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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
32
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.
Biofortis
Addison, Illinois, United States
RECRUITINGArea 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).
Time frame: pre-dose, 1, 2, 4, 6, 8, 10, 12 hours post-dose
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.
Time frame: pre-dose, 1, 2, 4, 6, 8, 10, 12 hours post-dose
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).
Time frame: pre-dose, 1, 2, 4, 6, 8, 10, 12 hours post-dose
Plasma sphingomyelin and total plasma phosphatidylcholine
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
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).
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Time frame: pre-dose
Gastrointestinal (GI) Tolerability Questionnaire
Ratings from the GI Tolerability Questionnaire
Time frame: 0, 12 hours post-dose
Product Acceptability Questionnaire
Ratings from the Product Acceptability Questionnaire
Time frame: 0, 12 hours post-dose
Adverse Events (AE)
AE assessed at each visit
Time frame: pre-treatment, 0, 12 hours post-dose