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IRCT20090203001640N16 IRCT 2020-01-13 Shahid Beheshti University of Medical Sciences ٍEvaluation of substitution of animal proteins with plant proteins in DASH diet in obese individuals with metabolic syndrome effect of substitution of animal proteins with plant proteins in DASH diet on glycemic indicators, lipid profile, Apo lipoproteins, Blood pressure and anthropometric indicators in obese individuals with metabolic syndrome 2020-06-21 anticipated 80 Complete https://irct.ir/trial/39057 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This parallel-group randomized clinical trial will be conducted at Research Institute for Endocrine Sciences, SBMU, Tehran, Iran. In this study, patients will be divided into two groups [intervention(DASH diet containing 2/3 plant proteins and 1/3 animal proteins)] and control (DASH diet containing 2/3 animal protein and 1/3 plant proteins) by using random sequence. The allocation ratio will be 1:1. For randomly assignment of patients to the two groups, stratified blocked randomization method will be used.The division of the strata is based on the sexuality so that patients are first classified into men and women groups. After specifying four blocks in different layouts random selection approach will be used to set the allocation of treatment. the allocation of both groups will be concealed from main researcher in the biochemical laboratories and statistician who will analyze the data and the codes that will be placed to the packets will be available to the researchers for random sampling, Blinding description: This study is designed as a double blind study. The main researcher and patients are not aware which DASH diet group contains 2/3 plant proteins or 2/3 animal proteins, and the main investigator is not involved in the randomization process. 3 Condition 1: metabolic syndrome. Condition 2: obesity. Intervention 1: Intervention group: DASH diet including 15% protein, 30% fat and 55% carbohydrate with intake of 2/3 proteins need from plant proteins( contain grains, nuts or seeds and legumes) and 1/3 animal proteins( contain milk, meat, cheese and eggs). Intervention 2: Control group: DASH diet including 15% protein, 30% fat and 55% carbohydrate with intake of 1/3 proteins need from plant proteins( contain grains, nuts or seeds and legumes) and 2/3 animal proteins( contain milk, meat, cheese and eggs). 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 there is no more information
public Mohammad Hasan Vasei
No.46, Arghavan-E-Gharbi St., Farahzadi Blv., Shahrak-E-Ghods
Tehran Iran (Islamic Republic of) 193954741 +98 21 2235 7484 Ehsanvasei21@gmail.com Shahid Beheshti University of Medical Sciences scientific Mohammad Hasan Vasei
No 46, Arghavan-E-Gharbi St., Farahzadi Blv., Shahrak-E-Ghods
Tehran Iran (Islamic Republic of) 193954741 +98 21 2235 7484 Ehsanvasei21@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Agreement to participate in the study and completing informed consent form aged 30-70 years old No change in weight over the past 3 months body mass index: 25-40 having Metabolic syndrome Not having special diet Non-pregnancy and lactation 30 years 70 years Both Pregnancy and Lactation, having liver disease (non-alcoholic fatty liver Grade 3), kidney disease (GFR <60 ml / min / 1.73 m2), gastrointestinal disease, allergy. Use of effective drugs in weight loss Unwilling to consume legumes and nuts in the diet E88.81 E66.0 metabolic syndrome Obesity due to excess calories Treatment - Other Treatment - Other Intervention group: DASH diet including 15% protein, 30% fat and 55% carbohydrate with intake of 2/3 proteins need from plant proteins( contain grains, nuts or seeds and legumes) and 1/3 animal proteins( contain milk, meat, cheese and eggs) Control group: DASH diet including 15% protein, 30% fat and 55% carbohydrate with intake of 1/3 proteins need from plant proteins( contain grains, nuts or seeds and legumes) and 2/3 animal proteins( contain milk, meat, cheese and eggs) Serum concentration of blood glucose. Timepoint: befor the intervention and 8 weeks after intervention. Method of measurement: enzymatic method. Serum concentration of total cholesterol. Timepoint: before the intervention and 8 weeks after intervention. Method of measurement: enzymatic method. Serum concentrations of triglyceride. Timepoint: before the intervention and 8 weeks after intervention. Method of measurement: enzymatic method. Low density lipoprotein- cholesterol. Timepoint: before the intervention and 8 weeks after intervention. Method of measurement: enzymatic method. High density lipoprotein- cholesterol. Timepoint: before the intervention, 8 weeks after intervention. Method of measurement: enzymatic method. Serum concentration of Apolipoprotein- A1. Timepoint: before the intervention and 8 weeks after intervention. Method of measurement: enzymatic method. Serum concentration of apolipoprotein- B. Timepoint: before the intervention and 8 weeks after intervention. Method of measurement: enzymatic method. Height. Timepoint: before the intervention and 8 weeks after intervention. Method of measurement: stadiometer. Weight. Timepoint: before intervention and 8 weeks after intervention. Method of measurement: Seca scale. Blood pressure. Timepoint: before the intervention and 8 weeks after intervention. Method of measurement: Mercury barometer. Waist circumference. Timepoint: before the intervention and 8 weeks after intervention. Method of measurement: tape meter. Vice Chancellor for Research, Institute of Nutrition and Food Industry of Iran Approved 2019-06-19 ethics committee of national nutrition and food technology research institute No. 7, Shahid Farahzadi Blvd, Shahid Hafezi Street (West Arghavan), Qods Town (West), Tehran Tehran Tehran Iran (Islamic Republic of)