Effect of a short-term dietary supplementation with phytosterols, red yeast rice or both on lipid pattern in moderately hypercholesterolemic subjects: a three-arm, double-blind, randomized clinical trial

Arrigo F G Cicero, Federica Fogacci, Martina Rosticci, Angelo Parini, Marina Giovannini, Maddalena Veronesi, Sergio D'Addato, Claudio Borghi, Arrigo F G Cicero, Federica Fogacci, Martina Rosticci, Angelo Parini, Marina Giovannini, Maddalena Veronesi, Sergio D'Addato, Claudio Borghi

Abstract

Background: Phytosterols and red yeast rice are largely studied cholesterol-lowering nutraceuticals, respectively inhibiting the bowel absorption and liver synthesis of cholesterol. Our aim was to test the effect on lipid profile of phytosterols, red yeast rice and their association.

Methods: We performed a three parallel arms, double blind, clinical trial randomizing 90 moderately hypercholesterolemic subjects to treatment with phytosterols 800 mg (group 1), red yeast rice standardized to contain 5 mg monacolins from Monascus purpureus (group 2), or both combined nutraceuticals (group 3).

Results: After 8 weeks of treatment, in group 1 no significant variation of lipid parameters has been detected. In group 2 a significant reduction (p < 0.001) of LDL-Cholesterol (-20.5% vs. baseline) and Apolipoprotein B (-14.4% vs. baseline) as it occurred in group 3 (LDL-Cholesterol vs. baseline: -27.0%, Apolipoprotein B vs. baseline: -19.0%) (P < 0.001). LDL-Cholesterol and Apolipoprotein B changes were significantly different comparing group 2 with group 1 (P < 0.05), and group 3 with group 1 (P < 0.05). LDL-Cholesterol change was also significantly higher in group 3 than in group 2 (P < 0.05).

Conclusion: The association of phytosterol and red yeast rice seems to have additive cholesterol lowering effect, reaching a clinically significant LDL-Cholesterol reduction in mildly hypercholesterolemic patients.

Trial registration: ClinicalTrial.gov ID: NCT02603276, Registered 27/08/2015.

Keywords: Clinical trial; LDL-cholesterol; Monacolins; Nutraceuticals; Phytosterols; Red yeast Rice.

Conflict of interest statement

Ethics approval and consent to participate

The study was fully conducted in accordance with the Declaration of Helsinki, its protocol was approved by the Ethical Committee of the University of Bologna Written consent was obtained from all participants.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Percentage change of LDL-cholesterolemia (a), Total Cholesterol (b), Apolipoprotein B (c) and LDL to HDL ration (d) in the three treatment groups versus baseline

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