The Effect of Probiotics on Low-grade Inflammation, Microbiota and Risk Factors for Metabolic Syndrome in Obese Children

Obesity Clinical Trial

Official title:

Association Between the Diet, the Composition of Microbiota of the Intestinal Tract, Human Health and Well-being

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01020617
• Other study ID #: D206 ProTeen
• Status: Completed
• Phase: N/A
• First received: November 16, 2009
• Last updated: January 18, 2011
• Start date: April 2009
• Est. completion date: January 2011

Study information

• Verified date: November 2009
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: January 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 15 Years

Eligibility

Inclusion Criteria:

• 12-15 years

• IsoBMI>30

Exclusion Criteria:

• Chronical diseases

• Chronical medication

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Inflammation
• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity

Intervention

Dietary Supplement:
• Ls-33
10~10 CFU/day

Locations

Country	Name	City	State
Denmark	Copenhagen University	Frederiksberg

Sponsors (3)

Lead Sponsor	Collaborator
University of Copenhagen	Danisco, The Danish Medical Research Council

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbiota diversity		one year	No
Primary	Inflammation, CRP	high sensitive C-reactive protein	2 months	No
Secondary	Antropometry		one year	No
Secondary	Blood pressure		one year	No
Secondary	Blood lipids		one year	No
Secondary	Fasting insulin		one year	No
Secondary	Fasting glucose		one year	No
Secondary	C-reactive protein (CRP)		6 months	No
Secondary	Fecal calprotectin		7 months	No
Secondary	Interleukin-6 (Il-6)		one year	No
Secondary	Interleukin-10 (IL-10)		one year	No
Secondary	Tumor necrosis factor-alpha(TNF-a)		one year	No
Secondary	Adiponectin		one year	No
Secondary	Leptin		one year	No
Secondary	GIP		one year	No