An interventional study of Ls-33 in Metabolic Syndrome, Inflammation and Obesity, sponsored by University of Copenhagen. Completed at 1 site in Denmark. Open to participants aged 12 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-01-19.
Sponsored by University of Copenhagen · Not applicable, Interventional, and Supportive care
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.
1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.
This study's enrollment of 51 is below the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →University of Copenhagen is the lead sponsor of 450 studies on the registry; 61 are open to participants now.
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Exclusion Criteria:
10\~10 CFU/day
Also known as: L. salivarius Ls-33
Microbiota diversity
Time frame: one year
Inflammation, CRP
high sensitive C-reactive protein
Time frame: 2 months
Antropometry
Time frame: one year
Blood pressure
Time frame: one year
Blood lipids
Time frame: one year
Fasting insulin
Time frame: one year
Fasting glucose
Time frame: one year
C-reactive protein (CRP)
Time frame: 6 months
Fecal calprotectin
Time frame: 7 months
Interleukin-6 (Il-6)
Time frame: one year
Interleukin-10 (IL-10)
Time frame: one year
Tumor necrosis factor-alpha(TNF-α)
Time frame: one year
Adiponectin
Time frame: one year
Leptin
Time frame: one year
GIP
Time frame: one year
This study is completed, as verified in Nov 2009. You cannot join it, but the record below documents what was studied.
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University of Copenhagen