N/A
N=30
Obesity - Inflammation - Metabolic Disease: Effect of Lactobacillus Casei Shirota
Metabolic Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01182844 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Change of Neutrophil Phagocytosis From Baseline to 3 Months — 0.06; 3.48 percentage of monocytes and granulocytes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lactobacillus casei Shirota (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanessa Stadlbauer-Koellner, MD
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Neutrophil Phagocytosis From Baseline to 3 Months |
0.06; 3.48 | — |
| PRIMARY Change of Burst (%) From Baseline to 3 Months |
-8.68; -12.69 | — |
| SECONDARY Change in Indices of Glucose Tolerance and Insulin Resistance |
-0.5; 0.1; 0; 0; 0.004; 0.020 | — |
| SECONDARY Change of Gut Permeability From Baseline to 3 Months |
-0.01; -0.01 | — |
| SECONDARY Change in oxLDL (Oxidative Low Density Lipoprotein) From Baseline to 3 Months |
-55; -32 | — |
| SECONDARY Change in Interleukin-6 (IL-6) From Baseline to 3 Months |
0; -2.98 | — |
| SECONDARY Change in Interleukin-10 (IL-10) From Baseline to 3 Months |
0; -7.05 | — |
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
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT01182844). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.