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IRCT20131125015536N10 IRCT 2019-11-24 Tehran University of Medical Sciences Effect of diet restricted in advanced glycation end products (low-AGEs) in patients treated with angioplasty Effect of diet restricted in advanced glycation end products (low-AGEs) on vascular adhesion, inflammatory markers, vascular vasodilation (FMD), energy expenditure and brown adipose tissue activity in patients treated with angioplasty 2019-11-06 anticipated 42 Complete https://irct.ir/trial/40455 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Since the variable of gender affect the outcomes of the study, and the two groups must be similar in terms of this variable, randomization is done using stratified randomization based on this variable. Therefore, we will have two categories: men and women. Then for each of these categories, random binary blocks are determined using table of random numbers. Eligible individuals entered the study, are placed in their own category according to their gender and based on the randomized sequences defined for that category, are assigned to either of the two groups receiving low-AGEs diet or cardiovascular diet (on basis of AHA recommendations). Given that the intervention of this study is diet and the person who enters the patients in the study and describes the type of diet for each patient, cannot be blind to the type of diet that each patient receives, allocation concealment does not apply in this study. N/A Condition 1: Atherosclerotic heart disease. Condition 2: Non-alcoholic fatty liver disease. Intervention 1: Intervention group: Individuals in the intervention group will receive isocaloric low AGEs diet (based on dietary recommendations by Uribarrie et al.) for 12 weeks. The general recommendations of American Heart Association for cardiovascular diseases focused on reduction of saturated fats to less than 6 percent of calories, reduction of salt intake to less than 2400 mg per day, and reduction of calorie intake from simple sugars to less than 150 kilocalories per day in men and less than 100 kilocalories per day in women will be considered in the design of this diet, so that the only difference in the diet of the intervention and control group would be the amount of AGEs intake. The list of foods that should be omitted from diet (foods with high amount of AGEs), alternative food sources, the proper type and time of food preparation method in order to reduce the amount of AGEs intake will be explained both verbally and in writing. Intervention 2: Control group: To the individuals in the control group, isocaloric cardiovascular diet (based on general recommendations by American Heart Association) will be given for 12 weeks. This diet focused on the reduction of saturated fats to less than 6 percent of calories, reduction of salt intake to less than 2400 mg per day, and reduction of calorie intake from simple sugars to less than 150 kilocalories per day in men and less than 100 kilocalories per day in women. 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 -
public Mohammad Javad Hossein Zadeh
School of Nutritional Sciences and Dietetics, No. 44, Hodjat doost Alley, Naderi St., Keshavarz Blvd.
Tehran Iran (Islamic Republic of) - +98 21 8895 5975 mhosseinzadeh@tums.ac.ir Tehran University of Medical Sciences scientific Mohammad Javad Hossein Zadeh
School of Nutritional Sciences and Dietetics, No. 44, Hodjat doost Alley, Naderi St., Keshavarz Blvd.
Tehran Iran (Islamic Republic of) - +98 21 8895 5975 mhosseinzadeh@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age of 50 to 70 years BMI of 18.5 to 35 Kg/m2 Diagnosis of need for angioplasty treatment due to obstruction in one or two vessels 50 years 70 years Both History of diabetes, thyroid disorders, chronic kidney diseases, autoimmune diseases, cancer History of myocardial infarction and stroke in the past 3 months Use of multi-vitamin, mineral, and antioxidant supplements over the past 3 months Follow of any weight loss diet or other special diets over the past year Familial hypercholesterolemia and hypertriglyceridemia History of well-known food allergy History of previous angioplasty Smoking, use of hubble-bubble and other drugs Ladies before menopause I25.1 K76.0 Atherosclerotic heart disease of native coronary artery Fatty (change of) liver, not elsewhere classified Prevention Other Intervention group: Individuals in the intervention group will receive isocaloric low AGEs diet (based on dietary recommendations by Uribarrie et al.) for 12 weeks. The general recommendations of American Heart Association for cardiovascular diseases focused on reduction of saturated fats to less than 6 percent of calories, reduction of salt intake to less than 2400 mg per day, and reduction of calorie intake from simple sugars to less than 150 kilocalories per day in men and less than 100 kilocalories per day in women will be considered in the design of this diet, so that the only difference in the diet of the intervention and control group would be the amount of AGEs intake. The list of foods that should be omitted from diet (foods with high amount of AGEs), alternative food sources, the proper type and time of food preparation method in order to reduce the amount of AGEs intake will be explained both verbally and in writing. Control group: To the individuals in the control group, isocaloric cardiovascular diet (based on general recommendations by American Heart Association) will be given for 12 weeks. This diet focused on the reduction of saturated fats to less than 6 percent of calories, reduction of salt intake to less than 2400 mg per day, and reduction of calorie intake from simple sugars to less than 150 kilocalories per day in men and less than 100 kilocalories per day in women. Carboxy methyl lysine. Timepoint: Before and after 12 weeks of intervention. Method of measurement: ELISA method. High sensitive C-Reactive Protein (hs-CRP). Timepoint: Before and after 12 weeks of intervention. Method of measurement: ELISA method. Tumor necrosis factor alpha (TNF-α). Timepoint: Before and after 12 weeks of intervention. Method of measurement: ELISA method. Interleukin 6 (IL-6). Timepoint: Before and after 12 weeks of intervention. Method of measurement: ELISA method. Vascular cell adhesion molecule 1 (VCAM-1). Timepoint: Before and after 12 weeks of intervention. Method of measurement: ELISA method. Flow Mediated Dilation (FMD). Timepoint: Before and after 12 weeks of intervention. Method of measurement: Sonography. Basal metabolism rate. Timepoint: Before and after 12 weeks of intervention. Method of measurement: Bioelectrical Impedance Analysis (BIA). Neuregulin 4 (NRG4). Timepoint: Before and after 12 weeks of intervention. Method of measurement: ELISA method. Fibroblast growth factor 21 (FGF-21). Timepoint: Before and after 12 weeks of intervention. Method of measurement: ELISA method. Appetite. Timepoint: Before and after 12 weeks of intervention. Method of measurement: Visual analog scale. Nesfatin. Timepoint: Before and after 12 weeks of intervention. Method of measurement: ELSA method. Weight. Timepoint: Before and after 12 weeks of intervention. Method of measurement: Weigher. Waist circumference. Timepoint: Before and after 12 weeks of intervention. Method of measurement: Meter. Body composition. Timepoint: Before and after 12 weeks of intervention. Method of measurement: Bioelectrical Impedance Analysis (BIA). Serum lipid profile (total cholesterol, triglyceride, LDL and HDL). Timepoint: Before and after 12 weeks of intervention. Method of measurement: Enzymatic method. Fasting Blood Sugar. Timepoint: Before and after 12 weeks of intervention. Method of measurement: Enzymatic method. Hemoglobin A1C. Timepoint: Before and after 12 weeks of intervention. Method of measurement: Ion exchange chromatography. Serum fasting insulin. Timepoint: Before and after 12 weeks of intervention. Method of measurement: ELISA method. Omentin. Timepoint: Before and after 12 weeks of intervention. Method of measurement: ELISA method. Insulin resistance. Timepoint: Before and after 12 weeks of intervention. Method of measurement: Calculation based on HOMA-IR formula. Fatty liver grade. Timepoint: Before and after 12 weeks of intervention. Method of measurement: Sonography. Hepatic enzymes (ALT and AST). Timepoint: Before and after 12 weeks of intervention. Method of measurement: Enzymatic method. The amount of visceral adipose tissue in anterior to the aorta, posterior to the aorta and anterior to the liver. Timepoint: Before and after 12 weeks of intervention. Method of measurement: Sonography. Carotid intima-media thickness. Timepoint: Before and after 12 weeks of intervention. Method of measurement: Sonography. The amount of subcutaneous fat. Timepoint: Before and after 12 weeks of intervention. Method of measurement: Sonography. Tehran University of Medical Sciences Approved 2019-06-23 Ethics Committee on Research, Research and Technology department of Tehran University of Medical Sci Floor 6, Central Organization of University, corner of Qods St., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)