Status:
COMPLETED
Combination of AB-LIFE Probiotic Plus Monacolin K to Reduce Blood Cholesterol
Lead Sponsor:
AB Biotics, SA
Collaborating Sponsors:
University of Extremadura
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This randomized study evaluates the effectiveness of a nutraceutical combining billion colony forming units (cfu) of three L. plantarum strains (CECT7527, CECT7528 and CECT7529) and 10 mg of monacolin...
Detailed Description
Cardiovascular diseases (CVDs) are the number 1 cause of death globally, and retention of low-density lipoprotein cholesterol (LDL-C) and similar cholesterol-rich lipoproteins containing apolipoprotei...
Eligibility Criteria
Inclusion
- Total cholesterol (TC) ≥200 mg/dL and statin-naïve or having recently stopped statin treatment because of statin intolerance.
Exclusion
- History of cardiovascular events or alcohol abuse, presence of diabetes, chronic advanced kidney disease, thyroid disorders, hepatic disorders, familial hypercholesterolemia or immunosuppression
- Body mass index (BMI) ≤ 18.5 or ≥40 Kg/m2
- Use of antibiotics within 4 weeks of study initiation, current use of other probiotics, lipid-lowering medications, corticoids, beta-blockers or calcium channel blockers, thiazide diuretics, estrogen replacement therapy
- Pregnant or lactating women
- Patients with other severe disease that could interfere with the results of the study.
- Patients not agreeing to maintain their usual physical activity throughout the study.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2017
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04677335
Start Date
October 1 2014
End Date
September 19 2017
Last Update
January 22 2021
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