Ignite Creation Date:
2024-05-06 @ 3:33 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04677335
Status:
COMPLETED
Last Update Posted:
2021-01-22
First Post:
2020-11-27
Brief Title:
Combination of AB-LIFE Probiotic Plus Monacolin K to Reduce Blood Cholesterol
Sponsor:
AB Biotics SA
Organization:
AB Biotics SA
Study Overview
Official Title:
Effect of a Nutritional Supplement AB-LIFE Plus Monacolin K to Reduce Total and LDL Cholesterol Levels
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None