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

M

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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