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

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ClinicalTrials.gov Identifier: NCT02427373
Recruitment Status : Completed
First Posted : April 28, 2015
Last Update Posted : April 28, 2015
Sponsor:
Information provided by (Responsible Party):
DSM Nutritional Products, Inc.

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.

Condition or disease Intervention/treatment Phase
Healthy Adults Dietary Supplement: fish oil ethyl ester Dietary Supplement: fish oil triglyceride Dietary Supplement: krill oil Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: A Parallel Bioavailability Study of Fish Oil-Ethyl Ester Versus Fish Oil-Triglyceride Versus Krill Oil
Study Start Date : June 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Fish oil

Arm Intervention/treatment
Active Comparator: fish oil ethyl ester
1.3g/d dose of DHA+EPA in fish oil EE (6 capsules) administered for 4 weeks
Dietary Supplement: fish oil ethyl ester
Active Comparator: fish oil triglyceride
1.3g/d dose of DHA+EPA in fish oil TG (6 capsules) administered for 4 weeks
Dietary Supplement: fish oil triglyceride
Active Comparator: krill oil
1.3g/d dose of DHA+EPA in krill oil (6 capsules) administered for 4 weeks
Dietary Supplement: krill oil



Primary Outcome Measures :
  1. Comparison of total plasma DHA+EPA levels across 3 treatment groups [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Comparison of RBC DHA+EPA levels across 3 treatment groups [ Time Frame: 4 weeks ]
  2. pharmacokinetic parameter: AUC to 672hr [ Time Frame: 4 weeks ]
  3. pharmacokinetic parameter: AUC to 336hr [ Time Frame: 2 weeks ]
  4. pharmacokinetic parameter: Cmax [ Time Frame: 4 weeks ]
  5. pharmacokinetic parameter: Tmax [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02427373


Sponsors and Collaborators
DSM Nutritional Products, Inc.
Investigators
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Principal Investigator: Vanessa Smeberg, MD Worldwide Clinical Trials

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: DSM Nutritional Products, Inc.
ClinicalTrials.gov Identifier: NCT02427373     History of Changes
Other Study ID Numbers: 2013-10701
First Posted: April 28, 2015    Key Record Dates
Last Update Posted: April 28, 2015
Last Verified: April 2015

Keywords provided by DSM Nutritional Products, Inc.:
bioavailability
fish oil
krill oil