NCT02427373

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2014

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 28, 2015

Completed
Last Updated

April 28, 2015

Status Verified

April 1, 2015

Enrollment Period

2 months

First QC Date

April 20, 2015

Last Update Submit

April 27, 2015

Conditions

Healthy Adults

Keywords

bioavailabilityfish oilkrill oil

Outcome Measures

Primary Outcomes (1)

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

    4 weeks

Secondary Outcomes (5)

  • 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

Study Arms (3)

fish oil ethyl ester

ACTIVE COMPARATOR

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

Dietary Supplement: fish oil ethyl ester

fish oil triglyceride

ACTIVE COMPARATOR

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

Dietary Supplement: fish oil triglyceride

krill oil

ACTIVE COMPARATOR

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

Dietary Supplement: krill oil

Interventions

fish oil ethyl esterDIETARY_SUPPLEMENT
fish oil ethyl ester
fish oil triglycerideDIETARY_SUPPLEMENT
fish oil triglyceride
krill oilDIETARY_SUPPLEMENT
krill oil

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 26328782DERIVED

Study Officials

  • Vanessa Smeberg, MD

    Worldwide Clinical Trials

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2015

First Posted

April 28, 2015

Study Start

June 1, 2014

Primary Completion

August 1, 2014

Study Completion

December 1, 2014

Last Updated

April 28, 2015

Record last verified: 2015-04