Non-alcoholic fatty liver disease. Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
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 Oleylethanol
Sponsors
Tabriz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
20 Years to 50 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gene expression of PPAR-a. 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 int | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHelda Tutunchi
Tabriz University of Medical Sciences
Outcome results
None listed