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IRCT20110530006652N2 IRCT 2019-02-07 Tabriz University of Medical Sciences Evaluation of Oleoylethanolamide supplementation in the prevention and treatment of non-alcoholic fatty liver disease The effect of Oleoylethanolamide supplementation on peroxisome proliferator-activated receptor alpha gene expression, pyroptosis pathway genes (TLR4, TRIF, MYD88, NLRP3, Caspase 1, Caspase 8, IL1β and IL18), lipopolysaccharide binding protein, metabolic parameters, and anthropometric indices in obese patients with non-alcoholic fatty liver disease 2019-04-09 anticipated 74 Complete https://irct.ir/trial/37228 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Among volunteers to participate in the study, 74 individuals will be selected by simple randomization. Then the subjects will be allocated into either intervention or placebo group by the Random Allocation Software, based on their gender and grade of fatty liver, Blinding description: In this study, the main investigator, the patients and the data analyst will be blinded to the supplement type (Oleoylethanolamide or placebo). 3 Non-alcoholic fatty liver disease. Intervention 1: Intervention group: Patients in this group will receive a weight-loss diet (500 Kcal less than current intake) and Oleylethanolamide supplements (125 mg) for 12 weeks. The Oleylethanolamide supplements are made in Islamic Republic of Iran and will be consumed twice (before lunch and dinner) daily . Intervention 2: Control group: Patients in this group will receive a weight-loss diet (500 Kcal less than current intake) with placebo for 12 weeks. The placebo is starch (125 mg) and will be consumed twice daily before lunch and dinner. Yes - There is a plan to make this available What will be shared: Publication of Results When: After finishing and publishing the project article To whom: University researchers Conditions: With permission from the project researcher and the supporting organization (Nutrition Research Center and the Deputy of Research) Where to obtain: Dr. Maryam Saghafi-Asl - School of Nutrition and Food Sciences, Tabriz University of Medical Sciences - Email: Saghafiaslm@gmail.com How to obtain: The recipient can send a request to the study corresponding person via email Comments:
public Helda Tutunchi
School of Nutrition and Food Sciences, Golgasht Street
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 7580 helda.nutrition@gmail.com Tabriz University of Medical Sciences scientific Dr. Maryam Saghafi-Asl
School of Nutrition and Food Sciences, Golgasht Street
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 7580 saghafiaslm@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Age between 20 to 50 years old Body mass index (BMI) of 30 to 40 Kg/m2 Diagnosis of non-alcoholic fatty liver disease by a radiologist based on ultrasonography 20 years 50 years Both Regular use of non-steroidal anti-inflammatory drugs (NSAIDs), antibiotics and corticosteroids Use of hormonal drugs, hepatotoxic drugs (such as Phenytoin, Amiodarone, Levothyroxine, Tamoxifene and Lithium), anti-hypertensive drugs, weight loss and lipid lowering drugs Use of prebiotic and probiotic supplements, vitamins, minerals, antioxidants, and omega 3 supplements Diagnosed pathological conditions affecting the liver such as liver transplantation, acute or chronic hepatic impairment, viral hepatitis, cystic fibrosis, Haemochromatosis, Wilson's disease, Alpha-1 antitrypsin deficiency, and acute systemic disease Diagnosed thyroid disorders Diagnosed kidney diseases Diagnosed gastrointestinal diseases (e.g. Celiac disease) Diagnosed diabetes Diagnosed heart failure Diagnosed autoimmune diseases Diagnosed malignancies Diagnosed severe psychological disorders Pregnancy and lactation K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Drugs Placebo Intervention group: Patients in this group will receive a weight-loss diet (500 Kcal less than current intake) and Oleylethanolamide supplements (125 mg) for 12 weeks. The Oleylethanolamide supplements are made in Islamic Republic of Iran and will be consumed twice (before lunch and dinner) daily . Control group: Patients in this group will receive a weight-loss diet (500 Kcal less than current intake) with placebo for 12 weeks. The placebo is starch (125 mg) and will be consumed twice daily before lunch and dinner. Gene expression of PPAR-α. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Real time-PCR. Serum levels of triglyceride. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: enzymatic kit. Serum levels of total cholesterol. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: enzymatic kit. Serum levels of High-Density Lipoprotein cholesterol (HDL-c). Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: enzymatic kit. Serum levels of Low-Density Lipoprotein cholesterol (LDL-c). Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: enzymatic kit. Fasting blood glucose levels. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: enzymatic kit. Fasting insulin levels. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kit. Gene expression of TLR4. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Real-time PCR. Gene expression of NLRP3. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Real-time PCR. Gene expression of Caspase1. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Real-time PCR. Gene expression of IL18. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Real-time PCR. Serum level of LBP. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kit. Gene expression of MYD88. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Real-time PCR. Gene expression of TRIF. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Real-time PCR. Gene expression of Caspase 8. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Real-time PCR. Gene expression of IL1- β. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Real-time PCR. Serum levels of alanine transaminase (ALT). Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: enzymatic kit. Serum levels of aspartate aminotransferase (AST). Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: enzymatic kit. Severity of liver steatosis. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Ultrasonography. Liver fibrosis score. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Non-alcoholic fatty liver disease (NAFLD) fibrosis score formula. Dietary assessment. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Dietary recall. Appetite assessment. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Visual analog scales (VAS). Anthropometric incidies. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Waist circumference by a non-stretching measuring tape - BMI by dividing weight (kg) to height square (m2) - WHR by waist circumference/hip circumference. Physical activity. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: The International Physical Activity Questionnaires (IPAQ). Tabriz University of Medical Sciences Approved 2018-11-19 Ethics Committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences, Golghasht Street Tabriz East Azarbaijan Iran (Islamic Republic of) Approved 2020-01-21 Ethics Committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences, Golghasht Street Tabriz East Azarbaijan Iran (Islamic Republic of) Approved 2020-02-04 Ethics Committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences, Golghasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)