Non-alcoholic fatty liver disease. Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Intervention 1: Intervention group: daily 2 capsules including 125 mg oleoylethanolamide. Intervention 2: Control group: daily 2 capsules including 125 mg placebo.
Sponsors
Vice chancellor for research , Tabriz University of Medical Sciences, Nutrition Research Center
Eligibility
Sex/Gender
All
Age
20 Years to 50 Years
Inclusion criteria
Inclusion criteria: Ages between 20 to 50 years body mass index (BMI) 30 to 40 kg/m2 Diagnosis of non-alcoholic fatty liver disease by a liver specialist based on ultrasound
Exclusion criteria
Exclusion criteria: Regular use of nonsteroidal anti-inflammatory agents (NSAIDs) and antibiotics Use of hepatotoxic drugs such as phenytoin, amiodarone, levothyroxine, amoxifene, lithium Use of antihypertensive drugs Using weight loss and lipid-lowering drugs Use of probiotic and prebiotic supplements; vitamins; minerals; antioxidants; and omega 3 supplements in the last 3 months Smoking Pregnancy Breast-feeding Menopause Pathological conditions affecting the liver such as viral hepatitis, acute or chronic hepatic impairment, liver transplantation, acute systemic disease Gastrointestinal diseases Diabetes Heart failure Thyroid disorders Kidney Diseases Haemochromatosis Wilson's disease Alpha-1 antitrypsin deficiency Autoimmune diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum levels of hs-CRP. Timepoint: before intervention, and 3 months after intervention. Method of measurement: By laboratory ELISA kits.;Serum levels of IL-1ß. Timepoint: before intervention, and 3 months after intervention. Method of measurement: By laboratory ELISA kits.;Serum levels of TNF-a. Timepoint: before intervention, and 3 months after intervention. Method of measurement: By laboratory ELISA kits.;Levels of total antioxidant capacity (TAC). Timepoint: before intervention, and 3 months after intervention. Method of measurement: By colorimetric method using Randox total antioxidant status kit.;Levels of glutathione peroxidase (GSH-Px). Timepoint: before intervention, and 3 months after intervention. Method of measurement: By spectrophotometric method using Ransel and Ransod kits.;Levels of superoxide dismutase (SOD). Timepoint: before intervention, and 3 months after intervention. Method of measurement: By spectrophotometric method using Ransel and Ransod kits.;Level of malondialdehyde (MDA). Timepoint: before intervention, and 3 months after intervention. Method of measurement: By the spectrophotometric thiobarbituric acid reactive substances (TBARS) method.;Levels of catalase activity. Timepoint: before intervention, and 3 months after intervention. Method of measurement: By Aebi's method.;Serum levels of oxidized-low density lipoprotein (ox-LDL). Timepoint: before intervention, and 3 months after intervention. Method of measurement: By laboratory ELISA kits.;Gene expression of IL-6. Timepoint: before intervention, and 3 months after intervention. Method of measurement: Real time-PCR.;Gene expression of IL-10. Timepoint: before intervention, and 3 months after intervention. Method of measurement: Real time- PCR.;Serum levels of IL-6. Timepoint: before intervention, and 3 months after intervention. Method of measurement: By laboratory ELISA kits.;Serum levels of IL-10. Timepoint: Before intervention, and 3months after intervention. Method of measurement: | — |
Secondary
| Measure | Time frame |
|---|---|
| Body composition. Timepoint: Before intervention, and 3 months after intervention. Method of measurement: Measurement of body composition, including fat mass, fat free mass and total body water determination using bioelectrical impedance analyser (BIA). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHelda Tutunchi
Nutrition Faculty, Tabriz University of Medical Sciences
Outcome results
None listed