The Effect of Chitosan Functional Fiber on Metabolic Indicators and Hepatic Steatosis Predictors in Individuals with Non-alcoholic Fatty Liver Disease

Determining the effect of chitosan functional fiber on metabolic indicators and hepatic steatosis predictors in individuals with NAFLD.

This study is a phase 3 double-blind, randomized, controlled clinical trial with two parallel groups (intervention and control). 36 eligible individuals will be randomly assigned to each group by means of the block randomization method (72 participants in total).

72 eligible individuals referred to Moslemin hospital (Shiraz), after signing an informed consent form, were randomly assigned to 2 study groups. Along with the low-calorie diet, the participants received chitosan supplements or a placebo, named the same as the groups' names (A and B) for blinding the participant and the research team, with water daily for 8 weeks, daily. Anthropometrics, liver enzymes, fasting blood sugar, lipid profile, liver steatosis indicators, dietary intake, and physical activity will be assessed before and after the study.

Inclusion criteria: adult (>18 years old) with grade 1 to 3 of NAFLD, with no history of shellfish or shrimp allergy, alcohol abuse (more than 10 grams for women and 20 grams for men per day), viral hepatitis, liver cancer or other cancers, diabetes, untreated thyroid problems, mental or kidney disorders, and nutritional supplements consumption in the 3 months before the study, pregnancy or breastfeeding at the initiation of the study; Exclusion conditions: drinking alcohol, beginning pregnancy, taking fiber containing supplements, and showing signs of allergy to supplements،

The participants will consume chitosan capsules (1.5 gr, Karen Co., Iran) in the intervention group or placebo (control group) for 8 weeks, daily. Also, all the participants will be given a low-calorie diet (with a reduction of 500 kcal).

Aspartate transaminase

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.

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.