Lipid-lowering Effect of Phytosterols, Red Yeast Rice and Their Combination

University of Bologna

Status: Completed

Conditions: Hypercholesterolemia

Treatments: Dietary Supplement: Plant sterols; Dietary Supplement: Red Yeast Rice plus Plant sterols; Dietary Supplement: Red Yeast Rice

Study type: Interventional

Funder types: Other

Identifiers

NCT02603276

PhytoRed

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups

Plant sterols

Active Comparator group

Description:

Plant sterols 800 mg per dose, 1 liquid stick per day, per 8 weeks

Treatment:

Dietary Supplement: Plant sterols

Red Yeast Rice

Active Comparator group

Description:

Red Yeast Rice 200 mg containing 5 mg monacolin K per daily dose, 1 liquid stick per day, per 8 weeks

Treatment:

Dietary Supplement: Red Yeast Rice

Red Yeast Rice plus Plant sterols

Experimental group

Description:

lant sterols 800 mg per dose + Red Yeast Rice 200 mg containing 5 mg monacolin K per daily dose, 1 liquid stick per day, per 8 weeks

Treatment:

Dietary Supplement: Plant sterols

Dietary Supplement: Red Yeast Rice plus Plant sterols