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IRCT20110123005670N26 IRCT 2019-01-07 Tabriz University of Medical Sciences The Effects of Intake of the Fortified Bread by Whey Protein Concentrate in Women With Type 2 Diabetes Mellitus The Effects of Intake of the Fortified Bread by Whey Protein Concentrate on Glycemic Control, Lipid Profile, Blood Presure, Anthropometric Parameters, Resting Energy Expenditure, Oxidative Stress Markers and Appetite in Women With Type 2 Diabetes Mellitus 2019-01-20 anticipated 44 Complete https://irct.ir/trial/33894 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Women who have the inclusion criteria, will be divided to intervention and placebo groups via simple randomization method. N/A type 2 diabetes. Intervention 1: Intervention group: About 120 g fortified whole bread by whey protein concentrate per day for 90 days. Intervention 2: Control group: About 120 g whole bread per day for 90 days. 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 No more information
public Dr. Ali Tarighat-Esfanjani
Golgasht Street
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3336 2117 Tarighata@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Dr. Ali Tarighat-Esfanjani
Golgasht Street
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3336 2117 Tarighata@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Willingness to cooperation Women with type 2 diabetes mellitus Women aged 25-55 years glucose lowering tablets usage BMI= 25-35 kg/m2 GFR > 60 ml/min 25 years 55 years Female Unwillingness to cooperation Patients with inflammatory, immunologic, psychologic, pulmonary, and neoplastic diseases Patients with renal, hepatic, and thyroid disorders Supplement intake Use of corticosteroids, non-steroidal anti-inflammatory, and hormonal drugs Change in type or dosage of used drugs during the study Change in diet and physical activity during the study Tobacco use Use of insulin Special physiologic conditions such as pregnancy, lactation, and menopause Patients with malabsorption diseases such as sprue and Crohn's disease Allergy or intolerance to milk components E11 Type 2 diabetes mellitus Treatment - Other Other Intervention group: About 120 g fortified whole bread by whey protein concentrate per day for 90 days Control group: About 120 g whole bread per day for 90 days Fasting Blood Glucose. Timepoint: Before the intervention and 90 days after the start of the intervention. Method of measurement: Enzymatic by commercial kits. Insulin. Timepoint: Before the intervention and 90 days after the start of the intervention. Method of measurement: ELISA. Hemoglobin A1C. Timepoint: Before the intervention and 90 days after the start of the intervention. Method of measurement: ELISA with commercial kits. HOMA-IR. Timepoint: Before the intervention and 90 days after the start of the intervention. Method of measurement: Calculation. Triglyceride. Timepoint: Before the intervention and 90 days after the start of the intervention. Method of measurement: Enzymatic. HDL-Cholesterol. Timepoint: Before the intervention and 90 days after the start of the intervention. Method of measurement: Enzymatic. MDA. Timepoint: Before the intervention and 90 days after the start of the intervention. Method of measurement: spectrophotometry. TAC. Timepoint: Before the intervention and 90 days after the start of the intervention. Method of measurement: spectrophotometry. Blood Pressure. Timepoint: Before the intervention and 90 days after the start of the intervention. Method of measurement: Digital Barometer. Weight. Timepoint: Before the intervention and 90 days after the start of the intervention. Method of measurement: Scale. Body Mass Index (BMI). Timepoint: Before the intervention and 90 days after the start of the intervention. Method of measurement: Computing. Body fat percent. Timepoint: Before the intervention and 90 days after the start of the intervention. Method of measurement: Bio impedance set. Waist circumference. Timepoint: Before the intervention and 90 days after the start of the intervention. Method of measurement: measurement by meter. Hip circumference. Timepoint: Before the intervention and 90 days after the start of the intervention. Method of measurement: measurement by meter. WHR. Timepoint: Before the intervention and 90 days after the start of the intervention. Method of measurement: Computing. Appetite. Timepoint: Before the intervention and 90 days after the start of the intervention. Method of measurement: Appetite Assessment Questionnaire. Tabriz University of Medical Sciences Approved 2018-11-19 Ethics Committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences, Golgasht street, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)