Evaluation of a Probiotic on LDL-cholesterol Levels

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04029818
• Other study ID #: P046
• Status: Completed
• Phase: Phase 1
• Start date: May 24, 2019
• Est. completion date: July 31, 2019

Study information

• Verified date: July 2019
• Source: Biosearch S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• LDL-cholesterol

Intervention

Biological:
• Bifidobacterium BSL_PS404
Each participant will consume 1 capsule daily at lunch for 8 weeks.
• Placebo
Each participant will consume 1 capsule daily at lunch for 8 weeks.

Locations

Country	Name	City	State
Spain	Hospital San Cecilio	Granada	Andalucia

Sponsors (1)

Lead Sponsor	Collaborator
Biosearch S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL-cholesterol	Levels of LDL-cholesterol in plasma	8 weeks
Secondary	Total cholesterol	Levels of total cholesterol in plasma	8 weeks
Secondary	HDL-cholesterol	Levels of HDL-cholesterol in plasma	8 weeks
Secondary	Triglycerides	Levels of triglycerides in plasma	8 weeks
Secondary	Glucose	Levels of glucose in plasma	8 weeks
Secondary	Blood pressure	Systolic and diastolic pressure	8 weeks
Secondary	Body mass index	A person's weight in kilograms (kg) divided by his or her height in meters squared	8 weeks