A Parallel Bioavailability Study of Fish Oil-Ethyl Ester Versus Fish Oil-Triglyceride Versus Krill Oil (KOMPARE)

April 27, 2015 updated by: DSM Nutritional Products, Inc.
A multiple-dose, double-blind, randomized, four-week, three-treatment, parallel study in which 66 healthy adult subjects will receive 6 capsules/d, administered as a dose of 1.3 g/d eicosapentaenoic acid (EPA)+docosahexaenoic acid (DHA) in fish oil ethyl ester (EE), or fish oil triglyceride (TG) or krill oil for a total of 4 weeks. The objective of the study is to compare the oral bioavailability of EPA+DHA in total plasma across the three formulations at the end of the 4 week study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy,
  • adult female who is neither pregnant nor breastfeeding, or
  • a healthy, adult male
  • with a body mass index (BMI) between 18 and 30 kg/m2 (inclusive), and
  • with a minimum weight of 50 kg (110 lbs).

Exclusion Criteria:

  • history or presence of diabetes, high triglycerides (≥240 mg/dL), or high cholesterol (≥240 mg/dL);
  • clinically significant abnormal finding on the physical exam, medical history, vital signs, or clinical laboratory results at screening;
  • history or presence of allergic response to omega-3-fatty acids or sensitivity or allergy to fish or shellfish;
  • history of coagulation disorder or current anticoagulation therapy;
  • has used any nutritional supplements, omega-3 supplements, fish oil, chia, krill oil, flaxseed or foods supplemented with omega-3s within 3 months prior to the first dose of study medication;
  • has used any prescription medication, except hormonal contraceptive or hormonal replacement therapy, within 14 days prior to the first dose of study medication.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: fish oil ethyl ester
1.3g/d dose of DHA+EPA in fish oil EE (6 capsules) administered for 4 weeks
Dietary supplement: fish oil ethyl ester
Active Comparator: fish oil triglyceride
1.3g/d dose of DHA+EPA in fish oil TG (6 capsules) administered for 4 weeks
Dietary supplement: fish oil triglyceride
Active Comparator: krill oil
1.3g/d dose of DHA+EPA in krill oil (6 capsules) administered for 4 weeks
Dietary supplement: krill oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of total plasma DHA+EPA levels across 3 treatment groups
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of RBC DHA+EPA levels across 3 treatment groups
Time Frame: 4 weeks
4 weeks
pharmacokinetic parameter: AUC to 672hr
Time Frame: 4 weeks
4 weeks
pharmacokinetic parameter: AUC to 336hr
Time Frame: 2 weeks
2 weeks
pharmacokinetic parameter: Cmax
Time Frame: 4 weeks
4 weeks
pharmacokinetic parameter: Tmax
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DSM Nutritional Products, Inc.

Investigators

  • Principal Investigator: Vanessa Smeberg, MD, Worldwide Clinical Trials

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

April 20, 2015

First Submitted That Met QC Criteria

April 27, 2015

First Posted (Estimate)

April 28, 2015

Study Record Updates

Last Update Posted (Estimate)

April 28, 2015

Last Update Submitted That Met QC Criteria

April 27, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2013-10701

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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