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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01182844
• Date of registration: 13/08/2010
• Prospective Registration: No
• Primary sponsor: Vanessa Stadlbauer-Koellner, MD
• Public title: Obesity - Inflammation - Metabolic Disease: Effect of Lactobacillus Casei Shirota
• Scientific title: Obesity - Inflammation - Metabolic Disease: Effect of Lactobacillus Casei Shirota
• Date of first enrolment: January 2010
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01182844
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Austria

Contacts

• Name: Harald Sourij, MD
• Affiliation: Dept. of Internal Medicine, Medical University of Graz, Austria

• Name: Vanessa Stadlbauer-Köllner, MD
• Affiliation: Dept. of Internal Medicine, Medical University of Graz, Austria

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Metabolic Syndrome

Intervention(s)

Dietary Supplement: Lactobacillus casei Shirota

Primary Outcome(s)

Change of Burst (%) From Baseline to 3 Months [Time Frame: 3 months]

Change of Neutrophil Phagocytosis From Baseline to 3 Months [Time Frame: 3 months]

Secondary Outcome(s)

Change in oxLDL (Oxidative Low Density Lipoprotein) From Baseline to 3 Months [Time Frame: 3 months]

Change in Interleukin-10 (IL-10) 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 Indices of Glucose Tolerance and Insulin Resistance [Time Frame: 3 months]

Change of Gut Permeability From Baseline to 3 Months [Time Frame: 3 months]

Secondary ID(s)

vs09.2008

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 02/04/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01182844