Study Protocol for a Randomized Controlled Trial Evaluating the Effectof Chromium Picolinate Supplementation on Gene Expression of TumorNecrosis Factor-α and DNA Damage in Metabolic Syndrome Patients.
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| Abstract |
Metabolic syndrome (MS) is caused by environmental factors as well as genetic. Human studies of efficacy of chromium for glucose and lipid metabolism and insulin function is not still definitive. Furthermore, the effect of chromium supplementation on the expression of inflammatory genes in patients with MS has not been studied. We will assess effects of chromium picolinate supplementation on gene expression of tumor necrosis factor-α (TNF-α) and DNA damage in MS patients. In this triple-blind randomized placebo-controlled clinical trial, 48 MS patients will be randomly assigned into two groups to receive daily 400 μg chromium picolinate supplement or placebo for 12 weeks. The outcome measures include of change in fasting blood sugar, glycosylated hemoglobin A1C, inflammatory biomarkers, lipid profile, blood pressure, gene expression of TNF-α, and 8-hydroxy-deoxyguanosine concentration as DNA damage biomarker, will be quantified at baseline and end of intervention. This protocol was approved by Institutional Research Ethics Committee School of Public Health Shahid Sadoughi University of Medical Sciences (Approval ID: IR.SSU.SPH.REC.1399.141).
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| Authors | Hassan Mozaffari-Khosravi, Sara Jambarsan, Fazad Karimpour, Seyyed Ebrahim Hosseini, Behrooz Ebrahimzadeh Kour |
| Journal | Saudi journal of kidney diseases and transplantation : an official publication of the Saudi Center for Organ Transplantation, Saudi Arabia (Saudi J Kidney Dis Transpl) 2021 Nov-Dec Vol. 32 Issue 6 Pg. 1671-1678 ISSN: 1319-2442 [Print] Saudi Arabia |
| PMID | 35946280 (Publication Type: Clinical Trial Protocol, Journal Article) |
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