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

Montefarmaco OTC SpA33 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hypercholesterolemia

Interventions

Lactoflorene colesteroloDIETARY_SUPPLEMENT

1.8 g + 1.8 g once a day per os

Placebo lactoflorene colesteroloDIETARY_SUPPLEMENT

1.8 g + 1.8 g once a day per os

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Milan, Mi, Italy

Outcomes

Primary Outcomes

Percent Change in LDL-C From Baseline

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

Time frame: 12 weeks

Secondary Outcomes

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

Incidence of treatment-related adverse events

Time frame: 12 weeks

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

Time frame: 12 weeks

Changes in Vital Signs

Time frame: 12 weeks

Data from ClinicalTrials.gov

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