The Effect of Probiotics on Low-grade Inflammation, Microbiota and Risk Factors for Metabolic Syndrome in Obese Children
Primary Purpose
Metabolic Syndrome, Inflammation, Obesity
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Ls-33
Sponsored by
About this trial
This is an interventional supportive care trial for Metabolic Syndrome
Eligibility Criteria
Inclusion Criteria:
- 12-15 years
- IsoBMI>30
Exclusion Criteria:
- Chronical diseases
- Chronical medication
Sites / Locations
- Copenhagen University
Outcomes
Primary Outcome Measures
Microbiota diversity
Inflammation, CRP
high sensitive C-reactive protein
Secondary Outcome Measures
Antropometry
Blood pressure
Blood lipids
Fasting insulin
Fasting glucose
C-reactive protein (CRP)
Fecal calprotectin
Interleukin-6 (Il-6)
Interleukin-10 (IL-10)
Tumor necrosis factor-alpha(TNF-α)
Adiponectin
Leptin
GIP
Full Information
NCT ID
NCT01020617
First Posted
November 16, 2009
Last Updated
January 18, 2011
Sponsor
University of Copenhagen
Collaborators
The Danish Medical Research Council, Danisco
1. Study Identification
Unique Protocol Identification Number
NCT01020617
Brief Title
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
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Copenhagen
Collaborators
The Danish Medical Research Council, Danisco
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Inflammation, Obesity
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Dietary Supplement
Intervention Name(s)
Ls-33
Other Intervention Name(s)
L. salivarius Ls-33
Intervention Description
10~10 CFU/day
Primary Outcome Measure Information:
Title
Microbiota diversity
Time Frame
one year
Title
Inflammation, CRP
Description
high sensitive C-reactive protein
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Antropometry
Time Frame
one year
Title
Blood pressure
Time Frame
one year
Title
Blood lipids
Time Frame
one year
Title
Fasting insulin
Time Frame
one year
Title
Fasting glucose
Time Frame
one year
Title
C-reactive protein (CRP)
Time Frame
6 months
Title
Fecal calprotectin
Time Frame
7 months
Title
Interleukin-6 (Il-6)
Time Frame
one year
Title
Interleukin-10 (IL-10)
Time Frame
one year
Title
Tumor necrosis factor-alpha(TNF-α)
Time Frame
one year
Title
Adiponectin
Time Frame
one year
Title
Leptin
Time Frame
one year
Title
GIP
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
12-15 years
IsoBMI>30
Exclusion Criteria:
Chronical diseases
Chronical medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim F Michaelsen, Professor
Organizational Affiliation
University of Copenhagen, Department of Human Nutrition
Official's Role
Principal Investigator
Facility Information:
Facility Name
Copenhagen University
City
Frederiksberg
ZIP/Postal Code
1958
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
23510724
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.
Results Reference
derived
PubMed Identifier
23462537
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.
Results Reference
derived
PubMed Identifier
22695039
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.
Results Reference
derived
Learn more about this trial
The Effect of Probiotics on Low-grade Inflammation, Microbiota and Risk Factors for Metabolic Syndrome in Obese Children
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