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OpenTrials
Completed

NCT Number: NCT01020617

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

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.

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Key information

Age range

12 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Copenhagen University

Frederiksberg, 1958, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 12-15 years
  • IsoBMI>30

Exclusion criteria

  • Chronical diseases
  • Chronical medication

Treatment and study plan

Ls-33

Dietary Supplement

10~10 CFU/day

Other names: L. salivarius Ls-33

Primary outcomes

  1. Microbiota diversity

    Time frame: one year

  2. Inflammation, CRP

    Time frame: 2 months

    high sensitive C-reactive protein

Secondary outcomes

  1. Antropometry

    Time frame: one year

  2. Blood pressure

    Time frame: one year

  3. Blood lipids

    Time frame: one year

  4. Fasting insulin

    Time frame: one year

  5. Fasting glucose

    Time frame: one year

  6. C-reactive protein (CRP)

    Time frame: 6 months

  7. Fecal calprotectin

    Time frame: 7 months

  8. Interleukin-6 (Il-6)

    Time frame: one year

  9. Interleukin-10 (IL-10)

    Time frame: one year

  10. Tumor necrosis factor-alpha(TNF-α)

    Time frame: one year

  11. Adiponectin

    Time frame: one year

  12. Leptin

    Time frame: one year

  13. GIP

    Time frame: one year

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Danisco
  • The Danish Medical Research Council

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Nov 25, 2009
Registry last updated
Jan 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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