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IRCT20100524004010N39 IRCT 2023-07-22 Shahid Beheshti University of Medical Sciences The effect of co-administration of Dietary Approaches To Stop Hypertension (DASH) and Intermittent Fasting IF diets on patients with Non-Alcoholic Fatty Liver Disease (NAFLD): a Randomized Control Trial The effect of co-administration of Dietary Approaches To Stop Hypertension (DASH) and Intermittent Fasting (IF) diets on hepatic parameters, glucose homeostasis, lipid profile and inflammatory biomarkers in patients with Non-Alcoholic Fatty Liver Disease (NAFLD): a Randomized Control Trial 2023-06-18 anticipated 50 Complete https://irct.ir/trial/70712 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The first step is to create a random sequence number. For this purpose, we will use a random number generator on Stattrek (https://stattrek.com/statistics/random-number-generator.aspx) for 50 numbers ranging from 1 to 2 (for example 2 1 1 2 1 2 1 1 2 2 2 1 1 2 2 1 2 2..............).Then, we will specify the numbers to the groups, for example, 1 will be assigned to the intervention group, and the numbers 2 to the control group. Each number will represent a group according to the defined numbers. With this method, we will have a specific sequence of 50 codes of 1, 2, which shows the first to 50th people who are going to be entered into the study in each group. We write the codes on a piece of paper and put them in an envelope to use during sampling. Thus, after reviewing the inclusion criteria and if the participants desire, we will enter each person included in the study according to our predetermined list. 2-3 Non-alcoholic fatty liver. Intervention 1: Intervention group :After calculating the amount of calories needed by each person using the Meflin formula, each person For 12 weeks, receiving the co-administration of DASH and intermittent fasting 16:8 diets . 16 hours of a day in intermittent fasting for example, from 8:00 PM to 12:00 noon the next day and 8 hours of receiving the DASH diet ,which includes the consumption of whole grains, 2 to 3 units of low-fat or fat-free dairy products, 7 to 8 units of fruits and vegetables, limiting saturated fats and sweets and sugar-sweetened drinks. Intervention 2: Control group: They receive nutritional recommendations to control the disease: Avoid consuming too much sugar, jam, honey, syrup, soft drinks, and other foods that contain sugar. These foods aggravate fatty liver. It should be noted that the consumption of alcoholic beverages can cause and aggravate the symptoms of fatty liver. Be sure to use different vegetables with meals. 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 Azita Hekmatdoost
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2235 7483 a_hekmat2000@yahoo.com Shahid Beheshti University of Medical Sciences scientific Azita Hekmatdoost
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2235 7483 a_hekmat2000@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Having evidence of non-alcoholic fatty liver in fibroscan (CAP score>260) Not having a history of alcohol consumption or alcohol consumption less than 10 grams per day in women and less than 20 grams per day in men. Not taking drugs that affect blood lipids, metformin, vitamin E and ursodeoxycholic acid (UDCA) and hepatotoxic drugs such as phenytoin, amoxifen and lithium. Not having chronic and acute liver diseases (hepatitis B, C, etc.), biliary disease, known autoimmune diseases, cancer and hereditary disorders affecting the liver (iron, copper storage disease) No history of weight loss surgery, weight loss program in the last 3 months Non-adherence to special diets such as vegetarianism No history of uncontrolled thyroid disease Willingness to participate in the studuy Not having uncontrolled celiac disease, diabetes, cardiovascular disease, lung disease and kidney disease 18 years no limit Both History of weight loss surgery and weight loss program during the last 3 months Failure to accept study conditions Taking medicine or supplements that can affect the results Following special diets and vegetarianism during the last 3 months Pregnancy or breastfeeding in women or Using birth control pills K76.0 Fatty (change of) liver, not elsewhere classified N/A Lifestyle Intervention group :After calculating the amount of calories needed by each person using the Meflin formula, each person For 12 weeks, receiving the co-administration of DASH and intermittent fasting 16:8 diets . 16 hours of a day in intermittent fasting for example, from 8:00 PM to 12:00 noon the next day and 8 hours of receiving the DASH diet ,which includes the consumption of whole grains, 2 to 3 units of low-fat or fat-free dairy products, 7 to 8 units of fruits and vegetables, limiting saturated fats and sweets and sugar-sweetened drinks. Control group: They receive nutritional recommendations to control the disease: Avoid consuming too much sugar, jam, honey, syrup, soft drinks, and other foods that contain sugar. These foods aggravate fatty liver. It should be noted that the consumption of alcoholic beverages can cause and aggravate the symptoms of fatty liver. Be sure to use different vegetables with meals. Level of steatosis and liver fibrosis. Timepoint: At the beginning and 3 months after the start of the study. Method of measurement: Fibroscan. Lipid profile. Timepoint: At the beginning of the study and at the end of the study (after 3 months). Method of measurement: blood sample. Insulin sensitivity index. Timepoint: At the beginning of the study and at the end of the study (after 3 months). Method of measurement: math formula. Insulin resistance index. Timepoint: At the beginning of the study and at the end of the study (after 3 months). Method of measurement: math formula. Insulin concentration. Timepoint: At the beginning of the study and at the end of the study (after 3 months). Method of measurement: blood sample. Anthropometric indices. Timepoint: At the beginning of the study and at the end of the study (after 3 months). Method of measurement: Tape measure, scale and mathematical formula. Blood pressure. Timepoint: At the beginning of the study and at the end of the study (after 3 months). Method of measurement: Sphygmomanometer. High-sensitivity C-reactive protein. Timepoint: At the beginning of the study and at the end of the study (after 3 months). Method of measurement: blood sample. Liver enzymes alanine transaminase, aspartate aminotransferase, gamma-glutamyl transferase. Timepoint: At the beginning of the study and at the end of the study (after 3 months). Method of measurement: blood sample. Shahid Beheshti University of Medical Sciences Approved 2023-06-14 Ethics Committee of National Nutrition and Food Technology Research Institute (NNFTRI #7, Shahid Hafezi Ave, Farahzadi Blvd, Shahrak Gharb Tehran Tehran Iran (Islamic Republic of)