A novel self-micro-emulsifying delivery system enhances enrichment of eicosapentaenoic acid and docosahexaenoic acid after single and repeated dosings in healthy adults in a randomized trial

Background A self-micro-emulsifying delivery system (SMEDS) promotes spontaneous emulsification of omega-3 (n–3) ethyl esters (EEs) into microdroplets in the stomach. Objective The objective was to compare the effect of SMEDS preparations of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) EEs with standard EEs on EPA and DHA concentrations in the bloodstream after a single dose and repeated daily dosing. Methods Eighty healthy subjects aged 18–65 y were randomly assigned to SMEDS-EPA or EE-EPA (both providing more EPA than DHA) or SMEDS-DHA or EE-DHA (both providing more DHA than EPA). They consumed a single dose (1.23–1.33 g EPA+DHA) without a meal, and EPA and DHA were measured in plasma over the following 24 h. Participants continued to take a single dose each morning before breakfast for 12 wk. EPA and DHA were measured in fasting plasma, mononuclear cells (MNCs), and RBCs. Results EPA and DHA were higher in plasma in the 24 h after a single dose of SMEDS-EPA or SMEDS-DHA than after consuming the comparator EE (P < 0.001 for both). Compared with the EE form, repeated daily dosing of the SMEDS formulations for 12 wk resulted in higher concentrations of EPA and DHA in plasma (P = 0.086 and 0.005, respectively), MNCs (P < 0.001 and 0.020, respectively), and RBCs (both P < 0.001). The omega-3 index increased over 12 wk from 5.1 ± 0.9 to 7.9 ± 0.9 in the SMEDS-EPA group, from 5.3 ± 1.1 to 9.0 ± 1.2 in the SMEDS-DHA group, from 4.8 ± 0.8 to 6.4 ± 0.9 in the EE-EPA group, and from 5.2 ± 0.9 to 7.2 ± 1.0 in the EE-DHA group (all P < 0.001). The omega-3 index was higher with SMEDS than with the comparator EE at 12 wk (both P < 0.001). Conclusions Compared with standard EEs, a SMEDS results in greater incorporation of EPA and DHA into blood pools after a single dose and with repeated daily dosing in healthy adults. A SMEDS enhances delivery of bioactive ω-3 fatty acids. This trial was registered at www.isrctn.com as ISRCTN96459690

A novel omega-3 glyceride mixture enhances enrichment of eicosapentaenoic acid and docosahexaenoic acid after single dosing in healthy older adults: results from a double-blind crossover trial

A glyceride mix of mono, di, and triglycerides increases solubilisation and enhances emulsification of omega-3 (ω-3) fatty acid (FA) containing lipids in the stomach. This allows for better access of digestive enzymes, pivotal for the release of bioactive ω-3 FA.The objective was to compare the effect of a glyceride formulation and an ethyl ester (EE) formulation of EPA+DHA on concentrations of EPA and DHA in plasma following single dosing.We conducted a double-blind crossover trial in which twenty healthy adults aged 50-70 y consumed a single dose (2.8 g EPA+DHA) of each EPA+DHA formulation without a meal in random order separated by a two-week wash out period. EPA and DHA were measured in plasma total lipid over the following 12 h.EPA and DHA in plasma total lipid increased over 12 h with both formulations. A 10 x greater Δ concentration of EPA, 3 x greater Δ concentration of DHA, and 5 x greater Δ concentration of EPA+DHA was seen with the glyceride-EPA+DHA. The time at which the maximal concentrations of ω-3 FA occurred was 4 h earlier for EPA, 1 h earlier for DHA, and 2 h earlier for EPA+DHA when consuming glyceride-EPA+DHA.A mix of mono, di, and triglycerides results in greater and faster incorporation of EPA and DHA into blood plasma lipid in the absence of a fatty meal. This may provide benefit to individuals on a low fat diet or with digestive impairments and could result in greater efficacy in clinical trials using ω-3 FA