Clinical Trials Directory

Trials / Completed

CompletedNCT04701775

Effect of Different Probiotic Strains in Hypercholesterolemic Patients

A Randomized Double-Blind Controlled Trial of Lactobacillus Acidophilus Plus Bifidobacterium Animalis Subsp.Lactis, Versus Lactobacillus Rhamnosus GG Versus Placebo in Patients With Hypercholesterolemia

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
51 (actual)
Sponsor
Eastern Mediterranean University · Academic / Other
Sex
All
Age
19 Years – 65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTOnly Lactobacillus rhamnosus GG strains1x106 colony forming unit (CFU) Lactobacillus rhamnosus GG probiotic capsule
COMBINATION_PRODUCTCombined Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis strainscombination of Lactobacillus acidophilus 1x109 CFU and Bifidobacterium animalis subsp.lactis 1x109 CFU probiotic capsule
OTHERPlaceboPlacebo probiotic capsule

Timeline

Start date
2018-09-28
Primary completion
2019-02-01
Completion
2019-03-07
First posted
2021-01-08
Last updated
2021-01-12

Locations

1 site across 1 country: Cyprus

Source: ClinicalTrials.gov record NCT04701775. Inclusion in this directory is not an endorsement.