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

The effect of chitosan supplementation on changes of body weight, glycemic risk factors (fasting glucose, insulin, glycated hemoglobin), lipid profile and visceral adiposity index in patients with nonalcoholic fatty liver disease (NAFLD)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180412039284N1

Enrollment

Registered

2018-05-09

Start date

2018-06-21

Completion date

Unknown

Last updated

2018-06-18

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

Conditions

Nonalcoholic fatty liver. Nonalcoholic fatty liver disease [NAFLD]

Interventions

Intervention 1: Intervention group: 1000 miligram of chitosan supplement (chitosan dose:500 miligram

twice a day). Intervention 2: control group: 1000 miligram placebo.

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Individuals of both genders (males and females) will be selected to participate in the study, aged between 18 and 65 years old that their fatty liver diagnosed by ultrasound testing No allergies to seafood

Exclusion criteria

Exclusion criteria: Hepatitis, liver cirrhosis, Wilson's disease, acute fatty liver, pregnancy, hepatocellular carcinoma, hypothyroidism and chronic liver disease Lipodystrophy Menopause Parenteral nutrition Diseases that involve bile ducts and bile ducts Severe weight loss (more than 10% of body weight) during last 6 months and weight loss surgery Congenital metabolic diseases Consumption of Herbal Supplements in the last three months Taking drugs that cause fatty liver and liver toxicity (amiodarone, antivirals, spirin, non-steroidal anti-inflammatory drugs, corticosteroids, methotrexate, tamoxifen, tetracycline, valproic acid Pregnancy and lactation Consumption of Omega 3 and Vitamin E and other antioxidant supplements over the past 6 months History of cardiovascular disease and kidney disease BMI between 25 and 40 Unwillingness to participate Energy consumption less than 800 or more than 4200kcal/day

Design outcomes

Primary

Measure	Time 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.;LDL. Timepoint: Before the intervention and twelve weeks after. Method of measurement: enzymatic method.;HDL. 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 mehod.	—

Measure

Time 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.;LDL. Timepoint: Before the intervention and twelve weeks after. Method of measurement: enzymatic method.;HDL. 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 mehod.

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Secondary

Measure	Time frame
Weight. Timepoint: before the intervention and 12 weeks after. Method of measurement: scale (seca).;BMI. Timepoint: before the intervention and 12 weeks after. Method of measurement: weight (kg) divided to height square.;Visceral adiposity index. Timepoint: before the intervention and 12 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 12 weeks after. Method of measurement: enzymatic method.;Alanine aminotransferase (ALT). Timepoint: before the intervention and 12 weeks after. Method of measurement: enzymatic method.;Model-insulin resistance index (HOMA-IR). Timepoint: before the intervention and 12 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 12 weeks after. Method of measurement: BIA.	—

Measure

Time frame

Weight. Timepoint: before the intervention and 12 weeks after. Method of measurement: scale (seca).;BMI. Timepoint: before the intervention and 12 weeks after. Method of measurement: weight (kg) divided to height square.;Visceral adiposity index. Timepoint: before the intervention and 12 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 12 weeks after. Method of measurement: enzymatic method.;Alanine aminotransferase (ALT). Timepoint: before the intervention and 12 weeks after. Method of measurement: enzymatic method.;Model-insulin resistance index (HOMA-IR). Timepoint: before the intervention and 12 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 12 weeks after. Method of measurement: BIA.

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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