title: Can red yeast rice and olive extract improve lipid profile and cardiovascular risk in metabolic syndrome?: A double blind, placebo controlled randomized trial.
abstract: BACKGROUND
  Metabolic syndrome (MetS) comprises a spectrum of clinical phenotypes in which dyslipidemia, dysglycemia and hypertension are clustered and where all share a high level of oxidative stress and an increased risk of cardiovascular disease. This study examines the effect of a nutritional supplement combining red yeast rice and olive fruit extract on the lipid profile and on oxidative stress in a population of patients with MetS.
  
  
  METHODS
  In a double blind placebo controlled randomized trial, 50 persons with MetS, as defined by the ATPIII criteria, received the study product or placebo for 8 weeks. The study product contained 10.82 mg of monacolins and 9,32 mg of hydroxytyrosol per capsule, and is commercialized as Cholesfytol plus. The primary outcome measure was the difference in LDL reduction between intervention and control groups. Furthermore, differences in changes of CH, HDL, ApoA1, ApoB, HbA1c and oxLDL were measured, as well as side-effects, CK elevation, changes in clinical parameters and in cardiovascular risk.
  
  
  RESULTS
  In the intervention group, LDL cholesterol was lowered by 24% whereas it increased by 1% in the control group (p < 0.001). Other effects observed were a change in total cholesterol (-17% in the intervention group vs +2% in the control group, p < 0.001), apolipoprotein B (-15% vs +6%, p < 0.001), and TG (-9% vs + 16%, p = 0.02). Oxidized LDL decreased by 20% vs an increase of 5% in the control group (p < 0.001). Systolic and diastolic arterial blood pressure decreased significantly by 10 mmHg (vs 0% in the control group, p = 0.001) and 7 mmHg (vs 0% in the control group, p = 0.05) respectively. One person in the intervention group, who suffered from Segawa's syndrome, dropped out because of severe muscle ache.
  
  
  CONCLUSIONS
  The combination of active products in this study may be an alternative approach to statins in people who do not need, or cannot or do not want to be treated with chemical statins. Side effects, effects on oxidative stress and on glucose metabolism need to be examined more thoroughly.
  
  
  BACKGROUND
  Clinicaltrials.gov NCT02065180 (February 2014).
authors: Academic center for Primary and Interdisciplinary care, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium. veronique.verhoeven@uantwerpen.be.
authors: Veronique
authors: V
authors: Verhoeven
authors: Natural Products and Food Research & Analysis (NatuRA), Department of Pharmaceutical Sciences, University of Antwerp, Universiteitsplein 1, Antwerp, Belgium. anastasia.vanderauwera@uantwerpen.be.
authors: Anastasia
authors: A
authors: Van der Auwera
authors: Department of Endocrinology, Diabetology, and Metabolism, Faculty of Medicine, Antwerp University Hospital, 2650 Edegem, Antwerp, Belgium. luc.vangaal@uza.be.
authors: Luc
authors: L
authors: Van Gaal
authors: Academic center for Primary and Interdisciplinary care, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium. roy.remmen@uantwerpen.be.
authors: Roy
authors: R
authors: Remmen
authors: Natural Products and Food Research & Analysis (NatuRA), Department of Pharmaceutical Sciences, University of Antwerp, Universiteitsplein 1, Antwerp, Belgium. Sandra.apers@uantwerpen.be.
authors: Sandra
authors: S
authors: Apers
authors: Laboratory of Molecular and Clinical Pathology (RIATOL), AML, Sonic Healthcare Benelux, Emiel Vloorsstraat 9, Antwerp, 2020, Belgium. Michel.stalpaert@aml-lab.be.
authors: Michel
authors: M
authors: Stalpaert
authors: Academic center for Primary and Interdisciplinary care, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium. johan.wens@uantwerpen.be.
authors: Johan
authors: J
authors: Wens
authors: Natural Products and Food Research & Analysis (NatuRA), Department of Pharmaceutical Sciences, University of Antwerp, Universiteitsplein 1, Antwerp, Belgium. nina.hermans@uantwerpen.be.
authors: Nina
authors: N
authors: Hermans
mesh_terms: D000328:Adult; D001688:Biological Products / Q000494:pharmacology / Q000627:therapeutic use*; D002318:Cardiovascular Diseases / Q000097:blood / Q000209:etiology / Q000517:prevention & control*; D002784:Cholesterol / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D019587:Dietary Supplements; D004311:Double-Blind Method; D050171:Dyslipidemias / Q000188:drug therapy; D005260:Female; D005638:Fruit; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000494:pharmacology / Q000627:therapeutic use*; D008055:Lipids / Q000097:blood*; D008077:Lipoproteins, LDL / Q000097:blood; D008297:Male; D024821:Metabolic Syndrome / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D008875:Middle Aged; D031658:Olea / Q000737:chemistry*; D008517:Phytotherapy; D010936:Plant Extracts / Q000494:pharmacology / Q000627:therapeutic use*; D012307:Risk Factors
chemical_list: D001688:Biological Products; D008078:Cholesterol, LDL; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D008055:Lipids; D008077:Lipoproteins, LDL; D010936:Plant Extracts; C099252:oxidized low density lipoprotein; C117343:red yeast rice; D002784:Cholesterol