A large body of evidence confirm the cholesterol lowering effect of phytosterols and red yeast rice. 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.
A large body of literature suggest that the patients are strongly interested in self-medicating them with "natural" products aimed at reducing their plasma level of LDL-cholesterol. Plant sterols and red yeast rice are among the most widely marketed product with these properties in Western countries. However plant sterols per se have a limited effect on cholesterolemia, while full dosed red yeast rice can induce myalgias and myopathies as statins do. In this context, the aim of the investigators' study was to evaluate if the association of both products at low dosage could induce an additive or synergistic effect in term of LDL-reduction in humans.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Plant sterols 800 mg/dose, 1 liquid stick per day, for 8 weeks
Red Yeast Rice titrated in 5 mg monacolin K per daily dose, 1 liquid stick per day, for 8 weeks
Red Yeast Rice titrated in 5 mg monacolin K per daily dose plus Plant sterols 800 mg/dose, together in 1 liquid stick per day, for 8 weeks
S. Orsola-Malpighi University Hospital
Bologna, Italy
LDL cholesterolemia reduction from baseline and between groups
Absolute and % reduction of LDL cholesterolemia after 8 weeks of treatment
Time frame: 8 weeks
Non-HDL cholesterolemia reduction from baseline and between groups
Absolute and % reduction of of non-HDL cholesterolemia after 8 weeks of treatment
Time frame: 8 weeks
Number of Participants With Treatment-Related Adverse Events
Subjective tolerability of the tested treatment
Time frame: 8 weeks
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