Effect of Different Probiotic Strains in Hypercholesterolemic Patients

Study Overview
=================
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.

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

Conditions
-----------------
Hyperlipidemias

Intervention / Treatment
-----------------
* Dietary Supplement: Only Lactobacillus rhamnosus GG strains
* Combination Product: Combined Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis strains
* Other: Placebo


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double-blind randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactobacillus rhamnosus GG Group<br>Participants received only 1x106 cfu Lactobacillus rhamnosus GG once a day for 8 weeks. | Dietary Supplement: Only Lactobacillus rhamnosus GG strains<br>* 1x106 colony forming unit (CFU) Lactobacillus rhamnosus GG probiotic capsule<br>|
| Experimental: Combined Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis Group<br>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<br>* combination of Lactobacillus acidophilus 1x109 CFU and Bifidobacterium animalis subsp.lactis 1x109 CFU probiotic capsule<br>|
| Placebo Comparator: Placebo<br>Those participants received placebo capsule once a day for 8 weeks. | Other: Placebo<br>* Placebo probiotic capsule<br>|

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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Lactobacillus rhamnosus GG microorganisms decreases fasting insulin level. Change = (Baseline fasting insulin-Week 8 fasting insulin) | Baseline and Week 8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
serum lipids, hyperlipidemia, probiotics