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

Montefarmaco

Status: Completed

Conditions: Hypercholesterolemia

Treatments: Dietary Supplement: Lactoflorene colesterolo; Dietary Supplement: Placebo lactoflorene colesterolo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02689934

PROBIOTICO - BB536

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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33 participants in 2 patient groups, including a placebo group

Lactoflorene colesterolo

Experimental group

Description:

Red Yeast Rice titrated in 10 mg monacolin K per daily dose plus Bifidobacterium longum 50 mg, powder form, 1 packet per day

Treatment:

Dietary Supplement: Lactoflorene colesterolo

Placebo Lactoflorene colesterolo

Placebo Comparator group

Description:

placebo, powder form, 1 packet per day

Treatment:

Dietary Supplement: Placebo lactoflorene colesterolo