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

NCT01182844 | Completed Results DMC

• 1 other identifier: vs09.2008
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Metabolic Syndrome

Keywords

metabolic syndrome, probiotic

Outcome Measures

Primary Outcomes (2)

• Change of Neutrophil Phagocytosis From Baseline to 3 Months

  The Phagotest® (Orpegen Pharma, Heidelberg, Germany) is used to measure phagocytosis by using Fluorescein isothiocyanate (FITC)-labelled opsonized E. coli bacteria.

  3 months

• Change of Burst (%) From Baseline to 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.

  3 months

Secondary Outcomes (5)

• Change in Indices of Glucose Tolerance and Insulin Resistance

  3 months

• Change of Gut Permeability From Baseline to 3 Months

  3 months

• Change in oxLDL (Oxidative Low Density Lipoprotein) From Baseline to 3 Months

  3 months

• Change in Interleukin-6 (IL-6) From Baseline to 3 Months

  3 months

• Change in Interleukin-10 (IL-10) From Baseline to 3 Months

  3 months

Study Arms (2)

Control

NO INTERVENTION

Usual care

Lactobacillus casei Shirota

EXPERIMENTAL

3 bottles of Yakult(R) light per day

Dietary Supplement: Lactobacillus casei Shirota

Interventions

Lactobacillus casei Shirota DIETARY_SUPPLEMENT

3 bottles of Yakult(R) light per day

Also known as: Yakult

Lactobacillus casei Shirota

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanessa Stadlbauer-Koellner, MD: lead

Study Sites (1)

Dept. of Internal Medicine, Medical University of Graz

Graz, 8036, Austria

Location

Related Publications (2)

• Stadlbauer V, Leber B, Lemesch S, Trajanoski S, Bashir M, Horvath A, Tawdrous M, Stojakovic T, Fauler G, Fickert P, Hogenauer C, Klymiuk I, Stiegler P, Lamprecht M, Pieber TR, Tripolt NJ, Sourij H. Lactobacillus casei Shirota Supplementation Does Not Restore Gut Microbiota Composition and Gut Barrier in Metabolic Syndrome: A Randomized Pilot Study. PLoS One. 2015 Oct 28;10(10):e0141399. doi: 10.1371/journal.pone.0141399. eCollection 2015.

  PMID: 26509793 DERIVED

• Leber B, Tripolt NJ, Blattl D, Eder M, Wascher TC, Pieber TR, Stauber R, Sourij H, Oettl K, Stadlbauer V. The influence of probiotic supplementation on gut permeability in patients with metabolic syndrome: an open label, randomized pilot study. Eur J Clin Nutr. 2012 Oct;66(10):1110-5. doi: 10.1038/ejcn.2012.103. Epub 2012 Aug 8.

  PMID: 22872030 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Dr. Norbert Tripolt
• Organization: Medical University of Graz

norbert.tripolt@medunigraz.at

+43 316 385

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 13, 2010
• First Posted: August 17, 2010
• Study Start: January 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: December 1, 2010
• Last Updated: September 29, 2020
• Results First Posted: April 2, 2020

Record last verified: 2020-09

Locations

AU (1)