Synbiotics on obesity and overweight in childre
Not Applicable
- Conditions
- obesity and overweight.Obesity, unspecified
- Registration Number
- IRCT201103081434N4
- Lead Sponsor
- Vice-chancellor for Research, Isfahan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 70
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.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.;Serum inflammatory values (IL-6 ,TNF-a,Adiponectin, hs-CRP). Timepoint: Baseline and at the end of intervention. Method of measurement: hs-CRP assess with Immunotorbidometric method and IL-6 & TNF-a,Adiponectin with Eliza method.;Fasting serum glucose values. Timepoint: Baseline and at the end of intervention. Method of measurement: Enzymatic method, Automatic analyzer.;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.;Blood pressure. Timepoint: Baseline and at the end of intervention. Method of measurement: Manometer.