CompletedNot Applicable

Effect of Red Yeast Rice, Phytosterols and L-tyrosol on Lipid Profile and Endothelial Function

Italy50 participantsStarted 2016-11-15

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

LDL-cholesterolemia absolute reduction from baseline and between groups

Timeframe: 8 weeks

LDL-cholesterolemia % reduction from baseline and between groups

Timeframe: 8 weeks

Trial details

NCT IDNCT03065491

SponsorUniversity of Bologna

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-02-15

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