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Trial record 7 of 228 for:    yeast

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

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ClinicalTrials.gov Identifier: NCT02603276
Recruitment Status : Completed
First Posted : November 11, 2015
Last Update Posted : February 8, 2017
Sponsor:
Information provided by (Responsible Party):
Claudio Borghi, University of Bologna

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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Dietary Supplement: Plant sterols Dietary Supplement: Red Yeast Rice Dietary Supplement: Red Yeast Rice plus Plant sterols Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : April 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Plant sterols
Plant sterols 800 mg per dose, 1 liquid stick per day, per 8 weeks
Dietary Supplement: Plant sterols
Plant sterols 800 mg/dose, 1 liquid stick per day, for 8 weeks

Active Comparator: Red Yeast Rice
Red Yeast Rice 200 mg containing 5 mg monacolin K per daily dose, 1 liquid stick per day, per 8 weeks
Dietary Supplement: Red Yeast Rice
Red Yeast Rice titrated in 5 mg monacolin K per daily dose, 1 liquid stick per day, for 8 weeks

Experimental: 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
Dietary Supplement: Plant sterols
Plant sterols 800 mg/dose, 1 liquid stick per day, for 8 weeks

Dietary Supplement: 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




Primary Outcome Measures :
  1. LDL cholesterolemia reduction from baseline and between groups [ Time Frame: 8 weeks ]
    Absolute and % reduction of LDL cholesterolemia after 8 weeks of treatment


Secondary Outcome Measures :
  1. Non-HDL cholesterolemia reduction from baseline and between groups [ Time Frame: 8 weeks ]
    Absolute and % reduction of of non-HDL cholesterolemia after 8 weeks of treatment

  2. Number of Participants With Treatment-Related Adverse Events [ Time Frame: 8 weeks ]
    Subjective tolerability of the tested treatment



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02603276


Locations
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Italy
S. Orsola-Malpighi University Hospital
Bologna, Italy, 40038
Sponsors and Collaborators
University of Bologna
Investigators
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Principal Investigator: Claudio Borghi, MD University of Bologna

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Claudio Borghi, Full professor of internal medicine, University of Bologna
ClinicalTrials.gov Identifier: NCT02603276     History of Changes
Other Study ID Numbers: PhytoRed
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: February 8, 2017
Last Verified: February 2017
Keywords provided by Claudio Borghi, University of Bologna:
hypercholesterolemia
dietary supplements
red yeast rice
plant sterols
Additional relevant MeSH terms:
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Red yeast rice
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lovastatin
L 647318
Dihydromevinolin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents