Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE April 20, 2015
First Posted Date  ICMJE April 28, 2015
Last Update Posted Date April 28, 2015
Study Start Date  ICMJE June 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2015)
Comparison of total plasma DHA+EPA levels across 3 treatment groups [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2015)
  • Comparison of RBC DHA+EPA levels across 3 treatment groups [ Time Frame: 4 weeks ]
  • pharmacokinetic parameter: AUC to 672hr [ Time Frame: 4 weeks ]
  • pharmacokinetic parameter: AUC to 336hr [ Time Frame: 2 weeks ]
  • pharmacokinetic parameter: Cmax [ Time Frame: 4 weeks ]
  • pharmacokinetic parameter: Tmax [ Time Frame: 4 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Parallel Bioavailability Study of Fish Oil-Ethyl Ester Versus Fish Oil-Triglyceride Versus Krill Oil
Official Title  ICMJE A Parallel Bioavailability Study of Fish Oil-Ethyl Ester Versus Fish Oil-Triglyceride Versus Krill Oil
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Condition  ICMJE Healthy Adults
Intervention  ICMJE
  • Dietary Supplement: fish oil ethyl ester
  • Dietary Supplement: fish oil triglyceride
  • Dietary Supplement: krill oil
Study Arms  ICMJE
  • Active Comparator: fish oil ethyl ester
    1.3g/d dose of DHA+EPA in fish oil EE (6 capsules) administered for 4 weeks
    Intervention: 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
    Intervention: 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
    Intervention: Dietary Supplement: krill oil
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 27, 2015)
66
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02427373
Other Study ID Numbers  ICMJE 2013-10701
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party DSM Nutritional Products, Inc.
Study Sponsor  ICMJE DSM Nutritional Products, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Vanessa Smeberg, MD Worldwide Clinical Trials
PRS Account DSM Nutritional Products, Inc.
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP