PubMed 30106311

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02428699
Acronym / sponsor ID: 202359
Conditions: Growth and Development
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Collaborators: Hammersmith Medicines Research
Study start: 20 May 2015 (actual)
Primary completion: 15 Jul 2015 (actual)
Study completion: 15 Jul 2015 (actual)
First posted: 29 Apr 2015 (estimated)
Results: Posted 28 Aug 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Test	Experimental	Other: Emulsified cod liver oil product30mL Test contains 10%w/w cod oil + 10%w/w cod liver oil in an emulsion formulation
Control	Active comparator	Other: Non-emulsified cod liver oil product5.8mL of cod liver oil in a free flowing non-emulsified formulation

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Healthy volunteers aged 18 to 45 years (both inclusive)
Body mass index (BMI) of 18.5-29.9 kg/m2 inclusive

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Emulsified cod liver oil productParticipants 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	Other	Test
Non-emulsified cod liver oil productParticipants 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	Other	Control

Primary outcome

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.

11 secondary outcomes

iAUC0-24h of Sum of Total and Free DHA
Time frame: Baseline and up to Day 2
iAUC0-24h of Sum of Total and Free EPA
Time frame: Baseline and up to Day 2
iAUC0-10h of Sum of Total and Free DHA
Time frame: Upto 10 h
iAUC0-10h of Sum of Total and Free EPA
Time frame: Upto 10 h
iAUC0-10h of Sum of Total and Free DHA and EPA
Time frame: Upto 10 h
Maximum Concentration (Cmax) of Sum of Total and Free DHA and EPA
Time frame: Baseline and up to Day 2
Cmax of Sum of Total and Free DHA
Time frame: Baseline and up to Day 2
Cmax of Sum of Total and Free EPA
Time frame: Baseline and up to Day 2
Time to Maximum Concentration (Tmax) of Sum of Total and Free DHA and EPA
Time frame: Baseline and up to Day 2
Tmax of Sum of Total and Free DHA
Time frame: Baseline and up to Day 2
Tmax of Sum of Total and Free EPA
Time frame: Baseline and up to Day 2

Results and safety

Results posted to the registry on 28 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Scott's Emulsion Followed by Non Emulsified Cod Liver Oil	25	25
Non Emulsified Cod Liver Oil Followed by Scott's Emulsion	25	25

Primary outcome: 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. Mean (Standard Deviation). Unit: Microgram per mililiter (µg/mL)

Measure	Test Product n = 44	Reference Product n = 45
Value	13.19 (8.368)	7.73 (6.532)

Test Product vs Reference Product: Mean Difference (Net): 5.16 (95% CI 2.79 to 7.53), p <.0001, ANCOVA

Population analysed: Per protocol (PP) population (N=47) was the primary population of analysis defined as all participants in the safety population who have at least one post-baseline assessment of efficacy considered unaffected by protocol violations. From the PP population, 3 participants were not analysed in test group and 2 in control group, due to missing data.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: approximately 45 days. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test Product	0 of 48 (0%)	9 of 48 (18.8%)	0 of 48
Reference Product	0 of 49 (0%)	3 of 49 (6.1%)	0 of 49

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30106311Conus N, Burgher-Kennedy N, van den Berg F, Kaur Datta G. A randomized trial comparing omega-3 fatty acid plasma levels after ingestion of emulsified and non-emulsified cod liver oil formulations. Curr Med Res Opin. 2019 Apr;35(4):587-593. doi: 10.1080/03007995.2018.1512479. Epub 2018 Sep 28.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Emulsified cod liver oil product and Non-emulsified cod liver oil product in people with Growth and Development, run by GlaxoSmithKline at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02428699, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2018.