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

NCT02689934 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2019-03-14

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Lactoflorene colesterolo

1.8 g + 1.8 g once a day per os

DIETARY_SUPPLEMENT

Placebo lactoflorene colesterolo

1.8 g + 1.8 g once a day per os

Sponsors & Collaborators

  • Montefarmaco OTC SpA

    lead INDUSTRY

Principal Investigators

  • Giuliana G Mombelli, MD · ASST Grande Ospedale Metropolitano Niguarda Cà Granda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-02-21
Completion
2017-03-09

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02689934 on ClinicalTrials.gov