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Effects of 10 mg Monacolins on Vascular Health: a Clinical Trial (Monasc10_15)

Primary Purpose

Atherosclerosis

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Red yeast rice
Placebo
Sponsored by
University of Bologna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atherosclerosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • LDL-cholesterol between 130 and 190 mg/dL

Exclusion Criteria:

  • Secundary prevention for cardiovascular disease
  • Type 2 diabetes
  • Assumption of lipid-lowering drug or dietary supplements
  • Previous intolerans to read yeast rice including dietary supplements

Sites / Locations

  • S. Orsola-Malpighi University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Red yeast rice

Placebo

Arm Description

Red yeast rice extract 200 mg, containing 10 mg monacolin K per daily dose, 1 capsule per day, per 6 months

Placebo 200 mg (neutral fibre), 1 capsule per day, per 6 months

Outcomes

Primary Outcome Measures

Flow mediated dilation (FMD) change from the baseline to the end of treatment period

Secondary Outcome Measures

12 hour fasting LDL-cholesterolemia change from the baseline to the end of treatment period

Full Information

First Posted
June 22, 2015
Last Updated
December 5, 2016
Sponsor
University of Bologna
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1. Study Identification

Unique Protocol Identification Number
NCT02492464
Brief Title
Effects of 10 mg Monacolins on Vascular Health: a Clinical Trial
Acronym
Monasc10_15
Official Title
Double-blind, Randomized Clinical Trial on the Middle-term Effect of the Red Yeast Rice Intake on Endothelial Function and Arterial Stiffness in Subjects With Suboptimal LDL-cholesterol Level in the Context of the Mediterranean Diet
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bologna

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This will be a double-blind randomized clinical trial carried out on subjects with suboptimal control of LDL-cholesterolemia, following a Mediterranean diet, and treated with a red yeast rice extract (containing 10 mg monacolin K per daily dose) or placebo, in order to evaluate the middle-term effects on vascular health evaluated by non invasive methods (Vicorder(R) apparatus)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Red yeast rice
Arm Type
Active Comparator
Arm Description
Red yeast rice extract 200 mg, containing 10 mg monacolin K per daily dose, 1 capsule per day, per 6 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 200 mg (neutral fibre), 1 capsule per day, per 6 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Red yeast rice
Intervention Description
1 capsule to be taken before to sleep, each day, for 6 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Flow mediated dilation (FMD) change from the baseline to the end of treatment period
Time Frame
6 months
Secondary Outcome Measure Information:
Title
12 hour fasting LDL-cholesterolemia change from the baseline to the end of treatment period
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: LDL-cholesterol between 130 and 190 mg/dL Exclusion Criteria: Secundary prevention for cardiovascular disease Type 2 diabetes Assumption of lipid-lowering drug or dietary supplements Previous intolerans to read yeast rice including dietary supplements
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
Citations:
PubMed Identifier
28687937
Citation
Cicero AFG, Fogacci F, Bove M, Veronesi M, Rizzo M, Giovannini M, Borghi C. Short-Term Effects of a Combined Nutraceutical on Lipid Level, Fatty Liver Biomarkers, Hemodynamic Parameters, and Estimated Cardiovascular Disease Risk: A Double-Blind, Placebo-Controlled Randomized Clinical Trial. Adv Ther. 2017 Aug;34(8):1966-1975. doi: 10.1007/s12325-017-0580-1. Epub 2017 Jul 7.
Results Reference
derived

Learn more about this trial

Effects of 10 mg Monacolins on Vascular Health: a Clinical Trial

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