NCT04029818

Evaluation of a Probiotic on LDL-cholesterol Levels

Preliminary Study to Evaluate the Effect of the Consumption of Bifidobacterium BSL_PS404 on LDL-cholesterol Levels in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Biosearch S.A. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cardiovascular Diseases
• LDL-cholesterol

Interventions

Type	Name	Description
BIOLOGICAL	Bifidobacterium BSL_PS404	Each participant will consume 1 capsule daily at lunch for 8 weeks.
BIOLOGICAL	Placebo	Each participant will consume 1 capsule daily at lunch for 8 weeks.

Timeline

• Start date: 2019-05-24
• Primary completion: 2019-07-31
• Completion: 2019-07-31
• First posted: 2019-07-23
• Last updated: 2019-11-15

Locations

1 site across 1 country: Spain