1
Academic center for Primary and Interdisciplinary care, Faculty of
Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium
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, Faculty of Medicine, Antwerp University Hospital, 2650 Edegem, Antwerp, Belgium
4 Laboratory of Molecular and Clinical Pathology (RIATOL), AML, Sonic Healthcare Benelux, Emiel Vloorsstraat 9, Antwerp 2020, Belgium
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, Faculty of Medicine, Antwerp University Hospital, 2650 Edegem, Antwerp, Belgium
4 Laboratory of Molecular and Clinical Pathology (RIATOL), AML, Sonic Healthcare Benelux, Emiel Vloorsstraat 9, Antwerp 2020, Belgium
BMC Complementary and Alternative Medicine 2015, 15:52
doi:10.1186/s12906-015-0576-9
The electronic version of this article is the complete one and can be found online at: http://www.biomedcentral.com/1472-6882/15/52
The electronic version of this article is the complete one and can be found online at: http://www.biomedcentral.com/1472-6882/15/52
| Received: | 22 October 2014 |
| Accepted: | 21 February 2015 |
| Published: | 10 March 2015 |
© 2015 Verhoeven et al.; licensee BioMed Central.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
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.
Trial registration
Clinicaltrials.gov NCT02065180 webcite (February 2014).
