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Clinical Trials/NCT01020617
NCT01020617
Completed
Not Applicable

Association Between the Diet, the Composition of Microbiota of the Intestinal Tract, Human Health and Well-being

University of Copenhagen1 site in 1 country51 target enrollmentApril 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Metabolic Syndrome
Sponsor
University of Copenhagen
Enrollment
51
Locations
1
Primary Endpoint
Microbiota diversity
Status
Completed
Last Updated
15 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2009
End Date
January 2011
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 12-15 years
  • IsoBMI\>30

Exclusion Criteria

  • Chronical diseases
  • Chronical medication

Outcomes

Primary Outcomes

Microbiota diversity

Time Frame: one year

Inflammation, CRP

Time Frame: 2 months

high sensitive C-reactive protein

Secondary Outcomes

  • Fecal calprotectin(7 months)
  • Interleukin-6 (Il-6)(one year)
  • Interleukin-10 (IL-10)(one year)
  • Tumor necrosis factor-alpha(TNF-α)(one year)
  • Adiponectin(one year)
  • Leptin(one year)
  • GIP(one year)
  • Antropometry(one year)
  • Blood pressure(one year)
  • Blood lipids(one year)
  • Fasting insulin(one year)
  • Fasting glucose(one year)
  • C-reactive protein (CRP)(6 months)

Study Sites (1)

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