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Study aim
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The effect of pomegranate extract tablet on some of metabolic factor, hepatokines (fetuin A, FGF21), inflammatory biomarkers, anthropometric indices and grade of fatty liver in patients with non-alcoholic fatty Liver disease
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Design
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The present study is a simple randomized clinical trial on 50 subjects with nonalcholic fatty liver. In this study, individuals are divided into two groups of drugs and placebo. Randomization will done using quadratic block. Statistical software (Minitab) will use to perform randomized block.
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Settings and conduct
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A double blind randomized clinical trial.
Blinding on patients and researchers.
50 Patients with non alcoholic fatty liver into pomegranate extract tabley and placebo groups.
The period of intervention:12 weeks.
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Participants/Inclusion and exclusion criteria
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inclusion criteria:
Age 18 to 65 years,
Body mass index 29.4 to 40,
Presence of non-alcoholic steathepatitis in ultrasonography with degree of steatosis higher than grade 1,
Not having a special diet,
The liver enzyme concentration greater than 1.5 times the highest normal up to a 5 times more than normal.
Exclusion criteria:
History of hepatitis,
Other liver diseases,
Gastrointestinal diseases,
Cardiovascular Diseases,
Anemia,
Hospitalized patients,
Kidney diseases,
Endocrine disorders,
Alcohol drinking,
Smoking,
Taking any medicine, insulin, hepatic steatosis drugs,
Intravenous nutrition,
Special diets,
Taking vitamin supplements,
Pregnancy or breastfeeding,
Menopause.
Weight loss surgery in the last year.
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Intervention groups
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Group 1: pomegranate extract tablet; Group 2: placebo
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Main outcome variables
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Anthropometry indices, liver enzymes,
fasting blood sugar; fasting insulin; Insulin resistance;
adiponectin; fetuin A; fibroblast growth factor 21;
inflammation factors; blood pressure; degree of hepatic steatosis