Obesity - Inflammation - Metabolic Disease: Effect of Lactobacillus Casei Shirota
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|ClinicalTrials.gov Identifier: NCT01182844|
Recruitment Status : Completed
First Posted : August 17, 2010
Results First Posted : April 2, 2020
Last Update Posted : September 29, 2020
Obesity and metabolic syndrome are linked by inflammation. Gut flora seems to play an important role in the development of inflammation and metabolic syndrome in obesity. Modulation of gut flora by probiotics has been shown in animal studies to positively influence inflammation and metabolic disturbances.
Lactobacillus casei Shirota is able to decrease metabolic endotoxemia by altering gut flora composition and gut permeability which leads to an improvement in neutrophil function and insulin resistance in obesity.
The aim of the current study is to investigate the effect of Lactobacillus casei Shirota supplementation over 12 weeks on neutrophil function (phagocytosis, oxidative burst and TLR expression) in patients with metabolic syndrome.
Furthermore the investigators aim to investigate the effect of Lactobacillus casei Shirota supplementation over 12 weeks on glucose tolerance, insulin resistance, inflammation, gut flora composition, gut permeability, and endotoxemia in metabolic syndrome
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome||Dietary Supplement: Lactobacillus casei Shirota||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Obesity - Inflammation - Metabolic Disease: Effect of Lactobacillus Casei Shirota|
|Actual Study Start Date :||January 2010|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||December 2010|
No Intervention: Control
Experimental: Lactobacillus casei Shirota
3 bottles of Yakult(R) light per day
Dietary Supplement: Lactobacillus casei Shirota
3 bottles of Yakult(R) light per day
Other Name: Yakult
- Change of Neutrophil Phagocytosis From Baseline to 3 Months [ Time Frame: 3 months ]The Phagotest® (Orpegen Pharma, Heidelberg, Germany) is used to measure phagocytosis by using Fluorescein isothiocyanate (FITC)-labelled opsonized E. coli bacteria.
- Change of Burst (%) From Baseline to 3 Months [ Time Frame: 3 months ]
The Phagotest® (Orpegen Pharma, Heidelberg, Germany) is used to measure phagocytosis by using FITC-labelled opsonized E. coli bacteria.
The Phagoburst® kit (Orpegen Pharma, Heidelberg, Germany) is used to determine the percentage of neutrophils that produce reactive oxidants with or without stimulation.
- Change in Indices of Glucose Tolerance and Insulin Resistance [ Time Frame: 3 months ]change in indices of glucose tolerance and insulin resistance (frequently sampled in an oral glucose tolerance test) at baseline and after 3 months Homeostasis model assessment (HOMA)- Insulin Resistance (IR): HOMA is calculated by [fasting glucose*fasting insulin/22.5] insulin (U/L), glucose (mmol/l) - higher values indicating more severe insulin resistance Quantitativer Insulin Sensitivitäts-Check Index (QUCIKI): QUICKI is calculated by [1/log (insulin0)+log(glucose0)] insulin (mU/L), glucose (mg/dL) - lower values indicating a improvement of insulin sensitivity Insulin Sensitivity Index (ISI): 0.222-00333*BMI - 0.0000779*Ins120 -0.0004222*age insulin (mU/L) lower values indicating a improvement of insulin sensitivity
- Change of Gut Permeability From Baseline to 3 Months [ Time Frame: 3 months ]Change of gut permeability (lactulose/mannitol-test) from Baseline to 3 months
- Change in oxLDL (Oxidative Low Density Lipoprotein) From Baseline to 3 Months [ Time Frame: 3 months ]
- Change in Interleukin-6 (IL-6) From Baseline to 3 Months [ Time Frame: 3 months ]
- Change in Interleukin-10 (IL-10) From Baseline to 3 Months [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01182844
|Dept. of Internal Medicine, Medical University of Graz|
|Graz, Austria, 8036|
|Principal Investigator:||Vanessa Stadlbauer-Köllner, MD||Dept. of Internal Medicine, Medical University of Graz, Austria|
|Principal Investigator:||Harald Sourij, MD||Dept. of Internal Medicine, Medical University of Graz, Austria|