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

March 12, 2019 updated by: Montefarmaco OTC SpA

Efficacy of Red Yeast Rice Based Nutraceutical (Monacolin K 10 mg/Dose) Plus Probiotic (Bifidobacterium Longum BB536 ®) in Patients With Moderate Hypercholesterolemia.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Mi
      • Milano, Mi, Italy, 20162
        • Centro Dislipidemie Dip. Cardiotoracovasc ASST Grande Ospedale Metropolitano Niguarda Cà Granda

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability of Lactoflorene colesterolo (Incidence of treatment-related adverse events)
Time Frame: 12 weeks
Incidence of treatment-related adverse events
12 weeks
Changes in Other Lipids (non HDL-C, TG, HDL-C) and Apolipoproteins
Time Frame: 12 weeks
12 weeks
Changes in Vital Signs
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefarmaco OTC SpA

Investigators

  • Principal Investigator: Giuliana G Mombelli, MD, ASST Grande Ospedale Metropolitano Niguarda Cà Granda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

February 21, 2017

Study Completion (Actual)

March 9, 2017

Study Registration Dates

First Submitted

February 9, 2016

First Submitted That Met QC Criteria

February 18, 2016

First Posted (Estimate)

February 24, 2016

Study Record Updates

Last Update Posted (Actual)

March 14, 2019

Last Update Submitted That Met QC Criteria

March 12, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROBIOTICO - BB536

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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