]>
IRCT20170202032367N5 IRCT 2022-03-05 Tehran University of Medical Sciences The effect of intermittent fasting diet on fatty liver The effects of intermittent fasting diet in comparison with low calorie diet on lipid profile, glycemic status and liver fibrosis in patients with non-alcoholic fatty liver 2022-04-21 anticipated 52 Complete https://irct.ir/trial/62008 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Permuted Block Randomization method is used for randomization. In this method, eligible individuals with inclusion criteria are selected and then they are randomly selected using 4 blocks that block based on BMI (greater than 30 and between 25 and 30) and age (20-35 and 35-40 years old) will be assigned to one of the two groups of intermittent fasting diet and calorie restricted diet. In addition, to generate random sequences, we use online software for random generation software allocation Random, which perform simple or blocked random sequences. 1-2 fatty liver. Intervention 1: Intervention group: In the intervention group, an intermittent fasting diet of the type (16: 8) will be used, in which individuals are allowed to receive only water and non-energy drinks for 16 hours (from 8 pm to 12 am the next day). Tea, coffee and sugar-free chewing gum are free to eat for 8 hours (from 12 noon to 8 pm). Intervention 2: Control group: People in the control group also receive a low-calorie diet (which is adjusted based on the history taken during the run-in period as well as the foods that are in the eating habits of the people). To adjust diet with a macronutrient ratio of 55% carbohydrate, 30% fat and 15% protein, first using the current age, sex, height and weight of patients in the Harris Benedict formula, the basal metabolic rate (BMR) of patients is calculated individually. Then, the total daily energy requirement of each person is calculated based on his physical activity and taking into account the thermogenic effect of food (TEF), and finally, the total calculated energy is reduced by 300 kcal. Based on these divisions, the required amounts from each food group will be calculated. The control group diet will be divided into six daily meals including 3 main meals and 3 snacks. Based on this, a food menu will be set up and the necessary alternatives will be taught to the people in the control group. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to confidentiality of participant information, it is not possible to publish it
public Hossien Imani
No. 44, Shahid Hojjat Doost Alley, Naderi St, Keshavarz Boulevard
Tehran Iran (Islamic Republic of) 1416643931 0098 21 889900285 h_imani@sina.tums.ac.ir Tehran University of Medical Sciences scientific Hossein Imani
No. 44, Shahid Hojatost Alley, Keshavarz Boulevard, Naderi St
Tehran Iran (Islamic Republic of) 1416643931 +98 21 8899 0285 h-imani@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age 50-20 years Body mass index 25 - 30 kg/m2 Both genders Diagnosis of osteohepatitis based on Cap-score> 263 subjects with hepatic fibrosis based on Metavir-score ≤ F2 Willingness to cooperate 20 years 50 years Both Consumption of alcohol Other acute and chronic liver diseases Autoimmune diseases, kidney diseases, biliary diseases, diabetes, cancer Pregnancy and lactation Use of hepatotoxic drugs (phenytoin, lithium, tamoxifen, antibiotics), weight loss drugs, sage and corticosteroids Follow a special diet in the last three months K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Other Treatment - Other Intervention group: In the intervention group, an intermittent fasting diet of the type (16: 8) will be used, in which individuals are allowed to receive only water and non-energy drinks for 16 hours (from 8 pm to 12 am the next day). Tea, coffee and sugar-free chewing gum are free to eat for 8 hours (from 12 noon to 8 pm). Control group: People in the control group also receive a low-calorie diet (which is adjusted based on the history taken during the run-in period as well as the foods that are in the eating habits of the people). To adjust diet with a macronutrient ratio of 55% carbohydrate, 30% fat and 15% protein, first using the current age, sex, height and weight of patients in the Harris Benedict formula, the basal metabolic rate (BMR) of patients is calculated individually. Then, the total daily energy requirement of each person is calculated based on his physical activity and taking into account the thermogenic effect of food (TEF), and finally, the total calculated energy is reduced by 300 kcal. Based on these divisions, the required amounts from each food group will be calculated. The control group diet will be divided into six daily meals including 3 main meals and 3 snacks. Based on this, a food menu will be set up and the necessary alternatives will be taught to the people in the control group. Fasting blood sugar. Timepoint: At the beginning and end of the study (after 12 weeks (84 days)). Method of measurement: Glucose oxidase enzymatic method using commercial kits of Pars Azmoon company in terms of (mg/dL). Total cholesterol. Timepoint: At the beginning and end of the study (after 12 weeks (84 days)). Method of measurement: Measurement of total cholesterol level using Pars Azmoon kits and auto analyzer. Triglyceride. Timepoint: At the beginning and end of the study (after 12 weeks (84 days)). Method of measurement: Measurement of triglyceride level using Pars Azmoon kits and auto analyzer. HDL cholesterol. Timepoint: At the beginning and end of the study (after 12 weeks (84 days)). Method of measurement: Measurement of HDL cholesterol level using Pars Azmoon kits and auto analyzer. LDL cholesterol. Timepoint: At the beginning and end of the study (after 12 weeks (84 days)). Method of measurement: Measurement of LDL cholesterol by Friedwald formula [LDL = Chol - (TG / 5 + HDL)], with plasma triglyceride concentrations below 400 mg/dL. Aspartate transaminase enzyme (AST). Timepoint: At the beginning and end of the study (after 12 weeks (84 days)). Method of measurement: Proposed IFCC method - Photometry Pars azmoon Kit. Alanin transaminase enzyme (ALT). Timepoint: At the beginning and end of the study (after 12 weeks (84 days)). Method of measurement: Proposed IFCC method - Photometry Pars azmoon Kit. Gamma glutamyl transferase enzyme (GGT). Timepoint: At the beginning and end of the study (after 12 weeks (84 days)). Method of measurement: Calorimetric-kinetic method proposed by IFCC. Steatosis. Timepoint: At the beginning and end of the study (after 12 weeks (84 days)). Method of measurement: Fibroscan. Hepatic fibrosis. Timepoint: At the beginning and end of the study (after 12 weeks (84 days)). Method of measurement: Fibroscan. Fasting blood insulin level. Timepoint: At the beginning and end of the study (after 12 weeks (84 days)). Method of measurement: Special laboratory kit. HOMA-IR. Timepoint: At the beginning and end of the study (after 12 weeks (84 days)). Method of measurement: Using the formula. QUICKI. Timepoint: At the beginning and end of the study (after 12 weeks (84 days)). Method of measurement: Using the formula. Weight. Timepoint: At the beginning and end of the study (after 12 weeks (84 days)). Method of measurement: Use digital scales with an accuracy of 0.1 kg and with minimal clothing and no shoes. BMI. Timepoint: At the beginning and end of the study (after 12 weeks (84 days)). Method of measurement: Weight in kilograms divided by height squared in meters. Waist circumference. Timepoint: At the beginning and end of the study (after 12 weeks (84 days)). Method of measurement: Tape meter. Physical activity. Timepoint: At the beginning and end of the study (after 12 weeks (84 days)). Method of measurement: Record physical activity. Tehran University of Medical Sciences Approved 2021-09-21 Ethics Committee of Tehran University of Medical Sciences Room 605, Sixth Floor, Central Building of Tehran University of Medical Sciences, Qods Street, Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)