Effects of 10 mg Monacolins on Vascular Health: a Clinical Trial

Conditions

Atherosclerosis

Brief summary

This will be a double-blind randomized clinical trial carried out on subjects with suboptimal control of LDL-cholesterolemia, following a Mediterranean diet, and treated with a red yeast rice extract (containing 10 mg monacolin K per daily dose) or placebo, in order to evaluate the middle-term effects on vascular health evaluated by non invasive methods (Vicorder(R) apparatus)

Cicero AFG, Fogacci F, Bove M, Veronesi M, Rizzo M, Giovannini M, Borghi C.

2017-07-0723 citations

10.1007/s12325-017-0580-1

[OP.8E.07] MIDDLE-TERM DIETARY SUPPLEMENTATION WITH RED YEAST RICE PLUS COENZYME Q10 IMPROVES LIPID PATTERN, ENDOTHELIAL REACTIVITY AND ARTERIAL STIFFNESS IN MODERATELY HYPERCHOLESTEROLEMICS

Arrigo F.G. Cicero, Martino Morbini, Martina Rosticci, Sergio D’Addato, Elisa Grandi et al. (6 authors)

Journal of Hypertension2016-08-101 citations

10.1097/01.hjh.0000491621.83495.00

Middle-Term Dietary Supplementation with Red Yeast Rice Plus Coenzyme Q10 Improves Lipid Pattern, Endothelial Reactivity and Arterial Stiffness in Moderately Hypercholesterolemic Subjects.

Cicero AF, Morbini M, Rosticci M, D''Addato S, Grandi E, Borghi C.

2016-04-0833 citations

10.1159/000445359

Papers published before 2007-03-01 may not appear yet. Historical indexing is in progress.

Interventions

DIETARY_SUPPLEMENTRed yeast rice

1 capsule to be taken before to sleep, each day, for 6 months

DIETARY_SUPPLEMENTPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

No

Inclusion criteria

* LDL-cholesterol between 130 and 190 mg/dL

Exclusion criteria

* Secundary prevention for cardiovascular disease * Type 2 diabetes * Assumption of lipid-lowering drug or dietary supplements * Previous intolerans to read yeast rice including dietary supplements

Design outcomes

Primary

Measure	Time frame
Flow mediated dilation (FMD) change from the baseline to the end of treatment period	6 months

Secondary

Measure	Time frame
12 hour fasting LDL-cholesterolemia change from the baseline to the end of treatment period	6 months

Countries

Italy

Outcome results

None listed