Bioavailability of EPA and DHA From Two Dietary Supplements

Not Applicable

• Conditions: Hypertriglyceridemia
• Interventions: Dietary Supplement: DHA-rich fish oil versus Phospholipid-rich fish oil

• Registration Number: NCT01908374
• Lead Sponsor: Arctic Nutrition AS

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.

Study Timeline

• Status Verified: 2013-07
• Study Start: 2013-07
• Study First Submitted: 2013-07-19
• Study First Submitted QC: 2013-07-23
• Last Update Submitted: 2013-07-23
• Study First Posted: 2013-07-25
• Last Update Posted: 2013-07-25
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
DHA-rich fish oil	DHA-rich fish oil versus Phospholipid-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)
Phospholipid-rich fish oil	DHA-rich fish oil versus Phospholipid-rich fish oil	DHA-rich fish oil versus Phospholipid-rich fish oil Fish roe high in EPA/DHA phospholipids \[(12 capsules/d providing 628 mg/d EPA; 1810 mg/d DHA; 137 mg/d n-3 docosapentaenoic acid (DPA)\]

Primary Outcome Measures

Name	Time	Method
Area under the curve for plasma phosphatidylcholine omega-3 fatty acids	pre-dose, 1, 2, 4, 6, 8, 10, 12 hours post-dose	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

Name	Time	Method
Fasting plasma lipoprotein lipids	pre-dose	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).
Product Acceptability Questionnaire	0, 12 hours post-dose	Ratings from the Product Acceptability Questionnaire
Plasma sphingomyelin and total plasma phosphatidylcholine	pre-dose, 0, 1, 2, 4, 6, 8, 10, 12 hours post-dose	Plasma sphingomyelin and total plasma PC at visits 2, 3, 4, and 5
Area under the curve for plasma phosphatidylcholine omega-3 fatty acids Part 2	pre-dose, 1, 2, 4, 6, 8, 10, 12 hours post-dose	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).
Maximum concentration and Time to maximum concentration for plasma omega-3 phosphatidylcholine fatty acids	pre-dose, 1, 2, 4, 6, 8, 10, 12 hours post-dose	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.
Gastrointestinal (GI) Tolerability Questionnaire	0, 12 hours post-dose	Ratings from the GI Tolerability Questionnaire
Adverse Events (AE)	pre-treatment, 0, 12 hours post-dose	AE assessed at each visit

Trial Locations

Locations (1)

Biofortis; 🇺🇸 Addison, Illinois, United States