Abstract
BackgroundMetabolic syndrome (MetS) refers to clustered cardiovascular risk factors (abdominal obesity, pre-diabetes, high blood pressure, dyslipidaemia). Therapies targeting oxidative stress may delay progression to atherosclerosis and diabetes. We investigated the anti-oxidative effect of a supplement combining red yeast rice and olive extract in patients with MetS.MethodsA double-blind, placebo-controlled, randomised trial was conducted with 50 patients with MetS as defined by National Cholesterol Education Program Adult Treatment Panel III criteria. Forty-nine subjects randomly assigned to red yeast rice-olive extract (RYR-olive extract; 10.82 mg of monacolins and 9.32 mg of hydroxytyrosol per Cholesfytolplus capsule) or placebo completed the 8-week trial. Whereas effects on cardiovascular risk parameters of MetS have been reported recently, the observed significant 20% increase in oxidised low-density lipoprotein (OxLDL) prompted us to investigate other oxidative stress-related parameters: malondialdehyde (MDA), lipoprotein-associated phospholipase A2 (Lp-PLA2) and 8-hydroxy-2′-deoxyguanosine (8-OHdG). Statistical calculations included univariate quantitative analysis, multivariate linear regression and correlation analysis.ResultsThe updated results indicate that an RYR-olive extract supplement significantly reduced Lp-PLA2 by 7% (p < 0.001), but it failed to show a significant decrease in plasma MDA and 8-OHdG (p > 0.05). Reductions in OxLDL (20%) and Lp-PLA2 (7%) were associated with each other (r = 0.740, p < 0.001).ConclusionsRYR-olive extract significantly reduced Lp-PLA2 in correlation with the marked reduction in plasma OxLDL, which may lead to a reduced risk for cardiovascular disease in patients with MetS.Trial registrationClinicalTrials.gov identifier: NCT02065180. Registered on 13 February 2014.
Highlights
Metabolic syndrome (MetS) refers to clustered cardiovascular risk factors
Plasma oxidised low-density lipoprotein (OxLDL) was significantly reduced in the red yeast rice (RYR)-olive extract-treated group compared with the placebo group (p < 0.001)
A relative reduction of OxLDL of 20% was observed in patients receiving RYR-olive extract (p < 0.001) [27]
Summary
A double-blind, placebo-controlled, randomised trial was conducted with 50 patients with MetS as defined by National Cholesterol Education Program Adult Treatment Panel III criteria. A double-blind, placebo-controlled, randomised trial was conducted with 50 patients enrolled at the University of Antwerp. The sample size calculation was based on SD values in previous studies, and we determined that a minimum of 40 patients would be needed to establish an LDL cholesterol reduction of 15% between the intervention and control groups (power 0.80, significance level 0.05). Participants had MetS according to National Cholesterol Education Program Adult Treatment Panel III criteria [28], which define MetS as a constellation of metabolic abnormalities requiring at least three of the following: increased waist circumference (>120 cm for men, >88 cm for women), elevated serum triacylglycerol level (≥150 mg/dl), reduced high-density lipoprotein cholesterol (
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