A randomized double-blind trial to measure the absorption characteristics of eicosapentaenoic acid and docosahexaenoic acid rich oil blend with natural lipid-based delivery system

一项随机双盲试验,用于测量富含二十碳五烯酸和二十二碳六烯酸的油混合物与天然脂质输送系统的吸收特性

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作者:Jennifer Chuang, David Briskey, Jennifer Dang, Arun Rajgopal, Amanda Rao

Abstract

A randomized, double-blinded trial with 65 subjects was conducted to compare the pharmacokinetics between PhytoMarineCelle (PM) that consists of eicosapentaenoic acid and docosahexaenoic acid (EPA + DHA) plus a self-emulsifying drug delivery system (SEDDS), and a standard EPA + DHA ethyl ester (SEE) that does not contain SEDDS. PM showed 1.6-fold greater plasma area under the curve (AUC) than SEE at 300 mg, although no significant difference was observed. PM showed a 3.1 and 3.2-fold (p < 0.05) greater plasma AUC than SEE at 500 mg and 1000 mg respectively. The concentration max (Cmax) of EPA + DHA did not change between PM and SEE at 300 mg. Cmax of PM was twofold greater than SEE at 500 mg and 1000 mg respectively. The Cmax of EPA + DHA achieved significant difference (p < 0.05) only with the 500 mg dose. The PM formulation increased the bioavailability of EPA + DHA by threefold compared to SEE at 500 and 1000 mg.

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