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IRCT20140502017522N5 IRCT 2023-06-07 Bagheiat-allah University of Medical Sciences The effect of jujube in management patients with non-alcoholic fatty liver The effect of jujube on anthropometric , biochemical and hepatic steatosis predictors indices in patients with non-alcoholic fatty liver disease 2023-06-22 anticipated 88 Complete https://irct.ir/trial/69945 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation will be done using the block randomization method (block size= four). The possible blocks will be as follows:1- AABB, 2- ABAB، 3- BABA ، 4- BBAA، 5- BAAB، 6- ABBA Then, numbers (1 to 6) will be randomly selected using the random number table, and this process will be repeated 22 times until the sample size is reached, Blinding description: Outcome assessor and data analyser will be blinded. 3 Non alcoholic fatty liver disease. Intervention 1: Intervention group: Daily intake of 30 grams of jujube powder(Shaina Sharq Jujube company) ) for 12 weeks along with a low-calorie diet (500 kcal reduction). Intervention 2: Control group: Following a low-calorie diet (reduction of 500 kcal of energy intake) recommended by the researcher for 12 weeks. 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 Ronak Borzoei
Gomrok Street
Kermanshah Iran (Islamic Republic of) 7155166715 +98 83 2182 4025 ronakborzooie@yahoo.com Bagheiat-allah University of Medical Sciences scientific Maryam Taghdir
Baqiatallah University, South Sheikh Baha'i st., Molasadra st., Vanak sq.,
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8755 5511 mtaghdir@bmsu.ac.ir Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) diagnosed patients with nonalcoholic fatty liver not abusing alcohol not having diabetes, kidney disorders and other liver diseases Not having liver cancer, or other cancers not having allergy to Jujube not taking multivitamins and minerals supplements during 3 month ago 18 years 65 years Both pregnancy K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Other Placebo Intervention group: Daily intake of 30 grams of jujube powder(Shaina Sharq Jujube company) ) for 12 weeks along with a low-calorie diet (500 kcal reduction) Control group: Following a low-calorie diet (reduction of 500 kcal of energy intake) recommended by the researcher for 12 weeks Fasting blood sugar (FBS). Timepoint: At the beginning of the study and after the intervention (12 weeks after the start of the intervention). Method of measurement: Standard enzymatic method. Weight. Timepoint: At the beginning of the study and after the intervention (12 weeks after the start of the intervention). Method of measurement: scale. Waist circumference. Timepoint: At the beginning of the study and after the intervention (12 weeks after the start of the intervention). Method of measurement: tape measure. Body mass index. Timepoint: At the beginning of the study and after the intervention (12 weeks after the start of the intervention). Method of measurement: Standard formula. Aspartate aminotransferase (AST). Timepoint: At the beginning of the study and after the intervention (12 weeks after the start of the intervention). Method of measurement: Enzyme-linked immuno_sorbent assay (ELISA). Total cholesterol. Timepoint: At the beginning of the study and after the intervention (12 weeks after the start of the intervention). Method of measurement: Standard enzymatic method. High density lipoprotein. Timepoint: At the beginning of the study and after the intervention (12 weeks after the start of the intervention). Method of measurement: Standard enzymatic method. Low density lipoprotein. Timepoint: At the beginning of the study and after the intervention (12 weeks after the start of the intervention). Method of measurement: Standard enzymatic method. Triglyceride. Timepoint: At the beginning of the study and after the intervention (12 weeks after the start of the intervention). Method of measurement: Standard enzymatic method. Hepatic steatosis index(HS index). Timepoint: At the beginning of the study and after the intervention (12 weeks after the start of the intervention). Method of measurement: standard formula. Fatty liver index(FL index). Timepoint: At the beginning of the study and after the intervention (12 weeks after the start of the intervention). Method of measurement: standard formula. Triglyceride glucose index(TYG index). Timepoint: At the beginning of the study and after the intervention (12 weeks after the start of the intervention). Method of measurement: standard formula. Alanin amino transferase. Timepoint: At the beginning of the study and after the intervention (12 weeks after the start of the intervention). Method of measurement: Enzyme linked immuno sorbent assay(ELISA). Gamma-glutamyl transferase (GGT). Timepoint: At the beginning of the study (before the intervention) and the end of the study (12 weeks after the intervention). Method of measurement: Enzyme linked immuno sorbent assay(ELISA). Bagheiat-allah University of Medical Sciences Approved 2023-04-29 Ethics Commmittee of Baqiyatallah Hospital Baqiyatallah university, south sheikh bahai st, molasdra st, vanak sq Tehran Tehran Iran (Islamic Republic of)