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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20140502017522N4

Enrollment

Registered

2023-03-23

Start date

2023-05-22

Completion date

Unknown

Last updated

2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-alcoholic Fatty Liver. Fatty (change of) liver, not elsewhere classified

Interventions

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). In

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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).	—

Secondary

Measure	Time frame
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). Tim	—

Measure

Time frame

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). Tim

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Taghdir

Bagheiat-allah University of Medical Sciences

mtaghdir@bmsu.ac.ir+98 21 8248 3511

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 5, 2026