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Effect of Different Probiotic Strains in Hypercholesterolemic Patients

Primary Purpose

Hyperlipidemias

Status
Completed
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
Only Lactobacillus rhamnosus GG strains
Combined Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis strains
Placebo
Sponsored by
Eastern Mediterranean University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipidemias focused on measuring serum lipids, hyperlipidemia, probiotics

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Gözde Okburan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Lactobacillus rhamnosus GG Group

Combined Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis Group

Placebo

Arm Description

Participants received only 1x106 cfu Lactobacillus rhamnosus GG once a day for 8 weeks.

Participants recevied a combined Lactobacillus acidophilus 1x109 cfu and Bifidobacterium animalis subsp.lactis 1x109 cfu once a day for 8 weeks.

Those participants received placebo capsule once a day for 8 weeks.

Outcomes

Primary Outcome Measures

Change from baseline in total cholesterol level with the use of combined Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis capsules at week 8
Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis decreases total cholesterol level. Change = (Baseline total cholesterol-Week 8 total cholesterol)
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
Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis decreases LDL cholesterol. Change = (Baseline LDL cholesterol values -Week 8 LDL cholesterol values)
Change from baseline in Triglyceride levels with the use of combined Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis capsules at week 8
Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis decreases triglyceride levels. Change = (Baseline triglyceride values -Week 8 triglyceride values)
Change from baseline in fasting glucose levels with the use of combined Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis capsules at week 8
Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis decreases fasting blood glucose levels. Change = (Baseline fasting glucose values -Week 8 fasting glucose values)
Change from baseline in fasting insulin levels with the use of combined Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis capsules at week 8
Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis decreases fasting insulin levels. Change = (Baseline fasting insulin values -Week 8 fasting insulin values)

Secondary Outcome Measures

Change from baseline in total cholesterol level with the use of only Lactobacillus rhamnosus GG microorganism capsules at week 8
Lactobacillus rhamnosus GG microorganisms decreases total cholesterol level. Change = (Baseline total cholesterol-Week 8 total cholesterol)
Change from baseline in LDL cholesterol level with the use of only Lactobacillus rhamnosus GG microorganism capsules at week 8
Lactobacillus rhamnosus GG microorganisms decreases LDL cholesterol level. Change = (Baseline LDL cholesterol-Week 8 LDL cholesterol)
Change from baseline in triglyceride level with the use of only Lactobacillus rhamnosus GG microorganism capsules at week 8
Lactobacillus rhamnosus GG microorganisms decreases triglyceride level. Change = (Baseline triglyceride values-Week 8 trgylceride values)
Change from baseline in fasting glucose level with the use of only Lactobacillus rhamnosus GG microorganism capsules at week 8
Lactobacillus rhamnosus GG microorganisms decreases fasting glucosel level. Change = (Baseline fasting glucosel-Week 8 fasting glucose)
Change from baseline in fasting insulin with the use of only Lactobacillus rhamnosus GG microorganism capsules at week 8
Lactobacillus rhamnosus GG microorganisms decreases fasting insulin level. Change = (Baseline fasting insulin-Week 8 fasting insulin)

Full Information

First Posted
December 9, 2020
Last Updated
January 8, 2021
Sponsor
Eastern Mediterranean University
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1. Study Identification

Unique Protocol Identification Number
NCT04701775
Brief Title
Effect of Different Probiotic Strains in Hypercholesterolemic Patients
Official Title
A Randomized Double-Blind Controlled Trial of Lactobacillus Acidophilus Plus Bifidobacterium Animalis Subsp.Lactis, Versus Lactobacillus Rhamnosus GG Versus Placebo in Patients With Hypercholesterolemia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
September 28, 2018 (Actual)
Primary Completion Date
February 1, 2019 (Actual)
Study Completion Date
March 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Mediterranean University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemias
Keywords
serum lipids, hyperlipidemia, probiotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double-blind randomized controlled trial
Masking
ParticipantInvestigator
Masking Description
double blind
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lactobacillus rhamnosus GG Group
Arm Type
Experimental
Arm Description
Participants received only 1x106 cfu Lactobacillus rhamnosus GG once a day for 8 weeks.
Arm Title
Combined Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis Group
Arm Type
Experimental
Arm Description
Participants recevied a combined Lactobacillus acidophilus 1x109 cfu and Bifidobacterium animalis subsp.lactis 1x109 cfu once a day for 8 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Those participants received placebo capsule once a day for 8 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Only Lactobacillus rhamnosus GG strains
Intervention Description
1x106 colony forming unit (CFU) Lactobacillus rhamnosus GG probiotic capsule
Intervention Type
Combination Product
Intervention Name(s)
Combined Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis strains
Intervention Description
combination of Lactobacillus acidophilus 1x109 CFU and Bifidobacterium animalis subsp.lactis 1x109 CFU probiotic capsule
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo probiotic capsule
Primary Outcome Measure Information:
Title
Change from baseline in total cholesterol level with the use of combined Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis capsules at week 8
Description
Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis decreases total cholesterol level. Change = (Baseline total cholesterol-Week 8 total cholesterol)
Time Frame
Baseline and Week 8
Title
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
Description
Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis decreases LDL cholesterol. Change = (Baseline LDL cholesterol values -Week 8 LDL cholesterol values)
Time Frame
Baseline and Week 8
Title
Change from baseline in Triglyceride levels with the use of combined Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis capsules at week 8
Description
Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis decreases triglyceride levels. Change = (Baseline triglyceride values -Week 8 triglyceride values)
Time Frame
Baseline and Week 8
Title
Change from baseline in fasting glucose levels with the use of combined Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis capsules at week 8
Description
Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis decreases fasting blood glucose levels. Change = (Baseline fasting glucose values -Week 8 fasting glucose values)
Time Frame
Baseline and Week 8
Title
Change from baseline in fasting insulin levels with the use of combined Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis capsules at week 8
Description
Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis decreases fasting insulin levels. Change = (Baseline fasting insulin values -Week 8 fasting insulin values)
Time Frame
Baseline and Week 8
Secondary Outcome Measure Information:
Title
Change from baseline in total cholesterol level with the use of only Lactobacillus rhamnosus GG microorganism capsules at week 8
Description
Lactobacillus rhamnosus GG microorganisms decreases total cholesterol level. Change = (Baseline total cholesterol-Week 8 total cholesterol)
Time Frame
Baseline and Week 8
Title
Change from baseline in LDL cholesterol level with the use of only Lactobacillus rhamnosus GG microorganism capsules at week 8
Description
Lactobacillus rhamnosus GG microorganisms decreases LDL cholesterol level. Change = (Baseline LDL cholesterol-Week 8 LDL cholesterol)
Time Frame
Baseline and Week 8
Title
Change from baseline in triglyceride level with the use of only Lactobacillus rhamnosus GG microorganism capsules at week 8
Description
Lactobacillus rhamnosus GG microorganisms decreases triglyceride level. Change = (Baseline triglyceride values-Week 8 trgylceride values)
Time Frame
Baseline and Week 8
Title
Change from baseline in fasting glucose level with the use of only Lactobacillus rhamnosus GG microorganism capsules at week 8
Description
Lactobacillus rhamnosus GG microorganisms decreases fasting glucosel level. Change = (Baseline fasting glucosel-Week 8 fasting glucose)
Time Frame
Baseline and Week 8
Title
Change from baseline in fasting insulin with the use of only Lactobacillus rhamnosus GG microorganism capsules at week 8
Description
Lactobacillus rhamnosus GG microorganisms decreases fasting insulin level. Change = (Baseline fasting insulin-Week 8 fasting insulin)
Time Frame
Baseline and Week 8
Other Pre-specified Outcome Measures:
Title
Change from baseline in total cholesterol level with the use of placebo at week 8
Description
Placebo capsules usually do not improve total cholesterol. Change = (Baseline total cholesterol values - Week 8 total cholesterol values)
Time Frame
Baseline and Week 8
Title
Change from baseline in LDL cholesterol level with the use of placebo at week 8
Description
Placebo capsules usually do not improve LDL cholesterol. Change = (Baseline LDL cholesterol values - Week 8 LDL cholesterol values)
Time Frame
Baseline and Week 8
Title
Change from baseline in triglyceride level with the use of placebo at week 8
Description
Placebo capsules usually do not improve triglyceride levels. Change = (Baseline triglyceride values - Week 8 total triglyceride values)
Time Frame
Baseline and Week 8
Title
Change from baseline in fasting glucose level with the use of placebo at week 8
Description
Placebo capsules usually do not improve fasting glucose levels. Change = (Baseline fasting glucose values - Week 8 total fasting glucose values)
Time Frame
Baseline and Week 8
Title
Change from baseline in fasting insulin level with the use of placebo at week 8
Description
Placebo capsules usually do not improve fasting insulin levels. Change = (Baseline fasting insulin values - Week 8 fasting insulin values)
Time Frame
Baseline and Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gözde Okburan
Organizational Affiliation
Eastern Medittanean University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gözde Okburan
City
Famagusta
Country
Cyprus

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effect of Different Probiotic Strains in Hypercholesterolemic Patients

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