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IRCT20140208016529N4 IRCT 2020-02-01 Esfahan University of Medical Sciences The effect of synbiotic supplementation on patients with metabolic syndrome The effect of synbiotic supplementation on glycemic indices, inflammatory biomarkers, and appetite in patients with metabolic syndrome, an approach to prevent cardiovascular disease 2019-12-14 anticipated 48 Complete https://irct.ir/trial/42588 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization with size 4, Blinding description: This study is a randomized double-blind clinical trial. Participants and investigators will be blinded to the allocation of synbiotic or placebo. N/A Metabolic syndrome. Intervention 1: Intervention group: Synbiotic Supplement, as 500 mg capsule, twice a day orally, for 8 weeks. Intervention 2: Control group: Placebo (as 500 mg capsule, maltodexterin), quite similar to synbiotic capsules, twice a day orally , for 8 weeks. Yes - There is a plan to make this available What will be shared: The collected deidentified for the primary outcome measure only will be shared. When: starting 12 months after publication. To whom: Available for people working in academic institutions Conditions: The data will provide for educational use. Where to obtain: Dr.Mohammad hasan Entezar ientezari@hlth.mui.ac.ir How to obtain: The data will send as soon as possible, after receiving the request. Comments:
public Mohammad Hasan Entezari
Hezarjrib St.
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 1378 entezari@hlth.mui.ac.ir Esfahan University of Medical Sciences scientific Mohammad Hasan Entezari
Isfahan University of Medical Sciences, Hezarjrib St.
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 3171 entezari@hlth.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) 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 20 years 55 years Both 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 E88.9 Metabolic disorder, unspecified Treatment - Drugs Placebo Intervention group: Synbiotic Supplement, as 500 mg capsule, twice a day orally, for 8 weeks Control group: Placebo (as 500 mg capsule, maltodexterin), quite similar to synbiotic capsules, twice a day orally , for 8 weeks 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. High Sensitivity C-Reactive Protein. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Biochemical method. Tumor Necrosis Factor-Alpha (TNF-α). 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. Esfahan University of Medical Sciences Approved 2019-06-26 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezarjrib St. Isfahan Isfehan Iran (Islamic Republic of)