Nonalcoholic fatty liver disease (NAFLD). Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Intervention 1: Intervention group: Pomegranate extract tablet 225 mg twice daily for 12 weeks. Intervention 2: Control group: Placebo twice daily for 12 weeks.
Sponsors
Ahvaz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Age:18 to 65 years old Body mass index 29.4 to 40 Presence of non-alcoholic steathepatitis in ultrasonography with degree of steatosis higher than grade 1 consent with collaboration in study Not taking any dietary supplements Not being on a special diet the liver enzyme serum level (Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST)) 1.5 times greater than the highest normal up to a 5 times more than the highest level of normal range non diabetes
Exclusion criteria
Exclusion criteria: People with a history of hepatitis including A, B and C; Other liver diseases including autoimmune liver disease, liver transplantation, liver metabolic disease, Wilson's disease gastrointestinal diseases cardiovascular diseases anemia kidney diseases endocrine disorders (such as hypothyroidism or hyperthyroidism, Cushing's) having a history of drinking more than 10 grams per day in women and more than 20 grams per day in men smoking Taking any medicine, insulin, hepatic steatosis drugs getting intravenous nutrition getting special diets and taking vitamin supplements in the last three months pregnancy or lactating menopause weight loss surgery during the last year Unwillingness to cooperate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alanine aminotransferase. Timepoint: before intervention and after 12 weeks. Method of measurement: seum level.;Aspartate transaminase. Timepoint: before intervention and after 12 weeks. Method of measurement: serum level.;Gamma glutamyl transferase. Timepoint: before intervention and after 12 weeks. Method of measurement: serum level.;Alkaline phosphatase. Timepoint: before intervention and after 12 weeks. Method of measurement: serum level.;Triglycerides. Timepoint: before intervention and after 12 weeks. Method of measurement: serum level.;Total cholesterol. Timepoint: before intervention and after 12 weeks. Method of measurement: serum level.;Low density lipoprotein (LDL). Timepoint: before intervention and after 12 weeks. Method of measurement: serum level.;High density lipoprotein (HDL). Timepoint: before intervention and after 12 weeks. Method of measurement: serum level.;Fasting blood sugar. Timepoint: before intervention and after 12 weeks. Method of measurement: serum level.;Fasting insulin. Timepoint: before intervention and after 12 weeks. Method of measurement: serum level.;Insulin resistance. Timepoint: before intervention and after 12 weeks. Method of measurement: 405÷(insulin×glucose)=HOMA-IR ; Homeostatic model assessment.;Adiponectin. Timepoint: before intervention and after 12 weeks. Method of measurement: serum level.;Fetuin A. Timepoint: before intervention and after 12 weeks. Method of measurement: serum level.;Fibroblast growth factor 21(FGF 21). Timepoint: before intervention and after 12 weeks. Method of measurement: serum level.;Total antioxidant capacity. Timepoint: before intervention and after 12 weeks. Method of measurement: serum level.;High sensitive C reactive protein (hs-CRP). Timepoint: before intervention and after 12 weeks. Method of measurement: serum level.;Interlukin-6(IL-6). Timepoint: before intervention and after 12 weeks. Method of measurement: serum level.;Weight. Timepoint: before intervention and after 12 weeks. Method | — |
Secondary
| Measure | Time frame |
|---|---|
| Systolic blood pressure. Timepoint: before intervention and after 12 weeks. Method of measurement: Blood pressure monitor.;Diastolic blood pressure. Timepoint: before intervention and after 12 weeks. Method of measurement: Blood pressure monitor. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSima Jafarirad
Ahvaz University of Medical Sciences
Outcome results
None listed