Effect of Different Probiotic Strains in Hypercholesterolemic Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-28

Study Completion Date

2019-03-07

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hyperlipidemias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-blind randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

double blind

Study Groups

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Lactobacillus rhamnosus GG Group

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

Group Type EXPERIMENTAL

Only Lactobacillus rhamnosus GG strains

Intervention Type DIETARY_SUPPLEMENT

1x106 colony forming unit (CFU) Lactobacillus rhamnosus GG probiotic capsule

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.

Group Type EXPERIMENTAL

Combined Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis strains

Intervention Type COMBINATION_PRODUCT

combination of Lactobacillus acidophilus 1x109 CFU and Bifidobacterium animalis subsp.lactis 1x109 CFU probiotic capsule

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo probiotic capsule

Interventions

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Only Lactobacillus rhamnosus GG strains

1x106 colony forming unit (CFU) Lactobacillus rhamnosus GG probiotic capsule

Intervention Type DIETARY_SUPPLEMENT

Combined Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis strains

combination of Lactobacillus acidophilus 1x109 CFU and Bifidobacterium animalis subsp.lactis 1x109 CFU probiotic capsule

Intervention Type COMBINATION_PRODUCT

Placebo

Placebo probiotic capsule

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No