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IRCT201409033320N9 IRCT 2014-12-27 Vice Chancellor for Research (VCR) of Tabriz University of Medical Sciences Effects of hydro-alcoholic artichoke leaf extract supplementation on metabolic and antioxidant status in patients with metabolic syndrome with regard to genetic polymorphism Effects of hydro-alcoholic artichoke leaf extract supplementation on metabolic and antioxidant status in patients with metabolic syndrome with regard to genetic polymorphism of CETP, TCF7L2 and FTO 2014-11-21 anticipated 80 Complete https://irct.ir/trial/3405 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. N/A metabolic syndrom. Intervention 1: intervention group: 1800 mg hydro-alcoholic artichoke leaf extract as 4 tablets per day for 3 months. Intervention 2: Control group: 1800 mg placebo containing corn starch, lactose and Avicel as 4 tablets per day for 3 months.
public khatereh Rezazadeh
Faculty of Nutrition, Attar Neyshaboori Avenue, Golgasht Street
Tabriz Iran (Islamic Republic of) +98 41 3335 2292 rezazadekhatereh@gmail.com Ph.D Student of Nutrition scientific Mehranghiz Ebrahimi Mamaghani
Faculty of Nutrition, Golgasht Street, Attar neishaboori Avenue
Tabriz Iran (Islamic Republic of) +98 41 3335 2295 ebrahimimamagani@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: willingness and ability to collaborate on project ; aged between 20-60 years (both sexes); affected by metabolic syndrome: having at least 3 of 5 criteria according to international definition: waist circumference >91 cm in women and >89cm in men, serum glucose ≥100 mg/dl, serum triglyceride ≥150 mg/dl, HDL-C >40 mg/dl in men and >50 mg/dl in women, systolic blood pressure ≥ 130 mmHg and/or diastolic blood pressure ≥ 85 mmHg Exclusion criteria: Smoking ; Consumption of fish oil supplement or other antioxidant supplements currently or within 3 months before intervention; Consumption of lipid or blood pressure lowering drugs, corticosteroids currently or within 3 months before intervention; affected by cardiovascular disease, renal failure, diabetes mellitus, liver dysfunction, cancer; affected by Infectious or inflammatory disease or recent surgery; affected by malabsorption, such as sprue and Crohn's disease; affected by hypothyroidism or hyperthyroidism; having gallstones and biliary tract obstruction; having a weight loss diet at the time of the study; pregnancy or lactation; history of allergy to artichoke family plants and their products; menopause 20 years 50 years Both E88.9 Metabolic disorder, unspecified Treatment - Other Placebo intervention group: 1800 mg hydro-alcoholic artichoke leaf extract as 4 tablets per day for 3 months Control group: 1800 mg placebo containing corn starch, lactose and Avicel as 4 tablets per day for 3 months Fasting blood suger and Serum Lipid profile. Timepoint: at the beginning and end of intervention. Method of measurement: Fasting blood suger by enzymatic method and triglycerid, total cholestrol and HDL-C by espectrophotometry method and LDL-C by Friedewald Formula. Serum levels of total antioxidants capacity and Malondialdehyde. Timepoint: at the beginning and end of intervention. Method of measurement: TAC: Espectrophotometry by Rabdox enzymatic kit; MDA: Reaction with thiobarbituric acid by fluorimetry method. Serum level of CETP. Timepoint: at the beginning and end of intervention. Method of measurement: By Laboratory ELISA Kits. Energy and nutrient intake. Timepoint: 3 times; at first, midst and the end of intervention. Method of measurement: 3 dayes food record was used and analyzed with Nutritionist 4 software. Serum level of Insulin. Timepoint: at the beginning and end of intervention. Method of measurement: Chemilumines. Physical activity level. Timepoint: 3 times; at first, midst and the end of intervention. Method of measurement: International questionnaire. Systolic and Diastolic blood pressure. Timepoint: at the beginning and end of iintervention. Method of measurement: Automatic Blood Pressure Monitoring. Anthropometric measurements. Timepoint: 3 times during the study: at the beginning, midst and end of intervention. Method of measurement: Anthropometric measurements including weight using calibrated Omron scale with a precision of 0.1 kg and a minimum of clothes, height, waist and hip circumference using a tape measure with an accuracy of 0.1 cm will be done, and BMI will be calculated. Body composition. Timepoint: 3 times during the study: at the beginning, midst and end of intervention. Method of measurement: Measurement of body composition using Omron Bioelectric Impedance Analyzer. Vice Chancellor for Research (VCR) of Tabriz University of Medical Sciences Approved 2014-11-15 Ethics Committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences, Golgasht Street Tabriz Iran (Islamic Republic of)