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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02689934

Enrollment

Registered

2016-02-24

Start date

2016-04-30

Completion date

2017-03-09

Last updated

2019-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

Keywords

hypercholesterolemia, bifidobacterium longum BB536, red yeast rice, monacolin K, lactoflorene colesterolo

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.

Interventions

DIETARY_SUPPLEMENTLactoflorene colesterolo

1.8 g + 1.8 g once a day per os

DIETARY_SUPPLEMENTPlacebo lactoflorene colesterolo

1.8 g + 1.8 g once a day per os

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Double-blind (subjects, investigators)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026