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IRCT20200919048757N1 IRCT 2020-10-18 Yazd University of Medical Sciences effects of chromium picolinate in metabolic syndrome Effects of Chromium Picolinate on Glycemic Index,Lipid Profile ،Gene Expression of Inflammatory Biomarkers and DNA damage in Metabolic Syndrome Patients 2020-11-10 anticipated 48 Complete https://irct.ir/trial/51038 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In the first stage, from registered information of people in the Sisakht cityAdult Cohort Center,all eligible persons will be listed and numbered .Then,48 patients will be randomly selected using Random Numbers Generator software. In the next step, based on above mentioned software as a random sequencing tool, patients will be divided into two intervention groups A ( intervention) and B ( placebo), Blinding description: Patients participating in the study, laboratory technician , statistical analyst and researcher will not be aware from patient grouping until the end of the study and only a trusted health expert who has no involvement in the process of study will be informed. The tablets received by both groups will be the same in terms of color, smell and appearance . The label of the boxes containing the tablets will be removed and only will be marked with a special code . 3 metabolic syndrome. Intervention 1: Intervention group:daily intake of 400µg of trivalent chromium picolinate tablets (21 st CENTURY, US company) for 12 weeks. Intervention 2: Control group: daily intake of matched placebo tablet made by Barij Essential Oil Company for 12 weeks. Yes - There is a plan to make this available What will be shared: data related to anthropometric and biochemical data and the extent of their changes When: 6 months after the publication of the main article To whom: Researchers working in academic and scientific institutions andworking in industry Conditions: Statistical analysis is allowed provided the source of the data is mentioned and with the permission of the authors of the article Where to obtain: behrooz ebrahimzadeh koor(Yasuj University of medical sciences) hasan mozaffari (Yazd University of medical sciences) How to obtain: email and postal letter Comments:
public Behrooz Ebrahimzadehkoor
Shahid Motahhari Blvd,Jehad Keshavarzi Sq, Yasouj University of medical sciences
Yasouj Iran (Islamic Republic of) 7591741417 009833346074 ebrahimzadeh1358@gmail.com Yasouj University of Medical Sciences scientific Behrooz Ebrahimzadeh koor
Shohadaye Gomnam Blvd, Jehad Keshavarzi Sq, Yasuj University of Medical Sciences
Yasouj Iran (Islamic Republic of) 7591741417 +98 74 3334 6074 ebrahimzadeh1358@gmail.com Yasouj University of Medical Sciences Iran (Islamic Republic of) Metabolic syndrome characterized by"at least three of the five conditions: - waist circumference ≥94 cm - systolic blood pressure and diastolic greater than or equal to 130 and 85 mm Hg respectively or blood pressure lowering medication use - Fasting Blood Sugar≥ 100 mg / dl or hypoglycemic drugs use - Blood triglycerides ≥150 mg / dl or lipid-lowering drugs use - HDL<50mg/dl in women and less than 40 mg/ dl in Men" 20 years 60 years Both take any multivitamins or dietary supplements or medications Pregnancy or lactation uncontrolled hypertension or hyperglycemia chronic obstructive pulmonary disease heart arrhythmias stroke any other disease that requires medical treatment E88.81 Metabolic syndrome Prevention Placebo Intervention group:daily intake of 400µg of trivalent chromium picolinate tablets (21 st CENTURY, US company) for 12 weeks Control group: daily intake of matched placebo tablet made by Barij Essential Oil Company for 12 weeks Glycemic Index(Fasting Blood Sugar, Glycosylated Hemoglobin). Timepoint: Beginning of the study and at the end of the study (end of the fourth month). Method of measurement: enzymatic colorimetric method. Lipid Profile(TG, TC, LDL ,HDL). Timepoint: Beginning of the study and at the end of the study (end of the fourth month). Method of measurement: enzymatic colorimetric method. DNA damage(hydroxy-deoxyguanosine). Timepoint: Beginning of the study and at the end of the study (end of the fourth month). Method of measurement: Enzyme Linked Immunosorbent Assay (ELISA). Interleukin-1. Timepoint: Beginning of the study and at the end of the study (end of the fourth month). Method of measurement: Enzyme Linked Immunosorbent Assay (ELISA). Interleukin-6. Timepoint: Beginning of the study and at the end of the study (end of the fourth month). Method of measurement: Enzyme Linked Immunosorbent Assay (ELISA). Tumor Necrosing Factor-α. Timepoint: Beginning of the study and at the end of the study (end of the fourth month). Method of measurement: Enzyme Linked Immunosorbent Assay (ELISA). Gene Expression of Inflammatory Biomarkers (Tumor Necrosing Factor-α). Timepoint: Beginning of the study and at the end of the study (end of the fourth month). Method of measurement: reverse transcription polymerase chain (RT-PCR). Weight. Timepoint: The beginning of the study and the end of the fourth month. Method of measurement: standard scale. Waist circumference. Timepoint: The beginning of the study and the end of the fourth month. Method of measurement: non-stretching tape. Blood pressure. Timepoint: The beginning of the study and the end of the fourth month. Method of measurement: Blood pressure monitor. Yazd University of Medical Sciences Approved 2020-09-09 institutional research ethics committe of school of public health-Shahid sdoughi university of medic N.887, Shohadaye Gomnam Blvd, Alem Sq. Pardis oloompezeshki- school of public health Yazd Yazd Iran (Islamic Republic of)