Hypercholesterolemia
Conditions
Keywords
Red yeast rice, Phytosterols, L-Tyrosol, Lipids, LDL-cholesterol, Endothelial function
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTCombined 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
OTHERPlacebo
Oral administration: 1 tablet per day
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
* Suboptimal LDL level (115-160 mg/dL) * TG\<400 mg/dL * Signed informed consent form
Exclusion criteria
* Patients already affected by cardiovascular diseases (secondary prevention) or with estimated 10 years cardiovascular disease risk\> 10 years * LDL-C\<115 mg/dL or \>160 mg/dL, TG\>400 mg/dL * Obesity (BMI\>30 kg/m2) or diabetes mellitus * Assumption of lipid lowering drugs or dietary supplements, or drugs potentially affecting the lipid metabolism * Antihypertensive treatment not stabilized since at least 3 months * Known current thyroid, gastrointestinal or liver diseases * Any medical or surgical condition that would limit the patient adhesion to the study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LDL-cholesterolemia absolute reduction from baseline and between groups | 8 weeks | Absolute reduction of LDL-cholesterolemia after 8 weeks of treatment |
| LDL-cholesterolemia % reduction from baseline and between groups | 8 weeks | % reduction of LDL-cholesterolemia after 8 weeks of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Flow-mediated dilation improvement from baseline and between groups | 8 weeks | % vascular heath improvement after 8 weeks of treatment |
Countries
Italy
Outcome results
None listed