Non alcoholic fatty liver disease (NAFLD). Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Intervention 1: Intervention group 1 : 1200 mg N-acetylcysteine (two tablets) daily + healthy diet. Intervention 2: Intervention group 2 : Low acid load diet + two starch tablets daily. Intervention 3
Sponsors
Shiraz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Literate individuals diagnosed with NAFLD, exhibiting moderate to severe steatosis based on gastroenterology and liver specialist evaluations, with a CAP score of =260 dB/m obtained from a fibroscan Absence of pregnancy, breastfeeding, other liver diseases, hepatic encephalopathy, malignancies, diabetes mellitus, kidney disorders and mental health issues Fibroscan should have been conducted within the last three weeks Participants must have a body mass index between 25 and 35 (25=BMI=35) and a liver stiffness measurement (LSM) of =9.4 kPa Individuals who drink little or no alcohol (defined as < 20 g/d for women and < 30 g/d for men) No history of hormonal medication or weight-affecting drugs within the past three months, nor previous bariatric surgery or current antioxidant supplementation Individuals on fixed treatments for dyslipidemia or hypertension, with no history of infection, surgery, trauma, or hospitalization in the last two weeks
Exclusion criteria
Exclusion criteria: Individuals who become pregnant during the study or fail to return for follow-up assessments Participants demonstrating less than 70% adherence to diet or less than 80% adherence to supplement intake Occurrence of gastrointestinal side effects related to supplement use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Levels of liver enzymes (AST , ALT). Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Using a special kit and an autoanalyzer device.;Serum glutathione. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Using a special kit and an autoanalyzer device. | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting blood sugar. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Using a special kit and an autoanalyzer device.;Fasting insulin. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Using ELIZA kits and a ELIZA reader device.;Lipid profile (HDL, LDL, Total cholesterol, Triglycerides). Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Using a special kit and an autoanalyzer device.;Liver stiffness measurement (LSM). Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Vibration-controlled transient elastography (fibroscan).;Insulin resistance indices (HOMA-IR & QUICKI). Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Using special formulas containing fasting blood sugar and insulin.;Blood pressure. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Using a sphygmomanometer.;Anthropometric indices. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Using meter, body analyzer device and special formulas.;Controlled attenuation parameter (CAP) score. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Vibration-controlled transient elastography (fibroscan). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactShiraz University of Medical Sciences
Shiraz University of Medical Sciences
Outcome results
None listed