A large body of evidence confirm the cholesterol lowering effect of red yeast rice, phytosterols and L-tyrosol. Because their mechanisms of action mime the ones of chemical statins and cholesterol absorption inhibitors, it is plausible that their association will provide a more relevant (and safe) LDL cholesterolemia reduction.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
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
Oral administration: 1 tablet per day
S. Orsola-Malpighi University Hospital
Bologna, BO, Italy
LDL-cholesterolemia absolute reduction from baseline and between groups
Absolute reduction of LDL-cholesterolemia after 8 weeks of treatment
Time frame: 8 weeks
LDL-cholesterolemia % reduction from baseline and between groups
% reduction of LDL-cholesterolemia after 8 weeks of treatment
Time frame: 8 weeks
Flow-mediated dilation improvement from baseline and between groups
% vascular heath improvement after 8 weeks of treatment
Time frame: 8 weeks
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