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

DSM Nutritional Products

Status

Completed

Conditions

Healthy Adults

Treatments

Dietary Supplement: fish oil triglyceride

Dietary Supplement: fish oil ethyl ester

Dietary Supplement: krill oil

Study type

Interventional

Funder types

Industry

Identifiers

NCT02427373

2013-10701

Details and patient eligibility

About

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.

Enrollment

66 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.