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IRCT20201010048982N2 IRCT 2021-08-22 Oroumia University of Medical Sciences Evaluation the effect of meal pattern on Non alcoholic fatty liver disease Evaluation the effect of meal pattern on hepatic fibrosis, steatosis, and enzymes, lipid profile, and anthropometric measurements in patient with non alcoholic fatty liver disease 2021-06-20 anticipated 112 Complete https://irct.ir/trial/55211 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Eligible samples will be randomly divided into intervention and control groups. The intervention groups will be given codes A, B, C and the control group will receive code D. The study blocking is as follows: All block modes of these 4 groups are 24 numbers: ABCD, ABDC, ACDB, ACBD, ADBC, ADCB, BACD, BADC, BCAD, BCDA, BDAC, BDCA, CABD, CADB, CBAD, CBDA , CDAB, CDBA, DABC, DASB, DBCA, DBAC, DCAB, DCBA. These blocks will be placed in sealed envelopes inside a container. Then they will be drawn one by one, the first block to be removed will be selected as the first block. In fact, this will be repeated 28 times to complete the sample size. In this way, people enter the study and thus will be divided into groups. N/A Non-alcoholic fatty liver disease. Intervention 1: Intervention group 1: It will be recommended to eliminate their breakfast and during the day, in addition to lunch and dinner, receive two snacks in the evening and at the end of the night. Intervention 2: Intervention group 2: They will be advised to skip dinner and have two snacks during the day in addition to breakfast and lunch, and their last daily meal will be in the evening. Intervention 3: Intervention group 3: It will be recommended to eat only three main meals (breakfast, lunch and dinner) during the day. Intervention 4: Control group: It will be recommended to have three main meals (breakfast, lunch and dinner) and three snacks. 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 I have not decided yet
public Dr.Mohammad Alizadeh
Nazloo
Urmia Iran (Islamic Republic of) 5614687911 +98 45 3333 7906 far.alami28@gmail.com Oroumia University of Medical Sciences scientific Dr.Mohammad Alizadeh
Hashte shahrivar street
Urmia Iran (Islamic Republic of) 5614687911 +98 45 3333 7906 Far.alami28@gmail.com Oroumia University of Medical Sciences Iran (Islamic Republic of) older than 18 years of both sexes Non-alcoholic fatty liver disease diagnosed by FibroScan. Non-alcoholic fatty liver disease 18 years no limit Both Having special diets Viral hepatitis and ascites Alcohol consumption Diabetes mellitus kidney Diseases K76.0 Fatty (change of) liver, not elsewhere classified Lifestyle Lifestyle Lifestyle Lifestyle Intervention group 1: It will be recommended to eliminate their breakfast and during the day, in addition to lunch and dinner, receive two snacks in the evening and at the end of the night. Intervention group 2: They will be advised to skip dinner and have two snacks during the day in addition to breakfast and lunch, and their last daily meal will be in the evening. Intervention group 3: It will be recommended to eat only three main meals (breakfast, lunch and dinner) during the day. Control group: It will be recommended to have three main meals (breakfast, lunch and dinner) and three snacks. Fibrosis. Timepoint: At the beginning and end of the study (beginning and end of 3 months). Method of measurement: FibroScan. Liver enzymes. Timepoint: At the beginning and end of the study (beginning and end of 3 months). Method of measurement: At the beginning and end of the study, 5 cc of venous blood sample will be taken after 12 hours of fasting. Steatosis. Timepoint: At the beginning and end of the study (beginning and end of 3 months). Method of measurement: At the beginning and end of the study, 5 cc of venous blood sample will be taken after 12 hours of fasting. Lipid profile. Timepoint: At the beginning and end of the study (beginning and end of 3 months). Method of measurement: At the beginning and end of the study, 5 cc of venous blood sample will be taken after 12 hours of fasting. Anthropometric measurements. Timepoint: At the beginning and end of the study (beginning and end of 3 months). Method of measurement: At the beginning and end of the study, 5 cc of venous blood sample will be taken after 12 hours of fasting. Oroumia University of Medical Sciences Approved 2021-01-23 Ethnic committee of Urmia University of Medical Sciences Hashteshahrivar street Urmia West Azarbaijan Iran (Islamic Republic of)