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Study aim
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Determination of the effect of curcumin-piperine supplementation on cardiometabolic factors, hepatic steatosis and fibrosis of fibroscan results and liver function in patients with non-alcoholic fatty liver disease
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Design
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This is a randomized, placebo-controlled, double-blind parallel-group clinical trial. Sixty participants will randomly allocated to receive curcumin-piperine supplement per day (n = 30) or placebo (n = 30).
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Settings and conduct
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In this study, patients with NAFLD will recruited from Imam Musa Sadr Clinic , Isfahan, Iran. Subjects will stratified according to gender. Random assignment will done by the use of table of random numbers. The enrolling participants, and assigning participants to the groups will carried out by a trained nutritionist.The curcumin-piperine supplement and its placebos will be packed in similar boxes, and the researcher and the patients will not be aware of the content of the pack until the end of the study.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Tendency to participate in the study; People aged 18-65 years; Patients with Non-alcoholic fatty liver (grade 3-1) diagnosed by ultrasound
Exclusion criteria: Pregnancy and lactation; Patients with Alcoholic Fatty Liver; Smoking; People with heart , pulmonary and kidney diseases, hepatitis, cirrhosis, biliary and immune disorders, hypertension, diabetes, hypothyroidism and Cushing's syndrome; Consumption of lipid and glucose lowering medicine, Vitamin E, Vitamin D, Orsodeoxycholic acid, Phenytoin, Tamoxifen, Lithium, Corticosteroids and Methotrexate; Weight loss and bariatric surgery in the last year
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Intervention groups
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Individuals will randomly assigned to two groups to receive 500 mg/day curcumin-piperine supplement or placebo for 12 weeks.
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Main outcome variables
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TG; TC; HDL; LDL; Weight; BMI; Waist circumference; FBS; ALT; AST; Hepatic steatosis and fibrosis