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IRCT2013061613684N1 IRCT 2013-08-18 Vice chancellor for research,Isfahan University of Medical Sciences Effect of soybean flour enriched bread consumption on inflammation, lipid profile, glycemic indices and Anthropometric indices Effect of soybean flour enriched bread consumption or usual dietary recommendation on serum levels of inflammatory bio markers, lipid profile, glycemic indices and Anthropometric indices in patients with type 2 diabetes: a randomized controlled trial 2012-12-07 anticipated 30 Complete https://irct.ir/trial/13470 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Other design features: This study has a Cross-over design. 2 diabetes. Intervention 1: soybean flour enriched bread group: soy bread will be enriched by substituting 30% of the wheat flour by soybean flour. participants in the intervention group will be asked to replace 120 gr of soy bread with the equal amount of their usual bread intake. Intervention 2: Recommendation group: information about healthy diet has been prescribed for this group. usual dietary recommendation includes healthy food choices. participants in recommendation group will be asked not to consume foods includes soya during this period of study.
public Asma Salarimoghaddam
Department Of Clinical Nutrition, School Of Nutrition and Food Sciences, Isfahan University Of Medical Sciences, Hezar Jerib Street, Isfahan
Isfahan Iran (Islamic Republic of) +98 31 1792 2752 salarimoghaddam@hlth.mui.ac.ir Isfahan University Of Medical Sciences scientific Asma Salarimoghaddam
Department Of Clinical Nutrition, School Of Nutrition and Food Sciences, Isfahan University Of Medical Sciences, Hezar Jerib Street, Isfahan
Isfahan Iran (Islamic Republic of) +98 31 1792 2752 salarimoghaddam@hlth.mui.ac.ir Isfahan University Of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Diabetic non menopause; non-pregnant and non-lactating females; aged 30-50 y; body mass index greater than 25; Lack of insulin injection; non-smokers; lack of allergy to soyabean; lack of having a special diet; lack of sever weight loss in the last 3 months; lack of hormone therapy; not having sever infection in the last 3 months; trauma; surgery; hypo- and hyper-thyroidism; vitamin and mineral supplements; and corticosteroids. Exclusion criteria: affecting by the above-mentioned diseases or starting the use of above-mentioned medications; alterations in dosage and type of current medications; getting pregnant; allergy to soyabean; the use of medications and supplements such as multivitamin mineral supplementation; omega-3 fatty acids; smoking 30 years 50 years Female E11 diabetes mellitus, adult-onset, nonketotic, stable, type II Treatment - Other Treatment - Other soybean flour enriched bread group: soy bread will be enriched by substituting 30% of the wheat flour by soybean flour. participants in the intervention group will be asked to replace 120 gr of soy bread with the equal amount of their usual bread intake. Recommendation group: information about healthy diet has been prescribed for this group. usual dietary recommendation includes healthy food choices. participants in recommendation group will be asked not to consume foods includes soya during this period of study. Serum high sensitive-C Reactive Protein (hs-CRP) levels. Timepoint: Week 2, Week 8, Week 12, Week 18. Method of measurement: high sensitive immunoturbidimetry, mg/dL. Serum Inter-Cellular Adhesion Molecule 1 (sICAM-1) levels. Timepoint: Week 2, Week 8, Week 12, Week 18. Method of measurement: Enzyme-Linked Immunosorbent Assay (ELISA) ،µg/L. Serum vascular cell adhesion molecule 1 (sVCAM-1) levels. Timepoint: Week 2, Week 8, Week 12, Week 18. Method of measurement: Enzyme-Linked Immunosorbent Assay (ELISA) ،µg/L. Serum high sensitive tumor necrosis factor-alpha (hs TNF-α) levels. Timepoint: Week 2, Week 8, Week 12, Week 18. Method of measurement: Enzyme-Linked Immunosorbent Assay (ELISA) ،mg/dL. Serum high sensitive Interleukin 6 (hs IL-6) levels. Timepoint: Week 2, Week 8, Week 12, Week 18. Method of measurement: Enzyme-Linked Immunosorbent Assay (ELISA) ،ng/dL. Glycated hemoglobin(HbA1C). Timepoint: Week 2, Week 8, Week 12, Week 18. Method of measurement: Ion exchange chromatography. Weight. Timepoint: Baseline, Week 2, Week 8, Week 12, Week 18. Method of measurement: scale, kilogram. Waist circumference. Timepoint: Baseline, Week 2, Week 8, Week 12, Week 18. Method of measurement: meter, centimeter. Body mass index. Timepoint: Baseline, Week 2, Week 8, Week 12, Week 18. Method of measurement: kg/m2, Weight/Height square. Diastolic blood pressure. Timepoint: Baseline, Week 2, Week 8, Week 12, Week 18. Method of measurement: mmHg, Mercurial sphygmomanometer. Systolic blood pressure. Timepoint: Baseline, Week 2, Week 8, Week 12, Week 18. Method of measurement: mmHg, Mercurial sphygmomanometer. Fasting blood sugar. Timepoint: Week 2, Week 8, Week 12, Week 18. Method of measurement: mg/dL, Colorimetric. Serum Triglyceride levels. Timepoint: Week 2, Week 8, Week 12, Week 18. Method of measurement: photometrics, mg/dL. Serum total cholesterol levels. Timepoint: Week 2, Week 8, Week 12, Week 18. Method of measurement: photometrics, mg/dL. Serum Low-Density Lipoprotein cholesterol (LDL-c) levels. Timepoint: Week 2, Week 8, Week 12, Week 18. Method of measurement: Enzymatic, mg/dL. Serum High-Density Lipoprotein cholesterol (HDL-c) levels. Timepoint: Week 2, Week 8, Week 12, Week 18. Method of measurement: photometrics, mg/dL. Serum insulin levels. Timepoint: Week 2, Week 8, Week 12, Week 18. Method of measurement: Enzyme-Linked Immunosorbent Assay (ELISA)،µU/mL. HOMA-IR. Timepoint: Week 2, Week 8, Week 12, Week 18. Method of measurement: Formula. Body composition. Timepoint: Week 2, Week 8, Week 12, Week 18. Method of measurement: body analyser. Vice chancellor for research,Isfahan University of Medical Sciences Approved 2012-12-02 Ethical Committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jerib Avenue Isfahan Iran (Islamic Republic of)