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IRCT20131125015536N12 IRCT 2020-08-06 Tehran University of Medical Sciences Effects of Naringenin Supplement on Non-alcoholic Fatty Liver Disease Effects of Naringenin on Aminotransferase Level, Insulin Resistance, Cardiovascular Risk Factors, and Adiponectin and Neuregulin-4 levels in Overweight or Obese Patients with Non-alcoholic Fatty Liver Disease: A Randomized Controlled trial 2020-10-10 anticipated 44 Complete https://irct.ir/trial/49713 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In order to randomize the study groups, we will use the Stratified Permuted Block Randomization method. First, patients are stratified in terms of gender randomization, and since there will be different confounding factors in this study, a score for each individual in terms of disease risk is determined based on these confounding factors (BMI in the range of 29.9-25 = 0 and BMI in the range of ٔ30-35=1, age in the range of 20-43 years = 0 and age in the range of 43-65 years = 1, degree of mild fatty liver disease = 0 and degree of moderate and severe fatty liver disease = 1). The sum of these scores will be at least 0 and at most 3. According to these, people who get a score of zero and one are considered as low risk and the people who get a score of two and three are considered as high risk. After that, they will be randomized separately. Block sizes: 4 4 2 6 2, Blinding description: Double-blind study (participants and researcher blinding) through naringenin and placebo supplement packaging in one shape and naming with A and B letters. The mentioned process has done by a third person, so that the researcher and the patients are not aware of the type of intervention. 3 Non-alcoholic fatty liver disease. Intervention 1: Intervention group: Naringenin supplement (provided by Exir Nano Sina Co.) should consume before dinner and lunch at the dosages of 200 mg/day that divided into two 100 mg capsule per day for 4 weeks (method of naringenin extraction is alcoholic). Intervention 2: Control group: placebo (cellulose) should consume before dinner and lunch at the dosages of 200 mg/day that divided into two 100 mg capsule (provided by Exir Nano Sina Co.) per day for 4 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Mohammad Javad Hosseinzadeh Attar
Hojjatdoost St. Naderi Ave- Keshavar Blv- Tehran
Tehran Iran (Islamic Republic of) 1416643931 +98 21 8899 3059 mhosseinzadeh@tums.ac.ir Tehran University of Medical Sciences scientific Mohammad Javad Hosseinzadeh Attar
Hojjatdost st, Naderi st, Keshavarz blvd
Tehran Iran (Islamic Republic of) 1416643931 +98 21 8899 3059 mhosseinzadeh@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) 20 to 65 years old men and women Range of body mass index (BMI) should be between 25 to 35 Kg/m2 Diagnosis of Non-alcoholic fatty liver disease based on sonography by specialist Informed consent for participating in the study 20 years 65 years Both Regular consumption of Non-steroidal anti-inflammatory drugs (NSAIDs), antibiotics, corticosteroids, anti-hypertensive agents, lipid-lowering agents and weight-lowering agents in the period of last 3 months Regular consumption of multivitamin-minerals, antioxidants, omega3 supplement at the dosages of more than daily needs and also consumption of probiotic supplements and herbal drinks such as silymarine in the priod of last 3 months Diagnosis of pathological conditions affecting the liver such as viral hepatitis and liver transplantation Past medical history of diabetes, gastrointestinal tract disorders, organs failure, thyroid disorders, kidney diseases, autoimmune diseases, severe mental diseases and several types of malignancies Past medical history of cardiovascular accidents in the period of last 3 months Pregnancy, intention to be pregnant in the next 3 months, breastfeeding and menopause status Being addict, consumption of alcoholic drinks Professional exercise K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Other Placebo Intervention group: Naringenin supplement (provided by Exir Nano Sina Co.) should consume before dinner and lunch at the dosages of 200 mg/day that divided into two 100 mg capsule per day for 4 weeks (method of naringenin extraction is alcoholic) Control group: placebo (cellulose) should consume before dinner and lunch at the dosages of 200 mg/day that divided into two 100 mg capsule (provided by Exir Nano Sina Co.) per day for 4 weeks Serum aminoteransferase levels. Timepoint: Before and after the intervention (on the day of 0 and at the end of the next 4 weeks). Method of measurement: Blood levels through special kit. Insulin resistance index. Timepoint: Before and after the intervention (on the day of 0 and at the end of the next 4 weeks). Method of measurement: Formula. Hs-CRP. Timepoint: Before and after the intervention (on the day of 0 and at the end of the next 4 weeks). Method of measurement: Blood levels through special kit. Adiponectin. Timepoint: Before and after the intervention (on the day of 0 and at the end of the next 4 weeks). Method of measurement: Blood levels through special kit. Neuregulin-4. Timepoint: Before and after intervention (on the day of 0 and at the end of the next 4 weeks). Method of measurement: Blood levels through special kit. Blood pressure. Timepoint: Before and after the intervention (on the day of 0 and at the end of the next 4 weeks). Method of measurement: pressure indicator. Body mass index. Timepoint: Before and after the intervention (on the day of 0 and at the end of the next 4 weeks). Method of measurement: calculating according to related formula. Weight. Timepoint: Before and after the intervention (on the day of 0 and at the end of the next 4 weeks). Method of measurement: Digital scale. Height. Timepoint: Before and after the intervention (on the day of 0 and at the end of the next 4 weeks). Method of measurement: Standard tape meter. Physical activity score. Timepoint: every two weeks ( on the day 0, 14, 28). Method of measurement: international physical activity questionnaire: short. Lipid profile. Timepoint: Before and after the intervention (on the day of 0 and at the end of the next 4 weeks). Method of measurement: Blood levels through special kit. Tehran University of Medical Sciences Approved 2020-05-06 Ethics committee of Tehran University of Medical Science Sixth floor, central Building of Tehran University of Medical Science, Ghods street, Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)