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| Name | Class |
|---|---|
| The Danish Medical Research Council | OTHER |
| Danisco | INDUSTRY |
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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ls-33 | Dietary Supplement | 10~10 CFU/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Microbiota diversity | one year | |
| Inflammation, CRP | high sensitive C-reactive protein | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Antropometry | one year | |
| Blood pressure | one year | |
| Blood lipids |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kim F Michaelsen, Professor | University of Copenhagen, Department of Human Nutrition | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen University | Frederiksberg | 1958 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23510724 | Derived | Larsen N, Vogensen FK, Gobel RJ, Michaelsen KF, Forssten SD, Lahtinen SJ, Jakobsen M. Effect of Lactobacillus salivarius Ls-33 on fecal microbiota in obese adolescents. Clin Nutr. 2013 Dec;32(6):935-40. doi: 10.1016/j.clnu.2013.02.007. Epub 2013 Mar 4. | |
| 23462537 | Derived | Giacco R, Lappi J, Costabile G, Kolehmainen M, Schwab U, Landberg R, Uusitupa M, Poutanen K, Pacini G, Rivellese AA, Riccardi G, Mykkanen H. Effects of rye and whole wheat versus refined cereal foods on metabolic risk factors: a randomised controlled two-centre intervention study. Clin Nutr. 2013 Dec;32(6):941-9. doi: 10.1016/j.clnu.2013.01.016. Epub 2013 Feb 6. |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D007249 | Inflammation |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| one year |
| Fasting insulin | one year |
| Fasting glucose | one year |
| C-reactive protein (CRP) | 6 months |
| 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 |
| 22695039 | Derived | Gobel RJ, Larsen N, Jakobsen M, Molgaard 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. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |