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OpenTrials
Completed

NCT Number: NCT04029818

Evaluation of a Probiotic on LDL-cholesterol Levels

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hospital San Cecilio

Granada, Andalusia, 18016, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bifidobacterium BSL_PS404

Biological

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

Placebo

Biological

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

Primary outcomes

  1. LDL-cholesterol

    Time frame: 8 weeks

    Levels of LDL-cholesterol in plasma

Secondary outcomes

  1. Total cholesterol

    Time frame: 8 weeks

    Levels of total cholesterol in plasma

  2. HDL-cholesterol

    Time frame: 8 weeks

    Levels of HDL-cholesterol in plasma

  3. Triglycerides

    Time frame: 8 weeks

    Levels of triglycerides in plasma

  4. Glucose

    Time frame: 8 weeks

    Levels of glucose in plasma

  5. Blood pressure

    Time frame: 8 weeks

    Systolic and diastolic pressure

  6. Body mass index

    Time frame: 8 weeks

    A person's weight in kilograms (kg) divided by his or her height in meters squared

Sponsors and collaborators

Lead sponsor

Biosearch S.A.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 23, 2019
Registry last updated
Nov 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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