The effect of synbiotic supplementation on metabolic syndrome items in subjects aged 8-18 years

Phase 2

Recruiting

Conditions: Metabolic syndrome.
Metabolic disorder, unspecified
E88.9

Registration Number: IRCT20140208016529N7

Lead Sponsor: Esfahan University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 70

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

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.