Nonalcoholic fatty liver disease. Nonalcoholic steatohepatitis (NASH)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: General desire to participate in the study Age 50-30 years - Has evidence of non-alcoholic steatohepatitis and CAP score more than 263 Body mass index (BMI) = 25kg / m2 No history of alcohol consumption Lack of other diseases and chronic and acute liver disorders (hepatitis B, C, etc.), biliary disease, known autoimmune diseases and hereditary disorders affecting the condition of the liver (iron, copper and ... ) No pregnancy or breastfeeding in women Do not take hepatotoxic drugs such as phenytoin, amoxifen and lithium Do not take antibiotics for more than a week during or before the study period Do not consume Milk thistle(Silybum marianum) Lack of chronic inflammatory disease No history of cancer Lack of treatment with anti-inflammatory drugs Lack of recent weight loss diet Blood pressure less than 90/160 mmHg No kidney disease (GFR greater than 60 or creatinine between 7-1.4) No weight loss of more than 8% in the last 6 months Do not use weight loss drugs (chemical drugs and effective herbal products)
Exclusion criteria
Exclusion criteria: Changes in medications (lipid-lowering drugs, blood sugar control drugs, and blood pressure medications) during the study period Lack of adherence to the diet given to patients Take supplements or substances that change the individual effect of the diet during the intervention.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hepatic steatosis, Liver fibrosis. Timepoint: At the first and at the 12th week of the study. Method of measurement: fibroscan. | — |
Secondary
| Measure | Time frame |
|---|---|
| Weight. Timepoint: At the first and 12th week of the study. Method of measurement: Scale.;BMI. Timepoint: At the first and 12th week of the study. Method of measurement: Calculate.;Waist to hip ratio. Timepoint: At the first and 12th week of the study. Method of measurement: Calculate.;Liver enzymes (AST,ALT,GGT). Timepoint: At the first and 12th week of the study. Method of measurement: Enzymatic method.;Lipid profile (TG,Total cholesterol,LDL-C,HDL-C). Timepoint: At the first and 12th week of the study. Method of measurement: Enzymatic method.;FBS. Timepoint: At the first and 12th week of the study. Method of measurement: Enzymatic method.;Insulin. Timepoint: At the first and 12th week of the study. Method of measurement: Radioimmunoassay.;Hs-CRP. Timepoint: At the first and 12th week of the study. Method of measurement: ELISA.;CK-18. Timepoint: At the first and 12th week of the study. Method of measurement: ELISA.;HOMA-IR. Timepoint: At the first and 12th week of the study. Method of measurement: Calculate.;TAC. Timepoint: At the first and 12th week of the study. Method of measurement: ELISA. | — |
Countries
Iran (Islamic Republic of)
Contacts
Shahid Beheshti University of Medical Sciences