Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-02-28 @ 10:55 PM
Study NCT ID:
NCT04029818
Status:
COMPLETED
Last Update Posted:
2019-11-15
First Post:
2019-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Probiotic on LDL-cholesterol Levels
Sponsor:
Biosearch S.A.
Organization:
Study Overview
Official Title:
Preliminary Study to Evaluate the Effect of the Consumption of Bifidobacterium BSL_PS404 on LDL-cholesterol Levels in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2019-07
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:
The aim of the present study is to evaluate the ability of Bifidobacterium BSL\_PS404 in reducing LDL-cholesterol levels in healthy individuals.
Detailed Description:
There is a strong correlation between LDL-cholesterol and cardiovascular diseases.
Conjugated bile acids help to break down and emulsify dietary fat into micelles that promote their absorption by the enterocytes. The disruption or alteration of these micelles may interfere with the absorption of cholesterol.
Several intestinal bacteria strains are capable of carrying out numerous biotransformations of bile salts during their enterohepatic circulation, such as the hydrolysis of the conjugated bile acids by the action of hydrolases. The mechanism proposed to explain the cholesterol-lowering activity of these probiotic strains is that, due to the greater bile salt hydroxylation in the intestine, the formation of micelles would decrease and, therefore, the absorption of cholesterol and lipids would be decrease too. In addition, probiotics may also increase the excretion of bile acids in the stool, possibly by binding or absorbing them. This increase in fecal secretion of bile acids would require an increase in the hepatic catabolism of cholesterol for the synthesis of bile acids. All these processes may help to reduce LDL-cholesterol levels Bifidobacterium BSL\_PS404 is a bacterium isolated from maternal milk with QPS category that presents a high hydrolase activity that exceeds in more than 20% the activity of other reference strains.
Conjugated bile acids help to break down and emulsify dietary fat into micelles that promote their absorption by the enterocytes. The disruption or alteration of these micelles may interfere with the absorption of cholesterol.
Several intestinal bacteria strains are capable of carrying out numerous biotransformations of bile salts during their enterohepatic circulation, such as the hydrolysis of the conjugated bile acids by the action of hydrolases. The mechanism proposed to explain the cholesterol-lowering activity of these probiotic strains is that, due to the greater bile salt hydroxylation in the intestine, the formation of micelles would decrease and, therefore, the absorption of cholesterol and lipids would be decrease too. In addition, probiotics may also increase the excretion of bile acids in the stool, possibly by binding or absorbing them. This increase in fecal secretion of bile acids would require an increase in the hepatic catabolism of cholesterol for the synthesis of bile acids. All these processes may help to reduce LDL-cholesterol levels Bifidobacterium BSL\_PS404 is a bacterium isolated from maternal milk with QPS category that presents a high hydrolase activity that exceeds in more than 20% the activity of other reference strains.
Study Oversight
Has Oversight DMC:
True
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?: