Lipid-lowering Effect of Phytosterols, Red Yeast Rice and Their Combination
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 27, 2015
CompletedFirst Posted
Study publicly available on registry
November 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFebruary 1, 2024
January 1, 2024
8 months
August 27, 2015
January 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
LDL cholesterolemia reduction from baseline and between groups
Absolute and % reduction of LDL cholesterolemia after 8 weeks of treatment
8 weeks
Secondary Outcomes (2)
Non-HDL cholesterolemia reduction from baseline and between groups
8 weeks
Number of Participants With Treatment-Related Adverse Events
8 weeks
Study Arms (3)
Plant sterols
ACTIVE COMPARATORPlant sterols 800 mg per dose, 1 liquid stick per day, per 8 weeks
Red Yeast Rice
ACTIVE COMPARATORRed Yeast Rice 200 mg containing 5 mg monacolin K per daily dose, 1 liquid stick per day, per 8 weeks
Red Yeast Rice plus Plant sterols
EXPERIMENTALlant 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
Interventions
Plant sterols 800 mg/dose, 1 liquid stick per day, for 8 weeks
Red Yeast Rice titrated in 5 mg monacolin K per daily dose, 1 liquid stick per day, for 8 weeks
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
Eligibility Criteria
You may qualify if:
- LDL-cholesterolemia between 130 and 190 mg/dL
You may not qualify if:
- Type 2 diabetes
- Previous cardiovascular disease
- Assumption of lipid-lowering drugs or dietary supplements
- Previous intolerance to red yeast rice
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
S. Orsola-Malpighi University Hospital
Bologna, 40038, Italy
Related Publications (1)
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.
PMID: 29021813RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claudio Borghi, MD
University of Bologna
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
- Full professor of internal medicine
Study Record Dates
First Submitted
August 27, 2015
First Posted
November 11, 2015
Study Start
April 1, 2015
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
February 1, 2024
Record last verified: 2024-01