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IRCT20150909023957N10 IRCT 2022-05-16 Vice-Chancellor in Research Affairs -Medical University of Isfahan The effect of replacing animal-based proteins with plant-based proteins on metabolic syndrome treatment The comparison of the effectiveness of replacing animal-based proteins with plant-based proteins on adropin levels, atherogenic index of plasma, and metabolic syndrome components in subjects with metabolic syndrome. 2022-05-22 anticipated 66 Complete https://irct.ir/trial/63377 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Participants will be placed in one of two diet groups using balanced (permuted) block randomization method and using a valid site (https://www.se aledenvelope.com/simple-randomiser/v1/lists)for creating random numbers using quadratic blocks. N/A Metabolic syndrome. Intervention 1: Intervention group: Plant-based protein diet (diet containing 30% animal protein and 70% plant protein). Intervention 2: Control group: Animal-based protein diet (diet containing 70% animal protein and 30% plant protein). Yes - There is a plan to make this available What will be shared: Data of the main outcomes along with the method and materials and analysis as well as the informed consent can be shared after the hiding individuals. When: One year after the publication of the results To whom: Research centers and Vice-Chancellor in Research Affairs Conditions: research use Where to obtain: Dr. Sayyed Morteza Safavi How to obtain: Letter from the Vice-Chancellor in Research Affairs and the Ethics Committee Comments:
public Sayyed Morteza Safavi
Hezar jrib
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3168 safavimorteza@yahoo.com Esfahan University of Medical Sciences scientific Sayyed Morteza Safavi
Hezar Jarib Avenue, Isfahan University of Medical Sciences, School of Nutrition and Food Science, Is
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3168 safavimorteza@nutr.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Desire to participate in the study Male and female teachers working in Isfahan Age 20 to 55 years and Iranian nationality Diagnosis of metabolic syndrome based on JIS criteria Body mass index between 25 to 35 kg/m2 20 years 55 years Both Follow a special diet for the past 6 months Dietary supplements use History of kidney, liver, cardiovascular, thyroid and cancer diseases Use of hormonal drugs, birth control pills, glucocorticoids and drugs to lower blood sugar, blood pressure and lipids Pregnancy and lactation Alcohol, cigarettes and tobacco use E88.81 Metabolic syndrome Treatment - Other Treatment - Other Intervention group: Plant-based protein diet (diet containing 30% animal protein and 70% plant protein) Control group: Animal-based protein diet (diet containing 70% animal protein and 30% plant protein) Adropin. Timepoint: Initiation and end of the study (after 10 weeks). Method of measurement: ELISA. The atherogenic index of plasma (AIP). Timepoint: Initiation and end of the study (after 10 weeks). Method of measurement: Log (TG/HDL_C). Component of metabolic syndrome including fasting blood sugar, lipid profile, waist circumference, and blood pressure. Timepoint: Initiation and end of the study (after 10 weeks). Method of measurement: Fasting blood sugar and lipid profile by enzymatic method and auto-analyzer, waist circumference using tape measure and blood pressure using Omron Upper arm Blood Pressure. Vice-Chancellor in Research Affairs -Medical University of Isfahan Approved 2021-12-04 Research Ethics Committees of Vice-Chancellor in Research Affairs -Medical University of Isfahan Hezar jrib Isfahan Isfehan Iran (Islamic Republic of)