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OpenTrials
Completed

NCT Number: NCT02689934

Efficacy of a Red Yeast Rice Based Nutraceutical Plus Probiotic 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.

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Dislipidemie Dip. Cardiotoracovasc ASST Grande Ospedale Metropolitano Niguarda Cà Granda

Milan, Mi, 20162, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lactoflorene colesterolo

Dietary Supplement

1.8 g + 1.8 g once a day per os

Placebo lactoflorene colesterolo

Dietary Supplement

1.8 g + 1.8 g once a day per os

Primary outcomes

  1. Percent Change in LDL-C From Baseline

    Time frame: 12 weeks

    Percent change from baseline in LDL-C after 12 weeks of treatment in patients with moderate hypercholesterolemia

Secondary outcomes

  1. Safety and tolerability of Lactoflorene colesterolo (Incidence of treatment-related adverse events)

    Time frame: 12 weeks

    Incidence of treatment-related adverse events

  2. Changes in Other Lipids (non HDL-C, TG, HDL-C) and Apolipoproteins

    Time frame: 12 weeks

  3. Changes in Vital Signs

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Montefarmaco OTC SpA

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 24, 2016
Registry last updated
Mar 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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