Effect of Different Probiotic Strains in Hypercholesterolemic Patients

January 8, 2021 updated by: Gözde Okburan, Eastern Mediterranean University

A Randomized Double-Blind Controlled Trial of Lactobacillus Acidophilus Plus Bifidobacterium Animalis Subsp.Lactis, Versus Lactobacillus Rhamnosus GG Versus Placebo in Patients With Hypercholesterolemia

Regular probiotic use for 8 weeks was evaluated in individual with mild to moderate hyperlipidemia. Current study have been determined the use of different probiotics strains on lipid parameters such as; total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride levels as well as glycemic parameters such as; glucose, insulin, HOMA-IR levels. Also, hs-CRP levels were investigated as inflammatory parameter.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In the light of recent studies, it has been shown that probiotics may have positive effects on hyperlipidemia. The aim of this study was to investigate the effect of probiotics mainly on blood lipids as well as homocysteine levels, glycemic control parameters and hs-CRP levels A randomized, double-blind placebo-controlled study was completed with a total of 51 individuals who have diagnosed with hyperlipidemia. Participants were randomly assigned into 3 groups according to the probiotic type they would consume, groups were as follows; Lactobacillus (probiotic group I) (n=18), Lactobacillus and Bifidobacterium (probiotic group II) (n=17) and placebo group (n= 16). They were all requested to have placebo or probiotic capsules every day for 8 weeks. Total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride levels were investigated as lipid metabolism parameters while fasting blood glucose, insulin, HOMA-IR levels were investigated as glycemic parameters. Also, hs-CRP levels were investigated as inflammatory parameter.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
51

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cyprus
      • Famagusta, Cyprus
        • Gözde Okburan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

• Had a repeated total cholesterol level ≥200 mg/dL prior to allocate to the study group and to declined conventional lipid lowering medical treatment

Exclusion Criteria:

  • Those with any chronic conditions other than hypercholesterolemia,
  • Individuals with inherited lipid metabolic disorders,
  • Individuals with chronic gastrointestinal disease,
  • Individuals with immunodeficiency,
  • Individuals with malignancy,
  • Individuals with mental disabilities,
  • Patients currently using any lipid lowering drugs, or an alternative treatment to lower blood cholesterol (such as probiotics) and individuals who have used antibiotics in the previous three months prior to study and
  • Pregnant or lactating women were excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Lactobacillus rhamnosus GG Group
Participants received only 1x106 cfu Lactobacillus rhamnosus GG once a day for 8 weeks.
Dietary supplement: Only Lactobacillus rhamnosus GG strains
1x106 colony forming unit (CFU) Lactobacillus rhamnosus GG probiotic capsule
Experimental: Combined Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis Group
Participants recevied a combined Lactobacillus acidophilus 1x109 cfu and Bifidobacterium animalis subsp.lactis 1x109 cfu once a day for 8 weeks.
Combination product: Combined Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis strains
combination of Lactobacillus acidophilus 1x109 CFU and Bifidobacterium animalis subsp.lactis 1x109 CFU probiotic capsule
Placebo Comparator: Placebo
Those participants received placebo capsule once a day for 8 weeks.
Other: Placebo
Placebo probiotic capsule

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in total cholesterol level with the use of combined Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis capsules at week 8
Time Frame: Baseline and Week 8
Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis decreases total cholesterol level. Change = (Baseline total cholesterol-Week 8 total cholesterol)
Baseline and Week 8
Change from baseline in Low Density Lipoprotein (LDL) levels with the use of combined Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis capsules at week 8
Time Frame: Baseline and Week 8
Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis decreases LDL cholesterol. Change = (Baseline LDL cholesterol values -Week 8 LDL cholesterol values)
Baseline and Week 8
Change from baseline in Triglyceride levels with the use of combined Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis capsules at week 8
Time Frame: Baseline and Week 8
Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis decreases triglyceride levels. Change = (Baseline triglyceride values -Week 8 triglyceride values)
Baseline and Week 8
Change from baseline in fasting glucose levels with the use of combined Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis capsules at week 8
Time Frame: Baseline and Week 8
Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis decreases fasting blood glucose levels. Change = (Baseline fasting glucose values -Week 8 fasting glucose values)
Baseline and Week 8
Change from baseline in fasting insulin levels with the use of combined Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis capsules at week 8
Time Frame: Baseline and Week 8
Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis decreases fasting insulin levels. Change = (Baseline fasting insulin values -Week 8 fasting insulin values)
Baseline and Week 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in total cholesterol level with the use of only Lactobacillus rhamnosus GG microorganism capsules at week 8
Time Frame: Baseline and Week 8
Lactobacillus rhamnosus GG microorganisms decreases total cholesterol level. Change = (Baseline total cholesterol-Week 8 total cholesterol)
Baseline and Week 8
Change from baseline in LDL cholesterol level with the use of only Lactobacillus rhamnosus GG microorganism capsules at week 8
Time Frame: Baseline and Week 8
Lactobacillus rhamnosus GG microorganisms decreases LDL cholesterol level. Change = (Baseline LDL cholesterol-Week 8 LDL cholesterol)
Baseline and Week 8
Change from baseline in triglyceride level with the use of only Lactobacillus rhamnosus GG microorganism capsules at week 8
Time Frame: Baseline and Week 8
Lactobacillus rhamnosus GG microorganisms decreases triglyceride level. Change = (Baseline triglyceride values-Week 8 trgylceride values)
Baseline and Week 8
Change from baseline in fasting glucose level with the use of only Lactobacillus rhamnosus GG microorganism capsules at week 8
Time Frame: Baseline and Week 8
Lactobacillus rhamnosus GG microorganisms decreases fasting glucosel level. Change = (Baseline fasting glucosel-Week 8 fasting glucose)
Baseline and Week 8
Change from baseline in fasting insulin with the use of only Lactobacillus rhamnosus GG microorganism capsules at week 8
Time Frame: Baseline and Week 8
Lactobacillus rhamnosus GG microorganisms decreases fasting insulin level. Change = (Baseline fasting insulin-Week 8 fasting insulin)
Baseline and Week 8

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in total cholesterol level with the use of placebo at week 8
Time Frame: Baseline and Week 8
Placebo capsules usually do not improve total cholesterol. Change = (Baseline total cholesterol values - Week 8 total cholesterol values)
Baseline and Week 8
Change from baseline in LDL cholesterol level with the use of placebo at week 8
Time Frame: Baseline and Week 8
Placebo capsules usually do not improve LDL cholesterol. Change = (Baseline LDL cholesterol values - Week 8 LDL cholesterol values)
Baseline and Week 8
Change from baseline in triglyceride level with the use of placebo at week 8
Time Frame: Baseline and Week 8
Placebo capsules usually do not improve triglyceride levels. Change = (Baseline triglyceride values - Week 8 total triglyceride values)
Baseline and Week 8
Change from baseline in fasting glucose level with the use of placebo at week 8
Time Frame: Baseline and Week 8
Placebo capsules usually do not improve fasting glucose levels. Change = (Baseline fasting glucose values - Week 8 total fasting glucose values)
Baseline and Week 8
Change from baseline in fasting insulin level with the use of placebo at week 8
Time Frame: Baseline and Week 8
Placebo capsules usually do not improve fasting insulin levels. Change = (Baseline fasting insulin values - Week 8 fasting insulin values)
Baseline and Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eastern Mediterranean University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gözde Okburan, Eastern Medittanean University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 28, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 7, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018/60-26

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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