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

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

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; LDL-cholesterol
• Intervention / Treatment: Biological: Bifidobacterium BSL_PS404; Biological: Placebo

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: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Spain
  • Andalucia
    • Granada, Andalucia, Spain, 18016
      • Hospital San Cecilio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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
Triglycerides	Levels of triglycerides in plasma	8 weeks
Glucose	Levels of glucose in plasma	8 weeks
HDL-cholesterol	Levels of HDL-cholesterol 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

Collaborators and Investigators

• Sponsor: Biosearch S.A.
• Investigators: Study Chair: Miguel Quesada, MD, PhD, Medical specialist in Endocrinology, Hospital San Cecilio de Granada

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2019
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: July 22, 2019
• First Submitted That Met QC Criteria: July 22, 2019
• First Posted (Actual): July 23, 2019

Study Record Updates

• Last Update Posted (Actual): November 15, 2019
• Last Update Submitted That Met QC Criteria: November 14, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Probiotics; LDL-cholesterol
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: P046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No