A Novel Emulsion Gel Formulation Improves the Bioavailability of DHA in Healthy Adults: A Randomized Controlled Clinical Study

Docosahexaenoic acid (DHA) is an omega-3 long-chain polyunsaturated fatty acid (LCPUFA), playing roles structurally and functionally from growth to health and the pathogenesis of diseases. Being a common nutrient supplement, the bioavailability of DHA is practically important. This study assessed the bioavailability of DHA after oral administration of emulsified DHA Gel Tablet, which was developed and manufactured by SIRIO and non-emulsified DHA algal oil in healthy individuals. The protocol was designed as a randomized, open, parallel clinical study. 19 healthy adults between 23 and 40 years old were randomly assigned into two groups receiving equal doses (300 mg) but different forms of DHA (DHA Gel Tablet, n = 10; DHA algal oil, n=9) in a fasting state. The blood was sampled at 0, 1, 2, 2.5, 3, 3.5, 4, 5, and 6 hours after ingestion. Free DHA in plasma was measured by liquid chromatography with LC-MS/MS. The maximum plasma concentration (Cmax), the time to maximum concentration (Tmax), and the area under the curve (AUC0-6) were calculated from the measurements of free DHA. Compared with the DHA algal oil, the DHA Gel Tablet exhibited a higher Cmax (0.772 ± 0.556 vs 0.308 ± 0.186 g/ml, P= 0.0293) and greater AUC0-6 (1.611 ± 1.366 vs 0.550 ± 0.311 g/ml*h, P =0.0491). The pharmacokinetic results showed that the Cmax and AUC of the DHA Gel Tablet were 2.506 times higher and 2.929 times larger, indicating higher bioavailability of DHA treated with the emulsion technology. No side effects were observed in either group.