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Effects of an Eicosapentaenoic Acid and Antioxidant‐Containing Medical Food in Hypertriglyceridemia Management
Author(s) -
Maki Kevin,
Geohas Jeffrey,
Dicklin Mary,
Huebner Marjorie,
Udani Jay
Publication year - 2015
Publication title -
the faseb journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.709
H-Index - 277
eISSN - 1530-6860
pISSN - 0892-6638
DOI - 10.1096/fasebj.29.1_supplement.259.1
Subject(s) - eicosapentaenoic acid , hypertriglyceridemia , placebo , medicine , lipoprotein , apolipoprotein b , docosahexaenoic acid , high density lipoprotein , placebo controlled study , chemistry , food science , endocrinology , cholesterol , zoology , gastroenterology , polyunsaturated fatty acid , biochemistry , fatty acid , triglyceride , biology , double blind , alternative medicine , pathology
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 gamma/delta tocotrienol enriched with geranylgeraniol, extracted from annatto, on triglycerides (TG), other lipoprotein lipids, and oxidized low‐density lipoprotein (LDL) in subjects with hypertriglyceridemia. Participants included 102 predominantly Caucasian (72%) men (57%) and women with mean age 51.8 y, mean body mass index 31.2 kg/m 2 , TG 150‐499 mg/dL and LDL cholesterol (LDL‐C) 蠅70 mg/dL. Compared to placebo, after 8 wks of treatment, PDL‐0101 significantly lowered median TG (‐9.5% vs. 10.6% for PDL‐0101 and placebo, respectively, p < 0.001), while not significantly altering mean LDL‐C (‐3.0% vs. ‐8.0% PDL‐0101 and placebo, respectively, p = 0.071), mean high‐density lipoprotein cholesterol (HDL‐C; ~3% decrease in both, p = 0.732), or median oxidized LDL (5% vs. ‐5% PDL‐0101 and placebo, respectively, p = 0.112). PDL‐0101 was also more effective for lowering TG in the subset with TG 蠅200 mg/dL (‐12.7% vs. 9.8% PDL‐0101 and placebo, respectively, p < 0.001). There were no significant differences in responses to treatment in total‐C, non‐HDL‐C, or apolipoprotein B. These results demonstrate that PDL‐0101 is a well‐tolerated and effective medical food for managing elevated TG. Funded by Primus Pharmaceuticals, Inc. (Scottsdale, AZ) and Designs for Health, Inc. (Suffield, CT).