- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04701775
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
Completed
Conditions
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
Interventional
Enrollment (Actual)
51
Phase
- 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
-
-
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Famagusta, Cyprus
- Gözde Okburan
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-
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
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 |
Intervention / Treatment |
---|---|
Experimental: Lactobacillus rhamnosus GG Group
Participants received only 1x106 cfu Lactobacillus rhamnosus GG once a day for 8 weeks.
|
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 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.
|
Placebo probiotic capsule
|
What is the study measuring?
Primary Outcome Measures
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
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
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
Investigators
- 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)
September 28, 2018
Primary Completion (Actual)
February 1, 2019
Study Completion (Actual)
March 7, 2019
Study Registration Dates
First Submitted
December 9, 2020
First Submitted That Met QC Criteria
January 5, 2021
First Posted (Actual)
January 8, 2021
Study Record Updates
Last Update Posted (Actual)
January 12, 2021
Last Update Submitted That Met QC Criteria
January 8, 2021
Last Verified
December 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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