title: Efficacy of a unique omega-3 formulation on the correction of nutritional deficiency and its effects on cardiovascular disease risk factors in a randomized controlled VASCAZEN(®) REVEAL Trial.
abstract: Low blood levels of long chain omega-3 polyunsaturated fatty acids (LC n-3 PUFA) have been reported to be associated with increased risk for cardiovascular disease (CVD) deaths. Systematic studies measuring LC n-3 PUFA blood levels (pre and post-treatment) in defined subjects, and monitoring the correction of nutritional deficiency with a pure LC n-3 PUFA formulation in sufficient doses, while monitoring CVD risk factors are lacking. We tested the efficacy of a novel LC n-3 PUFA Medical Food formulation (VASCAZEN(®), > 90 % pure with a 6:1 eicosapentaenoic acid-(EPA):docosahexaenoic acid-(DHA) ratio; 6:1-OM3), to correct such deficiency and determine the concomitant effects on lipid profiles. Of 655 subjects screened, 89 % were LC n-3 PUFA deficient (Omega-Score, (OS) = blood EPA + DHA + Docosapentaenoic acid < 6.1 %). From these, a study was conducted on 110 ambulatory cardiovascular subjects. Placebo: corn oil. Primary endpoint: change in OS. Secondary endpoint: changes in blood lipid profiles. At 8 weeks of treatment with 6:1-OM3 (4 g/day), placebo-adjusted median OS levels (n = 56) significantly improved (132 %, P < 0.0001) with a decrease in AA (arachidonic acid): EPA ratio (82 %, P < 0.0001). In hypertriglyceridemic subjects (TG 2.26-5.65 mmol/L), HDL-C improved (9 %, P = 0.0069), TG-reduced (48 %, P < 0.0001), and VLDL-C reduced (30 %, P = 0.0023), without significantly affecting LDL-C levels. This study confirms that LC n-3 PUFA deficiency is prevalent in the US population, and its correction with 6:1-OM3 in CVD subjects improves lipid profiles. The purity, EPA:DHA ratio and dose are determinant factors for optimal efficacy of a formulation in reducing CVD risk factors.
authors.affiliation: University of Toronto, 6190 Tremaine court, Mississauga, ON, L5V 1B5, Canada, nshaikh6190@rogers.com.
authors.forename: Nisar A
authors.initials: NA
authors.lastname: Shaikh
authors.forename: Jason
authors.initials: J
authors.lastname: Yantha
authors.forename: Sabah
authors.initials: S
authors.lastname: Shaikh
authors.forename: William
authors.initials: W
authors.lastname: Rowe
authors.forename: Maggie
authors.initials: M
authors.lastname: Laidlaw
authors.forename: Carla
authors.initials: C
authors.lastname: Cockerline
authors.forename: Abbas
authors.initials: A
authors.lastname: Ali
authors.forename: Bruce
authors.initials: B
authors.lastname: Holub
authors.forename: George
authors.initials: G
authors.lastname: Jackowski
mesh_terms: D000328:Adult; D000368:Aged; D016718:Arachidonic Acid / Q000097:blood; D002318:Cardiovascular Diseases / Q000178:diet therapy* / Q000517:prevention & control; D003677:Deficiency Diseases / Q000178:diet therapy*; D019587:Dietary Supplements; D004281:Docosahexaenoic Acids / Q000097:blood / Q000494:pharmacology; D015118:Eicosapentaenoic Acid / Q000097:blood / Q000494:pharmacology; D015525:Fatty Acids, Omega-3 / Q000009:adverse effects / Q000097:blood* / Q000494:pharmacology*; D005231:Fatty Acids, Unsaturated / Q000097:blood; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012307:Risk Factors; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood
chemical_list: D015525:Fatty Acids, Omega-3; D005231:Fatty Acids, Unsaturated; D014280:Triglycerides; C000601813:VASCAZEN; D004281:Docosahexaenoic Acids; D016718:Arachidonic Acid; D015118:Eicosapentaenoic Acid; C026219:docosapentaenoic acid