Safety and lipid-altering efficacy of a new omega-3 fatty acid and antioxidant-containing medical food in men and women with elevated triacylglycerols

•PDL-0101 contains EPA+astaxanthin and γ/δ-tocotrienols, including geranylgeraniol.•This was a randomized, double-blind, controlled trial in adults with elevated TAG.•Eight-week treatment with PDL-0101 significantly reduced TAG vs. placebo.•LDL-C, HDL-C, and oxidized LDL were not significantly altered with PDL-0101.•PDL-0101 is an effective medical food for the management of elevated TAG.

This randomized, double-blind, placebo-controlled multi-center trial investigated the lipid-altering effects of a medical food (PDL-0101) providing 1.8 g/d eicosapentaenoic acid; 12 mg/d astaxanthin, a marine algae-derived carotenoid; and 100 mg/d tocopherol-free gamma/delta tocotrienols enriched with geranylgeraniol, extracted from annatto, on triacylglycerols (TAG), other lipoprotein lipids, and oxidized low-density lipoprotein (LDL) in 102 subjects with TAG 150-499 mg/dL (1.69-5.63 mmol/L) and LDL cholesterol (LDL-C) ≥70 mg/dL (1.81 mmol/L). Compared to placebo, after eight weeks of treatment, PDL-0101 significantly reduced median TAG (−9.5% vs. 10.6%, p<0.001), while not significantly altering mean LDL-C (−3.0% vs. −8.0% for PDL-0101 and placebo, respectively, p=0.071), mean high-density lipoprotein cholesterol (~3% decrease in both groups, p=0.732), or median oxidized LDL concentrations (5% vs. −5% for PDL-0101 and placebo, respectively, p=0.112). These results demonstrate that PDL-0101 is an effective medical food for the management of elevated TAG.