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IRCT20180818040827N1 IRCT 2018-09-04 Esfahan University of Medical Sciences Effect of wheat germ consumption in treatment of diabetes The effect of wheat germ consumption on anthropometric indices, lipid profile, glycemic indices, oxidative stress markers, mood and BDNF level in patients with type 2 diabetes 2018-07-23 anticipated 80 Complete https://irct.ir/trial/33397 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: A stratified randomized permuted block (with block size 4) will generated by an independent bio-statistician. Subjects will stratified according to gender and age (two levels: 30-50 years and 50-65 years). Random assignment will done by the use of table of random numbers. The enrolling participants, and assigning participants to the groups will carried out by a trained nutritionist. Researchers will not informed about randomization process until completion of data analyses (concealment), Blinding description: Wheat germ and its placebos (bread powder) will manufactured by Narin Company (Isfahan, Iran). All wheat germ and its placebo powders will provided by Narin Company in prepacked boxes numbered for each patient according to the randomization sequence. Wheat germ and its placebos will in the same form of package and the patients and researcher will not aware of the content of the pack until the end of trial. N/A Type 2 Diabetes. Intervention 1: Intervention group: 20 g/day wheat germ for 12 weeks. Wheat germ will manufactured by Narin Company (Isfahan, Iran). Intervention 2: Control group: 20 g/day placebo (bread powder) for 12 weeks. Placebo will manufactured by Narin company (Isfahan, Iran). 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: Reza Amani PO Box: 81746-73461 r_amani@nutr.mui.ac.ir How to obtain: The data will send as soon as possible, after receiving the request. Comments:
public Reza Amani
Hezarjarib Ave.
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 1378 r_amani@nutr.mui.ac.ir Esfahan University of Medical Sciences scientific Reza Amani
Hezarjarib Ave.
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 1378 r_amani@nutr.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Willingness to participation in the study Diagnosis of diabetes in the last 5 years Body mass index <35 30 years 65 years Both Using insulin or oral agents inducing insulin secretion Smoking Pregnancy and lactation Using anti-psychotic drugs Taking antioxidant supplements within the past 3 months before the intervention Having a history of cancer, cardiovascular disease, renal, hepatic and thyroid disorders E08 Diabetes mellitus due to underlying condition Treatment - Other Placebo Intervention group: 20 g/day wheat germ for 12 weeks. Wheat germ will manufactured by Narin Company (Isfahan, Iran). Control group: 20 g/day placebo (bread powder) for 12 weeks. Placebo will manufactured by Narin company (Isfahan, Iran). Fasting blood sugar. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Colorimetric. Hemoglobin A1C. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: High-performance liquid chromatography. Insulin. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA). Weight. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Digital scale. Waist Circumference. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: non-stretching tape measure. Systolic blood pressure. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Sphygmomonometer. Diastolic blood pressure. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Sphygmomonometer. Total cholesterol. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Enzymatic method. Triglyceride. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Enzymatic method. Low density lipoprotein-cholestrol. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Enzymatic method. High density lipoprotein-cholestrol. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Enzymatic method. Brain derived neurotrophic factor. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: enzyme-linked immunosorbent assay (ELISA). Malodialdehyde. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: enzyme-linked immunosorbent assay (ELISA). Total antioxidant capacity. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: enzyme-linked immunosorbent assay (ELISA). Depression score. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Depression Anxiety and Stress Scales (DASS-21). Anxiety score. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Depression Anxiety and Stress Scales (DASS-21). Stress score. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Depression Anxiety and Stress Scales (DASS-21). Appetite. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Visual Analogue Scale. Esfahan University of Medical Sciences Approved 2018-05-27 Ethics committee of Isfahan University of Medical Sciences Hezarjarib Ave., Isfahan University of Medical Sciences Isfahan Isfehan Iran (Islamic Republic of)