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Completed

NCT Number: NCT02427373

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

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.

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Key information

Conditions

Healthy Adults

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

fish oil ethyl ester

Dietary Supplement

fish oil triglyceride

Dietary Supplement

Krill oil

Dietary Supplement

Primary outcomes

  1. Comparison of total plasma DHA+EPA levels across 3 treatment groups

    Time frame: 4 weeks

Secondary outcomes

  1. Comparison of RBC DHA+EPA levels across 3 treatment groups

    Time frame: 4 weeks

  2. pharmacokinetic parameter: AUC to 672hr

    Time frame: 4 weeks

  3. pharmacokinetic parameter: AUC to 336hr

    Time frame: 2 weeks

  4. pharmacokinetic parameter: Cmax

    Time frame: 4 weeks

  5. pharmacokinetic parameter: Tmax

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

dsm-firmenich Switzerland AG

Industry

Registry information

Acronym: KOMPARE

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 28, 2015
Registry last updated
Apr 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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