obesity and overweight. Obesity, unspecified
Conditions
Interventions
Intervention 1: Intervention group :consume Synbiotic, 1 capsule daily for 8 weeks (each contains 108 cfu/100gr bacteria). Intervention 2: control group :consume 1 capsule each day for 8 weeks and eac
Treatment - Drugs
Intervention group :consume Synbiotic, 1 capsule daily for 8 weeks (each contains 108 cfu/100gr bacteria)
control group :consume 1 capsule each day for 8 weeks and each capsule involved maltodextrin
Sponsors
Vice-chancellor for Research, Isfahan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
6 Years to 18 Years
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSanam Farajian Mohtaram
Isfahan University of Medical Sciences
Outcome results
None listed