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IRCT20220814055693N1 IRCT 2022-12-23 Qazvin University of Medical Sciences Effect of ketogenic diet on fatty liver Investigating the effect of ketogenic diet on patients with fatty liver 2022-08-31 anticipated 60 Complete https://irct.ir/trial/65601 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be individually divided into two groups a (ketogenic diet) and b (common diet) using the random block method. The size of each block is 4. The random allocation tool is random allocation software. N/A Ketogenic diet. Intervention 1: Control group: A common diet (a low-calorie diet with moderate carbohydrates in which the share of carbohydrates is 55% of the total energy) is provided to the patients for 3 months. In the first session, under the supervision of the researcher, daily meals are given to the patient for a whole week and The method of food consumption is explained, then the other diet is provided to the patients by telephone or in person. If the patients need to change the diet or cause problems in its implementation, the researcher is informed. Intervention 2: Intervention group: Ketogenic diet (a high-fat, adequate-protein, low-carbohydrate diet(less than 20%). In this diet, foods containing meat, cheese, cream, healthy oils, nuts, and seeds, etc., are consumed instead of foods containing sugar, grains and starches, fruits except berries, beans and legumes, alcohol, etc.. ) for 3 months. In the first session, under the supervision of the researcher, daily meals are given to the patient for a whole week and the method of food consumption will be explained, then the other diet will be provided to the patients by phone or in person by the researcher. If the patients need to change their diet or cause problems in its implementation, the researcher will be informed. Yes - There is a plan to make this available What will be shared: All data can be shared after individuals are de-identified When: Access starts 6 months after results are published To whom: The data will be available to researchers working in academic and scientific institutions Conditions: Any kind of analysis on the delivered data is allowed Where to obtain: Refer to Dr. Ebrahimi's email How to obtain: After publication of the article, the applicant is able to access the information by sending an email to the author Comments:
public Mehran Ebrahimi
Velayat hospital,22 Bahman boulevard,Elahieh alley, Minoodar town, Qazvin
Qazvin Iran (Islamic Republic of) 3471976161 +98 28 3379 0620 Mehraneb.3046@gmail.com Qazvin University of Medical Sciences scientific Mehran Ebrahimi
Velayat hospital,22 Bahman boulevard,Elahieh alley, Minoodar town, Qazvin
Qazvin Iran (Islamic Republic of) 341976161 +98 28 3379 0620 Mehraneb.3046@gmail.com Qazvin University of Medical Sciences Iran (Islamic Republic of) Patients with Non-alcoholic fatty liver diseases Body mass index more than 25 kg/m2 Patient age between 20 and 60 years Not receiving the diet and exercise program in the past year 18 years 60 years Both Suffering from chronic kidney diseases, heart diseases and other liver diseases (hepatitis, liver cirrhosis), diabetic patients treated with insulin Pregnancy or breastfeeding among female participants Unwillingness to participate in the study K76.0 Fatty (change of) liver, not elsewhere classified, Nonalcoholic fatty liver disease [NAFLD] Treatment - Other Treatment - Other Control group: A common diet (a low-calorie diet with moderate carbohydrates in which the share of carbohydrates is 55% of the total energy) is provided to the patients for 3 months. In the first session, under the supervision of the researcher, daily meals are given to the patient for a whole week and The method of food consumption is explained, then the other diet is provided to the patients by telephone or in person. If the patients need to change the diet or cause problems in its implementation, the researcher is informed. Intervention group: Ketogenic diet (a high-fat, adequate-protein, low-carbohydrate diet(less than 20%). In this diet, foods containing meat, cheese, cream, healthy oils, nuts, and seeds, etc., are consumed instead of foods containing sugar, grains and starches, fruits except berries, beans and legumes, alcohol, etc.. ) for 3 months. In the first session, under the supervision of the researcher, daily meals are given to the patient for a whole week and the method of food consumption will be explained, then the other diet will be provided to the patients by phone or in person by the researcher. If the patients need to change their diet or cause problems in its implementation, the researcher will be informed. Alanine transaminase. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Blood test, Hitachi 912 biochemical machine. Aspartate aminotransferase. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Blood test, Hitachi 912 biochemical machine. Low-density lipoprotein. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Blood test, Hitachi 912 biochemical machine. High-density lipoprotein. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Blood test, Hitachi 912 biochemical machine. Triglycerides. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Blood test, Hitachi 912 biochemical machine. Blood Bilirubin. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Laboratory sample، Malloy_evelyn method. Fatty liver grade. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Ultrasonography. Qazvin University of Medical Sciences Approved 2021-01-20 Ethics Committee of Qazvin University of Medical Sciences Research and Technology deputy, Mavaddat Alley ,Shahid Beheshti Blvd, Qazvin Town Qazvin Qazvin Iran (Islamic Republic of)