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出境医 / 临床实验 / Evaluation of a Probiotic on LDL-cholesterol Levels

Evaluation of a Probiotic on LDL-cholesterol Levels

Study Description
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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases LDL-cholesterol Biological: Bifidobacterium BSL_PS404 Biological: Placebo Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preliminary Study to Evaluate the Effect of the Consumption of Bifidobacterium BSL_PS404 on LDL-cholesterol Levels in Healthy Volunteers
Actual Study Start Date : May 24, 2019
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : July 31, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: Probiotic
Volunteers will take a capsule with Bifidobacterium BSL_PS404 (3x109 cfu) daily.
 Biological: Bifidobacterium BSL_PS404
Each participant will consume 1 capsule daily at lunch for 8 weeks.
Placebo Comparator: Placebo
Volunteers will take a capsule with maltodextrin daily.
 Biological: Placebo
Each participant will consume 1 capsule daily at lunch for 8 weeks.
Outcome Measures
Primary Outcome Measures :
  1. LDL-cholesterol [ Time Frame: 8 weeks ]
    Levels of LDL-cholesterol in plasma


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Locations
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Spain
Hospital San Cecilio
Granada, Andalucia, Spain, 18016
Sponsors and Collaborators
Biosearch S.A.
Investigators
Layout table for investigator information
Study Chair: Miguel Quesada, MD, PhD Medical specialist in Endocrinology, Hospital San Cecilio de Granada
Tracking Information
First Submitted Date  ICMJE July 22, 2019
First Posted Date  ICMJE July 23, 2019
Last Update Posted Date November 15, 2019
Actual Study Start Date  ICMJE May 24, 2019
Actual Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2019) 		LDL-cholesterol [ Time Frame: 8 weeks ]
Levels of LDL-cholesterol in plasma
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2019)
  • Total cholesterol [ Time Frame: 8 weeks ]
    Levels of total cholesterol in plasma
  • HDL-cholesterol [ Time Frame: 8 weeks ]
    Levels of HDL-cholesterol in plasma
  • Triglycerides [ Time Frame: 8 weeks ]
    Levels of triglycerides in plasma
  • Glucose [ Time Frame: 8 weeks ]
    Levels of glucose in plasma
  • Blood pressure [ Time Frame: 8 weeks ]
    Systolic and diastolic pressure
  • Body mass index [ Time Frame: 8 weeks ]
    A person's weight in kilograms (kg) divided by his or her height in meters squared
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of a Probiotic on LDL-cholesterol Levels
Official Title  ICMJE Preliminary Study to Evaluate the Effect of the Consumption of Bifidobacterium BSL_PS404 on LDL-cholesterol Levels in Healthy Volunteers
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Cardiovascular Diseases
  • LDL-cholesterol
Intervention  ICMJE
  • Biological: Bifidobacterium BSL_PS404
    Each participant will consume 1 capsule daily at lunch for 8 weeks.
  • Biological: Placebo
    Each participant will consume 1 capsule daily at lunch for 8 weeks.
Study Arms  ICMJE
  • Experimental: Probiotic
    Volunteers will take a capsule with Bifidobacterium BSL_PS404 (3x109 cfu) daily.
    Intervention: Biological: Bifidobacterium BSL_PS404
  • Placebo Comparator: Placebo
    Volunteers will take a capsule with maltodextrin daily.
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 22, 2019) 		40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 31, 2019
Actual Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04029818
Other Study ID Numbers  ICMJE P046
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Biosearch S.A.
Study Sponsor  ICMJE Biosearch S.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Miguel Quesada, MD, PhD Medical specialist in Endocrinology, Hospital San Cecilio de Granada
PRS Account Biosearch S.A.
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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