Back to resultsEffect of Red Yeast Rice, Phytosterols and L-tyrosol on Lipid Profile and Endothelial Function
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Combined nutraceutical
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia focused on measuring Red yeast rice, Phytosterols, L-Tyrosol, Lipids, LDL-cholesterol, Endothelial function
Eligibility Criteria
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
Sites / Locations
- S. Orsola-Malpighi University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Active treatment
Placebo
Arm Description
Combined nutraceutical
Placebo
Outcomes
Primary Outcome Measures
LDL-cholesterolemia absolute reduction from baseline and between groups
Absolute reduction of LDL-cholesterolemia after 8 weeks of treatment
LDL-cholesterolemia % reduction from baseline and between groups
% reduction of LDL-cholesterolemia after 8 weeks of treatment
Secondary Outcome Measures
Flow-mediated dilation improvement from baseline and between groups
% vascular heath improvement after 8 weeks of treatment
Full Information
NCT ID
NCT03065491
First Posted
February 15, 2017
Last Updated
February 22, 2017
Sponsor
University of Bologna
1. Study Identification
Unique Protocol Identification Number
NCT03065491
Brief Title
Effect of Red Yeast Rice, Phytosterols and L-tyrosol on Lipid Profile and Endothelial Function
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
November 15, 2016 (Actual)
Primary Completion Date
February 15, 2017 (Actual)
Study Completion Date
February 17, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bologna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
Red yeast rice, Phytosterols, L-Tyrosol, Lipids, LDL-cholesterol, Endothelial function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active treatment
Arm Type
Active Comparator
Arm Description
Combined nutraceutical
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Combined nutraceutical
Intervention Description
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
Other
Intervention Name(s)
Placebo
Intervention Description
Oral administration: 1 tablet per day
Primary Outcome Measure Information:
Title
LDL-cholesterolemia absolute reduction from baseline and between groups
Description
Absolute reduction of LDL-cholesterolemia after 8 weeks of treatment
Time Frame
8 weeks
Title
LDL-cholesterolemia % reduction from baseline and between groups
Description
% reduction of LDL-cholesterolemia after 8 weeks of treatment
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Flow-mediated dilation improvement from baseline and between groups
Description
% vascular heath improvement after 8 weeks of treatment
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudio Borghi, MD
Organizational Affiliation
S. Orsola-Malpighi University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
S. Orsola-Malpighi University Hospital
City
Bologna
State/Province
BO
ZIP/Postal Code
40138
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Red Yeast Rice, Phytosterols and L-tyrosol on Lipid Profile and Endothelial Function
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