We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

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
Last Update Posted : June 4, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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
Metabolic Syndrome Dietary Supplement: Lactobacillus casei Shirota

  Show Detailed Description

Study Design

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
Primary Completion Date : November 2010
Study Completion Date : December 2010


Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Neutrophil phagocytosis; Neutrophil oxidative 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. glucose tolerance, insulin resistance [ Time Frame: 3 months ]
    frequently sampled oral glucose tolerance test

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

  3. Plasma cytokines [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Contacts and Locations

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
Austria
Dept. of Internal Medicine, Medical University of Graz
Graz, Austria, 8036
Sponsors and Collaborators
Vanessa Stadlbauer-Koellner, MD
Investigators
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
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vanessa Stadlbauer-Koellner, MD, Associate Professor, Medical University of Graz
ClinicalTrials.gov Identifier: NCT01182844     History of Changes
Other Study ID Numbers: vs09.2008
First Posted: August 17, 2010    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: June 2015

Keywords provided by Vanessa Stadlbauer-Koellner, MD, Medical University of Graz:
metabolic syndrome, probiotic

Additional relevant MeSH terms:
Inflammation
Metabolic Syndrome X
Metabolic Diseases
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders