COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu
Trial record 1 of 1 for:    NCT02689934
Previous Study | Return to List | Next Study

Efficacy of a Red Yeast Rice Based Nutraceutical Plus Probiotic in Patients With Moderate Hypercholesterolemia

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. Identifier: NCT02689934
Recruitment Status : Completed
First Posted : February 24, 2016
Last Update Posted : March 14, 2019
Information provided by (Responsible Party):
Montefarmaco OTC SpA

Brief Summary:
A randomized, double-blind, placebo-controlled, parallel study to evaluate the efficacy of a red yeast rice based nutraceutical (monacolin K 10 mg/dose) plus probiotic (Bifidobacterium longum BB536 ®), versus placebo, in patients with moderate hypercholesterolemia, in terms of improvement of the lipid profile and cardiovascular risk.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Dietary Supplement: Lactoflorene colesterolo Dietary Supplement: Placebo lactoflorene colesterolo Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind (subjects, investigators)
Primary Purpose: Treatment
Official Title: Efficacy of Red Yeast Rice Based Nutraceutical (Monacolin K 10 mg/Dose) Plus Probiotic (Bifidobacterium Longum BB536 ®) in Patients With Moderate Hypercholesterolemia.
Study Start Date : April 2016
Actual Primary Completion Date : February 21, 2017
Actual Study Completion Date : March 9, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Lactoflorene colesterolo
Red Yeast Rice titrated in 10 mg monacolin K per daily dose plus Bifidobacterium longum 50 mg, powder form, 1 packet per day
Dietary Supplement: Lactoflorene colesterolo
1.8 g + 1.8 g once a day per os

Placebo Comparator: Placebo Lactoflorene colesterolo
placebo, powder form, 1 packet per day
Dietary Supplement: Placebo lactoflorene colesterolo
1.8 g + 1.8 g once a day per os

Primary Outcome Measures :
  1. Percent Change in LDL-C From Baseline [ Time Frame: 12 weeks ]
    Percent change from baseline in LDL-C after 12 weeks of treatment in patients with moderate hypercholesterolemia

Secondary Outcome Measures :
  1. Safety and tolerability of Lactoflorene colesterolo (Incidence of treatment-related adverse events) [ Time Frame: 12 weeks ]
    Incidence of treatment-related adverse events

  2. Changes in Other Lipids (non HDL-C, TG, HDL-C) and Apolipoproteins [ Time Frame: 12 weeks ]
  3. Changes in Vital Signs [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  • 18 ≤ men or women ≤ 70
  • men or female. Female must be postmenopausal or surgically sterile
  • 130 mg/dl ≤ LDL-C ≤ 200 mg/dl
  • patients in primary cardiovascular prevention

Exclusion Criteria:

  • pregnancy and lactating
  • patients with chronic diseases
  • patients with serious hepatic diseases
  • patients with serious renal diseases
  • patients with thyroid diseases
  • diabetes mellitus or glycemia >126 mg/dl
  • uncontrolled or severe hypertension
  • obesity(BMI>30)
  • smoking status
  • drug or nutraceutical that can interfere with the experimental treatment

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 identifier (NCT number): NCT02689934

Layout table for location information
Centro Dislipidemie Dip. Cardiotoracovasc ASST Grande Ospedale Metropolitano Niguarda Cà Granda
Milano, Mi, Italy, 20162
Sponsors and Collaborators
Montefarmaco OTC SpA
Layout table for investigator information
Principal Investigator: Giuliana G Mombelli, MD ASST Grande Ospedale Metropolitano Niguarda Cà Granda
Additional Information:
Publications of Results:
Layout table for additonal information
Responsible Party: Montefarmaco OTC SpA Identifier: NCT02689934    
Other Study ID Numbers: PROBIOTICO - BB536
First Posted: February 24, 2016    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Montefarmaco OTC SpA:
bifidobacterium longum BB536
red yeast rice
monacolin K
lactoflorene colesterolo
Additional relevant MeSH terms:
Layout table for MeSH terms
Lipid Metabolism Disorders
Metabolic Diseases