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IRCT201503273320N11 IRCT 2015-07-27 Tabriz University of Medical Sciences The effect of Hydroxy citric acid on non alcoholic fatty liver disease The effect of weight loss diet with and without Hydroxy citric Acid supplement derived from Garcinia Cambogia on the serum hepcidin level and liver function in women with NAFLD: A randomized controlled clinical trial 2015-08-01 anticipated 40 Complete https://irct.ir/trial/3407 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: From among the patients who volunteer to participate in the study, 40 individuals will be selected by 4-blocks were randomly dهvided in 2 groups ( intervention and control) , Blinding description: In this study, the main investigators (including the student, and her supervisor and adviser professors) as well as the patients will be blinded to the type of the supplement (HCA) received by each group. N/A Non alcoholic fatty liver disease. Intervention 1: intervention group: weight loss diet plus 6 tablets (2 tablets 30 minutes before: breakfast- lunch - dinner) for 2 months. Intervention 2: control group: just get weight loss diet for 2 months. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Dr. Mehrangiz Ebrahimimamagani
Golgasht street ,Attar neyshaburi street, nutriton faculty
Tabriz Iran (Islamic Republic of) 5185747731 +98 41 3334 1113 ebrahimimamagani@tbzmed.ac.ir Nutrition faculty,Tabriz university of medical science scientific Dr. Mehrangiz Ebrahimimamagani
Golgasht street,Attar neyshabori street,Tabriz university of medical science,Nutrition faculty
Tabriz Iran (Islamic Republic of) 5185747731 +98 41 3334 1113 ebrahimimamagani@tbzmed.ac.ir Tabriz university of medical science- nutrition faculty Iran (Islamic Republic of) non-menopausal women with Non Alcoholic Fatty Liver Dieases 18-50 years BMI=27/5-40 kg/m2 moderate activity level 18 years 50 years Female pregnancy or lactation alcohol consumption smoking anemia or thalassemia other metabolic disorders K76.0 fatty (change) of liver,not elsewhere classified Treatment - Drugs Lifestyle intervention group: weight loss diet plus 6 tablets (2 tablets 30 minutes before: breakfast- lunch - dinner) for 2 months control group: just get weight loss diet for 2 months Serum level of hepcidin. Timepoint: at baseline,at the end of intervention. Method of measurement: ELIZA Kit. Liver enzymes( ALT,AST,ALP). Timepoint: at baseline,at the end of intervention. Method of measurement: IFCC. Liver steatosis. Timepoint: at baseline,at the end of intervention. Method of measurement: liver sonography. Added at 2017-02-13: high sensivity-C Reactive Protein. Timepoint: Added at 2017-02-13: At the baseline and at the end of intervention. Method of measurement: Added at 2017-02-13: immunoturbidometric. Added at 2017-02-13: Fasting blood sugar. Timepoint: Added at 2017-02-13: At the baseline and at the end of intervention. Method of measurement: Added at 2017-02-13: Radioimmunoassay. Added at 2017-02-13: Fasting insulin. Timepoint: Added at 2017-02-13: At the baseline and at the end of intervention. Method of measurement: Added at 2017-02-13: Radioimmunoassay. Fasting ferritin. Timepoint: At the baseline and at the end of intervention. Method of measurement: ELIZA Kit. Glycated Hemoglobin. Timepoint: At the baseline and at the end of intervention. Method of measurement: High Performance Liquid Chromatography (HPLC). Leptin. Timepoint: At the baseline and at the end of intervention. Method of measurement: ELIZA Kit. Adiponectin. Timepoint: At the baseline and at the end of intervention. Method of measurement: ELIZA Kit. Lipid profile ( HDL-C, TG,TC). Timepoint: At the baseline and at the end of intervention. Method of measurement: Enzymetic. Interleukin-1 beta (IL-1β). Timepoint: At the baseline and at the end of intervention. Method of measurement: ELIZA Kit. Interleukin- 6. Timepoint: At the baseline and at the end of intervention. Method of measurement: ELIZA Kit. Tumor Necrosis Factor (TNF-a). Timepoint: At the baseline and at the end of intervention. Method of measurement: ELIZA Kit. Anthropometry. Timepoint: at baseline and at the end of intervention. Method of measurement: scale,meter,bioelectrical impedance analyzer. Energy and nutrients intake. Timepoint: at baseline and at the end of intervention. Method of measurement: 24- hour dietary recall. Tabriz University of Medical Sciences Approved 2015-07-06 Ethics committee of Tabriz university of medical sciences Golgasht street , Tabriz Tariz East Azarbaijan Iran (Islamic Republic of)