Metabolic syndrome. Metabolic disorder, unspecified
Conditions
Interventions
Intervention 1: Intervention group: Intervention group: Two 0.5 g capsules of synbiotic twice daily for 8 weeks. Intervention 2: Control group: Two 0.5 g placebo capsules (maltodextrin) 2 times daily
Sponsors
Esfahan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
8 Years to 18 Years
Inclusion criteria
Inclusion criteria: Age range 10 to 18 years A parent's willingness to participate in the study and sign the informed consent form Has at least one item of metabolic syndrome Failure to participate in weight loss programs for the past 6 months
Exclusion criteria
Exclusion criteria: Unwillingness to continue attending the study Non-compliance with intervention (less than 90% product use) Major change in energy intake and nutrient intake or consumption of less than 800 kcal and more than 4200 kcal during the study based on the 3-day food registration method Start any weight loss or weight gain diet during the study Individual tobacco use during the study Use of antioxidants, multivitamins or any dietary supplements during intervention Antibiotic use during the study People with mental illnesses, cardiovascular, lung, liver, kidney, cancer, thyroid and eating disorders Type 1 diabetic patients with insulin and hypoglycemic drugs People taking drugs that affect appetite, body weight, blood sugar, lipid profile or anti-inflammatory drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting Blood Glucose (GBG). Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Colorimetric method.;High Sensitivity C-Reactive Protein (hs-CRP). Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Biochemical method.;Tumor Necrosis Factor-Alpha (TNF-Alpha). Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Elisa.;High Density Lipoprotein (HDL). Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Colorimetric method.;Low Density Lipoprotein (LDL). Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Colorimetric method.;Triglyceride (TG). Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Colorimetric method.;Total Cholesterol (TC). Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Colorimetric method. | — |
Secondary
| Measure | Time frame |
|---|---|
| The amount of energy consumed by food. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Food record questionnaire.;Physical activity energy expenditure. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Metabolic equivalent of tasks questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Hasan Entezari
Esfahan University of Medical Sciences
Outcome results
None listed