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Trial record 19 of 228 for:    yeast

Effect of Red Yeast Rice, Phytosterols and L-tyrosol on Lipid Profile and Endothelial Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03065491
Recruitment Status : Completed
First Posted : February 28, 2017
Last Update Posted : February 28, 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 red yeast rice, phytosterols and L-tyrosol. 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: Combined nutraceutical Other: Placebo Not Applicable

Detailed Description:

European Food Safety Authority approves some health claim related to the cardiometabolic effects of some nutraceuticals, and in particular of red yeast rice, phytosterols and L-tyrosol.

In a previous study the investigators have already demonstrated the synergistic effect of red yeast rice and phytosterols in term of lipid-lowering activity.

Preliminary data suggest that these nutraceuticals could also exert a positive effect on vascular health beyond the direct effects on serum lipids.

No data are available on the combined effects of these dietary supplement in humans.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Red Yeast Rice, Phytosterols and L-tyrosol on Lipid Profile and Endothelial Function: a Double-blind, Placebo-controlled, Randomized Clinical Trial
Actual Study Start Date : November 15, 2016
Actual Primary Completion Date : February 15, 2017
Actual Study Completion Date : February 17, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active treatment
Combined nutraceutical
Dietary Supplement: Combined nutraceutical
Plant sterols 800 mg + Red Yeast Rice containing 5 mg monacolin K + L-Tyrosol 50 mg per daily dose Oral administration: 1 tablet per day

Placebo Comparator: Placebo
Placebo
Other: Placebo
Oral administration: 1 tablet per day




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

  2. LDL-cholesterolemia % reduction from baseline and between groups [ Time Frame: 8 weeks ]
    % reduction of LDL-cholesterolemia after 8 weeks of treatment


Secondary Outcome Measures :
  1. Flow-mediated dilation improvement from baseline and between groups [ Time Frame: 8 weeks ]
    % vascular heath improvement after 8 weeks of 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:

  • Suboptimal LDL level (115-160 mg/dL)
  • TG<400 mg/dL
  • Signed informed consent form

Exclusion Criteria:

  • Patients already affected by cardiovascular diseases (secondary prevention) or with estimated 10 years cardiovascular disease risk> 10 years
  • LDL-C<115 mg/dL or >160 mg/dL, TG>400 mg/dL
  • Obesity (BMI>30 kg/m2) or diabetes mellitus
  • Assumption of lipid lowering drugs or dietary supplements, or drugs potentially affecting the lipid metabolism
  • Antihypertensive treatment not stabilized since at least 3 months
  • Known current thyroid, gastrointestinal or liver diseases
  • Any medical or surgical condition that would limit the patient adhesion to the study protocol

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): NCT03065491


Locations
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Italy
S. Orsola-Malpighi University Hospital
Bologna, BO, Italy, 40138
Sponsors and Collaborators
University of Bologna
Investigators
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Principal Investigator: Claudio Borghi, MD S. Orsola-Malpighi University Hospital

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Responsible Party: Claudio Borghi, Principal Investigator, Professor Claudio Borghi, University of Bologna
ClinicalTrials.gov Identifier: NCT03065491     History of Changes
Other Study ID Numbers: MPT_trial_2016
First Posted: February 28, 2017    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Claudio Borghi, University of Bologna:
Red yeast rice
Phytosterols
L-Tyrosol
Lipids
LDL-cholesterol
Endothelial function
Additional relevant MeSH terms:
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Red yeast rice
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
4-hydroxyphenylethanol
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents
Anti-Arrhythmia Agents
Antioxidants
Protective Agents
Physiological Effects of Drugs