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Obesity - Inflammation - Metabolic Disease: Effect of Lactobacillus Casei Shirota

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01182844
Recruitment Status : Completed
First Posted : August 17, 2010
Results First Posted : April 2, 2020
Last Update Posted : April 2, 2020
Sponsor:
Information provided by (Responsible Party):
Vanessa Stadlbauer-Koellner, MD, Medical University of Graz

Brief Summary:

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

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Obesity - Inflammation - Metabolic Disease: Effect of Lactobacillus Casei Shirota
Study Start Date : April 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
Usual care
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




Primary Outcome Measures :
  1. Change of Neutrophil Phagocytosis [ 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.


  2. Change of Burst (%) [ 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.



Secondary Outcome Measures :
  1. 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

  2. Gut Permeability [ Time Frame: 3 months ]
    Lactulose/Mannitol test

  3. oxLDL [ Time Frame: 3 months ]
  4. IL-6 [ Time Frame: 3 months ]
  5. IL-10 [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age >18
  • Informed consent
  • Fasting blood glucose >95mg/dL
  • Metabolic syndrome defined by the NCEP-ATPIII criteria (3 out of 5)

    • Abdominal obesity (waist circumference >102 in men or >88 in women)
    • Elevated blood pressure (>135/>85) or drug treatment for elevated blood pressure
    • Fasting blood glucose >100mg/dL or previously known type 2 diabetes mellitus,
    • HDL cholesterol <40 mg/dL (men) or <50 mg/dL (women) or drug treatment for low HDL cholesterol
    • Triglycerides >150 mg/dL or drug treatment for elevated for high triglycerides
  • HbA1C ≤7.0%

Exclusion Criteria:

  • Drug treatment for diabetes mellitus
  • Liver cirrhosis (biopsy proven) or elevated transaminases (>2x ULN)
  • Inflammatory bowel disease (Crohns disease, ulcerative colitis)
  • Celiac disease
  • Alcohol abuse (more than 40g alcohol per day in the history)
  • Clinical evidence of active infection
  • Antibiotic treatment within 7 days prior to enrolment
  • Use of immunomodulating agents within previous month (steroids etc.)
  • Concomitant use of supplements (pre-, pro-, or synbiotics) likely to influence the study
  • Any severe illness unrelated to metabolic syndrome
  • Malignancy
  • Pregnancy

Information from the National Library of Medicine

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


Locations
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Austria
Dept. of Internal Medicine, Medical University of Graz
Graz, Austria, 8036
Sponsors and Collaborators
Vanessa Stadlbauer-Koellner, MD
Investigators
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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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Vanessa Stadlbauer-Koellner, MD, Associate Professor, Medical University of Graz
ClinicalTrials.gov Identifier: NCT01182844    
Other Study ID Numbers: vs09.2008
First Posted: August 17, 2010    Key Record Dates
Results First Posted: April 2, 2020
Last Update Posted: April 2, 2020
Last Verified: March 2020
Keywords provided by Vanessa Stadlbauer-Koellner, MD, Medical University of Graz:
metabolic syndrome, probiotic
Additional relevant MeSH terms:
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Metabolic Syndrome
Metabolic Diseases
Inflammation
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders