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IRCT201611033664N18 IRCT 2017-01-31 Vice-chancellor for research, Tabriz Nutrition Research Center, Tabriz University of Medical Science The effect of genistein supplementation on metabolic parameters and oxidative stress in postmenopausal women with type 2 diabetes. The effect of genistein supplementation on metabolic parameters and oxidative stress in postmenopausal women with type 2 diabetes. 2017-01-20 anticipated 60 Complete https://irct.ir/trial/3762 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 2 type 2 diabetes. Intervention 1: Placebo groups: Placebo,54 mg/day for3 month. Intervention 2: Intervention Group: 54 mg/day in two capsule for 3 month.
public Hassan Braxas
Health and Nutrition school, Attare Neishabouri Avenue, Golgasht street, Tabriz
Tabriz Iran (Islamic Republic of) +98 44 4625 1716 h.nippon@yahoo.com Tabriz University Of Medical Sciences scientific Hassan Braxas
Attar Neyshabori Street, Golgasht Street, Nutrition Faculty, Tabriz
Tabrize Iran (Islamic Republic of) +98 44 4625 1716 h.nippon@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Willingness to participate in the study; Postmenopausal women with history of at least one year menopause ; menopause must not be a complication of surgery; Type-2 diabetes for at least 6 months; using blood glucose lowering drugs (metformin) . Exclusion criteria: Unwillingness to participate in the study; Surgery leads to menopause; Early menopause (before 40 years); Use of androgen and estrogen and other steroids can affect the estrogen receptor; Insulin injections; Use of any nutritional supplements (omega-3) or anti-inflammatory and antioxidant supplements in the last 3 months or during the study; Liver and kidney failure, cardiovascular disease, breast cancer and thyroid disease; Smoking and alcohol; Patients taking NSAID, corticosteroids (prednisone, methylprednisolone, and hydrocortisone), antidiuretic thiazide (furosemide and hydrochlorothiazide) and anti psychotics second generation (olanzapine, clozapine and). (All participants in the study shouldn't take these drugs at least three months before the study) 45 years 64 years Female E,11 Non-insulin-dependent type 2 diabetes Placebo Treatment - Drugs Placebo groups: Placebo,54 mg/day for3 month Intervention Group: 54 mg/day in two capsule for 3 month Indicators Blood Sugar (FBS, HbA1C, fasting insulin, insulin resistance and insulin sensitivity). Timepoint: Before and after intervention. Method of measurement: Fasting blood glucose by Spectrophotometry, serum insulin by ELISA and serum HbA1C measurements will be done by ion-exchange chromatography. As well as insulin resistance (HOMA-IR) and insulin sensitivity (QUICKI) will be calculated from formulas. Serum lipid profile (TG, TC, HDL-C, LDL-C). Timepoint: Before and after the intervention. Method of measurement: Measuring TG, TC and HDL-C were performed using spectrophotometric methods. LDL-C levels were determined using the formula Fried-Wald. Oxidative Stress (MDA, TAC). Timepoint: Before and after the intervention. Method of measurement: TAC and MDA measurements will be performed using spectrophotometry. Weight, BMI, waist circumference, hip circumference and waist-to-hip ratio. Timepoint: Before and after the intervention. Method of measurement: Body weight will be measured without shoes and with minimal coverage by Seca scales with an accuracy of 0.1 kg Height, waist and hip are also measured by inelastic meters with an accuracy of 0.5 cm. For calculate of BMI will be used, BMI = weight (kg)/height (cm)2 and , waist-to-hip ratio was calculated, WHR = waist / hip. Physical activity. Timepoint: before and after the intervention. Method of measurement: Physical Activity Questionnaire ipaq. Energy and macronutrients intakes (carbohydrates, proteins and fats). Timepoint: before, End of sixth week and after the intervention. Method of measurement: Dietary record. Vice-chancellor for research, Tabriz Nutrition Research Center, Tabriz University of Medical Science Approved 2016-12-05 Ethics Committee of Tabriz University of Medical Scince Golgasht Street, Tabriz University of Medical Sciences, East Azarbayjan Tabriz Iran (Islamic Republic of)