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IRCT20140208016529N5 IRCT 2020-02-02 Esfahan University of Medical Sciences The effect of synbiotic supplementation in patients with metabolic syndrome The effect of synbiotic supplementation on anthropometric parameters, lipid profiles, total antioxidant capacity and malondialdehyde in patients with metabolic syndrome, an approach to prevent cardiovascular disease 2019-12-14 anticipated 48 Complete https://irct.ir/trial/42589 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 Entezari entezari@hlth.mui.ac.ir How to obtain: The data will send as soon as possible, after receiving the request. Comments:
public Mohammad Hasan Entezari
Isfahan University of Medical Sciences ,Hezarjarib St.
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 3171 entezari@hlth.mui.ac.ir Esfahan University of Medical Sciences scientific Mohammad Hasan Entezari
Isfahan University of Medical Sciences , Hezarjerib 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 Mental illness, cancer, thyroid, cardiovascular, pulmonary, kidney, liver, eating disorders and digestive diseases Pregnancy or lactation or menopause Participate in weight loss or weight loss programs 3 months before the start of the study Use of Probiotic, Prebiotic and Synbiotic Foods, Antibiotic Antioxidants, Multivitamin, Nicotinic Acid and any dietary supplement 2 months before starting the study Drugs affecting appetite and body weight and anti-inflammatory drugs A history of allergies to pro-biotic, prebiotic 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 Weight. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Scale-mounted stadiometer(Seca). Waist circumference. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Flexible tape. High density lipoprotein (HDL). Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Colorimetric method. Triglyceride. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Colorimetric method. Body mass index (BMI). Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: BMI=weight(kg)/square of height(m)2. Hip circumference. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Flexible tape. Malondialdehyde (MDA). Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Colorimetric method. Total antioxidant capacity. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Colorimetric method. Body fat Percent. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Body composition analyzer. Waist circumference to Hip circumference ratio (WHR). Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: WHR=Waist circumference (cm)/Hip circumference (cm). Low density lipoprotein (LDL). Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Colorimetric method. 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 ٍEhtics committe of Isfahan University of Medical Sciences Isfahan University of Medical Sciences ,Hezarjerib St. Isfahan Isfehan Iran (Islamic Republic of)