Supplementary file 2_Enhanced bioavailability and short-term safety of a micellar green tea extract formulation co-delivered with N-acetylcysteine: a randomized crossover study in healthy adults.docx

To address these challenges, this study investigated the pharmacokinetics, safety, and tolerability of LipoMicel^® GTNAC^® (LGT), a novel lipid-based green tea extract formulation co- delivered with N-acetylcysteine (NAC), compared with a standard green tea formulation (SGT) in healthy adults.</p>Methods<p>The study comprised two parts: a randomized, double-blind, crossover pharmacokinetic trial in 16 healthy adults comparing LGT 330 mg with SGT 330 mg and SGT 660 mg, followed by a 30-day open-label, single-arm safety study evaluating LGT 1,320 mg/day in 13 participants.</p>Results<p>For EGCG, LGT significantly increased baseline-adjusted systemic exposure compared with dose-matched SGT, producing a 4.2-fold higher iAUC₀–₂₄ (1857 ± 1,479 vs. 443 ± 1,570 ng·h/mL; p = 0.032) and a 3.0-fold higher iC_max (267 ± 235 vs. 88.6 ± 60.0 ng/mL; p = 0.037).

No clinically significant adverse events or clinically meaningful changes in blood chemistry were observed during the 30-day safety phase.</p>Conclusion<p>These findings demonstrate that LGT significantly enhances systemic EGCG exposure while remaining well tolerated for over 30 days in healthy adults. Larger and longer-term studies are warranted to determine whether improved EGCG exposure translates into clinically meaningful health benefits.</p>Clinical trial registration<p>clinicaltrials.gov/, registration number NCT06971536.</p>