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

NCT ID: NCT02427373

Last Updated: 2015-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2014-12-31

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.

Conditions

Healthy Adults

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: QUADRUPLE

Study Groups

fish oil ethyl ester

1.3g/d dose of DHA+EPA in fish oil EE (6 capsules) administered for 4 weeks

Group Type: ACTIVE_COMPARATOR

fish oil ethyl ester

Intervention Type: DIETARY_SUPPLEMENT

fish oil triglyceride

1.3g/d dose of DHA+EPA in fish oil TG (6 capsules) administered for 4 weeks

Group Type: ACTIVE_COMPARATOR

fish oil triglyceride

Intervention Type: DIETARY_SUPPLEMENT

krill oil

1.3g/d dose of DHA+EPA in krill oil (6 capsules) administered for 4 weeks

Group Type: ACTIVE_COMPARATOR

krill oil

Intervention Type: DIETARY_SUPPLEMENT

Interventions

fish oil ethyl ester

Intervention Type: DIETARY_SUPPLEMENT

fish oil triglyceride

Intervention Type: DIETARY_SUPPLEMENT

krill oil

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

DSM Nutritional Products, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vanessa Smeberg, MD

Role: PRINCIPAL_INVESTIGATOR

Worldwide Clinical Trials

References

Yurko-Mauro K, Kralovec J, Bailey-Hall E, Smeberg V, Stark JG, Salem N Jr. Similar eicosapentaenoic acid and docosahexaenoic acid plasma levels achieved with fish oil or krill oil in a randomized double-blind four-week bioavailability study. Lipids Health Dis. 2015 Sep 2;14:99. doi: 10.1186/s12944-015-0109-z.

Reference Type: DERIVED

PMID: 26328782 (View on PubMed)

Other Identifiers

2013-10701

Identifier Type: -

Identifier Source: org_study_id