Evaluation of a Probiotic on LDL-cholesterol Levels

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cardiovascular Diseases, LDL-cholesterol

Intervention / Treatment
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* Biological: Bifidobacterium BSL_PS404
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic<br>Volunteers will take a capsule with Bifidobacterium BSL_PS404 (3x109 cfu) daily. | Biological: Bifidobacterium BSL_PS404<br>* Each participant will consume 1 capsule daily at lunch for 8 weeks.<br>|
| Placebo Comparator: Placebo<br>Volunteers will take a capsule with maltodextrin daily. | Biological: Placebo<br>* Each participant will consume 1 capsule daily at lunch for 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL-cholesterol | Levels of LDL-cholesterol in plasma | 8 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LDL-cholesterol, Probiotics