Effect of Different Probiotic Strains in Hypercholesterolemic Patients

Hyperlipidemias Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04701775
• Other study ID #: 2018/60-26
• Status: Completed
• Phase: N/A
• Start date: September 28, 2018
• Est. completion date: March 7, 2019

Study information

• Verified date: December 2020
• Source: Eastern Mediterranean University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: March 7, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

Dietary Supplement:
• Only Lactobacillus rhamnosus GG strains
1x106 colony forming unit (CFU) Lactobacillus rhamnosus GG probiotic capsule

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

Other:
• Placebo
Placebo probiotic capsule

Locations

Country	Name	City	State
Cyprus	Gözde Okburan	Famagusta

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Mediterranean University

Country where clinical trial is conducted

Cyprus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in total cholesterol level with the use of placebo at week 8	Placebo capsules usually do not improve total cholesterol. Change = (Baseline total cholesterol values - Week 8 total cholesterol values)	Baseline and Week 8
Other	Change from baseline in LDL cholesterol level with the use of placebo at week 8	Placebo capsules usually do not improve LDL cholesterol. Change = (Baseline LDL cholesterol values - Week 8 LDL cholesterol values)	Baseline and Week 8
Other	Change from baseline in triglyceride level with the use of placebo at week 8	Placebo capsules usually do not improve triglyceride levels. Change = (Baseline triglyceride values - Week 8 total triglyceride values)	Baseline and Week 8
Other	Change from baseline in fasting glucose level with the use of placebo at 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
Other	Change from baseline in fasting insulin level with the use of placebo at 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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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