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

University of Bologna

Status: Completed

Conditions: Hypercholesterolemia

Treatments: Dietary Supplement: Combined nutraceutical; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03065491

MPT_trial_2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Active treatment

Active Comparator group

Description:

Combined nutraceutical

Treatment:

Dietary Supplement: Combined nutraceutical

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo