Hypercholesterolemia
Conditions
Keywords
hypercholesterolemia, dietary supplements, red yeast rice, plant sterols
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTPlant sterols
Plant sterols 800 mg/dose, 1 liquid stick per day, for 8 weeks
DIETARY_SUPPLEMENTRed Yeast Rice
Red Yeast Rice titrated in 5 mg monacolin K per daily dose, 1 liquid stick per day, for 8 weeks
DIETARY_SUPPLEMENTRed Yeast Rice plus Plant sterols
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
Sponsors
University of Bologna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* LDL-cholesterolemia between 130 and 190 mg/dL
Exclusion criteria
* Type 2 diabetes * Previous cardiovascular disease * Assumption of lipid-lowering drugs or dietary supplements * Previous intolerance to red yeast rice
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LDL cholesterolemia reduction from baseline and between groups | 8 weeks | Absolute and % reduction of LDL cholesterolemia after 8 weeks of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Non-HDL cholesterolemia reduction from baseline and between groups | 8 weeks | Absolute and % reduction of of non-HDL cholesterolemia after 8 weeks of treatment |
| Number of Participants With Treatment-Related Adverse Events | 8 weeks | Subjective tolerability of the tested treatment |
Countries
Italy
Outcome results
None listed