Status:
COMPLETED
Obesity - Inflammation - Metabolic Disease: Effect of Lactobacillus Casei Shirota
Lead Sponsor:
Vanessa Stadlbauer-Koellner, MD
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
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 pr...
Detailed Description
Obesity and metabolic disorders (type 2 diabetes and insulin resistance) are tightly linked to inflammation. Obesity, a pandemic affecting 30-50% of the adult population, is mediated by a variety of g...
Eligibility Criteria
Inclusion
- Age \>18
- Informed consent
- Fasting blood glucose \>95mg/dL
- Metabolic syndrome defined by the National Cholesterol Education Program (NCEP) Adult Treatment Panel-III (ATP-III) -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,
- High Density Lipoprotein (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
- Drug treatment for diabetes mellitus
- Liver cirrhosis (biopsy proven) or elevated transaminases (\>2x Upper Limit of Normla (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
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01182844
Start Date
January 1 2010
End Date
December 1 2010
Last Update
September 29 2020
Active Locations (1)
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1
Dept. of Internal Medicine, Medical University of Graz
Graz, Austria, 8036