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

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.

Author information

1
Natural Products and Food - Research & Analysis (NatuRA), Department of Pharmaceutical Sciences, University of Antwerp, Universiteitsplein 1, Antwerp, Belgium. nina.hermans@uantwerpen.be.
2
Natural Products and Food - Research & Analysis (NatuRA), Department of Pharmaceutical Sciences, University of Antwerp, Universiteitsplein 1, Antwerp, Belgium.
3
Department of Endocrinology, Diabetology and Metabolism, Antwerp University Hospital, Wilrijkstraat 10, 2650, Edegem, Belgium.
4
The academic centre for primary and interdisciplinary care, Faculty of Medicine and Health Sciences, University of Antwerp, Universiteitsplein 1, Antwerp, Belgium.

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

PMID:
28673363
PMCID:
PMC5496259
DOI:
10.1186/s13063-017-2058-5
[Indexed for MEDLINE]
Free PMC Article

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