Health benefits of n-3 (Omega-3) polyunsaturated fatty acids are well studied. A self-emulsifying drug delivery system (SEDDS) is expected to improve n-3 polyunsaturated fatty acids absorption. The present study investigated how a single ingestion of a new SEDDS containing triglyceride form of docosahexaenoic acid (DHA/TG) would affect the plasma DHA level in healthy participants. Fifteen healthy participants (Age 20–65 years old, BMI, 18.5–25 kg/m²) were enrolled in this randomized, double-blind, crossover study. Participants in a fasting state consumed a single dose of 920 mg DHA and 80 mg eicosapentaenoic acid (EPA) in SEDDS soft capsules (SEDDS capsule) or non-emulsifying soft capsules (control capsule). Blood was sampled at 0, 1.5, 3, 5, 7, and 9 h after dosing. The primary outcome was the baseline-adjusted incremental area under the curve (AUC) for plasma DHA levels (iAUC_DHA). The iAUC_DHA were significantly higher for the SEDDS capsule (147.9 ± 15.8 µg · h/mL) than for the control capsule (106.4 ± 18.1 µg · h/mL) (P = 0.018, SEDDS/control ratio, 1.4). Although plasma EPA levels and iAUC values did not significantly differ between the SEDDS and control capsules. Cmax was significantly higher with the SEDDS capsule for both DHA (P = 0.019) and EPA (P = 0.012) than with the control capsule. These results suggest that SEDDS improves the absorbability of DHA/TG in healthy participants. This indicates that SEDDS capsules would be beneficial for efficient ingestion of DHA. This trial was registered at the University Hospital Medical Information Network Clinical Trials Registry as UMIN000044188 (https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050425).

Objectives: To assess the effects of agrimol-containing Agrimonia pilosa Ledeb. extract (APE) for senescent immune cell removal in middle-aged Japanese adults with immunosenescence. Design and Setting: A randomized, double-blind, placebo-controlled, parallel-group study was conducted in Japan between June 2023 and April 2024. Participants: 110 individuals aged 40–59, selected based on CD8+ T cells with highly-expressing-senescence-associated-β-galactosidase (SA-βGal). Intervention: Participants were randomly assigned to receive 50 mg APE containing 0.2 mg of agrimols or a placebo for eight consecutive weeks. Measurements: The primary endpoint was the change in the proportion of CD8+ T cells with high SA-βGal expression at 8 weeks of intake from the baseline. The secondary endpoints included the proportion of CD4+ T cells with high SA-βGal expression, CD4+ and CD8+ T cell subsets, and the ratio of various immune cells. Results: Of the 635 subjects screened, 110 with immunosenescence were included in this study. In total, 55 participants in the placebo group and 53 in the APE group completed the intervention. There were no statistically significant changes in either the primary or secondary endpoints due to APE intake. In the male population, the proportion of CD8+ T cells with high SA-βGal expression was reduced by APE intake (p = 0.044). Furthermore, the proportion of naïve CD8+ T cells increased and the number of effector memory CD8+ T cells decreased with the consumption of APE. Conclusions: APE was suggested to reduce senescent immune cells, indicating its potential as a candidate senolytic agent for humans; however, the results of this study are preliminary data, and further research on APE is needed (clinical trial registration: UMIN000051574).