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Trial record 9 of 228 for:    yeast

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

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ClinicalTrials.gov Identifier: NCT02492464
Recruitment Status : Completed
First Posted : July 8, 2015
Last Update Posted : December 7, 2016
Sponsor:
Information provided by (Responsible Party):
Claudio Borghi, University of Bologna

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)

Condition or disease Intervention/treatment Phase
Atherosclerosis Dietary Supplement: Red yeast rice Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : May 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Red yeast rice
Red yeast rice extract 200 mg, containing 10 mg monacolin K per daily dose, 1 capsule per day, per 6 months
Dietary Supplement: Red yeast rice
1 capsule to be taken before to sleep, each day, for 6 months

Placebo Comparator: Placebo
Placebo 200 mg (neutral fibre), 1 capsule per day, per 6 months
Dietary Supplement: Placebo



Primary Outcome Measures :
  1. Flow mediated dilation (FMD) change from the baseline to the end of treatment period [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. 12 hour fasting LDL-cholesterolemia change from the baseline to the end of treatment period [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02492464


Locations
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Italy
S. Orsola-Malpighi University Hospital
Bologna, BO, Italy, 40138
Sponsors and Collaborators
University of Bologna

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Claudio Borghi, Professor Claudio Borghi, University of Bologna
ClinicalTrials.gov Identifier: NCT02492464     History of Changes
Other Study ID Numbers: Monasc10_15
First Posted: July 8, 2015    Key Record Dates
Last Update Posted: December 7, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Red yeast rice
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents