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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02427373

Acronym

KOMPARE

Enrollment

Registered

2015-04-28

Start date

2014-06-30

Completion date

2014-12-31

Last updated

2015-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Adults

Keywords

bioavailability, fish oil, krill oil

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTfish oil ethyl ester

DIETARY_SUPPLEMENTfish oil triglyceride

DIETARY_SUPPLEMENTkrill oil

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026