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IRCT20100408003664N23 IRCT 2018-10-30 Nutritional Reseach Center of Tabriz University of Medical Sciences Effect of genistein supplementation on serum level of homocystein and PAI-1 (Plasminogen Activator Inhibitor-1) in postmenopausal women with type-2 diabetes mellitus. Effect of genistein supplementation on serum level of homocystein and PAI-1 (Plasminogen Activator Inhibitor-1) in postmenopausal women with type-2 diabetes mellitus. 2018-09-23 anticipated 60 Complete https://irct.ir/trial/33974 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples were selected using available methods and randomly assigned random blocks of 4 volumes to the study groups.A random sequence is generated using the STATA14 software.During the random assignment, individuals in the groups will be classified according to age and BMI variables, Blinding description: the placebo and supplement will be packed in the same number in similar packages. The method of blindness will be that the supplements and placebo will be delivered to the participants by someone other than the researcher, and the researcher will remain unaware until the end of the study. 2 Type 2 diabetes mellitus. Intervention 1: Intervention group: 54 mg/day genistein supplement in two capsule for 3 month. Intervention 2: Control group: 54 mg/day placebo in two capsule for 3 month. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Because the research project has not started yet.
public hassan Braxas
Health and Nutrition school, Attare Neishabouri Avenue, Golgasht street
tabriz Iran (Islamic Republic of) 5166614711 +98 44 4625 1716 h.nippon@yahoo.com Tabriz University of Medical Sciences scientific hassan braxas
Nutrition Faculty, Tabriz University of Medical Sciences, Golgasht street
tabriz Iran (Islamic Republic of) 5166614711 +98 44 4625 1716 h.nippon@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in the study Postmenopausal women with history of at least one year menopause Type-2 diabetes for at least 6 months using blood glucose lowering drugs (metformin) 45 years 67 years Female 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) E11.- Type 2 diabetes mellitus Treatment - Drugs Placebo Intervention group: 54 mg/day genistein supplement in two capsule for 3 month Control group: 54 mg/day placebo in two capsule for 3 month Homocysteine. Timepoint: Before the intervention and 12 weeks after starting. Method of measurement: ELISA. PAI-1. Timepoint: Before the intervention and 12 weeks after starting. Method of measurement: ELISA. Physical activity. Timepoint: Beginning and end of intervention. Method of measurement: International Assessment of Physical Activity (IPAQ) questionnaire. Diet. Timepoint: First, middle and end of study. Method of measurement: 3-day food record. Nutritional Reseach Center of Tabriz University of Medical Sciences Approved 2018-08-27 Ethics Committee of Tabriz University of Medical Science Tabriz University of Medical Science, Attar Neishabouri Avenue, Golgasht street, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)