Combination of AB-LIFE Probiotic Plus Monacolin K to Reduce Blood Cholesterol

Effect of a Nutritional Supplement (AB-LIFE Plus Monacolin K) to Reduce Total and LDL Cholesterol Levels

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.

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Dietary supplement: AB-LIFE with Monacolin K; Other: Placebo

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™).

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nutraceutical; Nutraceutical capsules taken once daily for 12 weeks	Dietary supplement: AB-LIFE with Monacolin K; Red yeast rice extract (also known by its scientific name, Monascus purpureus) certified to contain 10 mg of monacolin K, plus 1 billion total cfu of AB-LIFE probiotic formula, which is composed of 3 Lactoplantibacillus plantarum (formerly known as Lactobacillus plantarum) strains: CECT7527 (also known as KABP011™), CECT7528 (also known as KABP012™) and CECT7529 (also known as KABP013™), all in a maltodextrin carrier. Capsules are of vegetable origin (hydroxypropylmethyl cellulose).
Placebo Comparator: Control; Placebo capsules taken once daily for 12 weeks	Other: Placebo; Placebo capsules containing maltodextrin carrier only. Capsules are of vegetable origin (hydroxypropylmethyl cellulose).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in low density lipoprotein cholesterol (LDL-C)	Fasting serum levels of low density lipoprotein cholesterol (LDL-C), assessed by repeated measures analysis at three timepoints (baseline, mid of intervention and end of intervention).	0, 6 and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in total cholesterol (TC)	Fasting serum levels of total cholesterol (TC), assessed by repeated measures analysis at three timepoints (baseline, mid of intervention and end of intervention).	0, 6 and 12 weeks
Change in high density lipoprotein cholesterol (HDL-C)	Fasting serum levels of high density lipoprotein cholesterol (HDL-C), assessed by repeated measures analysis at three timepoints (baseline, mid of intervention and end of intervention).	0, 6 and 12 weeks
Change in triglycerides (TG)	Fasting serum levels of triglycerides (TG), assessed by repeated measures analysis at three timepoints (baseline, mid of intervention and end of intervention).	0, 6 and 12 weeks
Change in Body Mass Index (BMI)	Body Mass Index, calculated as body weight (in kilograms) divided by squared height (in meters), assessed by repeated measures analysis at two timepoints (baseline and end of intervention).	0 and 12 weeks
Change in body weight	Body weight in kilograms, assessed by repeated measures analysis at two timepoints (baseline and end of intervention).	0 and 12 weeks
Change in percent body fat	Percent of body fat (as determined with a MC780 Body Analyzer), assessed by repeated measures analysis at two timepoints (baseline and end of intervention).	0 and 12 weeks
Patient satisfaction with treatment	Rated with a Likert-type scale ranging 0 (very dissatisfied) to 4 (very satisfied), assessed at the end of the intervention.	12 weeks
Treatment-emergent adverse effects	Incidence of adverse effects (type and number) and relatedness to study product (using a 5 category system: certain, likely related, possibly related, conditionally related, unknown), as documented according to the Spanish Medicine and Medical Device Agency (AEMPS) pharmacovigilance system	12 weeks

Collaborators and Investigators

• Sponsor: AB Biotics, SA
• Collaborators: University of Extremadura
• Investigators: Principal Investigator: Rafael Guerrero Bonmatty, PhD, University of Extremadura (SPAIN)

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): April 15, 2016
• Study Completion (Actual): September 19, 2017

Study Registration Dates

• First Submitted: November 27, 2020
• First Submitted That Met QC Criteria: December 15, 2020
• First Posted (Actual): December 21, 2020

Study Record Updates

• Last Update Posted (Actual): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 19, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Probiotic; Lactobacillus; Monacolin K; Monascus purpureus
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Lovastatin
• Other Study ID Numbers: PRIMACOL01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No