Non-alcoholic fatty liver disease. Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Intervention 1: Intervention group: Receiving a 3-month diet plan based on the personal energy requirement calculated according to the Mifflin formula and in the form of a combination of the 16:8 tim
And the lacto-ovo-vegetarian diet, in which the consumption of red meat, poultry, fish, and other products containing this group of foods is not allowed in this diet. Intervention 2: Control group: Re
Sponsors
Vice chancellor for research, Shahid Beheshti University of Medical sciences- School of Nutrition
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age over 18 years Body mass index higher than 24.9 (BMI=25) Having evidence of steatohepatitis and non-alcoholic fatty liver based on the confirmation of the attending physician and the patient's laboratory and ultrasound results Not having a history of alcohol consumption or alcohol consumption less than 10 grams per day in women and less than 20 grams per day in men Willingness to participate in the study and ability to complete the study process
Exclusion criteria
Exclusion criteria: Having other chronic and acute liver diseases and disorders (hepatitis B, C, etc.), biliary disease, kidney diseases, endocrine disorders, confirmed autoimmune diseases, cancer and hereditary disorders affecting the liver (iron and copper storage disease) Having uncontrolled cardiovascular diseases, chronic inflammatory disease, diabetes and celiac disease Alcoholism or drug abuse Pregnancy or Lactation in women Consumption of hepatotoxic drugs such as phenytoin, amoxifen and lithium Consumption of fiber, omega-3 and antioxidant supplements during the last 3 months Consumption of weight loss drugs or supplements Following special weight loss diets during the last 3 months Losing more than 10% of body weight during the last 6 months Failure to accept study conditions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight. Timepoint: At the beginning and 3 months after the start of the study. Method of measurement: Scale.;Fibrosis index (FIB-4). Timepoint: At the beginning and 3 months after the start of the study. Method of measurement: Calculation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Body Mass Index (BMI). Timepoint: At the beginning and 3 months after the start of the study. Method of measurement: Calculation.;Fat Mass. Timepoint: At the beginning and 3 months after the start of the study. Method of measurement: Bio Impedance Analyzer.;Fat Free Mass. Timepoint: At the beginning and 3 months after the start of the study. Method of measurement: Bio Impedance Analyzer.;Fatty Liver Index (FLI). Timepoint: At the beginning and 3 months after the start of the study. Method of measurement: Calculation.;BARD score. Timepoint: At the beginning and 3 months after the start of the study. Method of measurement: Calculation.;AST to Platelet Ratio Index (APRI). Timepoint: At the beginning and 3 months after the start of the study. Method of measurement: Calculation.;Serum lipid profile (total cholesterol, triglyceride, HDL-C, LDL-C). Timepoint: At the beginning and 3 months after the start of the study. Method of measurement: Blood sample.;Liver enzymes (alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase). Timepoint: At the beginning and 3 months after the start of the study. Method of measurement: Blood sample.;Serum Insulin and Fasting Blood Sugar (FBS). Timepoint: At the beginning and 3 months after the start of the study. Method of measurement: Blood sample.;Insulin sensitivity index (QUICKI) and Insulin resistance index (HOMA-IR). Timepoint: At the beginning and 3 months after the start of the study. Method of measurement: Calculation.;Tumor necrosis factor alpha (TNF-a). Timepoint: At the beginning and 3 months after the start of the study. Method of measurement: Blood sample.;High-sensitivity C-reactive protein (hs-CRP). Timepoint: At the beginning and 3 months after the start of the study. Method of measurement: Blood sample. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMahshad Shafiee
Shahid Beheshti University of Medical Sciences
Outcome results
None listed