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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01020617
Enrollment
51
Registered
2009-11-25
Start date
2009-04-30
Completion date
2011-01-31
Last updated
2011-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation, Metabolic Syndrome, Obesity

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.

Interventions

DIETARY_SUPPLEMENTLs-33

10\ 10 CFU/day

Sponsors

The Danish Medical Research Council
CollaboratorOTHER
Danisco
CollaboratorINDUSTRY
University of Copenhagen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
12 Years to 15 Years
Healthy volunteers
Yes

Inclusion criteria

* 12-15 years * IsoBMI\>30

Exclusion criteria

* Chronical diseases * Chronical medication

Design outcomes

Primary

MeasureTime frameDescription
Microbiota diversityone year
Inflammation, CRP2 monthshigh sensitive C-reactive protein

Secondary

MeasureTime frame
Antropometryone year
Blood pressureone year
Blood lipidsone year
Fasting insulinone year
Fasting glucoseone year
Leptinone year
Fecal calprotectin7 months
Interleukin-6 (Il-6)one year
Interleukin-10 (IL-10)one year
Tumor necrosis factor-alpha(TNF-α)one year
Adiponectinone year
C-reactive protein (CRP)6 months
GIPone year

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026