Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
40 participants
INTERVENTIONAL
2019-05-24
2019-07-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Probiotic
Volunteers will take a capsule with Bifidobacterium BSL\_PS404 (3x109 cfu) daily.
Bifidobacterium BSL_PS404
Each participant will consume 1 capsule daily at lunch for 8 weeks.
Placebo
Volunteers will take a capsule with maltodextrin daily.
Placebo
Each participant will consume 1 capsule daily at lunch for 8 weeks.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Accept freely to participate in the study and sign the informed consent document.
Exclusion Criteria
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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Biosearch S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Miguel Quesada, MD, PhD
Role: STUDY_CHAIR
Medical specialist in Endocrinology, Hospital San Cecilio de Granada
Locations
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Hospital San Cecilio
Granada, Andalusia, Spain
Countries
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Other Identifiers
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P046
Identifier Type: -
Identifier Source: org_study_id
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