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

This study has been completed.
Sponsor:
Collaborators:
The Danish Medical Research Council
Danisco
Information provided by:
University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01020617
First received: November 16, 2009
Last updated: January 18, 2011
Last verified: November 2009
  Purpose

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.


Condition Intervention
Metabolic Syndrome
Inflammation
Obesity
Dietary Supplement: Ls-33

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Association Between the Diet, the Composition of Microbiota of the Intestinal Tract, Human Health and Well-being

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Microbiota diversity [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Inflammation, CRP [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    high sensitive C-reactive protein


Secondary Outcome Measures:
  • Antropometry [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Blood lipids [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Fasting insulin [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Fasting glucose [ Time Frame: one year ] [ Designated as safety issue: No ]
  • C-reactive protein (CRP) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Fecal calprotectin [ Time Frame: 7 months ] [ Designated as safety issue: No ]
  • Interleukin-6 (Il-6) [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Interleukin-10 (IL-10) [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Tumor necrosis factor-alpha(TNF-α) [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Adiponectin [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Leptin [ Time Frame: one year ] [ Designated as safety issue: No ]
  • GIP [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: April 2009
Study Completion Date: January 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Ls-33
    10~10 CFU/day
    Other Name: L. salivarius Ls-33
  Eligibility

Ages Eligible for Study:   12 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 12-15 years
  • IsoBMI>30

Exclusion Criteria:

  • Chronical diseases
  • Chronical medication
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01020617

Locations
Denmark
Copenhagen University
Frederiksberg, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
The Danish Medical Research Council
Danisco
Investigators
Principal Investigator: Kim F Michaelsen, Professor University of Copenhagen, Department of Human Nutrition
  More Information

No publications provided by University of Copenhagen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor Kim Fleischer Michaelsen, University of Copenhagen, Department of Human Nutrition
ClinicalTrials.gov Identifier: NCT01020617     History of Changes
Other Study ID Numbers: D206 ProTeen
Study First Received: November 16, 2009
Last Updated: January 18, 2011
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

Additional relevant MeSH terms:
Inflammation
Syndrome
Metabolic Syndrome X
Pathologic Processes
Disease
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 18, 2014