Clinical Trial Details

Trial ID: L0512
Source ID: IRCT20100123003140N15
Associated Drug: Chromium picolinate
Title: The effect of oral Chromium picolinate supplementation on Liver Function, Oxidative Indicators, Leptin, Resisten, lipid profile, Blood Glucose Control Indicators, serum levels of Fetuin A and inflammatory factors in Non-Alcoholic Fatty Liver
Acronym: --
Status: Recruiting
Study Results: No Results Available
Results: --
Conditions: Non-alcoholic fatty liver. <br>Fatty (change of) liver, not elsewhere classified;Fatty (change of) liver, not elsewhere classified
Interventions: Intervention 1: patients with NAFLD receiving 2 tablets of 200 microgram of chromium picolinate per day for 3 months. Delivery of medication to patients will be done every two weeks and it will be monitored during use by the phone for possible complicat
Outcome Measures: LDL. Timepoint: First and three months after the start of the study. Method of measurement: Enzyme colorimetry.;HDL. Timepoint: First and three months after the start of the study. Method of measurement: Enzyme colorimetry.;TNF-a. Timepoint: First and three months after the start of the study. Method of measurement: ELISA Kit.Plasma Atherogen Index. Timepoint: Study beginning and 90 days after the start. Method of measurement: Triglyceride logarithmic formulation divided by high density lipoprotein.;BMI. Timepoint: First and six weeks after study. Method of measurement: Weight divided by second power of height.;Dietary intakes. Timepoint: First and 6 weeks after the start. Method of measurement: 24-hour dietary recall inventory questionnaire.;Psychological stress. Timepoint: First and six weeks after the start of the study. Method of measurement: Holmes-and rahe scales questionnaire.;Insulin resistance index. Timepoint: First and three months after the study??. Method of measurement: Calculate Homeostatic model assessment.;The amount of physical activity. Timepoint: First and 6 weeks after study. Method of measurement: The International Physical Activity Questionnaire.;Waist circumference. Timepoint: First and Sixth Week. Method of measurement: measurement.;Boddy fat mass. Timepoint: First and Sixth Week. Method of measurement: Bioelectrical impedance analysis.;Blood pressure. Timepoint: Frist and sixth week. Method of measurement: Digital monometer.;Chromium levels of blood. Timepoint: First and 3 months later study. Method of measurement: Spectrophotometry.;SOD. Timepoint: First and three months after the start of the study. Method of measurement: Biochemical kit.;ALP. Timepoint: First and three months after the start of the study. Method of measurement: Biochemical kit.;AST. Timepoint: First and three months after the start of the study. Method of measurement: Biochemical kit.;Resistin. Timepoint: First and three months after the start of the study. Method of measurement: ELISA Kit.;Leptin. Timepoint: First and three months after the start of the study. Method of measurement: ELISA Kit.;MAD. Timepoint: First and three months after the start of the study. Method of measurement: Biochemical kit.;GPX. Timepoint: First and three months after the start of the study. Method of measurement: Biochemical kit.;ALT. Timepoint: First and three months after the start of the study. Method of measurement: Biochemical kit.;IL-17. Timepoint: First and three months after the start of the study. Method of measurement: ELISA kit.;Hs-CRP. Timepoint: First and three months after the start of the study. Method of measurement: ELISA Kit.;Concentration of Fetuin A. Timepoint: First and three months after the start of the study. Method of measurement: ELISA Kit.;Serum insulin concentration. Timepoint: First and three months after the start of the study. Method of measurement: ELISA Kit.;HbA1c. Timepoint: First and three months after the start of the study. Method of measurement: ELISA Kit.;TG. Timepoint: First and three months after the start of the study. Method of measurement: Enzyme colorimetry.;TC. Timepoint: First and three months after the start of the study. Method of measurement: Enzyme colorimetry.;Fasting blood sugar. Timepoint: First and three months after the start of the study. Method of measurement: Enzyme colorimetry.
Sponsor/Collaborators: Tabriz University of Medical Sciences
Gender: All
Age: 20 years50 years
Phases: Phase 2/Phase 3
Enrollment: 46
Study Type: interventional
Study Designs: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples were randomly assigned to either one of the two groups of chromium picolinate or placebo using RAS software, B
Start Date: 14/01/2018
Completion Date: --
Results First Posted: --
Last Update Posted: 22 February 2018
Locations: Iran (Islamic Republic of)
URL: http://en.irct.ir/trial/3187