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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-03-09

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.

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Detailed Description

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Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double-blind (subjects, investigators)

Study Groups

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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

Group Type EXPERIMENTAL

Lactoflorene colesterolo

Intervention Type DIETARY_SUPPLEMENT

1.8 g + 1.8 g once a day per os

Placebo Lactoflorene colesterolo

placebo, powder form, 1 packet per day

Group Type PLACEBO_COMPARATOR

Placebo lactoflorene colesterolo

Intervention Type DIETARY_SUPPLEMENT

1.8 g + 1.8 g once a day per os

Interventions

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Lactoflorene colesterolo

1.8 g + 1.8 g once a day per os

Intervention Type DIETARY_SUPPLEMENT

Placebo lactoflorene colesterolo

1.8 g + 1.8 g once a day per os

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No