Clinical trial NCT01020617: The Effect of Probiotics on Low-grade Inflammation, Microbiota and Risk Factors for Metabolic Syndrome in Obese Children
Official title: Association Between the Diet, the Composition of Microbiota of the Intestinal Tract, Human Health and Well-being
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Inflammation
Obesity
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: The Danish Medical Research Council
name: Danisco
First posted: 2009-11-25
Enrollment: 51
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

* 12-15 years
* IsoBMI\>30

Exclusion Criteria:

* Chronical diseases
* Chronical medication

Primary outcomes:
measure: Microbiota diversity
timeFrame: one year
measure: Inflammation, CRP
timeFrame: 2 months
Secondary outcomes:
measure: Antropometry
timeFrame: one year
measure: Blood pressure
timeFrame: one year
measure: Blood lipids
timeFrame: one year
measure: Fasting insulin
timeFrame: one year
measure: Fasting glucose
timeFrame: one year
measure: C-reactive protein (CRP)
timeFrame: 6 months
measure: Fecal calprotectin
timeFrame: 7 months
measure: Interleukin-6 (Il-6)
timeFrame: one year
measure: Interleukin-10 (IL-10)
timeFrame: one year
measure: Tumor necrosis factor-alpha(TNF-α)
timeFrame: one year
measure: Adiponectin
timeFrame: one year
measure: Leptin
timeFrame: one year
measure: GIP
timeFrame: one year
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Copenhagen University
Study officials:
affiliation: University of Copenhagen, Department of Human Nutrition
name: Kim F Michaelsen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.