]>
IRCT20121029011307N2 IRCT 2020-03-03 Shiraz University of Medical Sciences Comparison of the effect of dietary approaches to stop hypertension (DASH) diet to improve non-alcoholic fatty liver disease Comparison of the effect of dietary approaches to stop hypertension (DASH) diet with regular hypocaloric diet on cardiometabolic parameters, oxidative stress and inflammatory markers, hepatic enzymes, and fatty liver severity in patients with non-alcoholic fatty liver disease 2019-06-22 anticipated 120 Complete https://irct.ir/trial/45597 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Permuted block randomization: First, the list of participants was provided according to their referral. Then all possible sequences that can be written with three groups, were written on paper (for 3 groups 6 sequences can be written). Then one of the numbers from 1 to 6 was considered for each sequence, for example for the ABC sequence 1 and for the ACB sequence 2 and as such, one of the numbers 3 to 6 was considered for the other 4 sequences. Then, using random number table, the random numbers were selected from one point to the left or right. Wherever the random number was 1 to 6, the corresponding sequence was recorded on the paper, and wherever the numbers were 0 or 7, 8, 9, the next number that was between 1 to 6 was considered. This method continued until groups for the total number of participants were determined. Then, the names of subjects on the list were allocated to the specific groups according to the sequence of groups which had been determined by the above mentioned procedure, Blinding description: Participants are unaware of the differences in the incoming regimes. N/A Non-alcoholic fatty liver disease. Intervention 1: Intervention group 1: Receiving dietary approaches to stop hypertension diet(DASH ). In this group, the required energy of each person will be determined based on Harris Benedict formula and without deduction of energy, units of each food groups will be determined based on DASH diet. DASH diet is rich in fruits, vegetables, whole grains, low-fat dairy foods and is limited in saturated fatty acids, total fat and cholesterol, refined cereals and sugar sweetened drinks with an overall 2400 mg per day sodium intake. Intervention 2: Intervention group 2: Receiving hypocaloric diet. In this group, the required energy of each person will be determined based on Harris Benedict formula, the rate of 500 kcal will be deducted then units of each food groups will be determined based on a regular diet. Intervention 3: Control group: Receiving dietary approaches to stop hypertension diet (DASH) hypocaloric diet. In this group, the required energy of each person will be determined based on Harris Benedict formula, the rate of 500 kcal will be deducted then units of each food groups will be determined based on DASH diet. 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 Zeinab Hatami Zargaran
Reyhaneh building, 8/6 Alley, Southern Hemmat Avenue
Shiraz Iran (Islamic Republic of) 7188776461 +98 71 3632 1066 z_hatami_65@yahoo.com Shiraz University of Medical Sciences scientific Zeinab Hatami Zargaran
Reyhaneh building, 8/6 Alley, Southern Hemmat Avenue
Shiraz Iran (Islamic Republic of) 7188776461 +98 71 3632 1066 z_hatami_65@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Having a non alcoholic fatty liver disease (NAFLD) to diagnose a doctor (using Ultra Ultrasound) willing to participate in the study 20 years 60 years Both Patients with cardiovascular disease, liver disease (cirrhosis, alcoholic liver disease, viral hepatitis, autoimmune hepatitis, primary bile cirrhosis, bile obstruction, liver damage induced by hereditary hemochromatosis drugs, sclerosis, and α-antitrypsin deficiency), other dire diseases Such as cancer, kidney failure and... Celiac Pregnancy, lactation Taking medications that cause fatty liver (methotrexate, tamoxifen, Oalprowat, etc.) Taking blood lipid-lowering drugs Malnutrition Having certain diets like vegetarian and raw veganism Alcohol consumption K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Other Treatment - Other Treatment - Other Intervention group 1: Receiving dietary approaches to stop hypertension diet(DASH ). In this group, the required energy of each person will be determined based on Harris Benedict formula and without deduction of energy, units of each food groups will be determined based on DASH diet. DASH diet is rich in fruits, vegetables, whole grains, low-fat dairy foods and is limited in saturated fatty acids, total fat and cholesterol, refined cereals and sugar sweetened drinks with an overall 2400 mg per day sodium intake. Intervention group 2: Receiving hypocaloric diet. In this group, the required energy of each person will be determined based on Harris Benedict formula, the rate of 500 kcal will be deducted then units of each food groups will be determined based on a regular diet. Control group: Receiving dietary approaches to stop hypertension diet (DASH) hypocaloric diet. In this group, the required energy of each person will be determined based on Harris Benedict formula, the rate of 500 kcal will be deducted then units of each food groups will be determined based on DASH diet. Fatty liver severity. Timepoint: At the beginning of the study (before intervention) and three months after the beginning of the intervention. Method of measurement: Using Ultrasound. Isoprostane 8. Timepoint: At the beginning of the study (before intervention) and three months after the beginning of the intervention. Method of measurement: Enzyme-linked immunosorbent kit. Interleukin 6. Timepoint: At the beginning of the study (before intervention) and three months after the beginning of the intervention. Method of measurement: Enzyme-linked immunosorbent kit. C-Reactive Protein. Timepoint: At the beginning of the study (before intervention) and three months after the beginning of the intervention. Method of measurement: Enzyme-linked immunosorbent kit. Aspartate aminotransferase. Timepoint: At the beginning of the study (before intervention) and three months after the beginning of the intervention. Method of measurement: Calorimetry method. Shiraz University of Medical Sciences Approved 2019-04-22 Ethics committee of Shiraz University of Medical Sciences Reyhaneh building, 8/6 Alley, Southern Hemmat Avenue Shiraz Fars Iran (Islamic Republic of)