Clinical trial NCT04029818: Evaluation of a Probiotic on LDL-cholesterol Levels
Official title: Preliminary Study to Evaluate the Effect of the Consumption of Bifidobacterium BSL_PS404 on LDL-cholesterol Levels in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cardiovascular Diseases
LDL-cholesterol
Keywords: LDL-cholesterol
Probiotics
Lead sponsor: Biosearch S.A.
Sponsor class: INDUSTRY
First posted: 2019-07-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: LDL-cholesterol
timeFrame: 8 weeks
Secondary outcomes:
measure: Total cholesterol
timeFrame: 8 weeks
measure: HDL-cholesterol
timeFrame: 8 weeks
measure: Triglycerides
timeFrame: 8 weeks
measure: Glucose
timeFrame: 8 weeks
measure: Blood pressure
timeFrame: 8 weeks
measure: Body mass index
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Hospital San Cecilio
state: Andalucia
Study officials:
affiliation: Medical specialist in Endocrinology, Hospital San Cecilio de Granada
name: Miguel Quesada, MD, PhD
role: STUDY_CHAIR
References: