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IRCT2016030626941N1 IRCT 2016-04-19 Vice Chancellor for research of Ahvaz Jundishapur University of Medical Sciences Effect of green coffee bean extract supplementation on nonalcoholic fatty liver disease Supplementation effect of green coffee bean extract on lipid profile, inflammatory and oxidative stress biomarkers, insulin resistance and liver enzymes in overweight and obese patients with nonalcoholic fatty liver disease(NAFLD). 2016-03-24 anticipated 44 Complete https://irct.ir/trial/22204 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: participants will be randomly assigned to intervention or control group (1:1 ratio) based on the blocked randomization method. 3 Nonalcoholic Fatty Liver Disease. Intervention 1: Intervention group: All patients will receive 1g green coffee bean extract capsules once daily for 8 weeks. Intervention 2: Control group: All patients will receive 1g placebo capsules (Nokhodchi flour) once daily for 8 weeks.
public Hedayat allah shahmohammadi
Golestan Ave., Ahvaz, Paramedical School, Department of Nutrition, Ahvaz Jundishapur University of Medical Sciences
Ahvaz Iran (Islamic Republic of) +98 61 3333 3050 shahmohammadi.h@ajums.ac.ir Ahvaz Jundishapur University of Medical Sciences scientific Seyyed ahmad hosseini
Golestan Ave., Ahvaz, Paramedical School, Department of Nutrition, Ahvaz Jundishapur University of Medical Sciences
Ahvaz Iran (Islamic Republic of) +98 61 3333 3050 seyedahmadhosseini@yahoo.com Ahvaz Jundishapur University Of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Men or women aged between 20 to 70 years old who will be diagnosed with NAFLD by ultrasonography scan (with steatosis score equal or greater than 1) and increased levels of liver enzymes (serum levels of alanine aminotransferase and aspartate aminotransferase more than 40 U/L); and Body Mass Index (BMI) of them is grater than 24.9 and lower than 35. Exclusion criteria: Alcohol consumption; Pregnant and lactating women; Any known forms of hepatic or metabolic disease except NAFLD, such as hereditary hemochromatosis, Wilson’s disease, cirosis, diabetes and other metabolic disease; Any history of gastric bypass or intestine surgery; Taking hepatotoxic drugs such as calcium channel blocker, methotrexate, amiodarone, chloroquine and anti inflammatory drugs; Using nutrition supplements; Hormone Therapy; and Patients with a history of hypothyroidism, Cushing’s syndrome, renal failure, and kidney stones. 20 years 70 years Both K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Drugs Treatment - Drugs Intervention group: All patients will receive 1g green coffee bean extract capsules once daily for 8 weeks. Control group: All patients will receive 1g placebo capsules (Nokhodchi flour) once daily for 8 weeks. Liver steatosis index. Timepoint: Before and after intervention. Method of measurement: Sonography. Insulin Resistance (IR). Timepoint: Before and after intervention. Method of measurement: Based on HOMA IR equation. Liver enzymes (ALT, AST, ALP). Timepoint: Before and after intervention. Method of measurement: Microgram/ml - laboratory kit. Tomor necrosis factor alpha (TNF alpha). Timepoint: Before and after intervention. Method of measurement: ELISA. Serum Total Anti Oxidant Capacity (TAOC). Timepoint: Before and after intervention. Method of measurement: ELISA. High sensitive C reactive protein. Timepoint: Before and after intervention. Method of measurement: ELISA. Blood free fatty acids. Timepoint: Before and after intervention. Method of measurement: ELISA. Lipid profile (TG, LDL, HDL, Total cholestrol). Timepoint: Before and after intervention. Method of measurement: laboratory kit. Fasting Blood Sugar (FBS). Timepoint: Before and after intervention. Method of measurement: Colorimetric enzymatic method. Insulin. Timepoint: Before and after intervention. Method of measurement: ELISA. Waist to hip ratio. Timepoint: Before and after intervention. Method of measurement: Non-stretchable tape without any pressure. Body Mass Index (BMI). Timepoint: Before and after intervention. Method of measurement: Weight (kilograms) divided by the square of height (meters). Sistolic and diastolic blood pressure. Timepoint: Before and after intervention. Method of measurement: By mercury sphygmomanometer. Vice Chancellor for research of Ahvaz Jundishapur University of Medical Sciences Approved 2016-03-05 Ethics Committee of Ahvaz Jundishapur University Of Medical Sciences Golestan Ave., Ahvaz, Ahvaz Jundishapur University of Medical Sciences, Ethics Committee of Ahvaz Jundishapur University Of Medical Sciences Ahvaz Iran (Islamic Republic of)