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

NCT02492464 — Not applicable, Completed, 40 participants, University of Bologna

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Double-blind, Randomized Clinical Trial on the Middle-term Effect of the Red Yeast Rice Intake on Endothelial Function and Arterial Stiffness in Subjects With Suboptimal LDL-cholesterol Level in the Context of the Mediterranean Diet

Registry	NCT02492464, acronym Monasc10_15
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	40 (Actual)
Sponsor	University of Bologna (Other)
Conditions	Atherosclerosis
Interventions	Red yeast rice, Placebo (Dietary supplement)
Dates	start 2015-05-01, primary completion 2015-06-01, completion 2015-12-01, first posted 2015-07-08, last updated 2024-02-01
Locations	1 site in Italy

-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)

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+Arms and interventions

Arm	Type	Interventions	Description
Red yeast rice	Active comparator	Dietary Supplement: Red yeast rice	Red yeast rice extract 200 mg, containing 10 mg monacolin K per daily dose, 1 capsule per day, per 6 months
Placebo	Placebo comparator	Dietary Supplement: Placebo	Placebo 200 mg (neutral fibre), 1 capsule per day, per 6 months

Red yeast rice (Dietary supplement): 1 capsule to be taken before to sleep, each day, for 6 months
Placebo (Dietary supplement)

+Outcome measures

Primary outcomes

Flow mediated dilation (FMD) change from the baseline to the end of treatment period [6 months]

Secondary outcomes

12 hour fasting LDL-cholesterolemia change from the baseline to the end of treatment period [6 months]

+Eligibility

Sex: All, ages: 18 Years to 70 Years

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

+Locations (1)

Facility	City	Country	Status
S. Orsola-Malpighi University Hospital	Bologna, BO	Italy

+Publications

Results publication: Cicero AF, Morbini M, Rosticci M, D''Addato S, Grandi E, Borghi C. Middle-Term Dietary Supplementation with Red Yeast Rice Plus Coenzyme Q10 Improves Lipid Pattern, Endothelial Reactivity and Arterial Stiffness in Moderately Hypercholesterolemic Subjects. Ann Nutr Metab. 2016;68(3):213-9. doi: 10.1159/000445359. Epub 2016 Apr 8. PMID 27055107
Results publication: Cicero AFG, Fogacci F, Bove M, Veronesi M, Rizzo M, Giovannini M, Borghi C. Short-Term Effects of a Combined Nutraceutical on Lipid Level, Fatty Liver Biomarkers, Hemodynamic Parameters, and Estimated Cardiovascular Disease Risk: A Double-Blind, Placebo-Controlled Randomized Clinical Trial. Adv Ther. 2017 Aug;34(8):1966-1975. doi: 10.1007/s12325-017-0580-1. Epub 2017 Jul 7. PMID 28687937

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