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

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02689934
• Other study ID #: PROBIOTICO - BB536
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: March 9, 2017

Study information

• Verified date: March 2019
• Source: Montefarmaco OTC SpA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: March 9, 2017
• Est. primary completion date: February 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Dietary Supplement:
• Lactoflorene colesterolo
1.8 g + 1.8 g once a day per os
• Placebo lactoflorene colesterolo
1.8 g + 1.8 g once a day per os

Locations

Country	Name	City	State
Italy	Centro Dislipidemie Dip. Cardiotoracovasc ASST Grande Ospedale Metropolitano Niguarda Cà Granda	Milano	Mi

Sponsors (1)

Lead Sponsor	Collaborator
Montefarmaco OTC SpA

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Ruscica M, Pavanello C, Gandini S, Macchi C, Botta M, Dall'Orto D, Del Puppo M, Bertolotti M, Bosisio R, Mombelli G, Sirtori CR, Calabresi L, Magni P. Nutraceutical approach for the management of cardiovascular risk - a combination containing the probioti — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in LDL-C From Baseline	Percent change from baseline in LDL-C after 12 weeks of treatment in patients with moderate hypercholesterolemia	12 weeks
Secondary	Safety and tolerability of Lactoflorene colesterolo (Incidence of treatment-related adverse events)	Incidence of treatment-related adverse events	12 weeks
Secondary	Changes in Other Lipids (non HDL-C, TG, HDL-C) and Apolipoproteins		12 weeks
Secondary	Changes in Vital Signs		12 weeks

External Links

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