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Evaluation of a Probiotic on LDL-cholesterol Levels

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04029818
Enrollment
40
Registered
2019-07-23
Start date
2019-05-24
Completion date
2019-07-31
Last updated
2019-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, LDL-cholesterol

Keywords

LDL-cholesterol, Probiotics

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.

Interventions

BIOLOGICALBifidobacterium BSL_PS404

Each participant will consume 1 capsule daily at lunch for 8 weeks.

BIOLOGICALPlacebo

Each participant will consume 1 capsule daily at lunch for 8 weeks.

Sponsors

Biosearch S.A.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
LDL-cholesterol8 weeksLevels of LDL-cholesterol in plasma

Secondary

MeasureTime frameDescription
HDL-cholesterol8 weeksLevels of HDL-cholesterol in plasma
Triglycerides8 weeksLevels of triglycerides in plasma
Total cholesterol8 weeksLevels of total cholesterol in plasma
Blood pressure8 weeksSystolic and diastolic pressure
Body mass index8 weeksA person's weight in kilograms (kg) divided by his or her height in meters squared
Glucose8 weeksLevels of glucose in plasma

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026