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

NCT ID: NCT03065491

Last Updated: 2017-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-15

Study Completion Date

2017-02-17

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypercholesterolemia

Keywords

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Red yeast rice Phytosterols L-Tyrosol Lipids LDL-cholesterol Endothelial function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active treatment

Combined nutraceutical

Group Type ACTIVE_COMPARATOR

Combined nutraceutical

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Oral administration: 1 tablet per day

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Oral administration: 1 tablet per day

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Bologna

OTHER

Sponsor Role lead

Responsible Party

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Claudio Borghi

Principal Investigator, Professor Claudio Borghi

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claudio Borghi, MD

Role: PRINCIPAL_INVESTIGATOR

S. Orsola-Malpighi University Hospital

Locations

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S. Orsola-Malpighi University Hospital

Bologna, BO, Italy

Site Status

Countries

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Italy

Other Identifiers

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MPT_trial_2016

Identifier Type: -

Identifier Source: org_study_id