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

Hypercholesterolemia Clinical Trial

Official title:

Lipid-lowering Effect of Phytosterols, Red Yeast Rice and Their Combination in Moderately Hypercholesterolemic Subjects in Primary Prevention for Cardiovascular Diseases: a Randomized, Double Blind, Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02603276
• Other study ID #: PhytoRed
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: December 2015

Study information

• Verified date: January 2024
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Dietary Supplement:
• Plant sterols
Plant sterols 800 mg/dose, 1 liquid stick per day, for 8 weeks
• Red Yeast Rice
Red Yeast Rice titrated in 5 mg monacolin K per daily dose, 1 liquid stick per day, for 8 weeks
• Red 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

Locations

Country	Name	City	State
Italy	S. Orsola-Malpighi University Hospital	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Cicero AFG, Fogacci F, Rosticci M, Parini A, Giovannini M, Veronesi M, D'Addato S, Borghi C. Effect of a short-term dietary supplementation with phytosterols, red yeast rice or both on lipid pattern in moderately hypercholesterolemic subjects: a three-arm — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL cholesterolemia reduction from baseline and between groups	Absolute and % reduction of LDL cholesterolemia after 8 weeks of treatment	8 weeks
Secondary	Non-HDL cholesterolemia reduction from baseline and between groups	Absolute and % reduction of of non-HDL cholesterolemia after 8 weeks of treatment	8 weeks
Secondary	Number of Participants With Treatment-Related Adverse Events	Subjective tolerability of the tested treatment	8 weeks