NCT01020617

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2009

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 25, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

January 19, 2011

Status Verified

November 1, 2009

Enrollment Period

1.3 years

First QC Date

November 16, 2009

Last Update Submit

January 18, 2011

Conditions

Metabolic SyndromeInflammationObesity

Outcome Measures

Primary Outcomes (2)

  • Microbiota diversity

    one year

  • Inflammation, CRP

    high sensitive C-reactive protein

    2 months

Secondary Outcomes (13)

  • Antropometry

    one year

  • Blood pressure

    one year

  • Blood lipids

    one year

  • Fasting insulin

    one year

  • Fasting glucose

    one year

  • +8 more secondary outcomes

Interventions

Ls-33DIETARY_SUPPLEMENT

10\~10 CFU/day

Also known as: L. salivarius Ls-33

Eligibility Criteria

Age12 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • years
  • IsoBMI\>30

You may not qualify if:

  • Chronical diseases
  • Chronical medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen University

Frederiksberg, 1958, Denmark

Location

Related Publications (3)

  • 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.

    PMID: 23510724DERIVED

  • 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.

    PMID: 23462537DERIVED

  • 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.

    PMID: 22695039DERIVED

MeSH Terms

Conditions

Metabolic SyndromeInflammationObesity

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersBody WeightSigns and Symptoms

Study Officials

  • Kim F Michaelsen, Professor

    University of Copenhagen, Department of Human Nutrition

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 16, 2009

First Posted

November 25, 2009

Study Start

April 1, 2009

Primary Completion

August 1, 2010

Study Completion

January 1, 2011

Last Updated

January 19, 2011

Record last verified: 2009-11

Locations

DK(1)