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Study aim:
The effects of nanocurcumin supplementation on fibrosis، steatosis، Inflammatory and metabolic status of liver fibrosis patients with non-alcoholic fatty liver origin
Design:
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 50 patients. Blocked randomization will be used for randomization.
Settings and conduct:
50 patients will be selected among referring to Gastroenterology and endocrinology Clinic. At the beginning and end of the study (end of week 16), 14 ml of fasting blood samples will be taken. In this way, the appearance of the capsules will be the same and their packaging will be the same. Coding (A and B) will be done by someone outside the study. The given codes will be provided to the researchers after the statistical analysis of the data and when writing the article. At the beginning of the study and at the end of the fourth month, the liver fibrosis and steatosis will be determined by fibroscan, anthropometric factors including weight, height, waist circumference, body composition,and inflammatory, metabolic factors and blood pressure will be measured for all patients. Also, 3-day food recall questionnaire, physical activity questionnaire, and demographic information will be completed from the patients.
Participants/Inclusion and exclusion criteria:
Inclusion criteria:
patients between 30 and 70 years of age with liver fibrosis F≥2
exclusion criteria:
Alcohol addiction
Suffering from other chronic and acute liver disorders
Pregnancy or breastfeeding
current Lung and kidney disease and history of cancer
Drug abuse
Treatment with anti-inflammatory, hepatotoxic, corticosteroids and hormones medications
Use of weight loss medication or diets
current warfarin medications
Intervention groups:
1 capsule of 40 mg of nanocurcumin or 1 capsule of identical-looking placebo two times daily.
Main outcome variables:
liver fibrosis and steatosis