title: Safety and lipid-altering efficacy of a new omega-3 fatty acid and antioxidant-containing medical food in men and women with elevated triacylglycerols.
abstract: 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.
authors.affiliation: Midwest Center for Metabolic and Cardiovascular Research, Glen Ellyn, IL formerly with Biofortis Clinical Research, Addison, IL, USA. Electronic address: kmaki@mc-mcr.com.
authors.forename: K C
authors.initials: KC
authors.lastname: Maki
authors.affiliation: Evanston Premier Healthcare Research, Evanston, IL, USA.
authors.forename: J G
authors.initials: JG
authors.lastname: Geohas
authors.affiliation: Midwest Center for Metabolic and Cardiovascular Research, Glen Ellyn, IL formerly with Biofortis Clinical Research, Addison, IL, USA.
authors.forename: M R
authors.initials: MR
authors.lastname: Dicklin
authors.affiliation: ClinData Services, Inc., Fort Collins, CO, USA.
authors.forename: M
authors.initials: M
authors.lastname: Huebner
authors.affiliation: Medicus Research, LLC, Agoura Hills, CA, USA.
authors.forename: J K
authors.initials: JK
authors.lastname: Udani
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000975:Antioxidants / Q000627:therapeutic use*; D001055:Apolipoproteins B / Q000378:metabolism; D001835:Body Weight; D008076:Cholesterol, HDL / Q000378:metabolism; D008078:Cholesterol, LDL / Q000378:metabolism; D004311:Double-Blind Method; D004435:Eating; D015525:Fatty Acids, Omega-3 / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D015228:Hypertriglyceridemia / Q000188:drug therapy* / Q000378:metabolism / Q000503:physiopathology; D050356:Lipid Metabolism; D008077:Lipoproteins, LDL / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D014280:Triglycerides / Q000378:metabolism*; D055986:Vital Signs
chemical_list: D000975:Antioxidants; D001055:Apolipoproteins B; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D015525:Fatty Acids, Omega-3; D008077:Lipoproteins, LDL; D014280:Triglycerides; C099252:oxidized low density lipoprotein
keywords: Antioxidants; High-density lipoprotein cholesterol; Hyperlipidemia; Hypertriglyceridemia; Omega-3 fatty acids; Oxidized low-density lipoprotein