Lipid-lowering Effect of Phytosterols, Red Yeast Rice and Their Combination
NCT ID: NCT02603276
Last Updated: 2024-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2015-04-30
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Plant sterols
Plant sterols 800 mg per dose, 1 liquid stick per day, per 8 weeks
Plant sterols
Plant sterols 800 mg/dose, 1 liquid stick per day, for 8 weeks
Red Yeast Rice
Red Yeast Rice 200 mg containing 5 mg monacolin K per daily dose, 1 liquid stick per day, per 8 weeks
Red Yeast Rice
Red Yeast Rice titrated in 5 mg monacolin K per daily dose, 1 liquid stick per day, for 8 weeks
Red Yeast Rice plus Plant sterols
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
Plant sterols
Plant sterols 800 mg/dose, 1 liquid stick per day, for 8 weeks
Red Yeast Rice plus Plant sterols
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
Interventions
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Plant sterols
Plant sterols 800 mg/dose, 1 liquid stick per day, for 8 weeks
Red Yeast Rice
Red Yeast Rice titrated in 5 mg monacolin K per daily dose, 1 liquid stick per day, for 8 weeks
Red Yeast Rice plus Plant sterols
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
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Inclusion Criteria
Exclusion Criteria
* Previous cardiovascular disease
* Assumption of lipid-lowering drugs or dietary supplements
* Previous intolerance to red yeast rice
18 Years
70 Years
ALL
Yes
Sponsors
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University of Bologna
OTHER
Responsible Party
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Claudio Borghi
Full professor of internal medicine
Principal Investigators
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Claudio Borghi, MD
Role: PRINCIPAL_INVESTIGATOR
University of Bologna
Locations
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S. Orsola-Malpighi University Hospital
Bologna, , Italy
Countries
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References
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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.
Other Identifiers
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PhytoRed
Identifier Type: -
Identifier Source: org_study_id
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