Bioavailability of EPA and DHA From Two Dietary Supplements



Status:Completed
Conditions:High Cholesterol, Metabolic
Therapuetic Areas:Cardiology / Vascular Diseases, Pharmacology / Toxicology
Healthy:No
Age Range:18 - 59
Updated:4/2/2016
Start Date:July 2013
End Date:December 2013
Contact:Kristen Sanoshy, MPH, RHIA
Email:kristen.sanoshy@mxns.com
Phone:(630) 516-3990

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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

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.

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.

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.
We found this trial at
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Addison, Illinois 60101
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Addison, IL
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