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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Dietary Supplement: Lactoflorene colesterolo
* Dietary Supplement: Placebo lactoflorene colesterolo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactoflorene colesterolo<br>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<br>* 1.8 g + 1.8 g once a day per os<br>|
| Placebo Comparator: Placebo Lactoflorene colesterolo<br>placebo, powder form, 1 packet per day | Dietary Supplement: Placebo lactoflorene colesterolo<br>* 1.8 g + 1.8 g once a day per os<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of Lactoflorene colesterolo (Incidence of treatment-related adverse events) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypercholesterolemia, bifidobacterium longum BB536, red yeast rice, monacolin K, lactoflorene colesterolo