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The Effect of Probiotics on Low-grade Inflammation, Microbiota and Risk Factors for Metabolic Syndrome in Obese Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01020617
Recruitment Status : Completed
First Posted : November 25, 2009
Last Update Posted : January 19, 2011
Sponsor:
Collaborators:
The Danish Medical Research Council
Danisco
Information provided by:
University of Copenhagen

Tracking Information
First Submitted Date  ICMJE November 16, 2009
First Posted Date  ICMJE November 25, 2009
Last Update Posted Date January 19, 2011
Study Start Date  ICMJE April 2009
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2011)
  • Microbiota diversity [ Time Frame: one year ]
  • Inflammation, CRP [ Time Frame: 2 months ]
    high sensitive C-reactive protein
Original Primary Outcome Measures  ICMJE
 (submitted: November 24, 2009)
Microbiota diversity [ Time Frame: one year ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2010)
  • Antropometry [ Time Frame: one year ]
  • Blood pressure [ Time Frame: one year ]
  • Blood lipids [ Time Frame: one year ]
  • Fasting insulin [ Time Frame: one year ]
  • Fasting glucose [ Time Frame: one year ]
  • C-reactive protein (CRP) [ Time Frame: 6 months ]
  • Fecal calprotectin [ Time Frame: 7 months ]
  • Interleukin-6 (Il-6) [ Time Frame: one year ]
  • Interleukin-10 (IL-10) [ Time Frame: one year ]
  • Tumor necrosis factor-alpha(TNF-α) [ Time Frame: one year ]
  • Adiponectin [ Time Frame: one year ]
  • Leptin [ Time Frame: one year ]
  • GIP [ Time Frame: one year ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2009)
  • Antropometry [ Time Frame: one year ]
  • Blood pressure [ Time Frame: one year ]
  • Blood lipids [ Time Frame: one year ]
  • Fasting insulin [ Time Frame: one year ]
  • Fasting glucose [ Time Frame: one year ]
  • C-reactive protein (CRP) [ Time Frame: 6 months ]
  • Fecal calprotectin [ Time Frame: 7 months ]
  • Interleukin-6 (Il-6) [ Time Frame: one year ]
  • Interleukin-10 (IL-10) [ Time Frame: one year ]
  • Tumor necrosis factor-alpha(TNF-α) [ Time Frame: one year ]
  • Adiponectin [ Time Frame: one year ]
  • Ghrelin [ Time Frame: one year ]
  • Leptin [ Time Frame: one year ]
  • Glucagon [ Time Frame: one year ]
  • Resistin [ Time Frame: one year ]
  • GIP [ Time Frame: one year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Probiotics on Low-grade Inflammation, Microbiota and Risk Factors for Metabolic Syndrome in Obese Children
Official Title  ICMJE Association Between the Diet, the Composition of Microbiota of the Intestinal Tract, Human Health and Well-being
Brief Summary

Metabolic syndrome and thereby obesity is associated with low-grade systemic inflammation and it is likely that this is also the case in children (Ley et al., 2005). It has also been shown that the gut microbiota is different in obese individuals compared to normal weight individuals and that the microbiota seems to have a role in fat storage (Backhead et al, 2004).

Intervention study with overweight and normal weight school age children. The children will be randomised to receive selected probiotics or a placebo. Fecal and blood samples will be collected, and anthropometric measurements (weight, height, skin folds) will be recorded before and after the intervention. The dynamic of the microbiota of the GI will be monitored by molecular methods. Markers of intestinal inflammation (calprotectin) and permeability will be analysed. Blood samples will be analysed to evaluate how the intervention influence the systemic polarization of the immune response by means of cytokine analyses. Furthermore, blood pressure, blood lipid profile and early markers of metabolic syndrome will be evaluated. Hypotheses This study will examine if overweight in children is associated with a different intestinal microbiota and if a change in microbiota caused by probiotics can modify inflammation and risk factors for the metabolic syndrome.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Metabolic Syndrome
  • Inflammation
  • Obesity
Intervention  ICMJE Dietary Supplement: Ls-33
10~10 CFU/day
Other Name: L. salivarius Ls-33
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 18, 2011)
51
Original Estimated Enrollment  ICMJE
 (submitted: November 24, 2009)
60
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 12-15 years
  • IsoBMI>30

Exclusion Criteria:

  • Chronical diseases
  • Chronical medication
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01020617
Other Study ID Numbers  ICMJE D206 ProTeen
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Professor Kim Fleischer Michaelsen, University of Copenhagen, Department of Human Nutrition
Study Sponsor  ICMJE University of Copenhagen
Collaborators  ICMJE
  • The Danish Medical Research Council
  • Danisco
Investigators  ICMJE
Principal Investigator: Kim F Michaelsen, Professor University of Copenhagen, Department of Human Nutrition
PRS Account University of Copenhagen
Verification Date November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP