NCT02689934

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 24, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2017

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2017

Completed
Last Updated

March 14, 2019

Status Verified

March 1, 2019

Enrollment Period

11 months

First QC Date

February 9, 2016

Last Update Submit

March 12, 2019

Conditions

Hypercholesterolemia

Keywords

hypercholesterolemiabifidobacterium longum BB536red yeast ricemonacolin Klactoflorene colesterolo

Outcome Measures

Primary Outcomes (1)

  • Percent Change in LDL-C From Baseline

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

    12 weeks

Secondary Outcomes (3)

  • Safety and tolerability of Lactoflorene colesterolo (Incidence of treatment-related adverse events)

    12 weeks

  • Changes in Other Lipids (non HDL-C, TG, HDL-C) and Apolipoproteins

    12 weeks

  • Changes in Vital Signs

    12 weeks

Study Arms (2)

Lactoflorene colesterolo

EXPERIMENTAL

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

Placebo Lactoflorene colesterolo

PLACEBO COMPARATOR

placebo, powder form, 1 packet per day

Dietary Supplement: Placebo lactoflorene colesterolo

Interventions

Lactoflorene colesteroloDIETARY_SUPPLEMENT

1.8 g + 1.8 g once a day per os

Lactoflorene colesterolo
Placebo lactoflorene colesteroloDIETARY_SUPPLEMENT

1.8 g + 1.8 g once a day per os

Placebo Lactoflorene colesterolo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Milan, Mi, 20162, Italy

Location

Related Publications (1)

  • 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.

    PMID: 30795775RESULT

Related Links

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Giuliana G Mombelli, MD

    ASST Grande Ospedale Metropolitano Niguarda Cà Granda

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double-blind (subjects, investigators)
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2016

First Posted

February 24, 2016

Study Start

April 1, 2016

Primary Completion

February 21, 2017

Study Completion

March 9, 2017

Last Updated

March 14, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)