Evaluation of a Probiotic on LDL-cholesterol Levels

Biosearch Life

Status and phase

Completed

Phase 1

Conditions

LDL-cholesterol

Cardiovascular Diseases

Treatments

Biological: Placebo

Biological: Bifidobacterium BSL_PS404

Study type

Interventional

Funder types

Industry

Identifiers

NCT04029818

P046

Details and patient eligibility

About

The aim of the present study is to evaluate the ability of Bifidobacterium BSL_PS404 in reducing LDL-cholesterol levels in healthy individuals.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Levels of LDL-cholesterol between 100 and 190 mg/dL.
Accept freely to participate in the study and sign the informed consent document.

Exclusion criteria

Be pregnant.
Have planned to carry out a dietary intervention or exercise practice with the aim of losing weight in the coming weeks.
Having a serious illness.
Having diabetes.
Having a cerebrovascular disease.
Being allergic to any group of antibiotics.
Take probiotics in the form of supplements at least 4 weeks before.
Take antibiotics at least 4 weeks before.
Being taking products or drugs to control cholesterol levels