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The effect of synbiotic supplement on obesity, cardiovascular disease risk factors and inflammatory factors in 6-18 years old overweight and obese children.

Protocol summary

Summary
The objective of this randomized double-blind placebo controlled trial is to investigate the effect of symbiotic supplementation on the metabolic outcomes of obesity in obese and overweight children. Subjects with obesity and overweight will be recruited from medical clinics of obesity including 70 individuals. Subjects will be randomly assigned to receive either synbiotics capsule or corn starch placebo capsules for 8 weeks. Anthropometric measurements (weight, height, waist and hip and neck circumference, waist to hip ratio ), biochemical parameters (lipid profile including total cholesterol, LDL and HDL cholesterol and triglyceride concentrations, fasting glucose , IL-6 ,TNF-α ,hs-CRP,adiponectin )and blood pressure, dietary data obtained from twice 3-day food records and physical activity data obtained from physical questionary will be measured before and after treatment and compared between groups. Also to follow up the bacterial colonization in cases gut, Stool samples were collected and analysis from both case and control groups on the first, 15th ,and 60th days of study.

General information

Acronym
Synbiotics and obesity in children
IRCT registration information
IRCT registration number: IRCT201103081434N4
Registration date: 2012-07-05, 1391/04/15
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-07-05, 1391/04/15
Registrant information
Name
Roya Kelishadi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 3060
Email address
kelishadi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research, Isfahan University of Medical Sciences
Expected recruitment start date
2011-03-20, 1389/12/29
Expected recruitment end date
2011-11-22, 1390/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
The effect of synbiotic supplement on obesity, cardiovascular disease risk factors and inflammatory factors in 6-18 years old overweight and obese children.
Public title
Synbiotics on obesity and overweight in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: children with BMI ≥ 85 centiles and age between 6-18 years old. Exclusion criteria: any disease that influence metabolic parameters in this trial (liver, cardiovascular, kidney or gastrointestinal diseases,pulmonary and diabetes); any special diet and drug; any side effects from supplement like allergy; Diarrhea; severe vomiting,Malabsorption syndrome and chronic GI disease; infection and high dose antibiotics.
Age
From 6 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Vice-chancellor for Research, Isfahan University Of Medical Sciences
Street address
Isfahan-hezar jarib st.-Isfahan University Of Medical Sciences
City
Isfahan
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
189139

Health conditions studied

1

Description of health condition studied
obesity and overweight
ICD-10 code
E66.9
ICD-10 code description
Obesity, unspecified

Primary outcomes

1

Description
bacterial count in stool
Timepoint
begining of study, 2 weeks after begining, at the end of the study
Method of measurement
bacterial count in MRS media

Secondary outcomes

1

Description
Antropometric indicators (Weight, Height, BMI, Waist circumference, Hip circumference,Neck circumference,Wrist circumference, Waist to Hip Ratio)
Timepoint
Baseline and at the end of intervention
Method of measurement
Physical exam

2

Description
Serum inflammatory values (IL-6 ,TNF-α,Adiponectin, hs-CRP)
Timepoint
Baseline and at the end of intervention
Method of measurement
hs-CRP assess with Immunotorbidometric method and IL-6 & TNF-α,Adiponectin with Eliza method

3

Description
Fasting serum glucose values
Timepoint
Baseline and at the end of intervention
Method of measurement
Enzymatic method, Automatic analyzer

4

Description
Fasting srum lipid profile (LDL,HDL,total cholesterol,TG)
Timepoint
Baseline and at the end of intervention
Method of measurement
Enzymatic method, with special kits for assessing TG, HDL, Total cholestrol and Friedewald equation for assessing LDL cholestrol

5

Description
Blood pressure
Timepoint
Baseline and at the end of intervention
Method of measurement
Manometer

Intervention groups

1

Description
Intervention group :consume Synbiotic, 1 capsule daily for 8 weeks (each contains 108 cfu/100gr bacteria)
Category
Treatment - Drugs

2

Description
control group :consume 1 capsule each day for 8 weeks and each capsule involved maltodextrin
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Children Clinics belongs to Isfahan University of Medical Science
Full name of responsible person
Street address
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for Research, Isfahan University of Medical Sciences
Full name of responsible person
Dr Peiman Adibi
Street address
Isfahan University of Medical Sciences
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research, Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Sanam Farajian Mohtaram
Position
Master degree student
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 1792 2709
Fax
Email
farajiansanam@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Roya Kelishadi
Position
Professor
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 1792 2291
Fax
Email
roya.kelishadi@med.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Roya Kelishadi
Position
Professor
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 1792 2291
Fax
Email
roya.kelishadi@med.mui.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
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Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
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Clinical Study Report
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Analytic Code
empty
Data Dictionary
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