Effect of Red Yeast Rice, Phytosterols and L-tyrosol on Lipid Profile and Endothelial Function
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|ClinicalTrials.gov Identifier: NCT03065491|
Recruitment Status : Completed
First Posted : February 28, 2017
Last Update Posted : February 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hypercholesterolemia||Dietary Supplement: Combined nutraceutical Other: Placebo||Not Applicable|
European Food Safety Authority approves some health claim related to the cardiometabolic effects of some nutraceuticals, and in particular of red yeast rice, phytosterols and L-tyrosol.
In a previous study the investigators have already demonstrated the synergistic effect of red yeast rice and phytosterols in term of lipid-lowering activity.
Preliminary data suggest that these nutraceuticals could also exert a positive effect on vascular health beyond the direct effects on serum lipids.
No data are available on the combined effects of these dietary supplement in humans.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effect of Red Yeast Rice, Phytosterols and L-tyrosol on Lipid Profile and Endothelial Function: a Double-blind, Placebo-controlled, Randomized Clinical Trial|
|Actual Study Start Date :||November 15, 2016|
|Actual Primary Completion Date :||February 15, 2017|
|Actual Study Completion Date :||February 17, 2017|
Active Comparator: Active treatment
Dietary Supplement: Combined nutraceutical
Plant sterols 800 mg + Red Yeast Rice containing 5 mg monacolin K + L-Tyrosol 50 mg per daily dose Oral administration: 1 tablet per day
Placebo Comparator: Placebo
Oral administration: 1 tablet per day
- LDL-cholesterolemia absolute reduction from baseline and between groups [ Time Frame: 8 weeks ]Absolute reduction of LDL-cholesterolemia after 8 weeks of treatment
- LDL-cholesterolemia % reduction from baseline and between groups [ Time Frame: 8 weeks ]% reduction of LDL-cholesterolemia after 8 weeks of treatment
- Flow-mediated dilation improvement from baseline and between groups [ Time Frame: 8 weeks ]% vascular heath improvement after 8 weeks of treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03065491
|S. Orsola-Malpighi University Hospital|
|Bologna, BO, Italy, 40138|
|Principal Investigator:||Claudio Borghi, MD||S. Orsola-Malpighi University Hospital|