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

Healthy Adults Clinical Trial

— KOMPARE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02427373
• Other study ID #: 2013-10701
• Status: Completed
• Phase: N/A
• First received: April 20, 2015
• Last updated: April 27, 2015
• Start date: June 2014
• Est. completion date: December 2014

Study information

• Verified date: April 2015
• Source: DSM Nutritional Products, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Healthy Adults

Intervention

Dietary Supplement:
• fish oil ethyl ester

• fish oil triglyceride

• krill oil

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
DSM Nutritional Products, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of total plasma DHA+EPA levels across 3 treatment groups		4 weeks	No
Secondary	Comparison of RBC DHA+EPA levels across 3 treatment groups		4 weeks	No
Secondary	pharmacokinetic parameter: AUC to 672hr		4 weeks	No
Secondary	pharmacokinetic parameter: AUC to 336hr		2 weeks	No
Secondary	pharmacokinetic parameter: Cmax		4 weeks	No
Secondary	pharmacokinetic parameter: Tmax		4 weeks	No