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Bioavailability of EPA and DHA From Two Dietary Supplements

Primary Purpose

Hypertriglyceridemia

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

DHA-rich fish oil versus Phospholipid-rich fish oil

About this trial

This is an interventional treatment trial for Hypertriglyceridemia focused on measuring Active-placebo controlled double blind cross over

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Subject is male or female, 18-59 years of age, inclusive.
Subject has a body mass index (BMI) of ≥18.50 and ≤29.99 kg/m2 at visit 1b (day -7).
Subject has a score of 7 to 10 on the Vein Access Scale at visit 1b (day -7; Appendix 3).
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.
Subject has a fasting TG 100-249 mg/dL at visit 1b (day -7). One venous retest allowed if ≥250 mg/dL.
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).
Subject is willing to limit alcohol consumption to no more than 1 drink/d following visit 1b (day -7) and throughout the study.
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].
Subject is willing to comply with fecal collection procedures.
Subject is willing to maintain habitual diet (with the exception of foods to be restricted), physical activity patterns, and body weight throughout the trial.
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:

Subject is male or female, 18-59 years of age, inclusive.
Subject has a body mass index (BMI) of ≥18.50 and ≤29.99 kg/m2 at visit 1b (day -7).
Subject has a score of 7 to 10 on the Vein Access Scale at visit 1b (day -7; Appendix 3).
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.
Subject has a fasting TG 100-249 mg/dL at visit 1b (day -7). One venous retest allowed if ≥250 mg/dL.
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).
Subject is willing to limit alcohol consumption to no more than 1 drink/d following visit 1b (day -7) and throughout the study.
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].
Subject is willing to comply with fecal collection procedures.
Subject is willing to maintain habitual diet (with the exception of foods to be restricted), physical activity patterns, and body weight throughout the trial.
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.

Sites / Locations

BiofortisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

DHA-rich fish oil

Phospholipid-rich fish oil

Arm Description

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)

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)]

Outcomes

Primary Outcome Measures

Area under the curve for plasma phosphatidylcholine omega-3 fatty acids

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

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

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

Plasma sphingomyelin and total plasma PC at visits 2, 3, 4, and 5

Fasting plasma lipoprotein lipids

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

Ratings from the GI Tolerability Questionnaire

Product Acceptability Questionnaire

Ratings from the Product Acceptability Questionnaire

Adverse Events (AE)

AE assessed at each visit

Full Information

NCT ID

NCT01908374

First Posted

July 19, 2013

Last Updated

July 23, 2013

Sponsor

Arctic Nutrition AS

Collaborators

BioFortis, University of British Columbia

1. Study Identification

Unique Protocol Identification Number

NCT01908374

Brief Title

Bioavailability of EPA and DHA From Two Dietary Supplements

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

Unknown status

Study Start Date

July 2013 (undefined)

Primary Completion Date

December 2013 (Anticipated)

Study Completion Date

December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Arctic Nutrition AS

Collaborators

BioFortis, University of British Columbia

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertriglyceridemia

Keywords

Active-placebo controlled double blind cross over

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

DHA-rich fish oil

Arm Type

Active Comparator

Arm Description

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)

Arm Title

Phospholipid-rich fish oil

Arm Type

Experimental

Arm Description

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)]

Intervention Type

Dietary Supplement

Intervention Name(s)

DHA-rich fish oil versus Phospholipid-rich fish oil

Other Intervention Name(s)

MOPL(TM)30, Marine Omega-3 Phospholipids, Herring Caviar Phospholipids

Intervention Description

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.

Primary Outcome Measure Information:

Title

Area under the curve for plasma phosphatidylcholine omega-3 fatty acids

Description

Time Frame

pre-dose, 1, 2, 4, 6, 8, 10, 12 hours post-dose

Secondary Outcome Measure Information:

Title

Maximum concentration and Time to maximum concentration for plasma omega-3 phosphatidylcholine fatty acids

Description

Time Frame

pre-dose, 1, 2, 4, 6, 8, 10, 12 hours post-dose

Title

Area under the curve for plasma phosphatidylcholine omega-3 fatty acids Part 2

Description

Time Frame

pre-dose, 1, 2, 4, 6, 8, 10, 12 hours post-dose

Title

Plasma sphingomyelin and total plasma phosphatidylcholine

Description

Plasma sphingomyelin and total plasma PC at visits 2, 3, 4, and 5

Time Frame

pre-dose, 0, 1, 2, 4, 6, 8, 10, 12 hours post-dose

Title

Fasting plasma lipoprotein lipids

Description

Time Frame

pre-dose

Title

Gastrointestinal (GI) Tolerability Questionnaire

Description

Ratings from the GI Tolerability Questionnaire

Time Frame

0, 12 hours post-dose

Title

Product Acceptability Questionnaire

Description

Ratings from the Product Acceptability Questionnaire

Time Frame

0, 12 hours post-dose

Title

Adverse Events (AE)

Description

AE assessed at each visit

Time Frame

pre-treatment, 0, 12 hours post-dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

59 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject is male or female, 18-59 years of age, inclusive. Subject has a body mass index (BMI) of ≥18.50 and ≤29.99 kg/m2 at visit 1b (day -7). Subject has a score of 7 to 10 on the Vein Access Scale at visit 1b (day -7; Appendix 3). 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. Subject has a fasting TG 100-249 mg/dL at visit 1b (day -7). One venous retest allowed if ≥250 mg/dL. 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). Subject is willing to limit alcohol consumption to no more than 1 drink/d following visit 1b (day -7) and throughout the study. 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]. Subject is willing to comply with fecal collection procedures. Subject is willing to maintain habitual diet (with the exception of foods to be restricted), physical activity patterns, and body weight throughout the trial. 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: Subject is male or female, 18-59 years of age, inclusive. Subject has a body mass index (BMI) of ≥18.50 and ≤29.99 kg/m2 at visit 1b (day -7). Subject has a score of 7 to 10 on the Vein Access Scale at visit 1b (day -7; Appendix 3). 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. Subject has a fasting TG 100-249 mg/dL at visit 1b (day -7). One venous retest allowed if ≥250 mg/dL. 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). Subject is willing to limit alcohol consumption to no more than 1 drink/d following visit 1b (day -7) and throughout the study. 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]. Subject is willing to comply with fecal collection procedures. Subject is willing to maintain habitual diet (with the exception of foods to be restricted), physical activity patterns, and body weight throughout the trial. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kristen Sanoshy, MPH, RHIA

Phone

(630) 516-3990

kristen.sanoshy@mxns.com

First Name & Middle Initial & Last Name or Official Title & Degree

Pam Coleman, MBA, CFS

Phone

(708) 557-8020

pam.coleman@mxns.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kevin C Maki, Ph. D

Organizational Affiliation

BioFortis

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Kathleen Kelley, M.D.

Organizational Affiliation

BioFortis

Official's Role

Principal Investigator

Facility Information:

Facility Name

Biofortis

City

Addison

State/Province

Illinois

ZIP/Postal Code

60101

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kevin C Maki, Ph. D.

12. IPD Sharing Statement

Citations:

PubMed Identifier

21291831

Citation

Davidson MH, Maki KC, Bays H, Carter R, Ballantyne CM. Effects of prescription omega-3-acid ethyl esters on lipoprotein particle concentrations, apolipoproteins AI and CIII, and lipoprotein-associated phospholipase A(2) mass in statin-treated subjects with hypertriglyceridemia. J Clin Lipidol. 2009 Oct;3(5):332-40. doi: 10.1016/j.jacl.2009.08.001. Epub 2009 Aug 31.

Results Reference

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PubMed Identifier

23312053

Citation

Davidson MH, Johnson J, Rooney MW, Kyle ML, Kling DF. A novel omega-3 free fatty acid formulation has dramatically improved bioavailability during a low-fat diet compared with omega-3-acid ethyl esters: the ECLIPSE (Epanova((R)) compared to Lovaza((R)) in a pharmacokinetic single-dose evaluation) study. J Clin Lipidol. 2012 Nov-Dec;6(6):573-84. doi: 10.1016/j.jacl.2012.01.002. Epub 2012 Jan 24.

Results Reference

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PubMed Identifier

9280188

Citation

Grimsgaard S, Bonaa KH, Hansen JB, Nordoy A. Highly purified eicosapentaenoic acid and docosahexaenoic acid in humans have similar triacylglycerol-lowering effects but divergent effects on serum fatty acids. Am J Clin Nutr. 1997 Sep;66(3):649-59. doi: 10.1093/ajcn/66.3.649.

Results Reference

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PubMed Identifier

19854375

Citation

Maki KC, Reeves MS, Farmer M, Griinari M, Berge K, Vik H, Hubacher R, Rains TM. Krill oil supplementation increases plasma concentrations of eicosapentaenoic and docosahexaenoic acids in overweight and obese men and women. Nutr Res. 2009 Sep;29(9):609-15. doi: 10.1016/j.nutres.2009.09.004.

Results Reference

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PubMed Identifier

21502576

Citation

Miller M, Stone NJ, Ballantyne C, Bittner V, Criqui MH, Ginsberg HN, Goldberg AC, Howard WJ, Jacobson MS, Kris-Etherton PM, Lennie TA, Levi M, Mazzone T, Pennathur S; American Heart Association Clinical Lipidology, Thrombosis, and Prevention Committee of the Council on Nutrition, Physical Activity, and Metabolism; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular Nursing; Council on the Kidney in Cardiovascular Disease. Triglycerides and cardiovascular disease: a scientific statement from the American Heart Association. Circulation. 2011 May 24;123(20):2292-333. doi: 10.1161/CIR.0b013e3182160726. Epub 2011 Apr 18. No abstract available.

Results Reference

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PubMed Identifier

10799369

Citation

Mori TA, Burke V, Puddey IB, Watts GF, O'Neal DN, Best JD, Beilin LJ. Purified eicosapentaenoic and docosahexaenoic acids have differential effects on serum lipids and lipoproteins, LDL particle size, glucose, and insulin in mildly hyperlipidemic men. Am J Clin Nutr. 2000 May;71(5):1085-94. doi: 10.1093/ajcn/71.5.1085.

Results Reference

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PubMed Identifier

21854650

Citation

Schuchardt JP, Schneider I, Meyer H, Neubronner J, von Schacky C, Hahn A. Incorporation of EPA and DHA into plasma phospholipids in response to different omega-3 fatty acid formulations--a comparative bioavailability study of fish oil vs. krill oil. Lipids Health Dis. 2011 Aug 22;10:145. doi: 10.1186/1476-511X-10-145.

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PubMed Identifier

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Citation

Ulven SM, Kirkhus B, Lamglait A, Basu S, Elind E, Haider T, Berge K, Vik H, Pedersen JI. Metabolic effects of krill oil are essentially similar to those of fish oil but at lower dose of EPA and DHA, in healthy volunteers. Lipids. 2011 Jan;46(1):37-46. doi: 10.1007/s11745-010-3490-4. Epub 2010 Nov 2.

Results Reference

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Bioavailability of EPA and DHA From Two Dietary Supplements

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