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IRCT201305191485N10 IRCT 2013-06-24 Vice Chancellor for Research, Isfahan University of Medical Sciences Effect of whole grain consumption on inflammation Effect of whole grain consumption or usual dietary recommendation on serum levels of inflammatory bio markers in obese children: a randomized controlled trial 2012-07-01 anticipated 44 Complete https://irct.ir/trial/769 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Other design features: Simple randomization. 2 obesity. Intervention 1: whole-grain group:The individual energy requirements will be calculated based on recommendations of the Institute of medicine. The target macro nutrient composition for all participants will be 53% of energy as carbohydrate, 30% of energy as fat and 17% of energy as protein. Subjects in intervention group will be given a list of whole grain foods and will be asked to obtain 50% of their grain servings from whole grain foods each day. Intervention 2: Recommendation group: information about healthy diet has been prescribed for this group.Subjects in the non intervention group also were given a list of whole grain foods and will be asked not to consume any of those foods during this period of study.
public Ahmad Esmaillzadeh
Isfahan University of Medical Sciences, Hezar Jerib Avenue
Isfahan Iran (Islamic Republic of) +98 31 1792 2720 Esmaillzadeh@hlth.mui.ac.ir Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medic scientific Ahmad Esmaillzadeh
Isfahan University of Medical Sciences, Hezar Jerib Avenue
Isfahan Iran (Islamic Republic of) +98 31 1792 2720 Esmaillzadeh@hlth.mui.ac.ir Food Security Research Center, Isfahan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: female; aged 8-15 years; body mass index greater than 85th percentile for age and sex; lack of adherence to a specific diet and the use of medications and supplements and no history of chronic diseases. Exclusion criteria: history of chronic diseases; the use of medications and supplements such as multivitamin mineral supplementation, omega-3 fatty acids, Aspirin, etc in the past 6 months, hormone therapy and alterations in physical activity 8 years 15 years Female E66.0 Obesity due to excess calories Treatment - Other Treatment - Other whole-grain group:The individual energy requirements will be calculated based on recommendations of the Institute of medicine. The target macro nutrient composition for all participants will be 53% of energy as carbohydrate, 30% of energy as fat and 17% of energy as protein. Subjects in intervention group will be given a list of whole grain foods and will be asked to obtain 50% of their grain servings from whole grain foods each day Recommendation group: information about healthy diet has been prescribed for this group.Subjects in the non intervention group also were given a list of whole grain foods and will be asked not to consume any of those foods 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 Amyloid A (SAA) levels. Timepoint: Week 2, Week 8, Week 12, Week 18. Method of measurement: Enzyme-Linked Immunosorbent Assay (ELISA) ،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 leptin levels. Timepoint: Week 2, Week 8, Week 12, Week 18. Method of measurement: Enzyme-Linked Immunosorbent Assay (ELISA) ،ng/mL. 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. Hip 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. Systolic blood pressure. Timepoint: Baseline, Week 2, Week 8, Week 12, Week 18. Method of measurement: mmHg, digital sphygmomanometer. Diastolic blood pressure. Timepoint: Baseline, Week 2, Week 8, Week 12, Week 18. Method of measurement: mmHg, digital 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. Vice Chancellor for Research, Isfahan University of Medical Sciences Approved 2012-06-10 Ethical Committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jerib Avenue Isfahan Iran (Islamic Republic of)