NCT02428699

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 29, 2015

Completed
21 days until next milestone

Study Start

First participant enrolled

May 20, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2015

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

August 28, 2018

Completed
Last Updated

August 28, 2018

Status Verified

June 1, 2018

Enrollment Period

2 months

First QC Date

April 9, 2015

Results QC Date

July 20, 2017

Last Update Submit

June 15, 2018

Conditions

Growth and Development

Outcome Measures

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)

    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.

    Baseline and up to Day 2

Secondary Outcomes (11)

  • iAUC0-24h of Sum of Total and Free DHA

    Baseline and up to Day 2

  • iAUC0-24h of Sum of Total and Free EPA

    Baseline and up to Day 2

  • iAUC0-10h of Sum of Total and Free DHA

    Upto 10 h

  • iAUC0-10h of Sum of Total and Free EPA

    Upto 10 h

  • iAUC0-10h of Sum of Total and Free DHA and EPA

    Upto 10 h

  • +6 more secondary outcomes

Study Arms (2)

Test

EXPERIMENTAL

30mL Test contains 10%w/w cod oil + 10%w/w cod liver oil in an emulsion formulation

Other: Emulsified cod liver oil product

Control

ACTIVE COMPARATOR

5.8mL of cod liver oil in a free flowing non-emulsified formulation

Other: Non-emulsified cod liver oil product

Interventions

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

Test
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

Control

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

London, NW10 7EW, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 30106311DERIVED

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
GSKClinicalSupportHD@gsk.com
866-435-7343

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2015

First Posted

April 29, 2015

Study Start

May 20, 2015

Primary Completion

July 15, 2015

Study Completion

July 15, 2015

Last Updated

August 28, 2018

Results First Posted

August 28, 2018

Record last verified: 2018-06

Locations

GB(1)