The effect of synbiotic supplementation on patients with metabolic syndrome

Not Applicable

Recruiting

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

• Registration Number: IRCT20140208016529N4
• Lead Sponsor: Esfahan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 February 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Willingness to participate in projects
Women and men aged 20-55 years
Waist circumference =88 cm in women and waist circumference =102 cm in men, serum triglyceride =150 mg/dl, serum HDL cholesterol <40 mg/dl in men and <50 mg/dl in women, fasting blood glucose =100 mg/dl
body mass index > 25 kg/m2

Exclusion Criteria

History of mental disease, cancer, cardiovascular disease, thyroid, pulmonary,renal and hepatic problems and eating disorders
Pregnant,lactating and post-menopausal women
Participating in weight loss or weight gain programs three months before the intervention
Taking any dietary supplements, probiotics, prebiotic, synbiotic food products, and antibiotics two months before the intervention
Taking drugs that affect appetite and body weight,and anti-inflammatory drugs
History of allergies to probiotics , prebiotics and maltodextrin products

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fasting Blood Sugar. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Colorimetric method.;Serum insulin. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: ELISA.;Homeostasis model assessment of insulin resistance (HOMA-IR). Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Equation.;Quantitative Insulin Sensitivity Check Index(QUICKI). Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Equation.

Secondary Outcome Measures

Name	Time	Method
High Sensitivity C-Reactive Protein. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Biochemical method.;Tumor Necrosis Factor-Alpha (TNF-a). Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: ELISA.;Appetite. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Visual Analogue Scale.;Energy content of 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.