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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
History of Changes

November 16, 2009
January 18, 2011
April 2009
August 2010   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01020617 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • Ghrelin [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Leptin [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Glucagon [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Resistin [ Time Frame: one year ] [ Designated as safety issue: No ]
  • GIP [ Time Frame: one year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
The Effect of Probiotics on Low-grade Inflammation, Microbiota and Risk Factors for Metabolic Syndrome in Obese Children
Association Between the Diet, the Composition of Microbiota of the Intestinal Tract, Human Health and Well-being

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
  • Metabolic Syndrome
  • Inflammation
  • Obesity
Dietary Supplement: Ls-33
10~10 CFU/day
Other Name: L. salivarius Ls-33
Not Provided
Gøbel RJ, Larsen N, Jakobsen M, Mølgaard C, Michaelsen KF. Probiotics to adolescents with obesity: effects on inflammation and metabolic syndrome. J Pediatr Gastroenterol Nutr. 2012 Dec;55(6):673-8. doi: 10.1097/MPG.0b013e318263066c.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
January 2011
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 12-15 years
  • IsoBMI>30

Exclusion Criteria:

  • Chronical diseases
  • Chronical medication
Both
12 Years to 15 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01020617
D206 ProTeen
No
Professor Kim Fleischer Michaelsen, University of Copenhagen, Department of Human Nutrition
University of Copenhagen
  • The Danish Medical Research Council
  • Danisco
Principal Investigator: Kim F Michaelsen, Professor University of Copenhagen, Department of Human Nutrition
University of Copenhagen
November 2009

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