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

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Lactoflorene colesterolo
Placebo lactoflorene colesterolo
Sponsored by
Montefarmaco OTC SpA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring hypercholesterolemia, bifidobacterium longum BB536, red yeast rice, monacolin K, lactoflorene colesterolo

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centro Dislipidemie Dip. Cardiotoracovasc ASST Grande Ospedale Metropolitano Niguarda Cà Granda

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lactoflorene colesterolo

Placebo Lactoflorene colesterolo

Arm Description

Red Yeast Rice titrated in 10 mg monacolin K per daily dose plus Bifidobacterium longum 50 mg, powder form, 1 packet per day

placebo, powder form, 1 packet per day

Outcomes

Primary Outcome Measures

Percent Change in LDL-C From Baseline
Percent change from baseline in LDL-C after 12 weeks of treatment in patients with moderate hypercholesterolemia

Secondary Outcome Measures

Safety and tolerability of Lactoflorene colesterolo (Incidence of treatment-related adverse events)
Incidence of treatment-related adverse events
Changes in Other Lipids (non HDL-C, TG, HDL-C) and Apolipoproteins
Changes in Vital Signs

Full Information

First Posted
February 9, 2016
Last Updated
March 12, 2019
Sponsor
Montefarmaco OTC SpA
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1. Study Identification

Unique Protocol Identification Number
NCT02689934
Brief Title
Efficacy of a Red Yeast Rice Based Nutraceutical Plus Probiotic in Patients With Moderate Hypercholesterolemia
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 Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
February 21, 2017 (Actual)
Study Completion Date
March 9, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefarmaco OTC SpA

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
hypercholesterolemia, bifidobacterium longum BB536, red yeast rice, monacolin K, lactoflorene colesterolo

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind (subjects, investigators)
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lactoflorene colesterolo
Arm Type
Experimental
Arm Description
Red Yeast Rice titrated in 10 mg monacolin K per daily dose plus Bifidobacterium longum 50 mg, powder form, 1 packet per day
Arm Title
Placebo Lactoflorene colesterolo
Arm Type
Placebo Comparator
Arm Description
placebo, powder form, 1 packet per day
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactoflorene colesterolo
Intervention Description
1.8 g + 1.8 g once a day per os
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo lactoflorene colesterolo
Intervention Description
1.8 g + 1.8 g once a day per os
Primary Outcome Measure Information:
Title
Percent Change in LDL-C From Baseline
Description
Percent change from baseline in LDL-C after 12 weeks of treatment in patients with moderate hypercholesterolemia
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Safety and tolerability of Lactoflorene colesterolo (Incidence of treatment-related adverse events)
Description
Incidence of treatment-related adverse events
Time Frame
12 weeks
Title
Changes in Other Lipids (non HDL-C, TG, HDL-C) and Apolipoproteins
Time Frame
12 weeks
Title
Changes in Vital Signs
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuliana G Mombelli, MD
Organizational Affiliation
ASST Grande Ospedale Metropolitano Niguarda Cà Granda
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Dislipidemie Dip. Cardiotoracovasc ASST Grande Ospedale Metropolitano Niguarda Cà Granda
City
Milano
State/Province
Mi
ZIP/Postal Code
20162
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30795775
Citation
Ruscica M, Pavanello C, Gandini S, Macchi C, Botta M, Dall'Orto D, Del Puppo M, Bertolotti M, Bosisio R, Mombelli G, Sirtori CR, Calabresi L, Magni P. Nutraceutical approach for the management of cardiovascular risk - a combination containing the probiotic Bifidobacterium longum BB536 and red yeast rice extract: results from a randomized, double-blind, placebo-controlled study. Nutr J. 2019 Feb 22;18(1):13. doi: 10.1186/s12937-019-0438-2. Erratum In: Nutr J. 2019 Sep 9;18(1):54.
Results Reference
result
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/30795775
Description
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Efficacy of a Red Yeast Rice Based Nutraceutical Plus Probiotic in Patients With Moderate Hypercholesterolemia

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