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IRCT20140502017522N4 IRCT 2023-03-23 Bagheiat-allah University of Medical Sciences The Effect of Chitosan in the management of non-alcoholic fatty liver disease The Effect of Chitosan Functional Fiber on Metabolic Indicators and Hepatic Steatosis Predictors in Individuals with Non-alcoholic Fatty Liver Disease 2023-05-22 anticipated 72 Complete https://irct.ir/trial/68615 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation will be done using the block randomization method (blocks of two with a 1:1 ratio). In this way, before conducting the study, blocks of two will be prepared by a person familiar with the block randomization method. Then one of the blocks is selected to determine the group assigned to the first two participants, and the second block should be assigned to the third and fourth participants. Selecting blocks will be done using a coin toss. This method will be used to randomly determine the allocation group of participants until the end of the desired sample size, Blinding description: In this study, the groups' names will be replaced by the letters A and B by the person who made the random allocation sequence, and the allocated group for each participant will be placed in sealed opaque envelopes. The envelopes are numbered according to the sequence and the envelopes will not be opened until the initiation of the study. In this way, the research team including researchers, clinical evaluators, statisticians, and participants will be blinded to the assigned group. Also, the supplement and placebo will be the same in terms of shape, color, and smell, and will be placed in packages with a similar appearance. Chitosan and placebo packages are also named by the same person, with the same letters as groups (A or B). In this way, the participant and the research team will be blinded with regard to receiving the supplement or placebo. 3 Non-alcoholic Fatty Liver. Intervention 1: Intervention group: Daily intake of 1.5 grams of chitosan functional powder (Karen Co., Iran) for 8 weeks in the form of capsules along with a low-calorie diet (500 kcal reduction). Intervention 2: Control group: Daily intake of placebo (Karen Co., Iran) for 8 weeks in the form of capsules along with a low-calorie diet (500 kcal reduction). 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 Maryam Taghdir
Baqiatallah University, South Sheikh Baha'i st., Molasadra st., Vanak sq.,
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8248 3511 mtaghdir@bmsu.ac.ir 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 8248 3511 mtaghdir@bmsu.ac.ir Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Adults (aged over 18 years old) with grade 1 to 3 non-alcoholic fatty liver disease Not abusing alcohol (more than 10 grams for women and 20 grams for men per day) Not having viral hepatitis, liver cancer, or other cancers Not suffering from diabetes or untreated thyroid problems Not suffering from mental disorders No history of kidney disease Willingness to cooperate 18 years 65 years Both Taking nutritional supplements and fiber containing supplements in the 3 months before the study History of allergy to chitosan supplements, shellfish or shrimp Pregnancy Being in breastfeeding period K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Other Placebo Intervention group: Daily intake of 1.5 grams of chitosan functional powder (Karen Co., Iran) for 8 weeks in the form of capsules along with a low-calorie diet (500 kcal reduction) Control group: Daily intake of placebo (Karen Co., Iran) for 8 weeks in the form of capsules along with a low-calorie diet (500 kcal reduction) Aspartate aminotransferase (AST). Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Enzyme-linked immuno_sorbent assay (ELISA). Weight. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Scale. Waist circumference. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Tape measure. Body mass index (BMI). Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Standard formula. Fasting blood sugar (FBS). Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Standard enzymatic method. Total cholesterol. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Standard enzymatic method. High density lipoprotein (HDL). Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Standard enzymatic method. Low density lipoprotein (LDL). Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Standard enzymatic method. Triglycerides (TG). Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Standard enzymatic method. Gamma-glutamyl transferase (GGT). Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Enzyme-linked immuno_sorbent assay (ELISA). Fatty liver index (FLI). Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Standard formula. Hepatic steatosis index (HSI). Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Standard formula. Triglyceride-glucose index (TyG). Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Standard formula. Alanine transaminase (ALT). Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Enzyme-linked immuno_sorbent assay (ELISA). Bagheiat-allah University of Medical Sciences Approved 2023-02-06 Ethics Committee of Baqiyatallah Hospital Baqiatallah University, South Sheikh Baha'i st., Molasadra st., Vanak sq., Tehran Tehran Iran (Islamic Republic of)