A red yeast rice-olive extract supplement reduces biomarkers of oxidative stress, OxLDL and Lp-PLA2, in subjects with metabolic syndrome: a randomised, double-blind, placebo-controlled trial

Trials. 2017 Jul 3;18(1):302. doi: 10.1186/s13063-017-2058-5.

Abstract

Background: Metabolic 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.

Methods: 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. 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.

Results: The 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).

Conclusions: RYR-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 registration: ClinicalTrials.gov identifier: NCT02065180 . Registered on 13 February 2014.

Keywords: Metabolic syndrome; Olive; Oxidative stress; Red yeast rice.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • 1-Alkyl-2-acetylglycerophosphocholine Esterase / blood*
  • 8-Hydroxy-2'-Deoxyguanosine
  • Antioxidants / adverse effects
  • Antioxidants / therapeutic use*
  • Belgium
  • Biological Products / adverse effects
  • Biological Products / therapeutic use*
  • Biomarkers / blood
  • Deoxyguanosine / analogs & derivatives
  • Deoxyguanosine / blood
  • Dietary Supplements* / adverse effects
  • Double-Blind Method
  • Female
  • Humans
  • Linear Models
  • Lipoproteins, LDL / blood*
  • Male
  • Malondialdehyde / blood
  • Metabolic Syndrome / blood
  • Metabolic Syndrome / diagnosis
  • Metabolic Syndrome / drug therapy*
  • Multivariate Analysis
  • Olea / adverse effects
  • Olea / chemistry*
  • Oxidative Stress / drug effects*
  • Plant Extracts / adverse effects
  • Plant Extracts / therapeutic use*
  • Time Factors
  • Treatment Outcome

Substances

  • Antioxidants
  • Biological Products
  • Biomarkers
  • Lipoproteins, LDL
  • Plant Extracts
  • olive extract
  • oxidized low density lipoprotein
  • red yeast rice
  • Malondialdehyde
  • 8-Hydroxy-2'-Deoxyguanosine
  • 1-Alkyl-2-acetylglycerophosphocholine Esterase
  • PLA2G7 protein, human
  • Deoxyguanosine

Associated data

  • ClinicalTrials.gov/NCT02065180