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Lipid-lowering Effect of Phytosterols, Red Yeast Rice and Their Combination

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Plant sterols
Red Yeast Rice
Red Yeast Rice plus Plant sterols
Sponsored by
University of Bologna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring hypercholesterolemia, dietary supplements, red yeast rice, plant sterols

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • LDL-cholesterolemia between 130 and 190 mg/dL

Exclusion Criteria:

  • Type 2 diabetes
  • Previous cardiovascular disease
  • Assumption of lipid-lowering drugs or dietary supplements
  • Previous intolerance to red yeast rice

Sites / Locations

  • S. Orsola-Malpighi University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Plant sterols

Red Yeast Rice

Red Yeast Rice plus Plant sterols

Arm Description

Plant sterols 800 mg per dose, 1 liquid stick per day, per 8 weeks

Red Yeast Rice 200 mg containing 5 mg monacolin K per daily dose, 1 liquid stick per day, per 8 weeks

lant sterols 800 mg per dose + Red Yeast Rice 200 mg containing 5 mg monacolin K per daily dose, 1 liquid stick per day, per 8 weeks

Outcomes

Primary Outcome Measures

LDL cholesterolemia reduction from baseline and between groups
Absolute and % reduction of LDL cholesterolemia after 8 weeks of treatment

Secondary Outcome Measures

Non-HDL cholesterolemia reduction from baseline and between groups
Absolute and % reduction of of non-HDL cholesterolemia after 8 weeks of treatment
Number of Participants With Treatment-Related Adverse Events
Subjective tolerability of the tested treatment

Full Information

First Posted
August 27, 2015
Last Updated
February 7, 2017
Sponsor
University of Bologna
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1. Study Identification

Unique Protocol Identification Number
NCT02603276
Brief Title
Lipid-lowering Effect of Phytosterols, Red Yeast Rice and Their Combination
Official Title
Lipid-lowering Effect of Phytosterols, Red Yeast Rice and Their Combination in Moderately Hypercholesterolemic Subjects in Primary Prevention for Cardiovascular Diseases: a Randomized, Double Blind, Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
December 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
A large body of evidence confirm the cholesterol lowering effect of phytosterols and red yeast rice. 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
A large body of literature suggest that the patients are strongly interested in self-medicating them with "natural" products aimed at reducing their plasma level of LDL-cholesterol. Plant sterols and red yeast rice are among the most widely marketed product with these properties in Western countries. However plant sterols per se have a limited effect on cholesterolemia, while full dosed red yeast rice can induce myalgias and myopathies as statins do. In this context, the aim of the investigators' study was to evaluate if the association of both products at low dosage could induce an additive or synergistic effect in term of LDL-reduction in humans.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
hypercholesterolemia, dietary supplements, red yeast rice, plant sterols

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Plant sterols
Arm Type
Active Comparator
Arm Description
Plant sterols 800 mg per dose, 1 liquid stick per day, per 8 weeks
Arm Title
Red Yeast Rice
Arm Type
Active Comparator
Arm Description
Red Yeast Rice 200 mg containing 5 mg monacolin K per daily dose, 1 liquid stick per day, per 8 weeks
Arm Title
Red Yeast Rice plus Plant sterols
Arm Type
Experimental
Arm Description
lant sterols 800 mg per dose + Red Yeast Rice 200 mg containing 5 mg monacolin K per daily dose, 1 liquid stick per day, per 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Plant sterols
Intervention Description
Plant sterols 800 mg/dose, 1 liquid stick per day, for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Red Yeast Rice
Intervention Description
Red Yeast Rice titrated in 5 mg monacolin K per daily dose, 1 liquid stick per day, for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Red Yeast Rice plus Plant sterols
Intervention Description
Red Yeast Rice titrated in 5 mg monacolin K per daily dose plus Plant sterols 800 mg/dose, together in 1 liquid stick per day, for 8 weeks
Primary Outcome Measure Information:
Title
LDL cholesterolemia reduction from baseline and between groups
Description
Absolute and % reduction of LDL cholesterolemia after 8 weeks of treatment
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Non-HDL cholesterolemia reduction from baseline and between groups
Description
Absolute and % reduction of of non-HDL cholesterolemia after 8 weeks of treatment
Time Frame
8 weeks
Title
Number of Participants With Treatment-Related Adverse Events
Description
Subjective tolerability of the tested 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: LDL-cholesterolemia between 130 and 190 mg/dL Exclusion Criteria: Type 2 diabetes Previous cardiovascular disease Assumption of lipid-lowering drugs or dietary supplements Previous intolerance to red yeast rice
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudio Borghi, MD
Organizational Affiliation
University of Bologna
Official's Role
Principal Investigator
Facility Information:
Facility Name
S. Orsola-Malpighi University Hospital
City
Bologna
ZIP/Postal Code
40038
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
29021813
Citation
Cicero AFG, Fogacci F, Rosticci M, Parini A, Giovannini M, Veronesi M, D'Addato S, Borghi C. Effect of a short-term dietary supplementation with phytosterols, red yeast rice or both on lipid pattern in moderately hypercholesterolemic subjects: a three-arm, double-blind, randomized clinical trial. Nutr Metab (Lond). 2017 Sep 25;14:61. doi: 10.1186/s12986-017-0214-2. eCollection 2017. Erratum In: Nutr Metab (Lond). 2018 Jun 20;15:44.
Results Reference
derived

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Lipid-lowering Effect of Phytosterols, Red Yeast Rice and Their Combination

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