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.

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.

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