NCT04677335

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: AB Biotics, SA · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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™).

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
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).
OTHER	Placebo	Placebo capsules containing maltodextrin carrier only. Capsules are of vegetable origin (hydroxypropylmethyl cellulose).

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-04-15
• Completion: 2017-09-19
• First posted: 2020-12-21
• Last updated: 2021-01-22