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IRCT20180412039284N1 IRCT 2018-05-09 Ahvaz University of Medical Sciences 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) 2018-06-21 anticipated 50 Complete https://irct.ir/trial/30682 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, individuals who have the characteristics necessary to enter the study are usually taken from a non-random sample using a simple sampling method. Then, randomization is done between study groups. In this study, a block randomization method (including 4 locks) is used. One of the study partners who has not been blindfolded, named chitosan and placebo with the letters A and B (for example). Then, the researcher distributed A and B packages among patients referring to Golestan Hospital in a randomized block method (ABAB, BABA, AABB, BBAA, ABBA, BAAB; A, first person; B, Second person; A, third person; B,fourth person B etc.). Then, selecting the blocks are continued until reaching the sample size, Blinding description: One of the study partners who has not been blindfolded, named chitosan and placebo with the letters A and B (for example). Then, the researcher distributed A and B packages among patients referring to Golestan Hospital in a randomized block method (ABAB, BABA, AABB, BBAA, ABBA, BAAB; A, first person; B, Second person; A, third person; B,fourth person B etc.). N/A Nonalcoholic fatty liver. Intervention 1: Intervention group: 1000 miligram of chitosan supplement (chitosan dose:500 miligram; twice a day). Intervention 2: control group: 1000 miligram placebo. 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 No reason
public Hedieh Rahmani
Ahvaz Jundishapur university of medical sciences, Golestan Ave, Ahvaz, Khuzestan
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 61 3373 8317 rahmani.he@ajums.ac.ir Ahvaz University of Medical Sciences scientific Dr. Bizhan Helli
Ahvaz Jundishapur university of medical sciences, Golestan Ave, Ahvaz, Khuzestan
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 61 3373 8317 bizahnhelli@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) 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 18 years 65 years Both 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 K76.0 Nonalcoholic fatty liver disease [NAFLD] Lifestyle Lifestyle Intervention group: 1000 miligram of chitosan supplement (chitosan dose:500 miligram; twice a day) control group: 1000 miligram placebo 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. 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. Ahvaz University of Medical Sciences Approved 2018-03-02 Ahvaz Jundishapur university of medical sciences Ahvaz Jundishapur university of medical sciences, Ahvaz, Khuzestan, Iran Ahvaz Khouzestan Iran (Islamic Republic of)