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The effect of chitosan supplementation in patients with nonalcoholic fatty liver disease

The effect of chitosan supplementation on changes of weight, glycemic risk factors, lipid profile, serum inflammatory factors, adipokines and total antioxidant capacity in patients with nonalcoholic fatty liver disease (NAFLD)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180412039284N2
Enrollment
50
Registered
2018-07-19
Start date
2018-09-22
Completion date
Unknown
Last updated
2018-09-11

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

Conditions

Nonalcoholic fatty liver. Fatty (change of) liver, not elsewhere classified

Interventions

Intervention 1: Intervention group: Consumption of chitosan (dose of supplements: 500 miligram) twice a day (one before lunch and one before dinner) for 12 weeks. Chitosan supplements are provided by

Sponsors

Ahvaz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Aged between 18-65 years (both genders) Diagnosis of nonalcoholic fatty liver disease by ultrasound Willingness to participate No allergies to seafood

Exclusion criteria

Exclusion criteria: Suffering from viral hepatitis, liver cirrhosis, Wilson's disease, acute fatty liver, hepatocellular carcinoma, hypothyroidism, lipodystrophy, diseases that involves bile ducts History of chronic liver disease History of significant weight loss (more than 10% of body weight during 6 months ago) or weight loss surgery History of antioxidant supplementation, omega 3 and milk thistle during 6 months ago History of liver damaging drugs History of cardiovascular History of renal disease Alcohol consumption more than 20 gram per day Pregnancy Lactation Menopause Energy consumption less than 800 or more than 4200 kilocalorie per day

Design outcomes

Primary

MeasureTime frame
Glycated hemoglobin A1c. Timepoint: Before the intervention and twelve weeks after. Method of measurement: Spectrophotometry.;Fasting blood glucose. Timepoint: Before the intervention and twelve weeks after. Method of measurement: Enzymatic method.;Plasma insulin. Timepoint: Before the intervention and twelve weeks after. Method of measurement: Calorimetry.;Serum adiponectin. Timepoint: Before the intervention and twelve weeks after. Method of measurement: ELISA.;Serum leptin. Timepoint: Before the intervention and twelve weeks after. Method of measurement: ELISA.;Interleukin-6. Timepoint: Before the intervention and twelve weeks after. Method of measurement: ELISA.;TNF-alpha. Timepoint: Before the intervention and twelve weeks after. Method of measurement: ELISA.;Serum total antioxidant capacity (TAC). Timepoint: Before the intervention and twelve weeks after. Method of measurement: ELISA.;High Density Lipoprotein (HDL). Timepoint: Before the intervention and twelve weeks after. Method of measurement: Enzymatic method.;Low Density Lipoprotein (LDL). Timepoint: Before the intervention and twelve weeks after. Method of measurement: Enzymatic method.;Total cholesterol. Timepoint: Before the intervention and twelve weeks after. Method of measurement: Enzymatic method.;Triglyceride. Timepoint: Before the intervention and twelve weeks after. Method of measurement: Enzymatic method.

Secondary

MeasureTime frame
Weight. Timepoint: Before the intervention and twelve weeks after. Method of measurement: Scale (seca).;Body Mass Index (BMI). Timepoint: Before the intervention and twelve weeks after. Method of measurement: Weight (kg) divided to height square.;Visceral Adiposity Index. Timepoint: Before the intervention and twelve weeks after. Method of measurement: Formula based on these variables: BMI, waist circumference, HDL-C and triglyceride (TG).;Aspartate aminotransferase (AST). Timepoint: Before the intervention and twelve weeks after. Method of measurement: Enzymatic method.;Alanine aminotransferase (ALT). Timepoint: Before the intervention and twelve weeks after. Method of measurement: Enzymatic method.;Model-insulin resistance index (HOMA-IR). Timepoint: Before the intervention and twelve weeks after. Method of measurement: HOMA= fasting serum insulin (µU/ml)× fasting plasma glucose (mM/L)/22.5.;Body fat percentage. Timepoint: Before the intervention and twelve weeks after. Method of measurement: Bioelectrical Impedance Analysis (BIA).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHedieh Rahmani

Ahvaz University of Medical Sciences

rahmani.he@ajums.ac.ir+98 61 3373 8317

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026