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

This study has been completed.
Sponsor:
Information provided by:
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01182844
First received: August 13, 2010
Last updated: February 9, 2011
Last verified: February 2011
History of Changes
  Purpose

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 Intervention
Metabolic Syndrome
 Dietary Supplement: Lactobacillus casei Shirota

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Obesity - Inflammation - Metabolic Disease: Effect of Lactobacillus Casei Shirota

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • Neutrophil phagocytosis; Neutrophil oxidative burst [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    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:
  • glucose tolerance, insulin resistance [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    frequently sampled oral glucose tolerance test

  • Gut permeability [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Lactulose/Mannitol test

  • Plasma cytokines [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: April 2010
Study Completion Date: December 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control Dietary Supplement: Lactobacillus casei Shirota
3 bottles of Yakult(R) light per day
Other Name: Yakult
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01182844

Locations
Austria
Dept. of Internal Medicine, Medical University of Graz
Graz, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
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

No publications provided by Medical University of Graz

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Vanessa Stadlbauer, MD, Dept. of Internal Medicine, Medical University of Graz, Austria
ClinicalTrials.gov Identifier: NCT01182844     History of Changes
Other Study ID Numbers: vs09.2008
Study First Received: August 13, 2010
Last Updated: February 9, 2011
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Graz:
metabolic syndrome, probiotic

Additional relevant MeSH terms:
Inflammation
Metabolic Diseases
Obesity
Metabolic Syndrome X
Pathologic Processes
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on June 18, 2013