Effect of Different Probiotic Strains in Hypercholesterolemic Patients

Eastern Mediterranean University

Status: Completed

Conditions: Hyperlipidemias

Treatments: Other: Placebo; Combination Product: Combined Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis strains; Dietary Supplement: Only Lactobacillus rhamnosus GG strains

Study type: Interventional

Funder types: Other

Identifiers

NCT04701775

2018/60-26

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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51 participants in 3 patient groups, including a placebo group

Lactobacillus rhamnosus GG Group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Only Lactobacillus rhamnosus GG strains

Combined Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis Group

Experimental group

Description:

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

Treatment:

Combination Product: Combined Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis strains

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo