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

Not Applicable

Completed

• Conditions: Hypercholesterolemia
• Interventions: Dietary Supplement: Lactoflorene colesterolo; Dietary Supplement: Placebo lactoflorene colesterolo

• Registration Number: NCT02689934
• Lead Sponsor: Montefarmaco OTC SpA

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-09
• Study First Submitted QC: 2016-02-18
• Study First Posted: 2016-02-24
• Study Start: 2016-04
• Primary Completion: 2017-02-21
• Study Completion: 2017-03-09
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-12
• Last Update Posted: 2019-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactoflorene colesterolo	Lactoflorene colesterolo	Red Yeast Rice titrated in 10 mg monacolin K per daily dose plus Bifidobacterium longum 50 mg, powder form, 1 packet per day
Placebo Lactoflorene colesterolo	Placebo lactoflorene colesterolo	placebo, powder form, 1 packet per day

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Centro Dislipidemie Dip. Cardiotoracovasc ASST Grande Ospedale Metropolitano Niguarda Cà Granda; 🇮🇹 Milano, Mi, Italy