Evidence map›Paper›PMID 25879228›Full record

Trial reportBMC complementary and alternative medicine2015

Can red yeast rice and olive extract improve lipid profile and cardiovascular risk in metabolic syndrome?: A double blind, placebo controlled randomized trial.

Veronique Verhoeven, Anastasia Van der Auwera, Luc Van Gaal, Roy Remmen, Sandra Apers, Michel Stalpaert, Johan Wens, Nina Hermans

Registry-linked trialOpen access · goldFull text readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC complementary and alternative medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02065180 (The Effect of a Red Rice and Olive Extract Nutrition Supplement on Cholesterol), which is not on this map. Cited by 28 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 3 pooled it
5.5field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02065180 phase4completednot on this map

The Effect of a Red Rice and Olive Extract Nutrition Supplement on Cholesterol

TypeinterventionalSponsorUniversiteit AntwerpenRan2014 to 2014Enrolled50ConditionsHypercholesterolaemiaArmscommercially available nutrition supplement, placebo
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 3 syntheses or guidelines pooled it, 51 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Veronique VerhoevenAcademic center for Primary and Interdisciplinary care, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium. veronique.verhoeven@uantwerpen.be.
Anastasia Van der AuweraNatural Products and Food Research & Analysis (NatuRA), Department of Pharmaceutical Sciences, University of Antwerp, Universiteitsplein 1, Antwerp, Belgium. anastasia.vanderauwera@uantwerpen.be.
Luc Van GaalDepartment of Endocrinology, Diabetology, and Metabolism, Faculty of Medicine, Antwerp University Hospital, 2650 Edegem, Antwerp, Belgium. luc.vangaal@uza.be.
Roy RemmenAcademic center for Primary and Interdisciplinary care, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium. roy.remmen@uantwerpen.be.
Sandra ApersNatural Products and Food Research & Analysis (NatuRA), Department of Pharmaceutical Sciences, University of Antwerp, Universiteitsplein 1, Antwerp, Belgium. Sandra.apers@uantwerpen.be.
Michel StalpaertLaboratory of Molecular and Clinical Pathology (RIATOL), AML, Sonic Healthcare Benelux, Emiel Vloorsstraat 9, Antwerp, 2020, Belgium. Michel.stalpaert@aml-lab.be.
Johan WensAcademic center for Primary and Interdisciplinary care, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium. johan.wens@uantwerpen.be.
Nina HermansNatural Products and Food Research & Analysis (NatuRA), Department of Pharmaceutical Sciences, University of Antwerp, Universiteitsplein 1, Antwerp, Belgium. nina.hermans@uantwerpen.be.
University of Antwerp · BEAntwerp University Hospital · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMetabolic 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.

methodsIn 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.

resultsIn 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.

conclusionsThe 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 registrationClinicaltrials.gov NCT02065180 (February 2014).

Indexed as

AdultBiological ProductsCardiovascular DiseasesCholesterolCholesterol, LDLDietary SupplementsDouble-Blind MethodDyslipidemiasFemaleFruitHumansHydroxymethylglutaryl-CoA Reductase InhibitorsLipidsLipoproteins, LDLMaleMetabolic SyndromeBiological ProductsCholesterolCholesterol, LDLHydroxymethylglutaryl-CoA Reductase InhibitorsLipidsLipoproteins, LDLoxidized low density lipoproteinPlant Extractsred yeast rice

Identifiers

PMID25879228
PMCPMC4364089
OpenAlexW2083436549

What OpenQuestion holds

Textfull text, public
LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.