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| Name | Class |
|---|---|
| BioFortis | OTHER |
| University of British Columbia | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DHA-rich fish oil | Active Comparator | 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) |
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| Phospholipid-rich fish oil | Experimental | 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)] |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DHA-rich fish oil versus Phospholipid-rich fish oil | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | pre-dose, 1, 2, 4, 6, 8, 10, 12 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | pre-dose, 1, 2, 4, 6, 8, 10, 12 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristen Sanoshy, MPH, RHIA | Contact | (630) 516-3990 | kristen.sanoshy@mxns.com | |
| Pam Coleman, MBA, CFS | Contact | (708) 557-8020 | pam.coleman@mxns.com |
| Name | Affiliation | Role |
|---|---|---|
| Kevin C Maki, Ph. D | BioFortis | Study Director |
| Kathleen Kelley, M.D. | BioFortis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biofortis | Recruiting | Addison | Illinois | 60101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21291831 | Background | 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. | |
| 23312053 |
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| ID | Term |
|---|---|
| D015228 | Hypertriglyceridemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| 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). | 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 | 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). | pre-dose |
| Gastrointestinal (GI) Tolerability Questionnaire | Ratings from the GI Tolerability Questionnaire | 0, 12 hours post-dose |
| Product Acceptability Questionnaire | Ratings from the Product Acceptability Questionnaire | 0, 12 hours post-dose |
| Adverse Events (AE) | AE assessed at each visit | pre-treatment, 0, 12 hours post-dose |
| 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. |
| 9280188 | Background | 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. |
| 19854375 | Background | 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. |
| 21502576 | Background | 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. |
| 10799369 | Background | 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. |
| 21854650 | Background | 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. |
| 21042875 | Background | 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. |
| D009750 |
| Nutritional and Metabolic Diseases |