NCT03065491

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2017

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2017

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 28, 2017

Completed
Last Updated

February 28, 2017

Status Verified

February 1, 2017

Enrollment Period

3 months

First QC Date

February 15, 2017

Last Update Submit

February 22, 2017

Conditions

Hypercholesterolemia

Keywords

Red yeast ricePhytosterolsL-TyrosolLipidsLDL-cholesterolEndothelial function

Outcome Measures

Primary Outcomes (2)

  • LDL-cholesterolemia absolute reduction from baseline and between groups

    Absolute reduction of LDL-cholesterolemia after 8 weeks of treatment

    8 weeks

  • LDL-cholesterolemia % reduction from baseline and between groups

    % reduction of LDL-cholesterolemia after 8 weeks of treatment

    8 weeks

Secondary Outcomes (1)

  • Flow-mediated dilation improvement from baseline and between groups

    8 weeks

Study Arms (2)

Active treatment

ACTIVE COMPARATOR

Combined nutraceutical

Dietary Supplement: Combined nutraceutical

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Combined nutraceuticalDIETARY_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

Active treatment
PlaceboOTHER

Oral administration: 1 tablet per day

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Suboptimal LDL level (115-160 mg/dL)
  • TG\<400 mg/dL
  • Signed informed consent form

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

S. Orsola-Malpighi University Hospital

Bologna, BO, 40138, Italy

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Claudio Borghi, MD

    S. Orsola-Malpighi University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Professor Claudio Borghi

Study Record Dates

First Submitted

February 15, 2017

First Posted

February 28, 2017

Study Start

November 15, 2016

Primary Completion

February 15, 2017

Study Completion

February 17, 2017

Last Updated

February 28, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)