Clinical Trial Details

Trial ID: L0870
Source ID: IRCT201503273320N11
Associated Drug: Hydroxy citric Acid
Title: 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
Acronym: --
Status: Not Recruiting
Study Results: No Results Available
Results: --
Conditions: Non alcoholic fatty liver disease. <br>fatty (change) of liver,not elsewhere classified
Interventions: 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.
Outcome Measures: 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-1??). 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.
Sponsor/Collaborators: Tabriz University of Medical Sciences
Gender: Female
Age: 18 years50 years
Phases: Not applicable
Enrollment: 40
Study Type: interventional
Study Designs: 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 we
Start Date: 27/07/2015
Completion Date: --
Results First Posted: --
Last Update Posted: 18 June 2018
Locations: Iran (Islamic Republic of)
URL: http://en.irct.ir/trial/3407