Bioavailability of EPA and DHA From Two Dietary Supplements

This study is currently recruiting participants.
Verified July 2013 by Arctic Nutrition AS
Sponsor:
Collaborators:
BioFortis
University of British Columbia
Information provided by (Responsible Party):
Arctic Nutrition AS
ClinicalTrials.gov Identifier:
NCT01908374
First received: July 19, 2013
Last updated: July 23, 2013
Last verified: July 2013
  Purpose

The primary objective of this study is to test the effects of two different fish oil products containing DHA and EPA by comparing the omega-3 fatty acid levels in the blood.


Condition Intervention
Hypertriglyceridemia
Dietary Supplement: DHA-rich fish oil versus Phospholipid-rich fish oil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Crossover Study to Evaluate the Acute and Subchronic Bioavailability of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) From Two Dietary Supplements in Men and Women With Mildly Elevated Triglycerides

Resource links provided by NLM:


Further study details as provided by Arctic Nutrition AS:

Primary Outcome Measures:
  • Area under the curve for plasma phosphatidylcholine omega-3 fatty acids [ Time Frame: pre-dose, 1, 2, 4, 6, 8, 10, 12 hours post-dose ] [ Designated as safety issue: No ]
    The primary outcome variable will be the net incremental area under the curve (niAUC) for plasma phosphatidylcholine (PC) EPA + DHA from pre-meal (t = -0.5 h pre-dose) to 12 h post-dose (niAUC 0-12 h post-dose) measured at visits 2 and 4 (analyzed with and without normalization to the intake of EPA+DHA in each group).


Secondary Outcome Measures:
  • Maximum concentration and Time to maximum concentration for plasma omega-3 phosphatidylcholine fatty acids [ Time Frame: pre-dose, 1, 2, 4, 6, 8, 10, 12 hours post-dose ] [ Designated as safety issue: No ]
    The maximal concentration (Cmax) and time to Cmax (Tmax) for plasma PC EPA + DHA, EPA, DHA, DPA, and EPA + DHA + DPA (analyzed with and without normalization to the intake of EPA, DHA, DPA, and EPA+DHA+DPA in each group) from pre-meal to 12 h post-dose at visits 2 and 4.

  • Area under the curve for plasma phosphatidylcholine omega-3 fatty acids Part 2 [ Time Frame: pre-dose, 1, 2, 4, 6, 8, 10, 12 hours post-dose ] [ Designated as safety issue: No ]
    The niAUC for plasma PC EPA; PC DHA; PC DPA; PC EPA + DHA + DPA from pre-meal (t = -0.5 h pre-dose) to 12 h post-dose (niAUC0-12 h) at visits 2 and 4 (analyzed with and without normalization to the intake of EPA, DHA, DPA, and EPA+DHA+DPA in each group).

  • Plasma sphingomyelin and total plasma phosphatidylcholine [ Time Frame: pre-dose, 0, 1, 2, 4, 6, 8, 10, 12 hours post-dose ] [ Designated as safety issue: No ]
    Plasma sphingomyelin and total plasma PC at visits 2, 3, 4, and 5

  • Fasting plasma lipoprotein lipids [ Time Frame: pre-dose ] [ Designated as safety issue: No ]
    Percent changes from baseline (average of values at visits 1 and 2) to the end of each treatment period (visits 3,4,5) in the following fasting lipoprotein lipids: high-density lipoprotein cholesterol (HDL-C), non-HDL-C, low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), triglycerides, and high sensitivity C reactive protein (hs-CRP).

  • Gastrointestinal (GI) Tolerability Questionnaire [ Time Frame: 0, 12 hours post-dose ] [ Designated as safety issue: No ]
    Ratings from the GI Tolerability Questionnaire

  • Product Acceptability Questionnaire [ Time Frame: 0, 12 hours post-dose ] [ Designated as safety issue: No ]
    Ratings from the Product Acceptability Questionnaire

  • Adverse Events (AE) [ Time Frame: pre-treatment, 0, 12 hours post-dose ] [ Designated as safety issue: Yes ]
    AE assessed at each visit


Estimated Enrollment: 32
Study Start Date: July 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: DHA-rich fish oil
DHA-rich fish oil versus Phospholipid-rich fish oil Fish oil in triglyceride form (12 capsules/d providing 575 mg/d EPA; 1843 mg/d DHA; 259 mg/d n-3 DPA)
Dietary Supplement: DHA-rich fish oil versus Phospholipid-rich fish oil
This randomized, controlled crossover study will include four treatment visits (visits 2, 3, 4, and 5; days 0, 14, 42, and 56). Subjects will be randomly assigned, by sex and age, to their first treatment study product (active or control), which will be administered with a standardized low-choline, DHA-, EPA- free breakfast meal at t = 0 h. Subjects will consume placebo or phospholipid-rich fish oil for two weeks, washed out for 4 weeks, then treatments switched. Blood samples will be obtained for acute measurements on visits 2 and 4, via an indwelling venous catheter or venipuncture at t = 1, 2, 4, 6, 8, 10, and 12 h ± 5 min, to determine plasma fatty acid profile. Chronic fatty acid measurements will be determined after 2 weeks on visits 3 and 5.
Other Names:
  • MOPL(TM)30
  • Marine Omega-3 Phospholipids
  • Herring Caviar Phospholipids
Experimental: Phospholipid-rich fish oil
DHA-rich fish oil versus Phospholipid-rich fish oil Fish roe high in EPA/DHA phospholipids [(12 capsules/d providing 628 mg/d EPA; 1810 mg/d DHA; 137 mg/d n-3 docosapentaenoic acid (DPA)]
Dietary Supplement: DHA-rich fish oil versus Phospholipid-rich fish oil
This randomized, controlled crossover study will include four treatment visits (visits 2, 3, 4, and 5; days 0, 14, 42, and 56). Subjects will be randomly assigned, by sex and age, to their first treatment study product (active or control), which will be administered with a standardized low-choline, DHA-, EPA- free breakfast meal at t = 0 h. Subjects will consume placebo or phospholipid-rich fish oil for two weeks, washed out for 4 weeks, then treatments switched. Blood samples will be obtained for acute measurements on visits 2 and 4, via an indwelling venous catheter or venipuncture at t = 1, 2, 4, 6, 8, 10, and 12 h ± 5 min, to determine plasma fatty acid profile. Chronic fatty acid measurements will be determined after 2 weeks on visits 3 and 5.
Other Names:
  • MOPL(TM)30
  • Marine Omega-3 Phospholipids
  • Herring Caviar Phospholipids

Detailed Description:

The objective of this study is to evaluate and compare the acute and sub-chronic (2 week) bioavailability of EPA and DHA from two marine oil supplements consumed with a meal in men and women with mildly elevated triglycerides. The supplements provide similar amounts of EPA + DHA esterified as either triglycerides; or esterified as phospholipids and triglycerides.

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subject is male or female, 18-59 years of age, inclusive.
  2. Subject has a body mass index (BMI) of ≥18.50 and ≤29.99 kg/m2 at visit 1b (day -7).
  3. Subject has a score of 7 to 10 on the Vein Access Scale at visit 1b (day -7; Appendix 3).
  4. Subject has no health conditions that would prevent him/her from fulfilling the study requirements as judged by the Investigator on the basis of medical history and routine laboratory test results.
  5. Subject has a fasting TG 100-249 mg/dL at visit 1b (day -7). One venous retest allowed if ≥250 mg/dL.
  6. Subject is willing to refrain from consumption of all fish/seafood (including shellfish), foods rich in choline, fatty acid-containing foods and supplements, and/or EPA-, DHA-containing foods and supplements (≤1.0 g/d ) 14 d prior to visit 2 (day 0) and throughout the study (Appendix 1).
  7. Subject is willing to limit alcohol consumption to no more than 1 drink/d following visit 1b (day -7) and throughout the study.
  8. Subject has no plans to change smoking habits during the study period and agrees to abstain from tobacco products for at least 1 h prior to and throughout the duration of the clinic visits [visits 1b, 3 and 5 (days -7, 14 and 56) for up to 2 h; and visits 2 and 4 (days 0 and 42) for up to 14 h].
  9. Subject is willing to comply with fecal collection procedures.
  10. Subject is willing to maintain habitual diet (with the exception of foods to be restricted), physical activity patterns, and body weight throughout the trial.
  11. Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.

Exclusion Criteria:

  1. Subject is male or female, 18-59 years of age, inclusive.
  2. Subject has a body mass index (BMI) of ≥18.50 and ≤29.99 kg/m2 at visit 1b (day -7).
  3. Subject has a score of 7 to 10 on the Vein Access Scale at visit 1b (day -7; Appendix 3).
  4. Subject has no health conditions that would prevent him/her from fulfilling the study requirements as judged by the Investigator on the basis of medical history and routine laboratory test results.
  5. Subject has a fasting TG 100-249 mg/dL at visit 1b (day -7). One venous retest allowed if ≥250 mg/dL.
  6. Subject is willing to refrain from consumption of all fish/seafood (including shellfish), foods rich in choline, fatty acid-containing foods and supplements, and/or EPA-, DHA-containing foods and supplements (≤1.0 g/d ) 14 d prior to visit 2 (day 0) and throughout the study (Appendix 1).
  7. Subject is willing to limit alcohol consumption to no more than 1 drink/d following visit 1b (day -7) and throughout the study.
  8. Subject has no plans to change smoking habits during the study period and agrees to abstain from tobacco products for at least 1 h prior to and throughout the duration of the clinic visits [visits 1b, 3 and 5 (days -7, 14 and 56) for up to 2 h; and visits 2 and 4 (days 0 and 42) for up to 14 h].
  9. Subject is willing to comply with fecal collection procedures.
  10. Subject is willing to maintain habitual diet (with the exception of foods to be restricted), physical activity patterns, and body weight throughout the trial.
  11. Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01908374

Contacts
Contact: Kristen Sanoshy, MPH, RHIA (630) 516-3990 kristen.sanoshy@mxns.com
Contact: Pam Coleman, MBA, CFS (708) 557-8020 pam.coleman@mxns.com

Locations
United States, Illinois
Biofortis Recruiting
Addison, Illinois, United States, 60101
Principal Investigator: Kevin C Maki, Ph. D.         
Sponsors and Collaborators
Arctic Nutrition AS
BioFortis
University of British Columbia
Investigators
Study Director: Kevin C Maki, Ph. D BioFortis
Principal Investigator: Kathleen Kelley, M.D. BioFortis
  More Information

Additional Information:
Publications:

Responsible Party: Arctic Nutrition AS
ClinicalTrials.gov Identifier: NCT01908374     History of Changes
Other Study ID Numbers: PRV-1302
Study First Received: July 19, 2013
Last Updated: July 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Arctic Nutrition AS:
Active-placebo controlled double blind cross over

Additional relevant MeSH terms:
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 15, 2014