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

Hypercholesterolemia Clinical Trial

Official title:

Effect of Red Yeast Rice, Phytosterols and L-tyrosol on Lipid Profile and Endothelial Function: a Double-blind, Placebo-controlled, Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03065491
• Other study ID #: MPT_trial_2016
• Status: Completed
• Phase: N/A
• First received: February 15, 2017
• Last updated: February 22, 2017
• Start date: November 15, 2016
• Est. completion date: February 17, 2017

Study information

• Verified date: February 2017
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 17, 2017
• Est. primary completion date: February 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Dietary Supplement:
• Combined 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

Other:
• Placebo
Oral administration: 1 tablet per day

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL-cholesterolemia absolute reduction from baseline and between groups	Absolute reduction of LDL-cholesterolemia after 8 weeks of treatment	8 weeks
Primary	LDL-cholesterolemia % reduction from baseline and between groups	% reduction of LDL-cholesterolemia after 8 weeks of treatment	8 weeks
Secondary	Flow-mediated dilation improvement from baseline and between groups	% vascular heath improvement after 8 weeks of treatment	8 weeks