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.
Mol Cell Biochem
; 396(1-2): 9-22, 2014 Nov.
Article
em En
| MEDLINE
| ID: mdl-25185754
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 61 eicosapentaenoic acid-(EPA)docosahexaenoic acid-(DHA) ratio; 61-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 61-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 61-OM3 in CVD subjects improves lipid profiles. The purity, EPADHA ratio and dose are determinant factors for optimal efficacy of a formulation in reducing CVD risk factors.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Doenças Cardiovasculares
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Ácidos Graxos Ômega-3
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Suplementos Nutricionais
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Deficiências Nutricionais
Tipo de estudo:
Clinical_trials
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Etiology_studies
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Risk_factors_studies
Limite:
Adult
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Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Mol Cell Biochem
Ano de publicação:
2014
Tipo de documento:
Article