Clinical trial NCT04677335: Combination of AB-LIFE Probiotic Plus Monacolin K to Reduce Blood Cholesterol
Official title: Effect of a Nutritional Supplement (AB-LIFE Plus Monacolin K) to Reduce Total and LDL Cholesterol Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Keywords: Probiotic
Lactobacillus
Monacolin K
Monascus purpureus
Lead sponsor: AB Biotics, SA
Sponsor class: INDUSTRY
Collaborators: name: University of Extremadura
First posted: 2020-12-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 K in reducing blood cholesterol.

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 apolipoprotein B (ApoB) within the arterial wall is a key initiating event in CVDs. Statins are the mainstay of pharmacological cholesterol-reduction therapy. However, a significant proportion of patients report some degree of statin intolerance, which typically fade away when the statin is switched, discontinued or the dosage reduced. A growing attention has been devoted to the correction of increased LDL-C levels through the use of dietary supplements, either because some patients have milder forms of hypercholesterolemia or as an alternative to statins in patients who may have experienced or are worried of side effects. Nutraceutical combinations are increasingly used in clinical practice. In this pilot randomized study, we sought to evaluate of the effect on LDL-C and other blood lipid parameters of a nutraceutical combining Red Yeast Rice extract (also known by its scientific name Monascus purpureus) containing 10 mg of monacolin K, plus 1 billion colony forming units (cfu) of the AB-LIFE probiotic formula. The later is composed of three L. plantarum strains, namely CECT7527 (also known as KABP011™), CECT7528 (also known as KABP012™) and CECT7529 (also known as KABP013™).

Eligibility criteria: Inclusion Criteria:

* Total cholesterol (TC) ≥200 mg/dL and statin-naïve or having recently stopped statin treatment because of statin intolerance.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in low density lipoprotein cholesterol (LDL-C)
timeFrame: 0, 6 and 12 weeks
Secondary outcomes:
measure: Change in total cholesterol (TC)
timeFrame: 0, 6 and 12 weeks
measure: Change in high density lipoprotein cholesterol (HDL-C)
timeFrame: 0, 6 and 12 weeks
measure: Change in triglycerides (TG)
timeFrame: 0, 6 and 12 weeks
measure: Change in Body Mass Index (BMI)
timeFrame: 0 and 12 weeks
measure: Change in body weight
timeFrame: 0 and 12 weeks
measure: Change in percent body fat
timeFrame: 0 and 12 weeks
measure: Patient satisfaction with treatment
timeFrame: 12 weeks
measure: Treatment-emergent adverse effects
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Extremadura (SPAIN)
name: Rafael Guerrero Bonmatty, PhD
role: PRINCIPAL_INVESTIGATOR
References: