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IRCT20180412039284N2 IRCT 2018-07-19 Ahvaz University of Medical Sciences 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) 2018-09-22 anticipated 50 Complete https://irct.ir/trial/31974 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, a nonrandom sample is chosen among the individuals ,who has the inclusion criteria, using a simple sampling method. Then, the randomization is performed between study groups. One of the hospital nurses ,who has not been blinded in the study, will change the names of chitosan and placebo on their packages to A and B (for example). Then, the researcher will distribute A and B packages among patients, who are referring to Golestan Hospital, using a randomized block method (ABAB, BABA, AABB, BBAA, ABBA, BAAB; A, first person; B, Second person; A, third person; B,fourth person B etc.). Finally, choosing the blocks will be continued until reaching the sample size, Blinding description: Study participants, the main researcher, the specialist, the person who collects the data and analyzes the outcomes are blinded. Supplement and placebo are the same in shape and color, so study participants will not be aware of supplements’ content. One of the nurses in hospital will change the names of chitosan and placebo on their packages to A and B, so the main researcher will not be aware of supplements’ content that are given to the patients. The specialist, the person who collects the data (the main researcher) and analyzes the outcomes (the main researcher) will not be aware of supplements’ content. N/A Nonalcoholic fatty liver. 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 Karen company. Intervention 2: Control group: Consumption of placebo (dose of placebo: 500 miligram) twice a day (one before lunch and one before dinner) for 12 weeks. Placebo is provided by Karen company. 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 Since the functional phase of this study has not started yet, there are no decisions for these information.
public Hedieh Rahmani
Ahvaz Jundishapur University Of Medical Sciences, Golestan Ave, Ahvaz, Khuzestan, Iran
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 bizhanhelli@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Aged between 18-65 years (both genders) Diagnosis of nonalcoholic fatty liver disease by ultrasound Willingness to participate No allergies to seafood 18 years 65 years Both 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 K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Drugs Placebo 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 Karen company Control group: Consumption of placebo (dose of placebo: 500 miligram) twice a day (one before lunch and one before dinner) for 12 weeks. Placebo is provided by Karen company 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. 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). Ahvaz University of Medical Sciences Approved 2018-05-12 Ahvaz Jundishapur University Of Medical Sciences Ahvaz Jundishapur University Of Medical Sciences, Golestan Ave, Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)