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IRCT20180201038585N12 IRCT 2022-10-21 Bagheiat-allah University of Medical Sciences The effect of DASH diet in subjects with metabolic syndrome The effect of dietary approaches to stop hypertension (DASH) diet on metabolic syndrome components and hepatic steatosis indices in subjects with metabolic syndrome 2022-10-22 anticipated 60 Complete https://irct.ir/trial/66161 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be divided into intervention group or control group utilizing a random allocation software by a third trained person. A computer-generated random numbers table, presented by Saghaei in 2004, will be used to generate the random sequence. Baseline characteristics of the participants such as gender and age will be determined and recorded before random allocation. Then, using a stratified randomization process based on gender (male/female) and age (30–45 and 45–60 years) the participants will be divided into intervention group or control group. Allocation concealment will be conducted using opaque sealed envelopes to prevent selection bias by concealing the allocation sequence from those assigning participants to the intervention groups. 3 Metabolic syndrome. Intervention 1: Intervention group: The intervention group will receive DASH (Dietary Approaches to Stop Hypertension) diet. This diet contains 52 to 55% carbohydrates, 16 to 18% protein and 30% fat. Calories needed by each patient are estimated based on basal metabolic rate (using the Harris-Benedict equation) and levels of physical activity and energy from food metabolism. 500 kcal for those with a BMI in the range of 25-31 kg/m2 and 700 kcal for those with a BMI more than 31 kg/m2 will be deducted from the total energy required by each person. Intervention 2: Control group: The control group will receive a standard diet. Calories needed by each patient are estimated based on basal metabolic rate (using the Harris-Benedict equation) and levels of physical activity and energy from food metabolism. 500 kcal for those with a BMI in the range of 25-31 kg/m2 and 700 kcal for those with a BMI more than 31 kg/m2 will be deducted from the total energy required by each person. 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 further information.
public Karim Parastouei
Mullasadra Ave, Vannak Sq,Tehran
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8248 3264 parastouei@gmail.com Bagheiat-allah University of Medical Sciences scientific Karim Parastouei
Mullasadra Ave, Vannak Sq, Tehran
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8248 3264 parastouei@gmail.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Age 30-60 years Diagnosis of Metabolic Syndrome based on IDF criteria Sign of informed written consent 30 years 60 years Both Pregnancy and lactation Hereditary hemochromatosis History of gingival or gastroplasty bypass surgery Use of hepatotoxic drugs such as calcium channel blocker and high doses of synthetic estrogens Patients with hypothyroidism Cushing syndrome Kidney failure and kidney stone Cardiovascular disease History of hepatitis B and C Wilson disease E88.81 Metabolic syndrome Lifestyle Lifestyle Intervention group: The intervention group will receive DASH (Dietary Approaches to Stop Hypertension) diet. This diet contains 52 to 55% carbohydrates, 16 to 18% protein and 30% fat. Calories needed by each patient are estimated based on basal metabolic rate (using the Harris-Benedict equation) and levels of physical activity and energy from food metabolism. 500 kcal for those with a BMI in the range of 25-31 kg/m2 and 700 kcal for those with a BMI more than 31 kg/m2 will be deducted from the total energy required by each person. Control group: The control group will receive a standard diet. Calories needed by each patient are estimated based on basal metabolic rate (using the Harris-Benedict equation) and levels of physical activity and energy from food metabolism. 500 kcal for those with a BMI in the range of 25-31 kg/m2 and 700 kcal for those with a BMI more than 31 kg/m2 will be deducted from the total energy required by each person. Diastolic Blood Pressure. Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: Sphygmomanometer. Waist Circumference. Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: Meter. Triglyceride. Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: Enzymatic method. High density lipoprotein cholesterol. Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: Enzymatic method. Systolic blood pressure. Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: Sphygmomanometer. Fasting blood glucose. Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: Enzymatic method. Low density lipoprotein cholesterol. Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: Enzymatic method. Total Cholesterol. Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: Enzymatic method. Alanine Aminotransferase. Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: Enzymatic method. Aspartat transaminase. Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: Enzymatic method. Weight. Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: Scale. Body mass index. Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: Formula. Hepatic steatosis index. Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: Formula. Lipid accumulation product. Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: Formula. Visceral adiposity index. Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: Formula. Fatty liver index. Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: Formula. Gamma-glutamyl transpeptidase. Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: Enzymatic method. Atherogenix index of plasma. Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: Formula. Atherogenic coefficient. Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: Formula. Castelli risk index. Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: Formula. Cardiometabolic index. Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: Formula. TyG index. Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: Formula. Metabolic score for insulin resistance. Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: Formula. Bagheiat-allah University of Medical Sciences Approved 2022-05-21 Ethics committee of baqiayatllah University of Medical Sciences Moulla Sadra Ave , Vannak Square Tehran Tehran Iran (Islamic Republic of)